list of registred drugs in armenia (up to 31.12.2017) · greece r05cb06 15404 09.03.2016 09.03.2021...
TRANSCRIPT
N Trade name
International
nonproprietary
name (generic) or
active ingredients
name
Drug form Dose and packaging Manufacturer Country ATC1 codeRegistration
number
Term of
registration
Legal status for
supplyLicense holder
1 Abaktal
pefloxacin
(pefloxacin
mesylate dihydrate)
tablets film-coated400mg,
in blister (10/1x10/)
Lek Pharmaceuticals
d.d., Verovskova Str.
57, 1526 Ljubljana
Slovenia J01MA03 1430810.03.2015
10.03.2020PoM2
Lek Pharmaceuticals
d.d., Verovskova Str.
57, 1526 Ljubljana,
Slovenia
2 Abasaglar insulin glargine solution for injection100IU/ml,
3ml cartridges (5)
Lilly France S.A.S.,
Zone Industrielle, 2
rue du Colonel Lilly,
67640 Fegersheim
France A10AE04 1653517.03.2017
17.03.2022PoM
Eli Lilly Regional
Operations GmbH.,
Koelblgasse 8-10,
1030, Vienna, Austria
3 Abrobion
ambroxol
(ambroxol
hydrochloride)
syrup6mg/ml,
125ml glass bottle
Help S.A. Pedini,
Ioanninon, Ioannina,
45500
Greece R05CB06 1540409.03.2016
09.03.2021OTC3
Help S.A ,10
Valaoritou str., GR
144 52,
Metamorphosis,
Attika, Greece
4 ACC acetylcysteine
powder for oral
solution with orange
flavour
100mg/5ml,
30g powder in 75ml glass
bottle and measuring
spoon 5ml, 60g powder in
150ml glass bottle and
measuring spoon 5ml
Salutas Pharma
GmbH, Otto-von-
Guericke-Alle-1,
39179 Barleben-batch
releaser, Allphamed
Pharbil Arzneimittel
GmbH Hildebrandstr.
12, 37081 Gottingen,
Germany-bulk
manufacturer,
packager
Germany R05CB01 1494720.10.2015
20.10.2020OTC
Sandoz
Pharmaceuticals d.d.,
Verovskova Str. 57,
1000 Ljubljana,
Slovenia
LIST OF REGISTRED DRUGS IN ARMENIA
(Up to 31.12.2017)
1
5 ACC 100 acetylcysteine tablets effervescent100mg,
in plastic container (20)
Salutas Pharma
GmbH, Otto-von-
Guericke-Alle-1,
39179 Barleben -
batch releaser
(Hermes Pharma
G.m.b.H., Allgau 36,
A-9400 Wolsberg,
Germany - bulk
manufacturer,
packager)
Germany R05CB01 1396721.11.2014
21.11.2019OTC
Sandoz
Pharmaceuticals d.d.,
Verovskova Str. 57,
1526 Ljubljana,
Slovenia
6 ACC 100 acetylcysteinepowder for oral
solution
100mg,
3g sachets (20)
Salutas Pharma
GmbH, Otto-von-
Guericke-Alle-1,
39179 Barleben-batch
releaser, Lindopharm
GmbH, Neustrasse 82,
D-40721 Hilden,
Germany- bulk
manufacturer,
packager
Germany R05CB01 1443014.04.2015
14.04.2020OTC
Sandoz
Pharmaceuticals d.d.,
Verovskova Str. 57,
1000 Ljubljana,
Slovenia
7 ACC 200 acetylcysteine tablets effervescent200mg,
in plastic container (20)
Salutas Pharma
GmbH, Otto-von-
Guericke-Alle-1,
39179 Barleben -
batch releaser
(Hermes Pharma
G.m.b.H., Allgau 36,
A-9400 Wolsberg,
Germany - bulk
manufacturer,
packager)
Germany R05CB01 1396821.11.2014
21.11.2019OTC
Sandoz
Pharmaceuticals d.d.,
Verovskova Str. 57,
1526 Ljubljana,
Slovenia
2
8 ACC 200 acetylcysteinepowder for oral
solution
200mg,
3g sachets (20)
Salutas Pharma
GmbH, Otto-von-
Guericke-Alle-1,
39179 Barleben-batch
releaser, Lindopharm
GmbH, Neustrasse 82,
D-40721 Hilden,
Germany- bulk
manufacturer,
packager
Germany R05CB01 1443114.04.2015
14.04.2020OTC
Sandoz
Pharmaceuticals d.d.,
Verovskova Str. 57,
1000 Ljubljana,
Slovenia
9 ACC Hot Drink acetylcysteinepowder for oral
solution
200mg,
3g sachets (20)
Salutas Pharma
GmbH, Otto-von-
Guericke-Alle-1,
39179 Barleben-batch
releaser, Lindopharm
GmbH, Neustrasse 82,
D-40721 Hilden,
Germany- bulk
manufacturer,
packager
Germany R05CB01 1436725.03.2015
25.03.2020OTC
Sandoz
Pharmaceuticals d.d.,
Verovskova Str. 57,
1000 Ljubljana,
Slovenia
10 ACC Long acetylcysteine tablets effervescent600mg,
in plastic container (10)
Salutas Pharma
GmbH, Otto-von-
Guericke-Alle-1,
39179 Barleben-batch
releaser, Hermes
Arzneimittel GmbH,
Hans-Urmiler Ring
52, Wolfratshausen,
Germany-packager,
bulk manufacturer
Germany R05CB01 1436225.03.2015
25.03.2020OTC
Sandoz
Pharmaceuticals d.d.,
Verovskova Str. 57,
1000 Ljubljana,
Slovenia
3
11Aceclofenac 100mg
film-coated Tabletsaceclofenac tablets fim-coated
100mg,
in blister (60/6x10/)
Accord Healthcare
Limited, Sage House,319
Pinner Road, North
Harrow, Middlesex, HA1
4HF- batch releaser, Intas
Pharmaceuticals Limited,
Plot No 457 & 458 &
191/218 P, Sarkhej-Bavla
Highway, Matoda Village,
Sanand, District-
Ahmedabad, 382 210,
Gujarat, India- bulk
manufacturer, Accord
Healthcare Limited, Unit C
& D, Homefield Business
Park, Homefield Road,
Haverhill, CB9 8QP, UK-
primary and secondary
packager
UK M01AB16 1485515.09.2015
15.09.2020PoM
Accord Healthcare
Limited, Sage
House,319 Pinner
Road, North Harrow,
Middlesex, HA1 4HF,
UK
12 Acellbia rituximabconcentrate for
solution for infusion
10mg/ml,
50ml glass vial
BIOCAD CJSC,
Petrovo-Dalnee,
Krasnogorsky district,
Moscow Region,
143422
Russia L01XC02 1642010.02.2017
10.02.2022PoM
BIOCAD CJSC, 34
bld., lit. A, Svyazi
st.,Strelna,
Petrodvortsoviy
district, Saint
Petersburg, 198515,
Russia
13 Acellbia rituximabconcentrate for
solution for infusion
10mg/ml,
10ml glass vial, in blister
(2/1x2/)
BIOCAD CJSC,
Petrovo-Dalnee,
Krasnogorsky district,
Moscow Region,
143422
Russia L01XC02 1642110.02.2017
10.02.2022PoM
BIOCAD CJSC, 34
bld., lit. A, Svyazi
st.,Strelna,
Petrodvortsoviy
district, Saint
Petersburg, 198515,
Russia
14 Acetylsalicylic acid acetylsalicylic acid tablets500mg,
in blister (10)
Technolog PJSC,
Manuylskogo str. 8,
20300 Uman,
Cherkassy region
Ukraine N02BA01 1233409.04.2013
09.04.2018OTC
Technolog PJSC,
Manuylskogo str. 8,
20300 Uman,
Cherkassy region,
UKRAINE
4
15 Acetylsalicylic acid acetylsalicylic acid tablets
500mg,
in blister
(10, 20/2x10/)
Pharmstandard-
Leksredstva OJSC,
305022, Kursk,
Agregatnaya 2nd str.,
1a/18
Russia N02BA01 1278214.08.2013
14.08.2018OTC
Pharmstandard-
Leksredstva OJSC,
305022, Kursk,
Agregatnaya 2nd str.,
1a/18, Russia
16 Acetylsalicylic acid acetylsalicylic acid tablets500mg,
in blister (10)
Irbitskiy
himfarmzavod JSC,
643 RU, Irbit, St.
Sverdlovsk, K. Marksa
str., 124
Russia N02BA01 1308709.12.2013
09.12.2018OTC
Irbitskiy
himfarmzavod JSC,
643 RU, Irbit, St.
Sverdlovsk, Kirova
str., 172, Russia
17 Acetylsalicylic acid acetylsalicylic acid tablets500mg,
in blister (10/1x10/)
Arpimed LLC, Kotayk
Marz, Abovyan, 2nd
Micro-District, 19
Building
Republic of
ArmeniaN02BA01 13969
21.11.2014
21.11.2019OTC
Arpimed LLC,
Kotayk Marz,
Abovyan, 2nd Micro-
District, 19 Building,
Republic of Armenia
18 Acetylsalicylic acid acetylsalicylic acid tablets
500mg,
in strip (10/1x10/,
3900/390x10/)
Open joint stock
company "Borisovskiy
zavod medicinskikh
preparatov" 64, ul.
Chapaeva, Borisov
222518, Minsk region
Belarus N02BA01 16730/104.07.2017
05.06.2022OTC
Open joint stock
company "Borisovskiy
zavod medicinskikh
preparatov" 64, ul.
Chapaeva, Borisov
222518, Minsk
region, Belarus
19 Acic aciclovir cream50mg/g,
2g aluminium tube
Salutas Pharma
GmbH, Lange
Goehren 3, 39171
Osterweddingen
Germany D06BB03 1458908.06.2015
08.06.2020OTC
Hexal AG,
Industriestrasse 25, D-
83607 Holzkirchen,
Germany
20 Aciclovir aciclovir cream50mg/g,
2g, 10g aluminium tube
Farmaprim SRL,
Crinilor str., 5,
Porumbeni, Criuleni
dis., MD-4829
Moldova D06BB03 1346206.05.2014
06.05.2019OTC
Farmaprim SRL,
Crinilor str., 5,
Porumbeni, Criuleni
dis., MD-4829,
Moldova
5
21 Aciclovir ointment aciclovirointment for
external use
50mg/g,
5g aluminium tube
Belmedpreparaty
RUE, 220007, Minsk,
Fabritsius St., 30
Belarus D06BB03 1301825.11.2013
25.11.2018OTC
Belmedpreparaty
RUE, 220007, Minsk,
Fabritsius St., 30,
Belarus
22 Aciclovir-Akri aciclovir tablets200mg,
in blister (20/2x10/)
Akrikhin
Pharmaceuticals Co.,
142450, Moscow
region, Noginsk
district, Staraya
Kupavna, Kirova
street 29
Russia J05AB01 1441408.04.2015
08.04.2020PoM
Akrikhin
Pharmaceuticals Co.,
142450, Moscow
region, Noginsk
district, Staraya
Kupavna, Kirova
street 29, Russia
23 Aciclovir-Akri aciclovir tablets400mg,
in blister (20/2x10/)
Akrikhin
Pharmaceuticals Co.,
142450, Moscow
region, Noginsk
district, Staraya
Kupavna, Kirova
street 29
Russia J05AB01 1441508.04.2015
08.04.2020PoM
Akrikhin
Pharmaceuticals Co.,
142450, Moscow
region, Noginsk
district, Staraya
Kupavna, Kirova
street 29, Russia
24 Aciclovir-Akri aciclovir ointment50mg/g,
5g aluminium tube
Akrikhin
Pharmaceuticals Co.,
142450, Moscow
region, Noginsk
district, Staraya
Kupavna, Kirova
street 29
Russia D06BB03 1441608.04.2015
08.04.2020OTC
Akrikhin
Pharmaceuticals Co.,
142450, Moscow
region, Noginsk
district, Staraya
Kupavna, Kirova
street 29, Russia
25 Aciclovir-Belmed aciclovir tablets
200mg,
in blister (10/1x10/,
20/2x10/),
in strip (10/1x10/,
20/2x10/)
Belmedpreparaty
RUE (220007, Minsk,
Fabritsius St., 30)
Belarus J05AB01 1291407.10.2013
07.10.2018PoM
Belmedpreparaty
RUE (220007, Minsk,
Fabritsius St., 30,
Belarus)
26Acidum
aminocapronicumaminocaproic acid solution for infusion
50mg/ml,
100ml plastic pack
Liqvor CJSC, 0089,
Yerevan, str.
Kochinyan, 7/9
Republic of
ArmeniaB02AA01 17095
23.10.2017
23.10.2022PoM
Liqvor CJSC, 0089,
Yerevan, str.
Kochinyan, 7/9,
Republic of Armenia
6
27 Aclasta zoledronic acid solution for infusion0,05mg/ml,
100ml plastic vial
Novartis Pharma
Stein AG
(Schaffhauserstrasse,
4332 Stein)
Switzerland M05BA08 1290707.10.2013
07.10.2018PoM
Novartis Pharma AG
(Switzerland 56,
Lichtstrasse, 4056
Basel, Switzerland)
28Acnamino MR
100mg Capsules
minocycline
(minocycline
hydrochloride)
capsules hard100mg,
in blister (56/8x7/)
Dexcel-Pharma Ltd.,
7 Sopwith Way,
Drayton Fields
Industrial Estate,
Daventry,
Northamptonshire,
NN11 8PB - batch
releaser (dosage form
manufacturer,
packager - Dexcel
Ltd, PO Box 50, Or
Akiva, IL-30600,
Israel)
UK J01AA08 1274926.07.2013
26.07.2018PoM
Dexcel-Pharma Ltd.,
7 Sopwith Way,
Drayton Fields
Industrial Estate,
Daventry,
Northamptonshire,
NN11 8PB, UK
29 Acne Wash salicylic acid soap liquid20mg/ml,
100ml plastic container
Arpimed LLC, Kotayk
Marz, Abovyan, 2nd
Micro-District, 19
Building
Republic of
ArmeniaD02AF 13863
18.09.2014
18.09.2019OTC
Arpimed LLC,
Kotayk Marz,
Abovyan, 2nd Micro-
District, 19 Building,
Republic of Armenia
30 A-cnotren isotretinoin capsules soft10mg,
in blister (30/3x10/)
Pharmathen
International S.A.,
Industrial Park Sapes,
Rodopi Prefecture,
Block No 5, Rodopi
69300-batch releaser,
packager, G.A.
Pharmaceuticals S.A.,
(GAP S.A), 46,
Agisilaou str., Agios
Dimitrios Attiki,
17341, Greece-bulk
manufacturer
Greece D10BA01 1494020.10.2015
20.10.2020PoM
Pharmathen S.A.,
Dervenakion 6, 15351
Pallini, Attiki, Greece
7
31 Acorta
rosuvastatin
(rosuvastatin
calcium)
tablets film-coated
10mg,
in blister (10/1x10/,
20/2x10/, 30/3x10/)
Pharmstandard-
Tomskhimpharm
OJSC, 634009, Tomsk,
Lenina str., 211
Russia C10AA07 1380505.09.2014
05.09.2019PoM
Pharmstandard-
Tomskhimpharm
OJSC, 634009, Tomsk,
Lenina str., 211,
Russia
32 Acorta
rosuvastatin
(rosuvastatin
calcium)
tablets film-coated
20mg,
in blister (10/1x10/,
20/2x10/, 30/3x10/)
Pharmstandard-
Tomskhimpharm
OJSC, 634009, Tomsk,
Lenina str., 211
Russia C10AA07 1380605.09.2014
05.09.2019PoM
Pharmstandard-
Tomskhimpharm
OJSC, 634009, Tomsk,
Lenina str., 211,
Russia
33 Actemra tocilizumab
concentrate for
solution for i/v
infusion
20mg/ml,
10ml glass vial (1)
F. Hoffmann-La
Roche Ltd.,
Grenzacherstrasse
124, 4070 Basel -
batch releaser (Chugai
Pharma
Manufacturing Co.,
Ltd., 16-3 Kiyohara
Kogyodanchi,Utsuno
miya-city, Tochigi,
321-3231, Japan -
bulk manufacturer,
primary packager),
(F.Hoffmann-La
Roche Ltd.,
Wurmisweg, 4303
Kaiseraugst,
Switzerland -
secondary packager)
Switzerland L04AC07 1376405.09.2014
05.09.2019PoM
F. Hoffmann-La
Roche Ltd.,
Grenzacherstrasse
124, 4070 Basel,
Switzerland
8
34 Actemra tocilizumab
concentrate for
solution for i/v
infusion
20mg/ml,
4ml glass vial (1)
F. Hoffmann-La
Roche Ltd.,
Grenzacherstrasse
124, 4070 Basel -
batch releaser (Chugai
Pharma
Manufacturing Co.,
Ltd., 16-3 Kiyohara
Kogyodanchi,Utsuno
miya-city,Tochigi,
321-3231, Japan -
bulk manufacturer,
primary packager),
(F.Hoffmann-La
Roche Ltd.,
Wurmisweg, 4303
Kaiseraugst,
Switzerland -
secondary packager)
Switzerland L04AC07 1376505.09.2014
05.09.2019PoM
F. Hoffmann-La
Roche Ltd.,
Grenzacherstrasse
124, 4070 Basel,
Switzerland
35 Activated charcoal activated charcoal tablets250mg,
in strip (10)
Irbitskiy
himfarmzavod JSC,
643 RU, Irbit, St.
Sverdlovsk, K. Marksa
str., 124
Russia A07BA01 1500902.12.2015
02.12.2020OTC
Irbitskiy
himfarmzavod JSC,
643 RU, Irbit, St.
Sverdlovsk, Kirova
str., 172, Russia
36 Actovegin
deproteinised
haemoderivate of
calf blood
solution for injection40mg/ml,
5ml ampoules (5)
Takeda Austria
GmbH, St. Peter
strasse 25, A-4020
Linz
Austria B06AB 13906/128.06.2016
17.10.2019PoM
Takeda
Pharmaceuticals LLC,
Usatcheva str 2 bld. 1,
Moscow 119048,
Russia
37 Actovegin
deproteinised
haemoderivate of
calf blood
solution for injection40mg/ml,
10ml ampoules (5)
Takeda Austria
GmbH, St. Peter
strasse 25, A-4020
Linz
Austria B06AB 13907/128.06.2016
17.10.2019PoM
Takeda
Pharmaceuticals LLC,
Usatcheva str 2 bld. 1,
Moscow 119048,
Russia
9
38 Actovegin
deproteinised
haemoderivate of
calf blood
tablets coated200mg,
in glass container (50)
Takeda GmbH,
Betriebsstatte
Oranienburg,
Lehnitzstrasse 70-98,
16515 Oranienburg
Germany B06AB 1599015.09.2016
15.09.2021PoM
Takeda
Pharmaceuticals LLC,
Usacheva str 2, bld. 1,
Moscow 119048,
Russia
39 Actovegin
deproteinised
haemoderivate of
calf blood
solution for injection
40mg/ml,
2ml ampoules,
in blister (25/5x5/)
Takeda Austria
GmbH, St. Peter
strasse 25, A-4020
Linz
Austria B06AB 1599415.09.2016
15.09.2021PoM
Takeda
Pharmaceuticals LLC,
Usacheva str 2, bld. 1,
Moscow 119048,
Russia
40 Actrapidinsulin human
(recombinant DNA)solution for injection
100IU/ml,
10ml glass vial (1)
Novo Nordisk A/S,
Novo Alle, DK-2880
Bagsvaerd
Denmark A10AB01 1369924.07.2014
24.07.2019PoM
Novo Nordisk A/S,
Novo Alle, DK-2880
Bagsvaerd, Denmark
41 Actrapid Penfill insulin human solution for injection100IU/ml,
3ml glass cartridges (5)
Novo Nordisk A/S,
Novo Alle, DK-2880
Bagsvaerd
Denmark A10AB01 13509/102.07.2014
30.05.2019PoM
Novo Nordisk A/S,
Novo Alle, DK-2880
Bagsvaerd, Denmark
42 Acupannefopam (nefopam
hydrochloride)solution for injection
10mg/ml,
2ml ampoules (5)
Biocodex
(1 avenue Blaise
Pascal, 60000
Beauvais)
France N02BG06 1299628.10.2013
28.10.2018PoM
Biocodex
(7 avenue Gallieni
94250 Gentilly,
France)
43 Acurmil 50mg/5ml
atracurium
(atracurium
besylate)
solution for i/v
infusion
10mg/ml,
5ml ampoules (5)
Laboratorio Italiano
Biochimico
Farmaceutico
Lisapharma S.p.A.,
Via Licinio, 11-22036
Erba (CO)
Italy M03AC04 1528704.02.2016
04.02.2021PoM
Laboratorio Italiano
Biochimico
Farmaceutico
Lisapharma S.p.A.,
Via Licinio, 11-22036
Erba (CO), Italy
44 Acyclovir aciclovir ointment50mg/g,
10g aluminium tube
Tatchempharmprepar
aty JSC, 420091
Kazan, str.
Belomorskaya 260
Russia D06BB03 1380905.09.2014
05.09.2019OTC
Tatchempharmprepar
aty JSC, 420091
Kazan, str.
Belomorskaya 260,
Russia
10
45Acyclovir Denk
200aciclovir tablets
200mg,
in blister (25/5x5/)
Denk Pharma GmbH
& Co. KG (Goellstr. 1,
84529 Tittmoning)
Germany J05AB01 1294628.10.2013
28.10.2018PoM
Denk Pharma GmbH
& Co. KG
(Prinzregentenstr. 79,
81675 Muenchen,
Germany)
46Acyclovir Denk 5%
Creamaciclovir cream for topical use
50mg/g,
7g aluminium tube
RubiePharm
Arzneimittel GmbH,
Bruder-Grimm-Str.
62, 36396 Steinau an
der Strasse
Germany D06BB03 1567308.06.2016
08.06.2021OTC
Denk Pharma GmbH
& Co. KG,
Prinzregentenstr. 79,
81675 Muenchen,
Germany
47 Adaptol mebicar capsules hard
300mg,
in blister (20/2x10/,
30/3x10/, 40/4x10/)
Olainfarm JSC, 5
Rupnicu Str., Olaine,
LV-2114
Latvia N06BX21 1644006.03.2017
06.03.2022PoM
Olainfarm JSC, 5
Rupnicu Str., Olaine,
LV-2114, Latvia
48 Adaptol mebicar tablets500mg,
in blister (20/2x10/)
Olainfarm JSC, 5
Rupnicu Str., Olaine,
LV-2114
Latvia N06BX21 1644106.03.2017
06.03.2022PoM
Olainfarm JSC, 5
Rupnicu Str., Olaine,
LV-2114, Latvia
49 Adelphane-Esidrex
reserpine,
dihydralazine
sulfate, hydrochloro-
thiazide
tablets0,1g+10mg+10mg, in
blister (250/10x5x5/)
Sandoz Private
Limited, Plot No. 8-
A/2 and 8-B, TTC
Industrial Area,
Kalwe Block, Village
Dighe, Opp. Thane-
Belapur Road, Navi
Mumbai, 400 708
India C02LA51 1358310.06.2014
10.06.2019PoM
Sandoz Private
Limited, Sandoz
House, Dr. Annie
Besant Road, Worli,
Mumbai 400 0018,
India
50 Adenoprosin adenoprosin suppositories rectal250mg
(10/2x5/)
Farmaprim SRL, MD-
4829, v. Porumbeni,
dis. Criuleni, str.
Crinilor, 5
Moldova G04CX 1318610.01.2014
10.01.2019PoM
Farmaprim SRL, MD-
4829, v. Porumbeni,
dis. Criuleni, str.
Crinilor, 5, Moldova
51 Adeno-Ritz
serenoa serrulata,
urtica urens,
pygeum africanum
capsules
160mg+50mg+ 50mg,
in blister (20/2x10/,
60/6x10/)
GM Pharmaceuticals
Ltd, PSP group 65,
Qvemo Phonichala
str., Tbilisi
GeorgiaG04CX
herbal drug13671
08.07.2014
08.07.2019PoM
GM Pharmaceuticals
Ltd, PSP group 65,
Qvemo Phonichala
str., Tbilisi, Georgia
11
52 Adenuric 120mg febuxostat tablets film-coated
120mg,
in blister (14/1x14/,
28/2x14/, 56/4x14/,
84/6x14/)
Menarini-Von
Heyden GmbH,
Leipziger Strasse 7-13,
01097 Dresden
Germany M04AA03 1637630.12.2016
30.12.2021PoM
Menarini
International
Operations
Luxembourg S.A.,1,
avenue de la Gare,
1611, Luxembourg
53 Adenuric 120mg febuxostat tablets film-coated
120mg,
in blister (28/2x14/,
56/4x14/, 84/6x14/)
Menarini-Von
Heyden GmbH,
Leipziger Strasse 7-13,
01097 Dresden- batch
releaser, packager,
Patheon France, 40
Boulevard de
Champaret, 38 300
Bourgoin Jallieu,
France- bulk
manufacturer
Germany M04AA03 1655803.04.2017
03.04.2022PoM
Menarini
International
Operations
Luxembourg S.A.,1,
avenue de la Gare,
1611, Luxembourg
54 Adenuric 80mg febuxostat tablets film-coated
80mg,
in blister (14/1x14/,
28/2x14/, 56/4x14/,
84/6x14/)
Menarini-Von
Heyden GmbH,
Leipziger Strasse 7-13,
01097 Dresden
Germany M04AA03 1637730.12.2016
30.12.2021PoM
Menarini
International O. L.
S.A., 1, Avenue de la
Gare, 1611,
Luxembourg
55 Adenuric 80mg febuxostat tablets film-coated
80mg,
in blister (28/2x14/,
56/4x14/)
Menarini-Von
Heyden GmbH,
Leipziger Strasse 7-13,
01097 Dresden- batch
releaser, packager,
Patheon France, 40
Boulevard de
Champaret, 38 300
Bourgoin Jallieu,
France- bulk
manufacturer
Germany M04AA03 1655903.04.2017
03.04.2022PoM
Menarini
International
Operations
Luxembourg S.A.,1,
avenue de la Gare,
1611, Luxembourg
12
56 Adiloc adapalene gel1mg/ml,
10ml and 30ml plastic vial
Arsanit Ltd, 110
Yerevanyan str.,
Masis- batch releaser,
secondary packager,
PharmaTech CJSC,
111 Raffi str., 0064,
Yerevan, Republic of
Armenia-bulk
manufacturer,
primary packager
Republic of
ArmeniaD10AD03 14983
18.11.2015
18.11.2020PoM
Arsanit Ltd, 110
Yerevanyan str.,
Masis, Republic of
Armenia
57 Adiloc adapalene gel3mg/ml,
10ml and 30ml plastic vial
Arsanit Ltd, 110
Yerevanyan str.,
Masis- batch releaser,
secondary packager,
PharmaTech CJSC,
111 Raffi str., 0064,
Yerevan, Republic of
Armenia-bulk
manufacturer,
primary packager
Republic of
ArmeniaD10AD03 14984
18.11.2015
18.11.2020PoM
Arsanit Ltd, 110
Yerevanyan str.,
Masis, Republic of
Armenia
58 Adipin
amlodipine
(amlodipine
besilate)
tablets film-coated5mg,
in blister (30/3x10/)
GM Pharmaceuticals
Ltd, PSP group 65,
Qvemo Phonichala
str., Tbilisi
Georgia C08CA01 1530504.02.2016
04.02.2021PoM
GM Pharmaceuticals
Ltd, PSP group 65,
Qvemo Phonichala
str., Tbilisi, Georgia
59 Adipin
amlodipine
(amlodipine
besilate)
tablets film-coated10mg,
in blister (30/3x10/)
GM Pharmaceuticals
Ltd, PSP group 65,
Qvemo Phonichala
str., Tbilisi
Georgia C08CA01 1530604.02.2016
04.02.2021PoM
GM Pharmaceuticals
Ltd, PSP group 65,
Qvemo Phonichala
str., Tbilisi, Georgia
60 Adiupresin
desmopressin
(desmopressin
acetate)
drops nasal
0,1mg/ml,
5ml glass vial with
dropper
Ameda Pharma Pvt.
Ltd., 809, Kerala
Industrial Estate,
G.I.D.C. Near Bavla,
Kerala-Bavla,
Ahmedabad-380 220,
Gujarat
India H01BA02 13397/111.06.2015
04.04.2019PoM
Ameda Pharma Pvt.
Ltd., 502, Shreeji
Chambers, Behind
Cargo Motors, Off. C.,
G., Road,
Navrangpura,
Ahmedabad-380 006,
Gujarat, India
13
61Adrenalin-
Zdorovye
epinephrine
(epinephrine
hydrotartrate)
solution for injection
1,82mg/ml,
1ml ampoules (5, 10), 1ml
ampoules in blister (5,
10/1x10/, 10/2x5/)
Pharmaceutical
Company "Zdorovye"
LLC, 61013, Kharkov,
Shevchenko str., 22
Ukraine C01CA24 1662025.04.2017
25.04.2022PoM
Pharmaceutical
Company "Zdorovye"
LLC, 61013, Kharkov,
Shevchenko str., 22,
Ukraine
62 Advagraf tacrolimuscapsules prolonged-
release
3mg,
in blister (50/5x10/)
Astellas Ireland Co.
Ltd., Kerry County,
Killorglin for Astellas
Pharma Europe B.
V.,Elisabethhof 19,
2353 EW Leiderdorp,
the Netherlands
Ireland L04AD02 1244407.05.2013
07.05.2018PoM
Astellas Pharma
Europe B.
V.,Elisabethhof 19,
2353 EW Leiderdorp,
the Netherlands
63 Advagraf tacrolimuscapsules prolonged-
release
0,5mg,
in blister (50/5x10/)
Astellas Ireland Co.
Ltd., Kerry County,
Killorglin for
Ireland L04AD02 1415729.12.2014
29.12.2019PoM
Astellas Pharma
Europe B. V.,
Sylviusweg 62, 2333
BE Leiden, the
Netherlands
64 Advagraf tacrolimuscapsules prolonged-
release
1mg,
in blister (50/5x10/)
Astellas Ireland Co.
Ltd., Kerry County,
Killorglin for
Ireland L04AD02 1415829.12.2014
29.12.2019PoM
Astellas Pharma
Europe B. V.,
Sylviusweg 62, 2333
BE Leiden, the
Netherlands
65 Advagraf tacrolimuscapsules prolonged-
release
5mg,
in blister (50/5x10/)
Astellas Ireland Co.
Ltd., Kerry County,
Killorglin
Ireland L04AD02 1415929.12.2014
29.12.2019PoM
Astellas Pharma
Europe B. V.,
Sylviusweg 62, 2333
BE Leiden, the
Netherlands
66 Advantan
methylprednisolone
(methylpredniso-
lone aceponate)
emulsion for
external use
1mg/g,
20g aluminium laminated
tube
Bayer Healthcare
Manufacturing S.r.l.,
Via E. Schering 21,
20090 Segrate
(Milano)
Italy D07AA01 1510015.12.2015
15.12.2020PoM
Bayer Pharma AG,
Mullerstrasse 178,
13353, Berlin,
Germany
14
67 Advantan
methylprednisolone
(methylpredniso-
lone aceponate)
cream for external
use
1mg/g,
15g aluminium tube
Bayer Healthcare
Manufacturing S.r.l.,
Via E. Schering 21,
20090 Segrate
(Milano)
Italy D07AA01 1518630.12.2015
30.12.2020PoM
Bayer Pharma AG,
Mullerstrasse 178,
13353, Berlin,
Germany
68 Advantan
methylprednisolone
(methylpredniso-
lone aceponate)
ointment for
external use
1mg/g,
15g aluminium tube
Bayer Healthcare
Manufacturing S.r.l.,
Via E. Schering 21,
20090 Segrate
(Milano)
Italy D07AA01 1540109.03.2016
09.03.2021PoM
Bayer Pharma AG,
Mullerstrasse 178,
13353, Berlin,
Germany
69 Advate octocog alfa
powder and solvent
for solution for
injection
1000IU,
glass vial with powder (1),
5ml ampoule with solvent
(1), BAXJECT II (1)
Baxalta Belgium
Manufacturing SA,
Boulevard Rene
Branquart 80, B-7860
Lessines-batch
releaser, secondary
packager, Baxalta
Manufacturing Sarl,
Route de Pierre-a-bot
111, 2000 Neuchatel,
Switzerland- bulk
manufacturer,
primary packager
Belgium B02BD02 1670923.05.2017
23.05.2022PoM
Baxter AG,
Industriestrasse 67, A-
1221 Vienna, Austria
70 Advate octocog alfa
powder and solvent
for solution for
injection
500IU,
glass vial with powder (1),
ampoule with 2ml solvent
(1), BAXJECT II (1)
Baxalta Belgium
Manufacturing SA,
Boulevard Rene
Branquart 80, B-7860
Lessines-batch
releaser, secondary
packager, Baxalta
Manufacturing Sarl,
Route de Pierre-a-bot
111, 2000 Neuchatel,
Switzerland- bulk
manufacturer,
primary packager
Belgium B02BD02 1671023.05.2017
23.05.2022PoM
Baxter AG,
Industriestrasse 67, A-
1221 Vienna, Austria
15
71 Advate octocog alfa
powder and solvent
for solution for
injection
250IU,
glass vial with powder (1),
ampoule with 2ml solvent
(1), BAXJECT II (1)
Baxalta Belgium
Manufacturing SA,
Boulevard Rene
Branquart 80, B-7860
Lessines-batch
releaser, secondary
packager, Baxalta
Manufacturing Sarl,
Route de Pierre-a-bot
111, 2000 Neuchatel,
Switzerland- bulk
manufacturer,
primary packager
Belgium B02BD02 1671123.05.2017
23.05.2022PoM
Baxter AG,
Industriestrasse 67, A-
1221 Vienna, Austria
72 Aerius desloratadine syrup
0,5mg/ml,
60ml, 120ml and
measuring spoon
Schering-Plough Labo
N.V., Industriepark
30 B-2220, Heist-op-
den-Berg
Belgium R06AX27 13975/107.10.2016
26.11.2019OTC
Bayer Consumer Care
AG, Peter Merian-
Strasse 84, 4052 Basel,
Switzerland
73 Aerius desloratadine tablets film-coated5mg,
blister (10/1x10/)
Schering-Plough Labo
N.V., Industriepark
30 B-2220, Heist-op-
den-Berg
Belgium R06AX27 14507/109.09.2016
15.05.2020OTC
Bayer Consumer Care
AG, Peter Merian-
Strasse 84, 4052 Basel,
Switzerland
74 Aerobreathsalbutamol
(salbutamol sulfate)
suspension,
pressurised
inhalation
100mcg/dose,
8.5g (200 inhalations)
aluminium container
with inhaler and plastic
applicator
Aeropharm GmbH,
Francois-Mitterrand-
Allee 1, 07407
Rudolstadt
Germany R03AC02 1597015.09.2016
15.09.2021PoM
Sandoz
Pharmaceuticals d.d.,
Verovskova Str. 57,
1526 Ljubljana,
Slovenia
75 Aescuvenhorse chestnut
seedstablets coated
30mg,
in bllster (40/2x20/)
Cesra Arzneimittel
GmbH & Co. KG,
Braunmattstr. 20,
Baden-Baden, 76532
GermanyC05CX03;
herbal drug16355
30.12.2016
30.12.2021OTC
Cesra Arzneimittel
GmbH & Co. KG,
Braunmattstr. 20,
Baden-Baden, 76532,
Germany
16
76 Aevit
retinol palmitate
(vitamin A), alpha-
tocopherol acetate
(vitamin E)
capsules55mg (100000IU)+100mg,
in blister (20/2x10/)
"Pharmaceutical
company "MELIGEN"
CJSC, 188676,
Leningrad region,
Vsevolozhsk district,
p.Shcheglovo, 53a
Russia A11JA 1696105.09.2017
05.09.2022OTC
"Pharmaceutical
company "MELIGEN"
CJSC, 188676,
Leningrad region,
Vsevolozhsk district,
p.Shcheglovo, 53a,
Russia
77 Aevit
retinol palmitate
(vitamin A), alfa-
tocopherol acetate
(vitamin E)
capsules
55,036mg (100000IU)+
100mg,
in blister (20/2x10/)
Minskintercaps U.V.,
26/3, Inzhenernaya
str., 220075, Minsk
Belarus A11JA 1718430.11.2017
30.11.2022OTC
Minskintercaps U.V.,
26, Inzhenernaya str.,
220075, Minsk,
Belarus
78 Aevit-AV
retinol palmitate
(vitamin A), alfa-
tocopherol acetate
(vitamin E)
capsules
0.1ml (100000IU)+100mg,
blister (10/1x10/,
30/3x10/)
Altayvitamini CJSC,
659325, The Altay
territory, Biysk, 69
Zavodskaya Str.
Russia A11JA 13088/115.01.2016
09.12.2018OTC
Altayvitamini CJSC,
659325, The Altay
territory, Biysk, 69
Zavodskaya Str.,
Russia
79 Afala
antibodies to
prostatospecific
antigen affinity
purified
tablets to be sucked
3mg (not more than 10-
15ng/g),
in blister (20/1x20/,
40/2x20/, 100/5x20/)
NPF Materia Medica
Holding Ltd., 54,
Buguruslanskaya st.,
Chelyabinsk 454139
Russia
G04CX
homeopathic
drug
12512/121.01.2014
01.06.2018OTC
NPF Materia Medica
Holding Ltd., 9 bld.,
3rd Samotyochny
per., Moscow 127473,
Russia
80 Afinitor everolimus tablets2,5mg,
in blister (30/3x10/)
Novartis Pharma
Stein AG,
Schaffhauserstrasse,
4332 Stein
Switzerland L01XE10 1329604.03.2014
04.03.2019PoM
Novartis Pharma AG,
Lichtstrasse 35, 4056
Basel, Switzerland
81 Afinitor everolimus tablets5mg,
in blister (30/3x10/)
Novartis Pharma
Stein AG,
Schaffhauserstrasse,
4332 Stein
Switzerland L01XE10 1549712.04.2016
12.04.2021PoM
Novartis Pharma AG,
35, Lichtstrasse, 4056
Basel, Switzerland
82 Afinitor everolimus tablets10mg,
in blister (30/3x10/)
Novartis Pharma
Stein AG,
Schaffhauserstrasse,
4332 Stein
Switzerland L01XE10 1549812.04.2016
12.04.2021PoM
Novartis Pharma AG,
35, Lichtstrasse, 4056
Basel, Switzerland
17
83 Aflubin
gentiana D1,
aconitum D6,
bryonia D6, ferrum
phosphoricum D12,
acidum
sacrolacticum D12
drops oral
1ml/100ml+ 10ml/100ml+
10ml/100ml+
10ml/100ml+
10ml/100ml,
20ml, 50ml glass bottle-
dropper
Richard Bittner AG,
Ossiacherstrasse 7, A-
9560 Feldkirchen
Austria
R05X;
homeopathic
drug
1578520.07.2016
20.07.2021OTC
Richard Bittner AG,
Reisnerstrasse 55-57,
A-1030 Wien, Austria
84 Aflubin
gentiana D1,
aconitum D6,
bryonia D6, ferrum
phosphoricum D12,
acidum
sacrolacticum D12
tablets sublingual
3,6mg+37,2mg+
37,2mg+37,2mg+ 37,2mg,
in blister (12/1x12/,
24/2x12/, 48/4x12/)
Richard Bittner AG,
Ossiacherstrasse 7, A-
9560 Feldkirchen
Austria
R05X;
homeopathic
drug
1578620.07.2016
20.07.2021OTC
Richard Bittner AG,
Reisnerstrasse 55-57,
A-1030 Wien, Austria
85 Afobazol
fabomotizole
(fabomotizole
dihydrochloride)
tablets
10mg,
in blisters (30/1x30/,
60/3x20/, 60/2x30/,
90/3x30/, 120/4x30/)
Pharmstandard-
Leksredstva JSC,
305022, Kursk,
Agregatnaya 2nd str.,
1a/18
Russia N05BX04 14729/227.03.2017
30.07.2020PoM
OTCPharm PJSC,
123317, Moscow,
Testovskaya str., 10,
Russia
86AgmenTRONN
1000
amoxicillin
(amoxicillin
trihydrate),
clavulanic acid
(potassium
clavulanate)
tablets film-coated875mg+125mg,
in blister (10)
Flamingo
Pharmaceuticals Ltd,
R-662,T.T.C. Ind.
Area, Rabale, Navi
Mumbai 400 701
India J01CR02 12175/113.03.2014
01.02.2018PoM
Flamingo
Pharmaceuticals Ltd,
R-662,T.T.C. Ind.
Area, Rabale, Navi
Mumbai 400 701,
India
87AgmenTRONN
625
amoxicillin
(amoxicillin
trihydrate),
clavulanic acid
(potassium
clavulanate)
tablets film-coated500mg+125mg,
in blister (10)
Flamingo
Pharmaceuticals Ltd,
R-662,T.T.C. Ind.
Area, Rabale, Navi
Mumbai 400 701
India J01CR02 12174/113.03.2014
01.02.2018PoM
Flamingo
Pharmaceuticals Ltd,
R-662,T.T.C. Ind.
Area, Rabale, Navi
Mumbai 400 701,
India
18
88 AirFluSal Forspiro
salmeterol
(salmeterol
xinafoate),
fluticasone
(fluticasone
propionate)
powder for
inhalation
50mcg/dose+
500mcg/dose, powder in
blister (60 dose), in plastic
inhaler
Aeropharm GmbH,
Francois-Mitterrand-
Alee 1, 07407
Rudolstadt
Germany R03AK06 1502202.12.2015
02.12.2020PoM
Sandoz
Pharmaceuticals d.d.,
Verovskova Str. 57,
1000 Ljubljana,
Slovenia
89 AirFluSal Forspiro
salmeterol
(salmeterol
xinafoate),
fluticasone
(fluticasone
propionate)
powder for
inhalation
50mcg/dose+
250mcg/dose, powder in
blister (60 dose), in plastic
inhaler
Aeropharm GmbH,
Francois-Mitterrand-
Alee 1, 07407
Rudolstadt
Germany R03AK06 1502302.12.2015
02.12.2020PoM
Sandoz
Pharmaceuticals d.d.,
Verovskova Str. 57,
1000 Ljubljana,
Slovenia
90 Airtal aceclofenac tablets film-coated
100mg,
in blister (20/2x10,
60/6x10/)
Gedeon Richter PLC,
Gyomroi ut 19-21,
1103 Budapest
Hungary M01AB16 1408616.12.2014
16.12.2019PoM
Gedeon Richter PLC,
Gyomroi ut 19-21,
1103 Budapest,
Hungary
91 Airtal aceclofenac cream15mg/g,
60g aluminium tube
Gedeon Richter PLC,
Gyomroi ut 19-21,
1103 Budapest
Hungary M01AB16 1651417.03.2017
17.03.2022OTC
Gedeon Richter PLC,
Gyomroi ut 19-21,
1103 Budapest,
Hungary
92 Airtal aceclofenacpowder for oral
suspension
100mg,
3g sachet (20)
Gedeon Richter PLC,
Gyomroi ut 19-21,
1103 Budapest - batch
releaser, Industrias
Farmaceuticas
Almirall S.L., Ctra.
Nacional II, Km. 593,
Sant Andreu de la
Barca, Barcelona,
08740, Spain-bulk
manufacturer,
packager
Hungary M01AB16 1651517.03.2017
17.03.2022PoM
Gedeon Richter PLC,
Gyomroi ut 19-21,
1103 Budapest,
Hungary
19
93 Akcipro-500
ciprofloxacin
(ciprofloxacin
hydrochloride)
tablets film-coated500mg,
in blister (10/1x10/)
Akriti
Pharmaceuticals Pvt.
Ltd., Plot No D-10, D-
11, M.I.D.C. Indl.
Estate., Nira Road,
Jejuri, Tal. Purandhar
(Saswad), Dist. Pune-
412 303, Maharashtra
India J01MA02 1337404.04.2014
04.04.2019PoM
Akriti
Pharmaceuticals Pvt.
Ltd., 117, Block No2,
Emerald Plaza,
Hiranandani
Meadows, Barrister
Nath Pai Road, Thane
(W) 400 610, India
94 Akistan latanoprost drops eye (solution)0,05mg/ml,
2,5ml plastic vial
Bruschettini S.r.l., Via
Isonzo, 6, 16147
Genova
Italy S01EE01 1223107.03.2013
07.03.2018PoM
Pharmaselect
International
Beteiligungs GmbH,
Ernst-Melchior-Gasse
20 1020 Vienna,
Austria
95 Aksastrol anastrozole tablets film-coated1mg,
in blister (28/2x14/)
Remedica Ltd,
Limassol Industrial
Estate, Aharnon
street, 3056 Limassol
Cyprus L02BG03 1437225.03.2015
25.03.2020PoM
Grindeks JSC,
Krustpils str. 53, LV-
1057, Riga, Latvia
96 AKSONE Injection
ceftriaxone
(ceftriaxone
sodium)
powder for solution
for injection
1000mg,
glass vial (1)
Akriti
Pharmaceuticals Pvt.
Ltd., Plot No. D-10, D-
11, M.I.D.C. Indl.
Estate, Nira Road,
Jejuri, Tal. Purandar
(Saswad), Dist. Pune-
412 303, Maharashtra
India J01DD04 1696905.09.2017
05.09.2022PoM
Akriti
Pharmaceuticals Pvt.
Ltd., 117, Block No. 2,
Emerald Plaza,
Hiranandani
Meadows, Barrister
Nath Pai Road, Thane
(West) 400 610, India
97 Alactin cabergoline tablets0,5mg,
in glass container (2, 8)
TEVA Czech
Industries s.r.o.,
Ostravska 29, c.p. 305,
747 70 Opava-
Komarov
Czech Republic G02CB03 1327304.03.2014
04.03.2019PoM
TEVA Czech
Industries s.r.o.,
Ostravska 29, c.p.
305, 747 70 Opava-
Komarov, Czech
Republic
20
98 Alamycin aerosol
oxytetracycline
(oxytetracycline
hydrochloride)
aerosol
5g/dose,
140g aluminium
container
Norbrook
Laboratories Limited,
Station Works
Camlough Road,
Newry, Co. Down,
BT35 6JP
UK
QD06AA03
veterinary
drug
1281517.09.2013
17.09.2018PoM
Norbrook
Laboratories Limited,
Station Works
Camlough Road,
Newry, Co. Down,
BT35 6JP, UK
99 Alamycin LA
oxytetracycline
(oxytetracycline
dihydrate)
solution for injection200mg/ml,
50ml, 100ml glass vial
Norbrook
Laboratories Limited,
Station Works
Camlough Road,
Newry, Co. Down,
BT35 6JP
UK
QJ01AA06
veterinary
drug
1231322.03.2013
22.03.2018PoM
Norbrook
Laboratories Limited,
Station Works
Camlough Road,
Newry, Co. Down,
BT35 6JP, UK
100 Alben albendazole granules
200mg/g,
500g pack,
1000g plastic container
NVT Agrovetzaschita
S-P (AVZ S-P) LLC,
Moscow region,
Sergiyev Posad, 1,
Tsentralnaya Str.,
141300
Russia
QP52AC11;
veterinary
drug
1421312.02.2015
12.02.2020PoM
Scientific and
Implementation
Center
Agrovetzaschita LLC,
Kolskaya str. 1, bldg.
1, Moscow 129329,
Russia
101 Alben albendazole tablets360mg,
in blister (100/4x25/)
NVT Agrovetzaschita
S-P (AVZ S-P) LLC,
Moscow region,
Sergiyev Posad, 1,
Tsentralnaya Str.,
141300
Russia
QP52AC11;
veterinary
drug
1421412.02.2015
12.02.2020PoM
Scientific and
Implementation
Center
Agrovetzaschita LLC,
Kolskaya str. 1, bldg.
1, Moscow 129329,
Russia
102 Albendazole albendazole tablets200mg,
in blister (20/2x10/)
"NOKI" JV LTD Co.,
Nor-Kharberd, Ararat
region
Republic of
ArmeniaP02CA03 15590
12.05.2016
12.05.2021PoM
"NOKI" JV LTD Co.,
Nor-Kharberd, Ararat
region, Republic of
Armenia
103 Albendazole albendazole tablets chewable400mg,
in plastic container (4)
Arpimed LLC, Kotayk
Marz, Abovyan, 2nd
Micro-District, 19
Building
Republic of
ArmeniaP02CA03 15949
02.09.2016
02.09.2021PoM
Arpimed LLC,
Kotayk Marz,
Abovyan, 2nd Micro-
District, 19 Building,
Republic of Armenia
21
104 Albendazole 10% albendazole suspension oral100mg/ml,
1l plastic container
Invesa Industrial
Veterinaria, S.A.,
08950 Esplugues de
Llobregat, Barcelona,
Esmeralda 19
Spain
QP52AC11
veterinary
drug
1300514.11.2013
14.11.2018PoM
Invesa Industrial
Veterinaria, S.A.,
08950 Esplugues de
Llobregat, Barcelona,
Esmeralda 19, Spain
105 Albenol-100 Oral albendazole suspension oral
100mg/ml,
plastic container 500ml,
1000ml, plastic bottle
100ml
Interchemie werken
'De Adelaar' B.V.,
Metaalweg 8, 5804
CG Venray
the Netherlands
QP52AC11;
veterinary
drug
14138/111.12.2017
29.12.2019PoM
Interchemie werken
'De Adelaar' B.V.,
Metaalweg 8, 5804
CG Venray
106 Albenol-300 bolus albendazole bolus (tablets)300mg,
in blister (50/10x5/)
Interchemie werken
'De Adelaar' B.V.,
Metaalweg 8, 5804
CG Venray
the Netherlands
QP52AC11;
veterinary
drug
1501002.12.2015
02.12.2020PoM
Interchemie werken
'De Adelaar' B.V.,
Metaalweg 8, 5804
CG Venray, the
Netherlands
107 Albucid
sulfacetamide
(sulfacetamide
sodium)
powder for external
use
500mg,
sachets (10)
Esco-Pharm LLC, Nor-
Norq, Mikoyan 13,
Yerevan
Republic of
ArmeniaS01AB04 12816
17.09.2013
17.09.2018OTC
Esco-Pharm LLC, Nor-
Norq, Mikoyan 13,
Yerevan, Republic of
Armenia
108 Albucid
sulfacetamide
(sulfacetamide
sodium)
powder for external
use
300mg,
sachets (10)
Esco-Pharm LLC, Nor-
Norq, Mikoyan 13,
Yerevan
Republic of
ArmeniaS01AB04 12817
17.09.2013
17.09.2018OTC
Esco-Pharm LLC, Nor-
Norq, Mikoyan 13,
Yerevan, Republic of
Armenia
109 Albucide Liqvo sulfacetamide drops eye200mg/ml,
5ml vial-dropper
Liqvor CJSC, 0089,
Yerevan, str.
Kochinyan, 7/9
Republic of
ArmeniaS01AB04 13747
24.07.2014
24.07.2019OTC
Liqvor CJSC, 0089,
Yerevan, str.
Kochinyan, 7/9,
Republic of Armenia
110Albumin-
Biopharmaalbumin human solution for infusion
100mg/ml,
50ml glass bottle
BIOPHARMA
PLASMA LLC, 9M.
Amosova St, Kyiv,
03680
Ukraine B05AA01 1724708.12.2017
08.12.2022PoM
BIOPHARMA
PLASMA LLC, 37,
Kyivska St., Bila
Tserkva, Kyiv region,
09100, Ukraine
22
111Albumin-
Biopharmaalbumin human solution for infusion
100mg/ml,
100ml glass bottle
BIOPHARMA
PLASMA LLC, 9M.
Amosova St, Kyiv,
03680
Ukraine B05AA01 1724808.12.2017
08.12.2022PoM
BIOPHARMA
PLASMA LLC, 37,
Kyivska St., Bila
Tserkva, Kyiv region,
09100, Ukraine
112Albumin-
Biopharmaalbumin human solution for infusion
200mg/ml,
50ml glass bottle
BIOPHARMA
PLASMA LLC, 9M.
Amosova St, Kyiv,
03680
Ukraine B05AA01 1724908.12.2017
08.12.2022PoM
BIOPHARMA
PLASMA LLC, 37,
Kyivska St., Bila
Tserkva, Kyiv region,
09100, Ukraine
113Albumin-
Biopharmaalbumin human solution for infusion
200mg/ml,
100ml glass bottle
BIOPHARMA
PLASMA LLC, 9M.
Amosova St, Kyiv,
03680
Ukraine B05AA01 1725008.12.2017
08.12.2022PoM
BIOPHARMA
PLASMA LLC, 37,
Kyivska St., Bila
Tserkva, Kyiv region,
09100, Ukraine
114 Albunorm 20% albumin humansolution for i/v
infusion
200mg/ml,
50ml and 100ml glass
bottle
Octapharma
Pharmazeutika
Produktionsges.
m.b.H., Oberlaaer
Strasse 235, A-1100
Vienna
Austria B05AA01 1493120.10.2015
20.10.2020PoM
Octapharma
Pharmazeutika
Produktionsges.
m.b.H., Oberlaaer
Strasse 235, A-1100
Vienna, Austria
115 Albunorm 5% albumin humansolution for i/v
infusion
50mg/ml,
100ml, 250ml, 500ml
glass bottle
Octapharma
Pharmazeutika
Produktionsges.
m.b.H., Oberlaaer
Strasse 235, A-1100
Vienna
Austria B05AA01 1493020.10.2015
20.10.2020PoM
Octapharma
Pharmazeutika
Produktionsges.
m.b.H., Oberlaaer
Strasse 235, A-1100
Vienna, Austria
116 Alcohol medical ethanol solution
70%,
25ml, 30ml, 50ml, 100ml,
250ml, 500ml, 750ml,
1000ml, 5000ml,
10000ml, 20000ml glass
or plastic bottle
Arsanit Ltd, 110
Yerevanyan str.,
Masis-batch releaser,
packager,
PharmaTech CJSC,
0064, Yerevan, Raffi
str. 111, Republic of
Armenia-bulk
manufacturer
Republic of
ArmeniaD08AX08 15487
05.04.2016
05.04.2021OTC
Arsanit Ltd, 110
Yerevanyan str.,
Masis, Republic of
Armenia
23
117 Alcohol medical ethanol solution
96%,
50ml, 100ml, 250ml,
1000ml, 5000ml,
10000ml, 20000ml glass
or plastic bottle
Arsanit Ltd, 110
Yerevanyan str.,
Masis-batch releaser,
packager,
PharmaTech CJSC,
0064, Yerevan, Raffi
str. 111, Republic of
Armenia-bulk
manufacturer
Republic of
ArmeniaD08AX08 15488
05.04.2016
05.04.2021OTC
Arsanit Ltd, 110
Yerevanyan str.,
Masis, Republic of
Armenia
118Alcohol Medical
70%ethanol
solution for external
use
70%,
50ml, 100ml, 250ml glass
and plastic bottles
Lizin OJSC,
Charentsavan, st.
Gortsaranayin 14
Republic of
ArmeniaD08AX08 13473
06.05.2014
06.05.2019OTC
Lizin OJSC,
Charentsavan, st.
Gortsaranayin 14,
Republic of Armenia
119Alcohol Medical
96%ethanol
solution for external
use
96%,
50ml, 100ml, 250ml,
500ml, 1000ml glass and
plastic bottles
Lizin OJSC,
Charentsavan, st.
Gortsaranayin 14
Republic of
ArmeniaD08AX08 13474
06.05.2014
06.05.2019OTC
Lizin OJSC,
Charentsavan, st.
Gortsaranayin 14,
Republic of Armenia
120 Aldara imiquimod cream for local use50mg/g,
250mg sachets (12)
3M Health Care
Limited, Derby Road,
Loughborough
Leicestershire LE11
5SF
UK D06BB10 1586701.08.2016
01.08.2021PoM
Meda AB, Pipersvag
2A, 170 73 Solna,
Sweden
24
121
Alendronic Acid
Once weekly 70mg
Tablets
alendronic acid tablets70mg,
in blister (4/1x4/)
Accord Healthcare
Limited, Sage House,319
Pinner Road, North
Harrow, Middlesex, HA1
4HF- batch releaser, Intas
Pharmaceuticals Limited,
Plot No 457 & 458 &
191/218 P, Sarkhej-Bavla
Highway, Matoda Village,
Sanand, District-
Ahmedabad, 382 210,
Gujarat, India- bulk
manufacturer, Accord
Healthcare Limited, Unit C
& D, Homefield Business
Park, Homefield Road,
Haverhill, CB9 8QP, UK-
primary and secondary
packager
UK M05BA04 1485415.09.2015
15.09.2020PoM
Accord Healthcare
Limited, Sage
House,319 Pinner
Road, North Harrow,
Middlesex, HA1 4HF,
UK
122 Aler-Gcetirizine (cetirizine
dihydrochloride)tablets film-coated
10mg,
in blister (20)
GM Pharmaceuticals
Ltd, PSP group 65,
Qvemo Phonichala
str., Tbilisi
Georgia R06AE07 1301525.11.2013
25.11.2018OTC
GM Pharmaceuticals
Ltd, PSP group 65,
Qvemo Phonichala
str., Tbilisi, Georgia
123 Alexan cytarabine solution for injection20mg/ml,
5ml glass vial (1)
EBEWE Pharma Ges.
m.b.H. Nfg. KG,
Mondseestrasse 11, A-
4866 Unterach am
Attersee
Austria L01BC01 1361627.06.2014
27.06.2019PoM
EBEWE Pharma Ges.
m.b.H. Nfg. KG,
Mondseestrasse 11, A-
4866 Unterach am
Attersee, Austria
124 Alexan cytarabine solution for injection50mg/ml,
10ml glass vial (1)
EBEWE Pharma Ges.
m.b.H. Nfg. KG,
Mondseestrasse 11, A-
4866 Unterach am
Attersee
Austria L01BC01 13617/120.11.2015
27.06.2019PoM
EBEWE Pharma Ges.
m.b.H. Nfg. KG,
Mondseestrasse 11, A-
4866 Unterach am
Attersee, Austria
125 Alfa Normix rifaximin tablets film-coated200mg,
in blister (12)
Alfa Wassermann
S.p.A., Via Enrico
Fermi, 1-65020,
Alanno
Italy A07AA11 12499/104.09.2013
01.06.2018PoM
Alfa Wassermann
S.p.A., Via Enrico
Fermi, 1-65020,
Alanno, Italy
25
126 Alfa Normix rifaximin tablets film-coated200mg,
in blister (12/1x12/)
Alfa Wassermann
S.p.A., Via Enrico
Fermi, 1-65020,
Alanno
Italy A07AA11 1712424.10.2017
24.10.2022PoM
Alfa Wassermann
S.p.A., Via Enrico
Fermi, 1-65020,
Alanno, Italy
127 Alfagin
panax ginseng,
eleutherococcus
senticosus ,
medicago sativa,
emblica officinalis,
trigonella foenum-
graecum
capsules
50mg+200mg+
500mg+800mg+ 500mg,
in plastic container, (20,
60)
Herbion Pakistan Pvt.
Ltd., 30/28, Korangi
Industrial area,
Karachi-74900
Pakistan herbal drug 1524225.12.2015
25.12.2020OTC
Herbion Pakistan Pvt.
Ltd., 30/28, Korangi
Industrial area,
Karachi-74900,
Pakistan
128 Alfagin
panax ginseng,
eleutherococcus
senticosus,
medicago sativa,
emblica officinalis,
trigonella foenum-
graecum
syrup
25mg/5ml+ 100mg/5ml+
250mg/5ml+ 400mg/5ml+
250mg/5ml,
120ml and 150ml glass
bottle
Herbion Pakistan Pvt.
Ltd., 30/28, Korangi
Industrial area,
Karachi-74900
Pakistan herbal drug 1667711.05.2017
11.05.2022OTC
Herbion Pakistan Pvt.
Ltd., 30/28, Korangi
Industrial area,
Karachi-74900,
Pakistan
129 Alfamec 1% ivermectin solution for injection
10mg/ml,
50ml glass vial (15),
100ml glass vial (12),
250ml glass vial (6)
Alfasan International
B.V., Kuipersweg 9-
3449 JA Woerden
the Netherlands
QP54AA01;
veterinary
drug
1458409.06.2015
09.06.2020PoM
Alfasan International
B.V., Kuipersweg 9-
3449 JA Woerden,
the Netherlands
130Alfa-tokopherol
acetate
tocopherol acetate
(vitamin E)capsules
100mg,
in blister (10/1x10/) and
(30/3x10/)
Marbiopharm JSC,
424006, the Republic
of Mari El,Yoshkar-
Ola, st. Karl Marx 121
Russia A11HA03 13639/116.07.2014
27.06.2019OTC
Marbiopharm JSC,
424006, the Republic
of Mari El,Yoshkar-
Ola, st. Karl Marx
121, Russia
26
131 Alflutop
bioactive
concentrate from
small sea fish
solution for injection
0,1ml/ml,
2ml ampoules,
in blister (5/1x5/)
S.C.Biotehnos S.A.,
Str. Gorunului nr. 3-
5, Otopeni, Jud. Ilfov,
075100- batch
releaser, secondary
packager, S.C. Zentiva
S.A., Theodor Pallady
Blvd nr. 50, sector 3,
032266 Bucharest,
Romania- bulk
manufacturer,
primary packager
Romania M09AX02 1645306.03.2017
06.03.2022PoM
S.C.Biotehnos S.A.,
Str. Gorunului nr. 3-
5, Otopeni, Jud. Ilfov,
075100, Romania
132 Alflutop
bioactive
concentrate from
small sea fish
solution for injection
0,1ml/ml,
1ml ampoules,
in blister (10/2x5/)
S.C.Biotehnos S.A.,
Str. Gorunului nr. 3-
5, Otopeni, Jud. Ilfov,
075100- batch
releaser, secondary
packager, S.C. Zentiva
S.A., Theodor Pallady
Blvd nr. 50, sector 3,
032266 Bucharest,
Romania- bulk
manufacturer,
primary packager
Romania M09AX02 1645406.03.2017
06.03.2022PoM
S.C.Biotehnos S.A.,
Str. Gorunului nr. 3-
5, Otopeni, Jud. Ilfov,
075100, Romania
133 Algavak Minactivated antigen
of hepatitis A
suspension for i/m
injection
not less than 25 ELISA
U/0,5ml(1dose for
children); (10/2x5/)
ampoules 0.5ml (10 doses)
Vector-BiAlgam JSC,
Industrial site of State
Research Center of
VB "Vector", building
N104, Koltsovo,
Novosibirsk oblast,
630559
RussiaJ07BC02;
vaccine17229
08.12.2017
08.12.2022PoM
Vector-BiAlgam JSC,
Industrial site of State
Research Center of
VB "Vector", building
N104, Koltsovo,
Novosibirsk oblast,
630559, Russia
134 Algavak Minactivated antigen
of hepatitis A
suspension for i/m
injection
not less than 50 ELISA
U/1ml (1dose for adult or
2 dose for children);
(10/2x5/) ampoules 1ml
(10 doses) or (10/2x5/)
ampoules 1ml (20 doses)
Vector-BiAlgam JSC,
Industrial site of State
Research Center of
VB "Vector", building
N104, Koltsovo,
Novosibirsk oblast,
630559
RussiaJ07BC02;
vaccine17230
08.12.2017
08.12.2022PoM
Vector-BiAlgam JSC,
Industrial site of State
Research Center of
VB "Vector", building
N104, Koltsovo,
Novosibirsk oblast,
630559, Russia
27
135 Algeroncepeginterferon alfa-
2b
solution for s/c
injection
200mcg/ml,
0.5ml glass syringes in
blister (1, 4/4x1/)
BIOCAD CJSC,
Petrovo-Dalnee,
Krasnogorsky district,
Moscow Region,
143422
Russia L03AB 1403119.12.2014
19.12.2019PoM
BIOCAD CJSC, 34
bld., lit. A, Svyazi
st.,Strelna,
Petrodvortsoviy
district, Saint
Peterburg, 198515,
Russia
136 Algeroncepeginterferon alfa-
2b
solution for s/c
injection
200mcg/ml,
0.6ml glass syringes in
blister (1, 4/4x1/)
BIOCAD CJSC,
Petrovo-Dalnee,
Krasnogorsky district,
Moscow Region,
143422
Russia L03AB 1403219.12.2014
19.12.2019PoM
BIOCAD CJSC, 34
bld., lit. A, Svyazi
st.,Strelna,
Petrodvortsoviy
district, Saint
Peterburg, 198515,
Russia
137 Algeroncepeginterferon alfa-
2b
solution for s/c
injection
200mcg/ml,
0.8ml glass syringe in
blister (1, 4/4x1/)
BIOCAD CJSC,
Petrovo-Dalnee,
Krasnogorsky district,
Moscow Region,
143422
Russia L03AB 1403319.12.2014
19.12.2019PoM
BIOCAD CJSC, 34
bld., lit. A, Svyazi
st.,Strelna,
Petrodvortsoviy
district, Saint
Peterburg, 198515,
Russia
138 Alimta
pemetrexed
(pemetrexed
disodium
heptahydrate)
powder lyophilized
for solution for
infusion
500mg,
glass vial
Lilly France S.A.S., 2,
rue du Colonel Lilly,
67640 Fegersheim
France L01BA04 1227022.03.2013
22.03.2018PoM
Eli Lilly Nederland
B.V., Grootslag 1-5,
NL-3991, RA Houten,
the Netherlands
139 Alimta
pemetrexed
(pemetrexed
disodium
heptahydrate)
powder for
concentrate for
solution for infusion
500mg,
glass vial
Lilly France (S.A.S)., 2
rue du Colonel Lilly,
67640 Fegersheim -
secondary packager,
batch releaser (bulk
manufacturer,
primary packager-Eli
Lilly and Company,
Indianapolis 46285,
Indiana, USA)
France L01BA04 14035/129.05.2015
19.12.2019PoM
Eli Lilly Nederland
B.V., Grootslag 1-5,
NL-3991, RA
Houteen, the
Netherlands
28
140 Alimta
pemetrexed
(pemetrexed
disodium
heptahydrate)
powder for
concentrate for
solution for infusion
100mg,
glass vial (1)
Lilly France, (S.A.S).,
2 rue du Colonel
Lilly, F-67640
Fegersheim -
secondary packager,
batch releaser, Eli
Lilly and Company,
Indianapolis, IN
46285, USA-bulk
manufacturer,
primary packager
France L01BA04 1521930.12.2015
30.12.2020PoM
Eli Lilly Nederland
B.V., Grootslag 1-5,
NL-3991, RA Houten,
the Netherlands
141 Alkadipin
amlodipine
(amlodipine
besilate)
tablets5mg,
in blister (30/3x10/)
Alkaloid AD-Skopje,
bul. Aleksandar
Makedonski 12, 1000
Skopje
Macedonia C08CA01 1252601.06.2013
01.06.2018PoM
Alkaloid AD-Skopje,
bul. Aleksandar
Makedonski 12, 1000
Skopje, Macedonia
142 Alkadipin
amlodipine
(amlodipine
besilate)
tablets10mg,
in blister (30/2x15/)
Alkaloid AD-Skopje,
bul. Aleksandar
Makedonski 12, 1000
Skopje
Macedonia C08CA01 1252701.06.2013
01.06.2018PoM
Alkaloid AD-Skopje,
bul. Aleksandar
Makedonski 12, 1000
Skopje, Macedonia
143 Alka-Seltzer
acetylsalicylic acid,
citric acid, sodium
bicarbonate
tablets effervescent324mg+965mg+ 1625mg,
in strip (10/5x2/)
Bayer Bitterfeld
GmbH, Ortsteil
Greppin Salegaster
Chaussee 1, 06803
Bitterfeld-Wolfen
Germany N02BA51 1283517.09.2013
17.09.2018OTC
Bayer Consumer
Care AG, Peter
Merian-Strasse 84,
4052 Basel,
Switzerland
144 Alkeran melphalan tablets film-coated2mg,
glass container (25)
EXCELLA GmbH &
Co.KG, Nuernberger
st. 12, 90537 Feucht
Germany L01AA03 12884/224.07.2017
27.09.2018PoM
Aspen Pharma
Trading Limited,
3016 Lake Drive,
Citywest Business
Campus, Dublin 24,
Ireland
29
145 Allergodil
azelastine
(azelastine
hydrochloride)
spray nasal
1mg/1ml,
10ml glass vial with pump
dispenser
MEDA Pharma
GmbH & Co. KG,
Benzstrasse 1, 61352
Bad Homburg - batch
releaser; MEDA
Manufacturing
GmbH, Neurather
Ring 1, Cologne,
51063, Germany -
bulk manufacturer,
packager
Germany R01AC03 15872/209.12.2016
11.08.2021OTC
MEDA Pharma
GmbH & Co. KG,
Benzstrasse 1, 61352
Bad Homburg,
Germany
146 Allergodil
azelastine
(azelastine
hydrochloride)
drops eye0,5mg/ml,
6ml plastic vial-dropper
MEDA Pharma
GmbH & Co. KG,
Benzstrasse 1, 61352
Bad Homburg - batch
releaser; Tubilux
Pharma S.p.A., Via
Costarica, 20/22,
00040 Pomezia/Rome,
Italy - bulk
manufacturer,
packager
Germany S01GX07 15873/124.09.2016
11.08.2021OTC
MEDA Pharma
GmbH & Co. KG,
Benzstrasse 1, 61352
Bad Homburg,
Germany
147 Allergosan
chloropyramine
(chloropyramine
hydrochloride)
ointment for
external use
10mg/g,
18g aluminium tube
Sopharma JSC, str.
Iliensko shosse 16,
1220 Sofia - batch
releaser, Sopharma
JSC, Vrabevo vlg.
5660, district of
Lovetch, Bulgaria-
bulk manufacturer,
primary and
secondary packager
Bulgaria D04AA09 1489524.09.2015
24.09.2020OTC
Sopharma JSC, str.
Iliensko shosse 16,
1220 Sofia, Bulgaria
30
148 Allergosan
chloropyramine
(chloropyramine
hydrochloride)
cream for external
use
10mg/g,
18g aluminium tube
Sopharma JSC, str.
Iliensko shosse 16,
1220 Sofia - batch
releaser, Sopharma
JSC, Vrabevo vlg.
5660, district of
Lovetch, Bulgaria-
bulk manufacturer,
primary and
secondary packager
Bulgaria D04AA09 1489624.09.2015
24.09.2020OTC
Sopharma JSC, str.
Iliensko shosse 16,
1220 Sofia, Bulgaria
149Allergosan 25mg
coated tablets
chloropyramine
(chloropyramine
hydrochloride)
tablets coated25mg,
in blister (20/1x20/)
Sopharma JSC, str.
Iliensko shosse 16,
1220 Sofia
Bulgaria R06AC03 1540709.03.2016
09.03.2021OTC
Sopharma JSC, str.
Iliensko shosse 16,
1220 Sofia, Bulgaria
150 Allochol
cattle bile dried,
dried garlic,
charcoal activated,
nettle leaves
tablets film-coated
80mg+40mg+25mg+ 5mg,
in blister (10/1x10/,
50/5x10/)
SIC Borshchahivskiy
Chemical-
Pharmaceutical Plant
PJSC, 17 Mira st.,
Kiev, 03134
Ukraine A05AX10 12844/104.05.2015
17.09.2018OTC
SIC Borshchahivskiy
Chemical-
Pharmaceutical Plant
PJSC, 17 Mira st.,
Kiev, 03134, Ukraine
151 Allochol
cattle bile dried,
dried garlic,
charcoal activated,
nettle leaves
tablets film-coated80mg+40mg+25mg+ 5mg,
in blister (10, 10/1x10/)
Pharmstandard-
Tomskchimpharm
OJSC, 634009, Tomsk,
avenue Lenina, 211
Russia A05AX 12952/122.01.2015
28.10.2018OTC
Pharmstandard-
Leksredstva OJSC,
305022, Kursk,
Agregatnaya 2nd str.,
1a/18, Russia
152 Allochol
cattle bile dried,
dried garlic,
charcoal activated,
nettle leaves
tablets coated
(80mg+40mg+
25mg+5mg),
in blister (10/1x10/),
in plastic container (50)
Irbitskiy
himfarmzavod JSC,
643 RU, Irbit, St.
Sverdlovsk, K. Marksa
str., 124
Russia A05AX 1358810.06.2014
10.06.2019OTC
Irbitskiy
himfarmzavod JSC,
643 RU, Irbit, St.
Sverdlovsk, Kirova
str., 172, Russia
153 Allopurinol allopurinol tablets300mg,
in blister (30/3x10/)
Arpimed LLC, Kotayk
Marz, Abovyan, 2nd
Micro-District, 19
Building
Republic of
ArmeniaM04AA01 12465
02.10.2013
02.10.2018PoM
Arpimed LLC,
Kotayk Marz,
Abovyan, 2nd Micro-
District, 19 Building,
Republic of Armenia
31
154 Allopurinol allopurinol tablets100mg,
in blister (30/3x10/)
Arpimed LLC, Kotayk
Marz, Abovyan, 2nd
Micro-District, 19
Building
Republic of
ArmeniaM04AA01 12865
17.09.2013
17.09.2018PoM
Arpimed LLC,
Kotayk Marz,
Abovyan, 2nd Micro-
District, 19 Building,
Republic of Armenia
155 Almagel
aluminium
hydroxide,
magnesium
hydroxide
suspension oral
43,6mg/ml+ 70mg/ml,
170ml glass or plastic
bottle and measuring
spoon 5ml, 10ml sachets
(10, 20)
Balkanpharma-
Troyan AD
(Krayrechna Str. N1,
5600, Troyan)
Bulgaria A02AB10 1297428.10.2013
28.10.2018OTC
Balkanpharma-
Troyan AD,
(ACTAVIS GROUP)
(Krayrechna Str. N1,
5600, Troyan,
Bulgaria)
156 Almagel A
aluminium
hydroxide,
magnesium
hydroxide,
benzocaine
suspension oral
436mg/ml+ 70mg/ml+
21,8mg/ml,
170ml glass or plastic
bottle and measuring
spoon 5ml, 10ml sachets
(10, 20)
Balkanpharma-
Troyan AD,
Krayrechna Str. N1,
5600, Troyan
Bulgaria A02AB10 1301725.11.2013
25.11.2018OTC
Balkanpharma-
Troyan AD,
(ACTAVIS GROUP)
Krayrechna Str. N1,
5600, Troyan,
Bulgaria
157 Almagel NEO
aluminium
hydroxide,
magnesium
hydroxide,
simethicone
suspension oral
340mg/5ml+ 395mg/5ml+
36mg/5ml,
170ml plastic bottle and
measuring spoon,
10ml sachets (10, 20)
Balkanpharma-
Troyan AD,
Krayrechna Str. N1,
5600, Troyan
Bulgaria A02AF02 1669123.05.2017
23.05.2022OTC
Balkanpharma-
Troyan AD,
(ACTAVIS GROUP)
Krayrechna Str. N1,
5600, Troyan,
Bulgaria
158 Alotendin
bisoprolol
(bisoprolol
fumarate),
amlodipine
(amlodipine
besilate)
tablets
5mg+5mg,
in blister, (28/4x7/,
30/3x10/, 56/8x7/,
90/9x10/)
Egis Pharmaceuticals
PLC, 1165 Budapest,
Bokenyfoldi st. 118-
120
Hungary C07FB 1404619.12.2014
19.12.2019PoM
Egis Pharmaceuticals
PLC, 1106 Budapest,
Kereszturi st. 30-38,
Hungary
159 Alotendin
bisoprolol
(bisoprolol
fumarate),
amlodipine
(amlodipine
besilate)
tablets
5mg+10mg,
in blister, (28/4x7/,
30/3x10/, 56/8x7/,
90/9x10/)
Egis Pharmaceuticals
PLC, 1165 Budapest,
Bokenyfoldi st. 118-
120
Hungary C07FB 1404719.12.2014
19.12.2019PoM
Egis Pharmaceuticals
PLC, 1106 Budapest,
Kereszturi st. 30-38,
Hungary
32
160 Alotendin
bisoprolol
(bisoprolol
fumarate),
amlodipine
(amlodipine
besilate)
tablets
10mg+5mg,
in blister, (28/4x7/,
30/3x10/, 56/8x7/,
90/9x10/)
Egis Pharmaceuticals
PLC, 1165 Budapest,
Bokenyfoldi st. 118-
120
Hungary C07FB 1404819.12.2014
19.12.2019PoM
Egis Pharmaceuticals
PLC, 1106 Budapest,
Kereszturi st. 30-38,
Hungary
161 Alotendin
bisoprolol
(bisoprolol
fumarate),
amlodipine
(amlodipine
besilate)
tablets
10mg+10mg,
in blister, (28/4x7/,
30/3x10/, 56/8x7/,
90/9x10/)
Egis Pharmaceuticals
PLC, 1165 Budapest,
Bokenyfoldi st. 118-
121
Hungary C07FB 1404919.12.2014
19.12.2019PoM
Egis Pharmaceuticals
PLC, 1106 Budapest,
Kereszturi st. 30-38,
Hungary
162 Altargo retapamulin ointment10mg/g,
5g aluminium tube
Glaxo Operations UK
Ltd. (trading as Glaxo
Wellcome
Operations), Harmire
Road, Barnard Castle,
Durham, DL12 8DT
UK D06AX13 1334913.03.2014
13.03.2019PoM
Glaxo Group Ltd.,
980 Great West Road,
Brentford, Middlesex,
TW8 9GS, UK
163 Altemarshmallow root
extractsyrup
349mg/g,
125g glass or plastic bottle
and measuring cup
Pharmaceutical
Manufacturing
Enterprise GEMI, 05-
480 Karczew,
Mickiewicza 36 str.
PolandR05CA05;
herbal drug14588
08.06.2015
08.06.2020OTC
Pharmaceutical
Manufacturing
Enterprise GEMI, 05-
480 Karczew,
Mickiewicza 36 str.,
Poland
164 Alteyka Arteriumalthaeae radix dry
extractsyrup
7,5mg/5ml,
100ml plastic or glass
bottle and measuring
spoon, 100ml plastic or
glass container and
measuring spoon, 200ml
plastic or glass bottle and
measuring spoon
Halychpharm JSC,
79024, city of Lviv, st.
Oprishkovskaya, 6/8
UkraineR05CA05;
herbal drug17207
08.12.2017
08.12.2022OTC
Halychpharm JSC,
79024, city of Lviv, st.
Oprishkovskaya, 6/8,
Ukraine
33
165 Aluvia lopinavir, ritonavir tablets film-coated100mg+25mg,
in plastic container (60)
AbbVie Deutschland
GmbH & Co. KG,
Knolstrasse, 67061
Ludwigshafen
Germany J05AE06 1525229.12.2015
29.12.2020PoM
AbbVie
Biopharmaceuticals
GmbH, Neuhofstrasse
23, 6341 Baar,
Switzerland
166 Aluvia lopinavir, ritonavir tablets film-coated 200mg+50mg,
in plastic container (120)
AbbVie Deutschland
GmbH & Co. KG,
Knolstrasse, 67061
Ludwigshafen
Germany J05AR10 1693023.08.2017
23.08.2022PoM
AbbVie
Biopharmaceuticals
GmbH, Neuhofstrasse
23, 6341 Baar,
Switzerland
167 Alzepil
donepezil
(donepezil
hydrochloride)
tablets coated
5mg,
in blister (28/2x14/,
56/4x14/)
Egis Pharmaceuticals
PLC, 1165 Budapest,
Bokenyfoldi st. 118-
120
Hungary N06DA02 13710/115.10.2015
24.07.2019PoM
Egis Pharmaceuticals
PLC, 1106 Budapest,
Kereszturi st. 30-38,
Hungary
168 Alzepil
donepezil
(donepezil
hydrochloride)
tablets coated
10mg,
in blister (28/2x14/,
56/4x14/)
Egis Pharmaceuticals
PLC, 1165 Budapest,
Bokenyfoldi st. 118-
120
Hungary N06DA02 13711/115.10.2015
24.07.2019PoM
Egis Pharmaceuticals
PLC, 1106 Budapest,
Kereszturi st. 30-38,
Hungary
169 Amaryl glimepiride tablets 1mg,
in blister (30/1x30/)
SANOFI S.P.A., S.S.
17 km 22, 67019
Scoppito (AQ)
Italy A10BB12 1692109.08.2017
09.08.2022PoM
Sanofi-Aventis
Deutschland GmbH,
Bruningstrasse 50, D-
65926 Frankfurt am
Main, Germany
170 Amaryl glimepiride tablets 4mg,
in blister (30/2x15/)
SANOFI S.P.A., S.S.
17 km 22, 67019
Scoppito (AQ)
Italy A10BB12 1692209.08.2017
09.08.2022PoM
Sanofi-Aventis
Deutschland GmbH,
Bruningstrasse 50, D-
65926 Frankfurt am
Main, Germany
171 Amaryl glimepiride tablets 2mg,
in blister (30/2x15/)
SANOFI S.P.A., S.S.
17 km 22, 67019
Scoppito (AQ)
Italy A10BB12 1692309.08.2017
09.08.2022PoM
Sanofi-Aventis
Deutschland GmbH,
Bruningstrasse 50, D-
65926 Frankfurt am
Main, Germany
34
172 Amaryl glimepiride tablets 3mg,
in blister (30/2x15/)
SANOFI S.P.A., S.S.
17 km 22, 67019
Scoppito (AQ)
Italy A10BB12 1692409.08.2017
09.08.2022PoM
Sanofi-Aventis
Deutschland GmbH,
Bruningstrasse 50, D-
65926 Frankfurt am
Main, Germany
173 Amaryl M
glimepiride,
metformin
(metformin
hydrochloride)
tablets film-coated2mg+500mg, blisters
(30/3x10/)
Handok Inc., 78
Daepungsandan-ro,
Daeso-myeon,
Eumseong-gun,
Chungcheongbuk-do,
Korea South
Korea South A10AE04 14305/125.07.2016
03.03.2020PoM
Sanofi-aventis group,
54, rue La Boetie,
75008 Paris, France
174 Amaryl M SR
glimepiride,
metformin
(metformin
hydrochloride)
tablets prolonged-
release film-coated
2mg+500mg,
in blister (30/3x10/)
Handok
Pharmaceuticals Co.
Ltd., 37, Daepung-ri,
Daeso-myeon,
Eumseong-gun,
Chungcheongbuk-do
Korea Sourth A10BD02 1249301.06.2013
01.06.2018PoM
Sanofi-Aventis, 20
avenue Raymond
Aron, 92165 Antony
Cedex, France
175 Ambrohexal
ambroxol
(ambroxol
hydrochloride)
tablets30mg,
blisters (20/1x20/)
Salutas Pharma
GmbH, Otto-von-
Guericke Allee 1,
39179 Barleben
Germany R05CB06 14171/130.01.2017
16.01.2020OTC
Hexal AG,
Industriestrasse 25, D-
83607 Holzkirchen,
Germany
176 Ambrohexal syrup
ambroxol
(ambroxol
hydrochloride)
syrup
3mg/ml,
100ml glass bottle and
measuring spoon
Salutas Pharma
GmbH, Otto-von-
Guericke-Alle-1,
39179 Barleben-
batch releaser,
Lichtenheldt GmbH,
Pharmazeutische
Fabrik,
Industriestrasse 7-10,
23812 Wahlstedt,
Germany-bulk
manufacturer,
packager
Germany R05CB06 14368/120.05.2017
25.03.2020OTC
Hexal AG,
Industriestrasse 25, D-
83607, Holzkirchen,
Germany
177 Ambroton
ambroxol
(ambroxol
hydrochloride)
syrup
15mg/5ml,
100ml glass bottle and
measuring spoon
Arpimed LLC, Kotayk
Marz, Abovyan, 2nd
Micro-District, 19
Building
Republic of
ArmeniaR05CB06 15663
08.06.2016
08.06.2021OTC
"Tonus-Les " LLC,
Yerevan, 1 Yervand
Kochar str., 0070,
Republic of Armenia
35
178 Ambroxol
ambroxol
(ambroxol
hydrochloride)
tablets30mg,
blisters (20/2x10/)
Kievmedpreparat
PJSC, 01032, Kiev,
Saksaganskogo street,
139
Ukraine R05CB06 12840/127.01.2017
17.09.2018OTC
Kievmedpreparat
PJSC, 01032, Kiev,
Saksaganskogo street,
139, Ukraine
179 Ambroxol
ambroxol
(ambroxol
hydrochloride)
tablets30mg,
in blister (20/2x10/)
Open joint stock
company "Borisovskiy
zavod medicinskikh
preparatov" 64,
Chapaev str., Borisov
222518, Minsk region
Belarus R05CB06 1580020.07.2016
20.07.2021OTC
Open joint stock
company "Borisovskiy
zavod medicinskikh
preparatov" 64,
Chapaev str., Borisov
222518, Minsk
region, Belarus
180 Ambroxol
ambroxol
(ambroxol
hydrochloride)
syrup
3mg/ml,
100ml plastic bottle and
measuring spoon
S.C. Rompharm
Company S.R.L.,
Ilfov, 075100
Otopeni, Str. Eroilor,
Nr. 1A
Romania R05CB06 1715707.11.2017
07.11.2022OTC
S.C. Rompharm
Company S.R.L.,
Ilfov, 075100
Otopeni, Str. Eroilor,
Nr. 1A, Romania
181Ambroxol
hydrochloride
ambroxol
(ambroxol
hydrochloride)
tablets30mg,
in blister (20/2x10/)
SIC "Borshchahivskiy
Chemical-
Pharmaceutical Plant"
PJSC, 17, Mira St,
Kyiv, 03134
Ukraine R05CB06 1648301.03.2017
01.03.2022OTC
SIC "Borshchahivskiy
Chemical-
Pharmaceutical
Plant" PJSC, 17, Mira
St, Kyiv, 03134,
Ukraine
182
AMBROXOL
SOPHARMA
15mg/5ml syrup
ambroxol
(ambroxol
hydrochloride)
syrup
15mg/5ml,
100ml glass bottle and
plastic measuring cup,
100ml plastic bottle and
plastic measuring cup
Sopharma JSC, str.
Iliensko shosse 16,
1220 Sofia - batch
releaser, Sopharma
JSC, Vrabevo vlg.
5660, district of
Lovetch, Bulgaria-
bulk manufacturer,
packager
Bulgaria R05CB06 15460/109.12.2016
02.04.2021OTC
Sopharma JSC, str.
Iliensko shosse 16,
1220 Sofia, Bulgaria
36
183Ambroxol-
Hemofarm
ambroxol
(ambroxol
hydrochloride)
syrup
15mg/5ml,
100ml glass bottle and
5ml measuring spoon
Hemofarm A.D.,
26300 Vrsac,
Beogradskii put bb-
batch releaser,
Hemofarm A.D.
Vrsac, branch plant
Sabac, 15000, Sabac,
Hajduk Veljkova str.
No: bb, Serbia-bulk
manufacturer,
packager
Serbia R05CB06 1551719.04.2016
19.04.2021OTC
Hemofarm A.D.,
26300 Vrsac,
Beogradskii put bb,
Serbia
184 Amikacinamikacin (amikacin
sulfate)
powder for solution
for i/v and i/m
injection
500mg,
10ml glass vial (50)
"Sintez" OJSC, Pr.
Konstitutsii, No. 7,
Kurgan, 640008
Russia J01GB06 1713307.11.2017
07.11.2022PoM
"Sintez" OJSC, Pr.
Konstitutsii, No. 7,
Kurgan, 640008,
Russia
185 Amikacinamikacin (amikacin
sulfate)
powder for solution
for i/v and i/m
injection
1000mg,
10ml glass vial (50)
"Sintez" OJSC, Pr.
Konstitutsii, No. 7,
Kurgan, 640008
Russia J01GB06 1713407.11.2017
07.11.2022PoM
"Sintez" OJSC, Pr.
Konstitutsii, No. 7,
Kurgan, 640008,
Russia
186Amikaton
500mg/2ml
amikacin (amikacin
sulfate)
solution for
injection/infusion
500mg/2ml,
2ml ampoules (10)
Medochemie Ltd., 48
Iapetou street, Agios
Athanassios Industrial
Area, 4101 Agios
Athanassios, Limassol
Cyprus J01GB06 1496418.11.2015
18.11.2020PoM
Medochemie Ltd., 1-
10
Constantinoupoleos
street, 3011 Limassol,
Cyprus
187 Amiksin tilorone tablets film-coated125mg,
blister (6/1x6/, 10/1x10/)
Pharmstandard-
Tomskchimpharm
OJSC, 634009, Tomsk,
avenue Lenina, 211
Russia J05AX 14563/120.07.2016
09.06.2020OTC
OTCPharm PJSC,
123317, Moscow,
Testovskaya str., 10,
Russia
188 Amiksin tilorone tablets film-coated60mg,
blister (10/1x10/)
Pharmstandard-
Tomskchimpharm
OJSC, 634009, Tomsk,
avenue Lenina, 211
Russia J05AX 14564/120.07.2016
09.06.2020OTC
OTCPharm PJSC,
123317, Moscow,
Testovskaya str., 10,
Russia
37
189 Amiksin tilorone tablets film-coated
125mg,
in blister (3/1x3/, 6/1x6/,
10/1x10/, 6/2x3/, 12/2x6/,
20/2x10/)
Pharmstandard-
Leksredstva JSC,
305022, Kursk,
Agregatnaya 2nd str.,
1a/18
Russia J05AX 1687708.08.2017
08.08.2022OTC
OTCPharm PJSC,
123317, Moscow,
Testovskaya str., 10,
Russia
190 Amiksin tilorone tablets film-coated
60mg,
in blister (6/1x6/,
10/1x10/, 12/2x6/,
20/2x10/)
Pharmstandard-
Leksredstva JSC,
305022, Kursk,
Agregatnaya 2nd str.,
1a/18
Russia J05AX 1687808.08.2017
08.08.2022OTC
OTCPharm PJSC,
123317, Moscow,
Testovskaya str., 10,
Russia
191Aminazin-
Zdorovye
chlorpromazine
(chlorpromazine
hydrochloride)
tablets film-coated
25mg,
in blister (20, 20/1x20/,
20/2x10/)
Pharmaceutical
Company "Zdorovye"
LLC, 61013, Kharkov,
Shevchenko str., 22
Ukraine N05AA01 1694505.09.2017
05.09.2022PoM/UC4
Pharmaceutical
Company "Zdorovye"
LLC, 61013, Kharkov,
Shevchenko str., 22,
Ukraine
192Aminoplasmal
B.Braun E10
isoleucine, leucine,
lysine (lysine
hydrochloride),
methionine,
phenylalanine,
threonine,
tryptophan, valine,
arginine, histidine,
alanine, glycine,
aspartic acid,
glutamic acid,
proline, serine,
tyrosine, sodium
acetate trihydrate,
sodium hydroxide,
potassium acetate,
magnesium
chloride
hexahydrate,
disodium phosphate
dodecahydrate
solution for infusion
5mg/ml+8.9mg/ml+8.56m
g/ml+ 4.4mg/ml+
4.7mg/ml+ 4.2mg/ml+
1.6mg/ml+ 6.2mg/ml+
11.5mg/ml+ 3mg/ml+
10.5mg/ml+ 12mg/ml+
5.6mg/ml+ 7.2mg/ml+
5.5mg/ml+ 2.3mg/ml+
0.4mg/ml+ 2.858mg/ml+
0.36mg/ml+ 2.453mg/ml+
0.508mg/ml+
3.581mg/ml, 500ml glass
bottles (10)
B.Braun Melsungen
AG, Carl-Braun-
Strasse 1, 34212
Melsungen
Germany B05BA10 1567708.06.2016
08.06.2021PoM
B.Braun Melsungen
AG, Carl-Braun-
Strasse 1, 34212
Melsungen, Germany
38
193 Aminosalicylic acid
sodium 4-
aminosalicylic acid
(sodium 4-
aminosalicylate
dihydrate)
powder lyophilized
for solution for
infusion
13490mg,
500ml glass vial 13,49g
Sanjivani Paranteral
Limited R-40, T.T.C.
Rabele, Thane-
Belapur Road, Navi
Mumbai Pin 400 701
India J04AA01 1223407.03.2013
07.03.2018PoM
Sanjivani Paranteral
Limited, 205, P.N.
Kothari Industrial
Estate, L.B.S. Marg,
Bhandup (W),
Mumbai-400 078,
India
194 Aminosol-Neo
L-isoleucine, L-
leucine, L-valine, L-
lysine (L-lysine
monoacetate), L-
methionine, L-
threonine, L-
phenylalanine, L-
alanine, L-arginine,
glicine, L-histidine,
L-proline, L-serine,
L-tyrosine, taurine,
L-tryptophan
solution for infusion
5mg/ml+7.4mg/ml+6.2mg
/ml+ 6.6mg/ml+
4.3mg/ml+ 4.4mg/ml+
5.1mg/ml+
14mg/ml+12mg/ml+11mg
/ml+3mg/ml+ 11.2mg/ml+
6.5mg/ml+ 0.4mg/ml+
1mg/ml+2mg/ml, 500ml
glass vial
Hemofarm A.D.
26300, Vrsac,
Beogradskii put bb-
batch releaser,
Hemomont d.o.o.,
81000,Podgorica, Ilije
Plamenca str. bb,
Montenegro-bulk
manufacturere,
packager
Serbia B05BA01 1625919.12.2016
19.12.2021PoM
Hemofarm A.D.,
26300, Vrsac,
Beogradskii put bb,
Serbia
195 Aminoven
L-isoleucine, L-
leucine, L-lysine
(lysine acetate), L-
methionine, L-
phenylalanine, L-
threonine, L-
triyptophan, L-
valine, L-arginine, L-
histidine, L-alanine,
glycine, L-proline,
L-serine, L-
tyrosine, taurine
solution for infusion
5mg/ml+7.4mg/ml+6.6mg
/ml+ 4.3mg/ml+
5.1mg/ml+ 4.4mg/ml+
2mg/ml+ 6.2mg/ml+
12mg/ml+
3mg/ml+14mg/ml+
11mg/ml+ 11.2mg/ml+
6.5mg/ml+
0.4mg/ml+1mg/ml, 500ml
glass bottle (10)
Fresenius Kabi
Austria GmbH,
Hafnerstrasse 36, 8055
Graz
Germany B05BA01 1464303.07.2015
03.07.2020PoM
Fresenius Kabi
Deutschland GmbH,
61346 Bad Homburg,
v.d.H, Germany
39
196 Aminoven
L-isoleucine, L-
leucine, L-lysine
(lysine acetate), L-
methionine, L-
phenylalanine, L-
threonine, L-
triyptophan, L-
valine, L-arginine, L-
histidine, L-alanine,
glycine, L-proline,
L-serine, L-
tyrosine, taurine
solution for infusion
5.2mg/ml+ 8.9mg/ml+
11.1mg/ml+ 3.8mg/ml+
5.5mg/ml+ 8.6mg/ml+
1.6mg/ml+ 5.5mg/ml+
20mg/ml+ 7.3mg/ml+
25mg/ml+ 18.5mg/ml+
17mg/ml+ 9.6mg/ml+
0.4mg/ml+2mg/ml,
500ml glass bottles (10)
Fresenius Kabi
Austria GmbH,
Hafnerstrasse 36, 8055
Graz
Germany B05BA01 1464403.07.2015
03.07.2020PoM
Fresenius Kabi
Deutschland GmbH,
61346 Bad Homburg,
v.d.H, Germany
197 Aminoven infant
L-isoleucine, L-
leucine, L-lysine
(lysine
monoacetate), L-
methionine, L-
phenylalanine, L-
threonine, L-
triyptophan, L-
valine, L-arginine, L-
histidine, glycine, L-
alanine, L-proline,
L-serine, taurine, L-
cysteine (N-acetyl L-
cysteine), L-
tyrosine (N-acetyl L-
tyrosine), L-malic
acid
solution for infusion
8mg/ml+13mg/ml+8.51m
g/ml+ 3.12mg/ml+
3.75mg/ml+ 4.4mg/ml+
2.01mg/ml+ 9mg/ml+
7.5mg/ml+ 4.76mg/ml+
4.15mg/ml+ 9.3mg/ml+
9.71mg/ml+ 7.67mg/ml+
0.4mg/ml+ 0.52mg/ml+
4.2mg/ml+ 2.62mg/ml,
100ml glass bottle (10)
Fresenius Kabi
Austria GmbH,
Hafnerstrasse 36, 8055
Graz
Germany B05BA01 1464203.07.2015
03.07.2020PoM
Fresenius Kabi
Deutschland GmbH,
61346 Bad Homburg,
v.d.H, Germany
198 Amiodaron
amiodarone
(amiodarone
hydrochloride)
solution for injection
50mg/ml,
3ml ampoules (10/2x5/,
10) label banderol, 3ml
ampoules dividella (10)
Open Joint Stock
Company , 64/27,
Chapayev str., Borisov
222120, Minsk oblast
Belarus C01BD01 1282917.09.2013
17.09.2018PoM
Open Joint Stock
Company , 64/27,
Chapayev str.,
Borisov 222120,
Minsk oblast, Belarus
40
199Amiodarone
100mg Tablets
amiodarone
(amiodarone
hydrochloride)
tablets100mg,
in blister (28/2x14/)
Accord Healthcare
Limited, Sage House,319
Pinner Road, North
Harrow, Middlesex, HA1
4HF- batch releaser, Intas
Pharmaceuticals Limited,
Plot No 457 & 458 &
191/218 P, Sarkhej-Bavla
Highway, Matoda Village,
Sanand, District-
Ahmedabad, 382 210,
Gujarat, India- bulk
manufacturer, Accord
Healthcare Limited, Unit C
& D, Homefield Business
Park, Homefield Road,
Haverhill, CB9 8QP, UK-
primary and secondary
packager
UK C01BD01 1514317.12.2015
17.12.2020PoM
Accord Healthcare
Limited, Sage
House,319 Pinner
Road, North Harrow,
Middlesex, HA1 4HF,
UK
200Amiodarone
200mg Tablets
amiodarone
(amiodarone
hydrochloride)
tablets200mg,
in blister (28/2x14/)
Accord Healthcare
Limited, Sage House,319
Pinner Road, North
Harrow, Middlesex, HA1
4HF- batch releaser, Intas
Pharmaceuticals Limited,
Plot No 457 & 458 &
191/218 P, Sarkhej-Bavla
Highway, Matoda Village,
Sanand, District-
Ahmedabad, 382 210,
Gujarat, India- bulk
manufacturer, Accord
Healthcare Limited, Unit C
& D, Homefield Business
Park, Homefield Road,
Haverhill, CB9 8QP, UK-
primary and secondary
packager
UK C01BD01 1514417.12.2015
17.12.2020PoM
Accord Healthcare
Limited, Sage
House,319 Pinner
Road, North Harrow,
Middlesex, HA1 4HF,
UK
201 Amipol-T amitraz, timolol strips wooden
6,75mg+0,8mg,
in aluminum pouch
(10/1x10/)
Agrobioprom CJSC,
143985, Moscow,
Balashikhinski
district, Novo-Milet
r/d, Poltevskoe shosse,
4
Russia
QP53AD51;
veterinary
drug
1676402.06.2017
02.06.2022OTC
Agrobioprom CJSC,
107139, Moscow,
pereulok
Orlikov,house 3,
Russia
41
202Amitriptylin
hydrochloride
amitriptyline
(amitriptyline
hydrochloride)
tablets25mg,
in blister (25, 50/5x10/)
KPE' Zdorovye
narodu' LLC,
Melnikova str., 41,
61002, Kharkov
Ukraine N06AA09 12869/118.01.2016
17.09.2018PoM
'KPE' Zdorovye
narodu' LLC,
Sevchenko str. 22,
61013, Kharkov,
Ukraine
203Amitriptylin
Zentiva
amitriptyline
(amitriptyline
hydrochloride)
tablets film-coated25mg,
in blister (50/5x10/)
Saneca
Pharmaceuticals. a.s.,
Nitrianska 100, 920 27
Hlohovec
Slovak Republic N06AA09 1719308.12.2017
08.12.2022PoM
Zentiva a.s.,
Einsteinova 24, 851
01 Bratislava, Slovak
Republic
204 Amitriptyline
amitriptyline
(amitriptyline
hydrochloride)
tablets coated25mg,
in blister (50/5x10/)
Experimental plant
GNCLS LLC, 61057,
Kharkov, Vorobeva
str., 8
Ukraine N06AA09 1303825.11.2013
25.11.2018PoM
Experimental plant
GNCLS LLC, 61057,
Kharkov, Vorobeva
str., 8, Ukraine
205 Amitriptyline
amitriptyline
(amitriptyline
hydrochloride)
tablets coated25mg,
in blister (50/5x10/)
PJSC "Technolog",
Manuylskogo str. 8,
20300
Uman,Cherkassy
region
Ukraine N06AA09 1358710.06.2014
10.06.2019PoM
PJSC "Technolog",
Manuylskogo str. 8,
20300
Uman,Cherkassy
region, Ukraine
206 Amitriptyline
amitriptyline
(amitriptyline
hydrochloride)
tablets coated25mg,
in blister (48/2x24/)
Arpimed LLC, Kotayk
Marz, Abovyan, 2nd
Micro-District, 19
Building
Republic of
ArmeniaN06AA09 13964
04.11.2014
04.11.2019PoM
Arpimed LLC,
Kotayk Marz,
Abovyan, 2nd Micro-
District, 19 Building,
Republic of Armenia
42
207
Amitriptyline
10mg Film-coated
Tablets
amitriptyline
(amitriptyline
hydrochloride)
tablets film-coated10mg,
in blister (28/2x14/)
Accord Healthcare
Limited, Sage House,319
Pinner Road, North
Harrow, Middlesex, HA1
4HF- batch releaser, Intas
Pharmaceuticals Limited,
Plot No 457 & 458 &
191/218 P, Sarkhej-Bavla
Highway, Matoda Village,
Sanand, District-
Ahmedabad, 382 210,
Gujarat, India- bulk
manufacturer, Accord
Healthcare Limited, Unit C
& D, Homefield Business
Park, Homefield Road,
Haverhill, CB9 8QP, UK-
primary and secondary
packager
UK N06AA09 1514017.12.2015
17.12.2020PoM
Accord Healthcare
Limited, Sage
House,319 Pinner
Road, North Harrow,
Middlesex, HA1 4HF,
UK
208
Amitriptyline
25mg Film-coated
Tablets
amitriptyline
(amitriptyline
hydrochloride)
tablets film-coated25mg,
in blister (28/2x14/)
Accord Healthcare
Limited, Sage House,319
Pinner Road, North
Harrow, Middlesex, HA1
4HF- batch releaser, Intas
Pharmaceuticals Limited,
Plot No 457 & 458 &
191/218 P, Sarkhej-Bavla
Highway, Matoda Village,
Sanand, District-
Ahmedabad, 382 210,
Gujarat, India- bulk
manufacturer, Accord
Healthcare Limited, Unit C
& D, Homefield Business
Park, Homefield Road,
Haverhill, CB9 8QP, UK-
primary and secondary
packager
UK N06AA09 1513917.12.2015
17.12.2020PoM
Accord Healthcare
Limited, Sage
House,319 Pinner
Road, North Harrow,
Middlesex, HA1 4HF,
UK
43
209 Amivit-Asteria
DL-methionine, L-
leucine, L-valine, L-
isoleucine, L-
threonine, L-
tryptophan, L-
phenylalanine, L-
lysine (L-lysine
hydrochloride),
vitamin A, vitamin
D2, vitamin E,
vitamin B1, vitamin
B2, vitamin B3,
vitamin B6, calcium
pantothenate,
vitamin B12, folic
acid, vitamin C
capsules
9,2mg+9,15mg+
5mg+5mg+5mg+
5mg+5mg+25mg+
1000IU+100IU+
10mg+2,5mg+
1,5mg+10mg+
5mg+2.5mg+
0,5mcg+100mcg+ 25mg,
in blister (30/3x10/)
Hankook Korus
Pharm Co., Ltd, 30,
Gangjeo-ro, Jecheon-
Si, Chungcheongbuk-
do
Korea South A11JC 1643506.03.2017
06.03.2022OTC
GL Corporation,
Woori Venture
Tower 201, 70,
Seonyu-ro,
YoungDeungPo-Ku,
Seoul, South Korea
210 Amlessa
perindopril
(perindopril tert-
butylamine),
amlodipine
(amlodipine
besilate)
tablets4mg+5mg,
in blister (30/3x10/)
KRKA d.d., Novo
mesto, Smarjeska
cesta 6, 8501 Novo
Mesto
Slovenia C09BB04 1314710.01.2014
10.01.2019PoM
KRKA d.d., Novo
mesto, Smarjeska
cesta 6, 8501 Novo
Mesto, Slovenia
211 Amlessa
perindopril
(perindopril tert-
butylamine),
amlodipine
(amlodipine
besilate)
tablets4mg+10mg,
in blister (30/3x10/)
KRKA d.d., Novo
mesto, Smarjeska
cesta 6, 8501 Novo
Mesto
Slovenia C09BB04 1314810.01.2014
10.01.2019PoM
KRKA d.d., Novo
mesto, Smarjeska
cesta 6, 8501 Novo
Mesto, Slovenia
212 Amlessa
perindopril
(perindopril tert-
butylamine),
amlodipine
(amlodipine
besilate)
tablets8mg+5mg,
in blister (30/3x10/)
KRKA d.d., Novo
mesto, Smarjeska
cesta 6, 8501 Novo
Mesto
Slovenia C09BB04 1314910.01.2014
10.01.2019PoM
KRKA d.d., Novo
mesto, Smarjeska
cesta 6, 8501 Novo
Mesto, Slovenia
44
213 Amlessa
perindopril
(perindopril tert-
butylamine),
amlodipine
(amlodipine
besilate)
tablets8mg+10mg,
in blister (30/3x10/)
KRKA d.d., Novo
mesto, Smarjeska
cesta 6, 8501 Novo
Mesto
Slovenia C09BB04 1315010.01.2014
10.01.2019PoM
KRKA d.d., Novo
mesto, Smarjeska
cesta 6, 8501 Novo
Mesto, Slovenia
214 Amlocim 10mg
amlodipine
(amlodipine
besilate)
tablets
10mg,
in blister (30/3x10/,
100/10x10/)
Acino Pharma AG,
Birsweg 2, 4253
Liesberg - packager,
batch releaser (dosage
form manufacturer -
Unichem Laboratories
Ltd., 17/18 Pilerne
Industrial Estate 403
511, Pilerne, Bardez,
India)
Switzerland C08CA01 13056/129.06.2015
25.11.2018PoM
Acino Pharma AG,
Birsweg 2, 4253
Liesberg, Switzerland
215 Amlocim 5mg
amlodipine
(amlodipine
besilate)
tablets
5mg,
in blister (30/3x10/,
100/10x10/)
Acino Pharma AG,
Birsweg 2, 4253
Liesberg - packager,
batch releaser (dosage
form manufacturer -
Unichem Laboratories
Ltd., 17/18 Pilerne
Industrial Estate 403
511, Pilerne, Bardez,
India)
Switzerland C08CA01 13055/129.06.2015
25.11.2018PoM
Acino Pharma AG,
Birsweg 2, 4253
Liesberg, Switzerland
216 Amlocor
amlodipine
(amlodipine
besilate)
tablets5mg,
in blister (30/3x10/)
ADIPHARM EAD,
130 Simeonovsko
shose Blvd., Sofia
1700
Bulgaria C08CA01 1346506.05.2014
06.05.2019PoM
ADIPHARM EAD,
130 Simeonovsko
shose Blvd., Sofia
1700, Bulgaria
217 Amlocor
amlodipine
(amlodipine
besilate)
tablets10mg,
in blister (30/3x10/)
ADIPHARM EAD,
130 Simeonovsko
shose Blvd., Sofia
1700
Bulgaria C08CA01 1346606.05.2014
06.05.2019PoM
ADIPHARM EAD,
130 Simeonovsko
shose Blvd., Sofia
1700, Bulgaria
45
218 Amlo-Denk 10
amlodipine
(amlodipine
mesilate
monohydrate)
tablets10mg,
in blister (50/5x10/)
Denk Pharma GmbH
& Co. KG, Goellstr. 1,
84529 Tittmoning
Germany C08CA01 1613210.11.2016
10.11.2021PoM
Denk Pharma GmbH
& Co. KG,
Prinzregentenstr. 79,
81675 Munchen,
Germany
219 Amlo-Denk 5
amlodipine
(amlodipine
mesilate
monohydrate)
tablets5mg,
in blister (50/5x10/)
Denk Pharma GmbH
& Co. KG, Goellstr. 1,
84529 Tittmoning
Germany C08CA01 1613310.11.2016
10.11.2021PoM
Denk Pharma GmbH
& Co. KG,
Prinzregentenstr. 79,
81675 Munchen,
Germany
220 Amlodigamma
amlodipine
(amlodipine
besilate)
tablets
5mg,
in blister (30/3x10/,
100/10x10/)
Woerwag Pharma
GmbH & Co. KG,
Calwer str. 7, 71034
Boblingen - batch
releaser (bulk
manufacturer,
packager - S.C.
Magistra C & C S.R.L.,
82A Aurel Vlaicu
Blvd. 900055
Constata, Romania)
Germany C08CA01 13270/102.06.2015
04.03.2019PoM
Woerwag Pharma
GmbH & Co. KG,
Calwer str. 7, 71034
Boblingen, Germany
221 Amlodigamma
amlodipine
(amlodipine
besilate)
tablets
10mg,
in blister (30/3x10/,
100/10x10/)
Woerwag Pharma
GmbH & Co. KG,
Calwer str. 7, 71034
Boblingen - batch
releaser (bulk
manufacturer,
packager - S.C.
Magistra C & C S.R.L.,
82A Aurel Vlaicu
Blvd. 900055
Constata, Romania)
Germany C08CA01 13271/102.06.2015
04.03.2019PoM
Woerwag Pharma
GmbH & Co. KG,
Calwer str. 7, 71034
Boblingen, Germany
222 Amlodipin
amlodipine
(amlodipine
besilate)
tablets5mg,
in blister (20/2x10/)
Replek Farm Ltd.-
Skopje, 188 str. Kozle,
1000 Skopje
Macedonia C08CA01 1328804.03.2014
04.03.2019PoM
Replek Farm Ltd.-
Skopje, 188 str. Kozle,
1000 Skopje,
Macedonia
46
223 Amlodipin
amlodipine
(amlodipine
besilate)
tablets10mg,
in blister (20/2x10/)
Replek Farm Ltd.-
Skopje Kozle 188,
1000 Skopje
Macedonia C08CA01 1328904.03.2014
04.03.2019PoM
Replek Farm Ltd.-
Skopje, 188 str. Kozle,
1000 Skopje,
Macedonia
224 Amlodipine
amlodipine
(amlodipine
besilate)
tablets10mg,
in blister (30/3x10/)
Arpimed LLC, Kotayk
Marz, Abovyan, 2nd
Micro-District, 19
Building
Republic of
ArmeniaC08CA01 13435
14.04.2014
14.04.2019PoM
Arpimed LLC,
Kotayk Marz,
Abovyan, 2nd Micro-
District, 19 Building,
Republic of Armenia
225 Amlodipine
amlodipine
(amlodipine
besilate)
tablets
5mg,
in blister (10/1x10/,
30/3x10/)
Belmedpreparaty
RUE, 220007, Minsk,
Fabritsius St., 30
Belarus C08CA01 1379805.09.2014
05.09.2019PoM
Belmedpreparaty
RUE, 220007, Minsk,
Fabritsius St., 30,
Belarus
226 Amlodipine
amlodipine
(amlodipine
besilate)
tablets5mg,
in blister (30/3x10/)
Arpimed LLC, Kotayk
Marz, Abovyan, 2nd
Micro-District, 19
Building
Republic of
ArmeniaC08CA01 14870
24.09.2015
24.09.2020PoM
Arpimed LLC,
Kotayk Marz,
Abovyan, 2nd Micro-
District, 19 Building,
Republic of Armenia
227 Amlodipine
amlodipine
(amlodipine
besilate)
tablets5mg,
in blister (30/3x10/)
Open joint stock
company "Borisovskiy
zavod medicinskikh
preparatov" 64,
Chapaev str., Borisov
222518, Minsk region
Belarus C08CA01 1590023.08.2016
23.08.2021PoM
Open joint stock
company "Borisovskiy
zavod medicinskikh
preparatov" 64,
Chapaev str., Borisov
222518, Minsk
region, Belarus
228 Amlodipine
amlodipine
(amlodipine
besilate)
tablets10mg,
in blister (30/3x10/)
Open joint stock
company "Borisovskiy
zavod medicinskikh
preparatov" 64,
Chapaev str., Borisov
222518, Minsk region
Belarus C08CA01 1590123.08.2016
23.08.2021PoM
Open joint stock
company "Borisovskiy
zavod medicinskikh
preparatov" 64,
Chapaev str., Borisov
222518, Minsk
region, Belarus
47
229Amlodipine 10mg
tablets
amlodipine
(amlodipine
besilate)
tablets10mg,
in blister (100/10x10/)
Lek Pharmaceuticals
d.d.,Trimlini 2D,
Lendava, 9220 -batch
releaser, packager,
Sandoz Grup Saglik
Ueruenleri Ilaclari
San. ve A.S., Gebze
Organized Industrial
Region Ihsan Dede,
Cadde No. 900 Sokak,
TR-41480, Gebze-
Kocaeli, Turkey-bulk
manufacturer
Slovenia C08CA01 1680222.06.2017
22.06.2022PoM
Sandoz
Pharmaceuticals d.d.,
Verovskova Str. 57,
1000 Ljubljana,
Slovenia
230Amlodipine 5mg
tablets
amlodipine
(amlodipine
besilate)
tablets5mg,
in blister (30/3x10/)
Lek Pharmaceuticals
d.d.,Trimlini 2D,
Lendava, 9220 -batch
releaser, packager,
Sandoz Grup Saglik
Ueruenleri Ilaclari
San. ve A.S., Gebze
Organized Industrial
Region Ihsan Dede,
Cadde No. 900 Sokak,
TR-41480, Gebze-
Kocaeli, Turkey-bulk
manufacturer
Slovenia C08CA01 1680122.06.2017
22.06.2022PoM
Sandoz
Pharmaceuticals d.d.,
Verovskova Str. 57,
1000 Ljubljana,
Slovenia
231Amlodipine-
Biocom
amlodipine
(amlodipine
besilate)
tablets
5mg,
in blister (10/1x10/,
12/1x12/, 20/2x10/,
24/2x12/, (30/3x10/,
36/3x12/, 40/4x10/,
48/4x12/, 50/5x10/,
60/5x12/, 60/6x10/,
(72/6x12/, 90/9x10/,
108/9x12/)
Biocom JSC, 54
Chapaevsky Cr.,
Stavropol, 355016
Russia C08CA01 12905/117.11.2014
07.10.2018PoM
Biocom JSC, 54
Chapaevsky Cr.,
Stavropol, 355016,
Russia
48
232Amlodipine-
Biocom
amlodipine
(amlodipine
besilate)
tablets
10mg,
in blister, (10/1x10/,
12/1x12/, 20/2x10/,
24/2x12/, (30/3x10/,
36/3x12/, 40/4x10/,
48/4x12/, 50/5x10/,
60/5x12/, 60/6x10/,
(72/6x12/, 90/9x10/,
108/9x12/)
Biocom JSC, 54
Chapaevsky Cr.,
Stavropol, 355016
Russia C08CA01 12906/117.11.2014
07.10.2018PoM
Biocom JSC, 54
Chapaevsky Cr.,
Stavropol, 355016,
Russia
233
Amlodipine-
Perindopril-
Richter
amlodipine
(amlodipine
besilate), perindipril
(perindopril tert-
butylamine)
tablets10mg+8mg,
in blister (30/3x10/)
Gedeon Richter PLC,
Gyomroi ut 19-21,
1103 Budapest - batch
releaser, Gedeon
Richter Poland Sp.z
o.o., ul.Graniczna
35,Grodzisk
Mazowiecki, 05-825,
Poland - bulk
manufacturer,
packager
Hungary C09BB04 1497918.11.2015
18.11.2020PoM
Gedeon Richter PLC,
Gyomroi ut 19-21,
1103 Budapest,
Hungary
234
Amlodipine-
Perindopril-
Richter
amlodipine
(amlodipine
besilate),
perindopril
(perindopril tert-
butylamine)
tablets10mg+4mg,
in blister (30/3x10/)
Gedeon Richter PLC,
Gyomroi ut 19-21,
1103 Budapest - batch
releaser, Gedeon
Richter Poland Sp.z
o.o., ul.Graniczna
35,Grodzisk
Mazowiecki, 05-825,
Poland - bulk
manufacturer,
packager
Hungary C09BB04 1498018.11.2015
18.11.2020PoM
Gedeon Richter PLC,
Gyomroi ut 19-21,
1103 Budapest,
Hungary
49
235
Amlodipine-
Perindopril-
Richter
amlodipine
(amlodipine
besilate),
perindopril
(perindopril tert-
butylamine)
tablets5mg+8mg,
in blister (30/3x10/)
Gedeon Richter PLC,
Gyomroi ut 19-21,
1103 Budapest - batch
releaser, Gedeon
Richter Poland Sp.z
o.o., ul.Graniczna
35,Grodzisk
Mazowiecki, 05-825,
Poland - bulk
manufacturer,
packager
Hungary C09BB04 1498118.11.2015
18.11.2020PoM
Gedeon Richter PLC,
Gyomroi ut 19-21,
1103 Budapest,
Hungary
236
Amlodipine-
Perindopril-
Richter
amlodipine
(amlodipine
besilate),
perindopril
(perindopril tert-
butylamine)
tablets5mg+4mg,
in blister (30/3x10/)
Gedeon Richter PLC,
Gyomroi ut 19-21,
1103 Budapest - batch
releaser, Gedeon
Richter Poland Sp.z
o.o., ul.Graniczna
35,Grodzisk
Mazowiecki, 05-825,
Poland - bulk
manufacturer,
packager
Hungary C09BB04 1498218.11.2015
18.11.2020PoM
Gedeon Richter PLC,
Gyomroi ut 19-21,
1103 Budapest,
Hungary
237Amlodipine-
Zdorovye
amlodipine
(amlodipine
besilate)
tablets
5mg,
in blister (20/2x10/,
30/3x10/)
Pharmaceutical
Company "Zdorovye"
LLC, 61013, Kharkov,
Shevchenko str., 22
Ukraine C08CA01 1657103.04.2017
03.04.2022PoM
Pharmaceutical
Company "Zdorovye"
LLC, 61013, Kharkov,
Shevchenko str., 22,
Ukraine
238Amlodipine-
Zdorovye
amlodipine
(amlodipine
besilate)
tablets
10mg,
in blister (20/2x10/,
30/3x10/)
Pharmaceutical
Company "Zdorovye"
LLC, 61013, Kharkov,
Shevchenko str., 22
Ukraine C08CA01 1657203.04.2017
03.04.2022PoM
Pharmaceutical
Company "Zdorovye"
LLC, 61013, Kharkov,
Shevchenko str., 22,
Ukraine
50
239 Amlofil 10
amlodipine
(amlodipine
besilate)
tablets
10mg,
in strip (50/5x10/,
100/10x10/)
Fourrts (India)
Laboratories Pvt. Ltd.,
Vandalur Road,
Kelambakkam,
Kancheepuram-603
103, Tamilnadu
India C08CA01 1381605.09.2014
05.09.2019PoM
Fourrts (India)
Laboratories Pvt.
Ltd., Vandalur Road,
Kelambakkam,
Kancheepuram-603
103, Tamilnadu, India
240 Amlofil 5
amlodipine
(amlodipine
besilate)
tablets
5mg,
in strip (50/5x10/,
100/10x10/)
Fourrts (India)
Laboratories Pvt. Ltd.,
Vandalur Road,
Kelambakkam,
Kancheepuram-603
103, Tamilnadu
India
D01AA01,
D07AB09,
D06AX04
1381505.09.2014
05.09.2019PoM
Fourrts (India)
Laboratories Pvt.
Ltd., Vandalur Road,
Kelambakkam,
Kancheepuram-603
103, Tamilnadu, India
241 Amlonor
amlodipine
(amlodipine
besilate)
tablets10mg,
in blister (30/3x10/)
Pharmaceutical
Works Polfa in
Pabianice JSC, 5
Marszalka J.
Pilsudskiego Str., 95-
200 Pabianice
Poland C08CA01 1615023.11.2016
23.11.2021PoM
Pharmaceutical
Works Polfa in
Pabianice JSC, 5
Marszalka J.
Pilsudskiego Str., 95-
200 Pabianice, Poland
242 Amlonor
amlodipine
(amlodipine
besilate)
tablets5mg,
in blister (30/3x10/)
Pharmaceutical
Works Polfa in
Pabianice JSC, 5
Marszalka J.
Pilsudskiego Str., 95-
200 Pabianice
Poland C08CA01 1615123.11.2016
23.11.2021PoM
Pharmaceutical
Works Polfa in
Pabianice JSC, 5
Marszalka J.
Pilsudskiego Str., 95-
200 Pabianice, Poland
243 Amlotenolatenolol,
amlodipinetablets
50mg+5mg,
in blister (50/5x10/)
Orion Pharma Ltd.,
Orion House, 153-154
Tejgaon Industrial
Area, Dhaka-1208
Bangladesh C07FB03 13629/101.09.2014
27.06.2019PoM
Orion Pharma Ltd.,
Orion House, 153-154
Tejgaon Industrial
Area, Dhaka-1208,
Bangladesh
51
244 Amlotop
amlodipine
(amlodipine
besilate)
tablets5mg,
in blister (30)
Makiz-Pharma LLC,
109029, Moscow, 6-5
Avtomobilny proezd
Russia C08CA01 1278014.08.2013
14.08.2018PoM
Nizhpharm OJSC,
603950, Nizhny
Novgorod, GSP-459,
Salganskaya st., 7,
Russia
245 Amlotop
amlodipine
(amlodipine
besilate)
tablets10mg,
in blister (30)
Makiz-Pharma LLC,
109029, Moscow, 6-5
Avtomobilny proezd
Russia C08CA01 1278114.08.2013
14.08.2018PoM
Nizhpharm OJSC,
603950, Nizhny
Novgorod, GSP-459,
Salganskaya st., 7,
Russia
246 Amlotop
amlodipine
(amlodipine
besilate)
tablets5mg,
in blister (30/1x30/)
Hemofarm LLC,
249030, Obninsk,
Kaluga Region, 62
Kievskoye highway
Russia C08CA01 1389006.10.2014
06.10.2019PoM
Nizhpharm OJSC,
603950, Nizhny
Novgorod, GSP-459,
Salganskaya st., 7,
Russia
247 Amlotop
amlodipine
(amlodipine
besilate)
tablets10mg,
in blister (30/1x30/)
Hemofarm LLC,
249030, Obninsk,
Kaluga Region, 62
Kievskoye highway
Russia C08CA01 1389106.10.2014
06.10.2019PoM
Nizhpharm OJSC,
603950, Nizhny
Novgorod, GSP-459,
Salganskaya st., 7,
Russia
248
Amoksiklav
156.25mg/5ml
powder for oral
suspension
amoxicillin
(amoxicillin
trihydrate),
clavulanic acid
(potassium
clavulanate)
powder for oral
suspension
125mg/5ml+
31,25mg/5ml,
glass bottle 100ml and
measuring spoon
Lek d.d., Perzonali 47,
2391 Prevalje Slovenia J01CR02 14320/1
02.06.2017
09.03.2020PoM
Lek d.d., Verovskova
str. 57, 1526
Ljubljana, Slovenia
249Amoksiklav
2x1000mg tablets
amoxicillin
(amoxicillin
trihydrate),
clavulanic acid
(potassium
clavulanate)
tablets film-coated
875mg+125mg,
in blister (10/2x5/,
14/2x7/)
Lek d.d., Perzonali 47,
2391 Prevalje Slovenia J01CR02 13909
17.10.2014
17.10.2019PoM
Lek d.d., Verovskova
str. 57, 1526
Ljubljana, Slovenia
52
250Amoksiklav
2x625mg tablets
amoxicillin
(amoxicillin
trihydrate),
clavulanic acid
(potassium
clavulanate)
tablets film-coated
500mg+125mg,
in blister (10/2x5/,
14/2x7/)
Lek d.d., Perzonali 47,
2391 Prevalje Slovenia J01CR02 13908
17.10.2014
17.10.2019PoM
Lek d.d., Verovskova
str. 57, 1526
Ljubljana, Slovenia
251Amoksiklav
312,5mg/5ml forte
amoxicillin
(amoxicillin
trihydrate),
clavulanic acid
(potassium
clavulanate)
powder for oral
suspension
250mg/5ml+ 62,5mg/5ml,
100ml glass bottle and
measuring spoon
Lek d.d., Perzonali 47,
2391 Prevalje Slovenia J01CR02 14366
25.03.2015
25.03.2020PoM
Lek d.d., Verovskova
str. 57, 1526
Ljubljana, Slovenia
252Amoksiklav 375mg
film-coated tablets
amoxicillin
(amoxicillin
trihydrate),
clavulanic acid
(potassium
clavulanate)
tablets film-coated250mg+125mg, glass
bottle (15)
Lek d.d., Perzonali 47,
2391 Prevalje Slovenia J01CR02 14315/1
02.06.2017
09.03.2020PoM
Lek d.d., Verovskova
str. 57, 1526
Ljubljana, Slovenia
253Amoksiklav 625mg
film-coated tablets
amoxicillin
(amoxicillin
trihydrate),
clavulanic acid
(potassium
clavulanate)
tablets film-coated500mg+125mg, glass
bottle (15)
Lek d.d., Perzonali 47,
2391 Prevalje Slovenia J01CR02 14314/1
02.06.2017
09.03.2020PoM
Lek d.d., Verovskova
str. 57, 1526
Ljubljana, Slovenia
254
Amoksiklav
powder for
solution for
injection 1000mg
/200mg
amoxicillin
(amoxicillin
sodium), clavulanic
acid (potassium
clavulanate)
powder for solution
for injection
1000mg+200mg, glass
vial (5)
Sandoz GmbH,
Biochemiestrasse 10,
A-6250 Kundl
Austria J01CR02 1607426.10.2016
26.10.2021PoM
Lek Pharmaceuticals
d.d., Verovskova Str.
57, 1526 Ljubljana,
Slovenia
255
Amoksiklav
powder for
solution for
injection
500mg/100mg
amoxicillin
(amoxicillin
sodium), clavulanic
acid (potassium
clavulanate)
powder for solution
for injection
500mg+100mg, glass vial
(5)
Sandoz GmbH,
Biochemiestrasse 10,
A-6250 Kundl
Austria J01CR02 1607526.10.2016
26.10.2021PoM
Lek Pharmaceuticals
d.d., Verovskova Str.
57, 1526 Ljubljana,
Slovenia
53
256Amoxicilin 250mg
capsules
amoxicillin
(amoxicillin
trihydrate)
capsules250mg,
in blister (20/2x10/)
Harbin
Pharmaceutical
Group Co., Ltd.,
General
Pharmaceutical
Factory,No 109 Xuefu
Road,Nangang
District., Harbin
China J01CA04 1266004.07.2013
04.07.2018PoM
Harbin
Pharmaceutical
Group Co., Ltd.,
General
Pharmaceutical
Factory,No 109 Xuefu
Road,Nangang
District., Harbin,
China
257Amoxicilin 500mg
capsules
amoxicillin
(amoxicillin
trihydrate)
capsules500mg,
in blister (20/2x10/)
Harbin
Pharmaceutical
Group Co., Ltd.,
General
Pharmaceutical
Factory,No 109 Xuefu
Road,Nangang
District., Harbin
China J01CA04 1266104.07.2013
04.07.2018PoM
Harbin
Pharmaceutical
Group Co., Ltd.,
General
Pharmaceutical
Factory,No 109 Xuefu
Road,Nangang
District., Harbin,
China
258 Amoxicillin amoxicillingranules for oral
suspension
250mg/5ml,
40g granules in 100ml
glass bottle and measuring
spoon 5ml
Hemofarm A.D.
26300, Vrsac,
Beogradskii put bb-
batch releaser,
Hemofarm A.D.,
Vrsac, 26224,
Dubovac, str. Cara
Lazara bb, Serbia-bulk
manufacturere,
packager
Serbia J01CA04 1617123.11.2016
23.11.2021PoM
Hemofarm A.D.,
26300, Vrsac,
Beogradskii put bb,
Serbia
259 Amoxicillin
amoxicillin
(amoxicillin
trihydrate)
capsules500mg,
in blister (100/10x10/)
Rusan Pharma Ltd.,
Plot No. 59 to 65,
Sector II, Kandla
Special Economic
Zone, Gandhidham,
Kutch, Gujarat State,
370230
India J01CA04 1686925.07.2017
25.07.2022PoM
Rusan Pharma Ltd.,
58-D, Government
Industrial Estate,
Charkop, Kandivali
(W), Mumbai 400
067, India
260 Amoxicillin
amoxicillin
(amoxicillin
trihydrate)
capsules 500mg,
in blister (20/2x10/)
NOKI JV LTD Co.,
Nor-Kharberd, Ararat
region
Republic of
Armenia J01CA04 16919
08.08.2017
08.08.2022PoM
NOKI JV LTD Co.,
Nor-Kharberd, Ararat
region, Republic of
Armenia
54
261 Amoxicillin 250mg
amoxicillin
(amoxicillin
trihydrate)
capsules250mg,
in bliste (100/10x10/)
Medopharm Private
Limited, No. 50
Kayarambedu Village,
Guduvanchery,
Chennai-603202
India J01CA04 1686410.07.2017
10.07.2022PoM
Troge Medical
GmbH, Milchstrasse
19, 20148 Hamburg,
Germany
262Amoxicillin
250mg/5ml
amoxicillin
(amoxicillin
trihydrate)
granules for oral
suspension
250mg/5ml,
40g granules in glass vial
for 100ml suspension
Hemofarm A.D.,
26224, Dubovac, str.
Cara Lazara bb
Serbia J01CA04 1355506.06.2014
06.06.2019PoM
Hemofarm A.D.,
26300, Vrsac,
Beogradskii put bb,
Serbia
263 Amoxicillin 500mg
amoxicillin
(amoxicillin
trihydrate)
capsules500mg,
in blister (100/10x10/)
Medopharm Private
Limited, No. 50
Kayarambedu Village,
Guduvanchery,
Chennai-603202
India J01CA04 1686510.07.2017
10.07.2022PoM
Troge Medical
GmbH, Milchstrasse
19, 20148 Hamburg,
Germany
264Amoxicillin-
Asteria Cap. 250mg
amoxicillin
(amoxicillin
trihydrate)
capsules250mg,
in blister (100/10x10/)
Chong Kun Dang
Pharmaceutical Corp,
15-20, Osaekdang-ri,
Seonggeo-Eup,
Cheonan-
si,Chungcheongnam-
do, 330-831
Korea Sourth J01CA04 1244107.05.2013
07.05.2018PoM
GL Corporation,
Woori Venture
Tower 201, 82-29,
MoonRae-Dong 3Ga,
YoungDeungPo-Ku,
Seoul, Korea (by
license of Hankook
Korus Pharm Co.,
Ltd, 1181, Geodu-ri,
Dongnae-myeon,
Chuncheon-si,
Gangwon-do, Korea)
265Amoxicillin-
Asteria Cap. 500mg
amoxicillin
(amoxicillin
trihydrate)
capsules500mg,
in blister (100/10x10/)
Chong Kun Dang
Pharmaceutical Corp,
15-20, Osaekdang-ri,
Seonggeo-Eup,
Cheonan-
si,Chungcheongnam-
do, 330-831 (by
license of Hankook
Korus Pharm Co., Ltd,
30, Gangjeo-ro,
Jecheon-si,
Chungcheongbuk-do,
Korea South)
Korea Sourth J01CA04 12442/106.07.2015
07.05.2018PoM
GL Corporation,
Woori Venture
Tower #201, 70,
Seonyu-ro,
Yeongdeungpo-ku,
Seoul, Korea South
55
266AmoxiClav-Denk
1000/125
amoxicillin
(amoxicillin
trihydrate),
clavulanic acid
(potassium
clavulanate)
powder for oral
suspension
1000mg+125mg, 3g
sachets, (8, 12)
PenCef Pharma
GmbH,
Breitenbachstrasse
13,13509 Berlin
Germany J01CR02 1600019.09.2016
19.09.2021PoM
Denk Pharma GmbH
& Co. KG,
Prinzregentenstr. 79,
81675 Muenchen,
Germany
267AmoxiClav-Denk
500/62,5
amoxicillin
(amoxicillin
trihydrate),
clavulanic acid
(potassium
clavulanate)
tablets film-coated500mg+62,5mg,
in blister (16/2x8/)
PenCef Pharma
GmbH,
Breitenbachstrasse
13,13509 Berlin
Germany J01CR02 1599919.09.2016
19.09.2021PoM
Denk Pharma GmbH
& Co. KG,
Prinzregentenstr. 79,
81675 Muenchen,
Germany
268 Amoxil
amoxicillin
(amoxicillin
trihydrate)
tablets250mg,
in blister (20/2x10/)
Kievmedpreparat
OJSC, 01032, Kiev,
Saksaganskogo street,
139
Ukraine J01CA04 1229522.03.2013
22.03.2018PoM
Kievmedpreparat
OJSC, 01032, Kiev,
Saksaganskogo street,
139, Ukraine
269 Amoxil
amoxicillin
(amoxicillin
trihydrate)
tablets500mg,
in blister (20/2x10/)
Kievmedpreparat
OJSC, 01032, Kiev,
Saksaganskogo street,
139
Ukraine J01CA04 1229622.03.2013
22.03.2018PoM
Kievmedpreparat
OJSC, 01032, Kiev,
Saksaganskogo street,
139, Ukraine
270 Amoxil
amoxicillin
(amoxicillin
trihydrate)
tablets500mg,
in blister (20/2x10/)
Kievmedpreparat
PJSC, 01032, Kiev,
Saksaganskogo street,
139
Ukraine J01CA04 1721408.12.2017
08.12.2022PoM
Kievmedpreparat
PJSC, 01032, Kiev,
Saksaganskogo street,
139, Ukraine
271 Amoxil
amoxicillin
(amoxicillin
trihydrate)
tablets250mg,
in blister (20/2x10/)
Kievmedpreparat
PJSC, 01032, Kiev,
Saksaganskogo street,
139
Ukraine J01CA04 1721508.12.2017
08.12.2022PoM
Kievmedpreparat
PJSC, 01032, Kiev,
Saksaganskogo street,
139, Ukraine
56
272Ampicilin sodium
for injection 1,0g
ampicillin
(ampicillin sodium)
powder for solution
for injection
1000mg,
glass vials (50)
Harbin
Pharmaceutical
Group Co., Ltd.
General
Pharmaceutical
Factory, No 109
Xuefu Road, Nangang
District., Harbin
China J01CA01 1372924.07.2014
24.07.2019PoM
Harbin
Pharmaceutical
Group Co., Ltd.
General
Pharmaceutical
Factory, No 109
Xuefu Road, Nangang
District., Harbin,
China
273 Ampicillinampicillin
(ampicillin sodium)
powder for solution
for injection
500mg,
glass vials (40)
Kievmedpreparat
PJSC, 01032, Kiev,
Saksaganskogo street,
139
Ukraine J01CA01 1596415.09.2016
15.09.2021PoM
Kievmedpreparat
PJSC, 01032, Kiev,
Saksaganskogo street,
139, Ukraine
274 Ampicillinampicillin
(ampicillin sodium)
powder for solution
for injection
1000mg,
glass vials (40)
Kievmedpreparat
PJSC, 01032, Kiev,
Saksaganskogo street,
139
Ukraine J01CA01 1596515.09.2016
15.09.2021PoM
Kievmedpreparat
PJSC, 01032, Kiev,
Saksaganskogo street,
139, Ukraine
275 Ampicillinampicillin
(ampicillin sodium)
powder for solution
for i/v and i/m
injection
500mg,
10ml glass vial (1, 50)
"Sintez" OJSC, Pr.
Konstitutsii, No. 7,
Kurgan, 640008
Russia J01CA01 1679122.06.2017
22.06.2022PoM
"Sintez" OJSC, Pr.
Konstitutsii, No. 7,
Kurgan, 640008,
Russia
276 Ampicillinampicillin
(ampicillin sodium)
powder for solution
for i/v and i/m
injection
1000mg,
10ml glass vial (1, 50)
"Sintez" OJSC, Pr.
Konstitutsii, No. 7,
Kurgan, 640008
Russia J01CA01 1679222.06.2017
22.06.2022PoM
"Sintez" OJSC, Pr.
Konstitutsii, No. 7,
Kurgan, 640008,
Russia
277Ampicillin
trihydrate
ampicillin
(ampicillin
trihydrate)
tablets250mg,
in blister (10)
Open Joint Stock
Company
<Borisovskiy zavod
Medicinckikh
Preparatov>, 64/27,
Chapayev str., Borisov
222120, Minsk oblast
Belarus J01CA01 1245007.05.2013
07.05.2018PoM
Open Joint Stock
Company
<Borisovskiy zavod
Medicinckikh
Preparatov>, 64/27,
Chapayev str.,
Borisov 222120,
Minsk oblast, Belarus
57
278 Amprilan ramipril tablets1,25mg,
in blister (30/3x10/)
KRKA d.d., Novo
mesto (Smarjeska
cesta 6, 8501 Novo
Mesto)
Slovenia C09AA05 1288707.10.2013
07.10.2018PoM
KRKA d.d., Novo
mesto (Smarjeska
cesta 6, 8501 Novo
Mesto, Slovenia)
279 Amprilan ramipril tablets2,5mg,
in blister (30/3x10/)
KRKA d.d., Novo
mesto (Smarjeska
cesta 6, 8501 Novo
Mesto)
Slovenia C09AA05 1288807.10.2013
07.10.2018PoM
KRKA d.d., Novo
mesto (Smarjeska
cesta 6, 8501 Novo
Mesto, Slovenia)
280 Amprilan ramipril tablets5mg,
in blister (30/3x10/)
KRKA d.d., Novo
mesto (Smarjeska
cesta 6, 8501 Novo
Mesto)
Slovenia C09AA05 1288907.10.2013
07.10.2018PoM
KRKA d.d., Novo
mesto (Smarjeska
cesta 6, 8501 Novo
Mesto, Slovenia)
281 Amprilan ramipril tablets10mg,
in blister (30/3x10/)
KRKA d.d., Novo
mesto (Smarjeska
cesta 6, 8501 Novo
Mesto)
Slovenia C09AA05 1289007.10.2013
07.10.2018PoM
KRKA d.d., Novo
mesto (Smarjeska
cesta 6, 8501 Novo
Mesto, Slovenia)
282 Amprilan HD
ramipril,
hydrochloro-
thiazide
tablets5mg+25mg,
in blister (30/3x10/)
KRKA d.d., Novo
mesto, Smarjeska
cesta 6, 8501 Novo
Mesto
Slovenia C09BA05 1362227.06.2014
27.06.2019PoM
KRKA d.d., Novo
mesto, Smarjeska
cesta 6, 8501 Novo
Mesto, Slovenia
283 Amprilan HL
ramipril,
hydrochloro-
thiazide
tablets2,5mg+12,5mg,
in blister (30/3x10/)
KRKA d.d., Novo
mesto, Smarjeska
cesta 6, 8501 Novo
Mesto
Slovenia C09BA05 1362127.06.2014
27.06.2019PoM
KRKA d.d., Novo
mesto, Smarjeska
cesta 6, 8501 Novo
Mesto, Slovenia
284 Anaesthesol
benzocaine,
bismuth subgallate,
zinc oxyde,
levomenthol
suppositories rectal100mg+40mg+
20mg+4mg, (10/2x5/)
Nizhpharm JSC,
603950, Nizhny
Novgorod,
Salganskaya st., 7
Russia C05A 1665411.05.2017
11.05.2022OTC
Nizhpharm JSC,
603950, Nizhny
Novgorod,
Salganskaya st., 7,
Russia
285 Anaferon
affinity purified
antibodies to
human interferon
gamma
tablets to be sucked
not more than 10^-15
ng/g,
in blister (20/1x20/)
NPF Materia Medica
Holding LLC, 54,
Buguruslanskaya st.,
Chelyabinsk 454139
Russia
L03;
homeopathic
drug
1570722.06.2016
22.06.2021OTC
NPF Materia Medica
Holding LLC, 9 bld.,
3rd Samotyochny
per., Moscow 127473,
Russia
58
286 Anaferon kids
affinity purified
antibodies to
human interferon
gamma
tablets to be sucked
not more than 10^-
16ng/g; (20/1x20/), in
blister
NPF Materia Medica
Holding LLC, 54,
Buguruslanskaya st.,
Chelyabinsk 454139
Russia
L03;
homeopathic
drug
1570022.06.2016
22.06.2021OTC
NPF Materia Medica
Holding LLC, 9 bld.,
3rd Samotyochny
per., Moscow 127473,
Russia
287 Analgin
metamizole
(metamizole
sodium)
tablets500mg,
in blister (10)
Marbiopharm JSC,
424006,The Republic
of Mari El,Yoshkar-
Ola, st. Karl Marx 121
Russia N02BB02 1239419.04.2013
19.04.2018OTC
Marbiopharm JSC,
424006,The Republic
of Mari El,Yoshkar-
Ola, st. Karl Marx
121, RUSSIA
288 Analgin
metamizole
(metamizole
sodium)
solution for injection500mg/ml,
2ml ampoules (10)
Yerevan Chemical-
Pharmaceutical firm
OJSC (Yerevan,
Ajaryan street, 2 Line,
No6)
Republic of
ArmeniaN02BB02 12934
07.10.2013
07.10.2018PoM
Yerevan Chemical-
Pharmaceutical firm
OJSC (Yerevan,
Ajaryan street, 2
Line, No6, Republic
of Armenia)
289 Analgin
metamizole
(metamizole
sodium)
tablets
500mg,
in blister (10),
in strip (10)
Arpimed LLC, Kotayk
Marz, Abovyan, 2nd
Micro-District, 19
Building
Republic of
ArmeniaN02BB02 13971
21.11.2014
21.11.2019OTC
Arpimed LLC,
Kotayk Marz,
Abovyan, 2nd Micro-
District, 19 Building,
Republic of Armenia
290 Analgin
metamizole
(metamizole
sodium)
tablets500mg,
in blister (10/1x10/)
Pharmstandard-
Leksredstva JSC,
305022, Kursk,
Agregatnaya 2nd str.,
1a/18
Russia N02BB02 1437025.03.2015
25.03.2020OTC
Pharmstandard-
Leksredstva JSC,
305022, Kursk,
Agregatnaya 2nd str.,
1a/18, Russia
291 Analgin
metamizole
(metamizole
sodium)
tablets
500mg,
in blister (10) and in strip
(10)
Irbitskiy
himfarmzavod JSC,
643 RU, Irbit, St.
Sverdlovsk, K. Marksa
str., 124
Russia N02BB02 1500802.12.2015
02.12.2020OTC
Irbitskiy
himfarmzavod JSC,
643 RU, Irbit, St.
Sverdlovsk, Kirova
str., 172, Russia
59
292 Analgin
metamizole
(metamizole
sodium)
solution for i/v and
i/m injection
500mg/ml,
2ml ampoules (10)
Open joint stock
company "Borisovskiy
zavod medicinskikh
preparatov" 64,
Chapaev str., Borisov
222518, Minsk region
Belarus N02BB02 1545002.04.2016
02.04.2021PoM
Open joint stock
company "Borisovskiy
zavod medicinskikh
preparatov" 64,
Chapaev str., Borisov
222518, Minsk
region, Belarus
293 Analgin
metamizole
(metamizole
sodium)
tablets500mg,
in blister (20/2x10/)
Sopharma JSC, str.
Iliensko shosse 16,
1220 Sofia
Bulgaria N02BB02 1684110.07.2017
10.07.2022OTC
Sopharma JSC, str.
Iliensko shosse 16,
1220 Sofia, Bulgaria
294 Analgin
metamizole
(metamizole
sodium)
tablets
500mg,
in blister (10),
in strip (10)
Tatchempharmprepar
aty JSC, 420091
Kazan, str.
Belomorskaya 260
Russia N02BB02 12947/1 03.08.2017
28.10.2018OTC
Tatchempharmprepar
aty JSC, 420091
Kazan, str.
Belomorskaya 260,
Russia
295 Analgin-Darnitsa
metamizole
(metamizole
sodium)
solution for injection
500mg/ml,
2ml ampoules,
in blister (10, 10/2x5/)
Darnitsa
Pharmaceutical Firm
PrJSC, 02093, Kiev,
Borisopolskaya Str.,13
Ukraine N02BB02 1234409.04.2013
09.04.2018PoM
Darnitsa
Pharmaceutical Firm
PrJSC, 02093, Kiev,
Borisopolskaya
Str.,13, Ukraine
296 Analgin-Darnitsa
metamizole
(metamizole
sodium)
tablets500mg,
in blister (10)
Darnitsa
Pharmaceutical Firm
PrJSC, 02093, Kiev,
Borispolskaya Str.,13
Ukraine N02BB02 12569/130.08.2013
06.06.2018OTC
Darnitsa
Pharmaceutical Firm
PrJSC, 02093, Kiev,
Borispolskaya Str.,13,
Ukraine
297 Analgin-Zdorovye
metamizole
(metamizole
sodium)
tablets
500mg,
in blister (6/1x6/,
10/1x10/, 6, 10)
Pharmaceutical
Company "Zdorovye"
LLC, 61013, Kharkov,
Shevchenko str., 22
Ukraine N02BB02 1631030.12.2016
30.12.2021OTC
Pharmaceutical
Company "Zdorovye"
LLC, 61013, Kharkov,
Shevchenko str., 22,
Ukraine
60
298 Anaprilin
propranolol
(propranolol
hydrochloride)
tablets
10mg,
blisters (50/5x10/,
50/2x25/)
Tatchempharmpre-
paraty JSC, 420091
Kazan, str.
Belomorskaya 260
Russia C07AA05 13810/130.05.2017
05.09.2019PoM
Tatchempharmpre-
paraty JSC, 420091
Kazan, str.
Belomorskaya 260,
Russia
299 Anaprilin
propranolol
(propranolol
hydrochloride)
tablets
40mg,
blisters (50/5x10/,
50/2x25/)
Tatchempharmpre-
paraty JSC, 420091
Kazan, str.
Belomorskaya 260
Russia C07AA05 13811/130.05.2017
05.09.2019PoM
Tatchempharmpre-
paraty JSC, 420091
Kazan, str.
Belomorskaya 260,
Russia
300 Anaprilin
propranolol
(propranolol
hydrochloride)
tablets40mg,
in blister (50/5x10/)
Open joint stock
company "Borisovskiy
zavod medicinskikh
preparatov" 64, ul.
Chapaeva, Borisov
222518, Minsk region
Belarus C07AA05 1659910.04.2017
10.04.2022PoM
Open joint stock
company "Borisovskiy
zavod medicinskikh
preparatov" 64, ul.
Chapaeva, Borisov
222518, Minsk
region, Belarus
301Anaprilin-
Zdorovye
propranolol
(propranolol
hydrochloride)
tablets
10mg,
in blister (50/1x50/,
50/5x10/),
in plastic container (50)
Pharmaceutical
Company "Zdorovye"
LLC, 61013, Kharkov,
Shevchenko str., 22
Ukraine C07AA05 1651617.03.2017
17.03.2022PoM
Pharmaceutical
Company "Zdorovye"
LLC, 61013, Kharkov,
Shevchenko str., 22,
Ukraine
302Anaprilin-
Zdorovye
propranolol
(propranolol
hydrochloride)
tablets
40mg,
in blister (50/1x50/,
50/5x10/),
in plastic container (50)
Pharmaceutical
Company "Zdorovye"
LLC, 61013, Kharkov,
Shevchenko str., 22
Ukraine C07AA05 1651717.03.2017
17.03.2022PoM
Pharmaceutical
Company "Zdorovye"
LLC, 61013, Kharkov,
Shevchenko str., 22,
Ukraine
303 Anastrozole anastrozole tablets film-coated 1mg,
in blister (30/3x10/)
Salutas Pharma
GmbH, Otto-von-
Guericke-Alle-1,
39179 Barleben
Germany L02BG03 1688508.08.2017
08.08.2022PoM
Sandoz
Pharmaceuticals d.d.,
Verovskova Str. 57,
1000 Ljubljana,
Slovenia
61
304Anastrozole
Denk 1anastrozole tablets film-coated
1mg,
in blister (30/3x10/)
Haupt Pharma
Munster GmbH
(Schleebruggenkamp
15, 48159 Munster)
Germany L02BG03 1298228.10.2013
28.10.2018PoM
Denk Pharma GmbH
& Co. KG
(Prinzregentenstr. 79,
81675 Munchen,
Germany)
305Anastrozole 1mg
film-coated tabletsanastrozole tablets film-coated
1mg,
in blister (28/2x14/)
Accord Healthcare
Limited, Sage House,319
Pinner Road, North
Harrow, Middlesex, HA1
4HF-batch releaser, Intas
Pharmaceuticals Limited,
Plot No 457 & 458 &
191/218 P, Sarkhej-Bavla
Highway, Matoda Village,
Sanand, District-
Ahmedabad, 382 210,
Gujarat, India-bulk
manufacturer, Accord
Healthcare Limited, Unit C
& D, Homefield Business
Park, Homefield Road,
Haverhill, CB9 8QP, UK-
primary and secondary
packager
UK L02BG03 1449018.05.2015
18.05.2020PoM
Accord Healthcare
Limited, Sage
House,319 Pinner
Road, North Harrow,
Middlesex, HA1 4HF,
UK
306 Anauran
lidocaine (lidocaine
hydrochloride),
neomycin
(neomycin sulfate),
polymyxin B
(polymyxin B
sulfate)
drops ear
4g/100ml+
0.5g(375000IU)/ 100ml+
1000000IU/100ml 25ml
glass bottle
Zambon S.P.A., Via
Della Chimica, 9,
Vicenza, 36100
Italy S02 1549612.04.2016
12.04.2021PoM
Zambon S.P.A., Via
Lillo Del Duca, 10,
Bresso, 20091, Italy
307 Ancodex 02
dexamethasone
(dexamethasone
sodium phosphate)
solution for injection
2,64mg/ml,
30ml, 50ml, 100ml glass
vial
KELA Laboratoria
NV, Sint-
Lenaartseweg 48,
Hoogstraten, 2320
Belgium
QH02AB02;
veterinary
drug
1703726.09.2017
26.09.2022PoM
Anupco LTD, IP7 6
RD, Suffolk,
Hadleigh, Crockatt
Road, Lady Lane
Industrial Estate, UK
62
308 Ancodoxin 75
doxycycline
(doxycycline
hyclate)
powder for oral
solution
750mg/g,
100g,1kg, 7.5kg pack
KELA Laboratoria
NV, Sint-
Lenaartseweg 48,
Hoogstraten, 2320
Belgium
QJ01AA02;
veterinary
drug
1703826.09.2017
26.09.2022PoM
Anupco LTD, IP7 6
RD, Suffolk,
Hadleigh, Crockatt
Road, Lady Lane
Industrial Estate, UK
309Ancomycine
200LA
oxytetracycline
(oxytetracycline
hydrochloride)
solution for injection
200mg/ml,
30ml, 50ml, 100ml glass
vial
KELA Laboratoria
NV, Sint-
Lenaartseweg 48,
Hoogstraten, 2320
Belgium
QG01AA07;
veterinary
drug
1703926.09.2017
26.09.2022PoM
Anupco LTD, IP7 6
RD, Suffolk,
Hadleigh, Crockatt
Road, Lady Lane
Industrial Estate, UK
310 Andipal
metamizole
(metamizole
sodium),
phenobarbital,
bendazol (bendazol
hydrochloride),
papaverine
(papaverine
hydrochloride)
tablets
250mg+20mg+
20mg+20mg,
in blister (10/1x10/)
Irbitskiy
himfarmzavod JSC,
643 RU, Irbit, St.
Sverdlovsk, K. Marksa
str., 124
Russia N02BB52 1363827.06.2014
27.06.2019OTC
Irbitskiy
himfarmzavod JSC,
643 RU, Irbit, St.
Sverdlovsk, Kirova
str., 172, Russia
311 Androcur
cyproterone
(cyproterone
acetate)
tablets10mg,
in blister (15/1x15/)
Bayer Weimer GmbH
und Co.KG,
Doebereinerstrasse
20, 99427, Weimer
Germany G03HA01 1442914.04.2015
14.04.2020PoM
Bayer Pharma AG,
Mullerstrasse 178,
13353, Berlin,
Germany
312 Androgel testosterone gel for external use10mg/g,
5g sachets (30)
Besins Manufacturing
Belgium SA, Groot
Bijgaardenstraat 128,
Drogenbos, B-1620 -
dosage form
manufacturer, batch
releaser (packager -
Enestia Belgium NV,
Klocknerstraat 13930
Hamont-Achel,
Limburg B-3930,
Belgium)
Belgium G03BA03 1304525.11.2013
25.11.2018PoM
Besins Healthcare SA,
Avenue Louise 287,
1050 Brussels,
Belgium
63
313 Anesteran isofluranesolution for
inhalation
100ml,
100ml glass bottle (1)
S.C. Rompharm
Company S.R.L.,
Ilfov, 75100 Otopeni,
Str. Eroilor, Nr. 1A
Romania N01AB06 1219501.02.2013
01.02.2018PoM
S.C. Rompharm
Company S.R.L.,
Ilfov, 75100 Otopeni,
Str. Eroilor, Nr. 1A,
ROMANIA
314 ANGAL
chlorhexidine
(chlorhexidine
dihydrochloride),
lidocaine (lidocaine
hydrochloride)
pastilles5mg+1mg,
in blister (24/2x12/)
Lek Pharmaceuticals
d.d., Verovskova Str.
57, 1526 Ljubljana-
batch releaser,
Laboratoria Qualiphar
NV, Rijksweg 9,
Bornem, B-2880,
Belgium-bulk
manufacturer,
packager
Slovenia R02A 1641610.02.2017
10.02.2022OTC
Lek Pharmaceuticals
d.d., Verovskova Str.
57, 1526 Ljubljana,
Slovenia
315 ANGAL LEMON
chlorhexidine
(chlorhexidine
dihydrochloride),
lidocaine (lidocaine
hydrochloride)
pastilles with lemon
flavour
5mg+1mg,
in blister (24/2x12/)
Lek Pharmaceuticals
d.d., Verovskova Str.
57, 1526 Ljubljana-
batch releaser,
Laboratoria Qualiphar
NV, Rijksweg 9,
Bornem, B-2880,
Belgium-bulk
manufacturer,
packager
Slovenia R02A 1641510.02.2017
10.02.2022OTC
Lek Pharmaceuticals
d.d., Verovskova Str.
57, 1526 Ljubljana,
Slovenia
316
ANGAL LEMON
spray for local
application
chlorhexidine
(chlorhexidine
digluconate),
lidocaine (lidocaine
hydrochloride)
spray for local
application with
lemon flavour
2mg/ml+0.5mg/ml, 30ml
glass bottle with
mechanical spray device
and spray nozzle
Lek Pharmaceuticals
d.d., Verovskova Str.
57, 1526 Ljubljana-
batch releaser,
Laboratoria Qualiphar
NV, Rijksweg 9,
Bornem, B-2880,
Belgium-bulk
manufacturer,
packager
Slovenia R02A 1626219.12.2016
19.12.2021OTC
Lek Pharmaceuticals
d.d., Verovskova Str.
57, 1526 Ljubljana,
Slovenia
64
317ANGAL S spray for
local application
chlorhexidine
(chlorhexidine
digluconate),
lidocaine (lidocaine
hydrochloride)
spray for local
application
2mg/ml+0.5mg/ml, 30ml
glass bottle with
mechanical spray device
and spray nozzle
Lek Pharmaceuticals
d.d., Verovskova Str.
57, 1526 Ljubljana-
batch releaser,
Laboratoria Qualiphar
NV, Rijksweg 9,
Bornem, B-2880,
Belgium-bulk
manufacturer,
packager
Slovenia R02A 1626119.12.2016
19.12.2021OTC
Lek Pharmaceuticals
d.d., Verovskova Str.
57, 1526 Ljubljana,
Slovenia
318 Anginovag
dequalinium
(dequalinium
chloride),
tyrothricin,
enoxolone,
hydrocortisone
(hydrocortisone
acetate),
tyrothricin,
lidocaine (lidocaine
hydrochloride)
spray
1mg/ml+
4mg/ml+0.6mg/ml+0.6mg
/ml+1mg/ml, 20ml (200
doses) pastic container
and pump dispenser
Ferrer Internacional,
S.A., Joan Buscalla, 1-
9 08173 Sant Cugat
del Valles, Barcelona
Spain R02A 1473403.08.2015
03.08.2020OTC
Laboratorios Novag,
S.A.,Gran Via Carlos
III, 94, 08028
Barcelona, Spain
319 Angiovit-AV
folic acid,
pyridoxine
(pyridoxine
hydrochloride),
cyanocobalamin
tablets film-coated5mg+4mg+ 0,006mg,
blisters (60/6x10/)
Altayvitamini CJSC,
659325, The Altay
territory, Biysk, 69
Zavodskaya Str.
Russia A11BA 13067/115.01.2016
09.12.2018OTC
Altayvitamini CJSC,
659325, The Altay
territory, Biysk, 69
Zavodskaya Str.,
Russia
320 Anoro Ellipta
umeclidinium
(umeclidinium
bromide), vilanterol
(vilanterol
trifenatate)
powder for
inhalation
62.5mcg/dose+
25mcg/dose, powder in
strip (60/2x30/ dose) in
plastic inhaler
Glaxo Operations UK
Ltd, Priory Street,
Ware, Hertfordshire
SG12 0DJ
UK R03AL03 1529604.02.2016
04.02.2021PoM
Glaxo Group Limited,
980 Great West Road,
Brentford, Middlesex,
TW8 9GS, UK
321 Antaxone
naltrexone
(naltrexone
hydrochloride)
capsules50mg,
in blister (10/1x10/)
Zambon S.P.A., Via
Della Chimica, 9,
Vicenza, 36100
Italy N07BB04 1459408.06.2015
08.06.2020PoM
Zambon S.P.A., Via
Lillo Del Duca, 10,
Bresso, 20091, Italy
65
322 Anti-Acnesalicylic acid, sulfur,
zinc oxidesuspension topical
20mg/ml+ 50mg/ml+
150mg/ml,
30ml glass bottle
Arpimed LLC, Kotayk
Marz, Abovyan, 2nd
Micro-District, 19
Building
Republic of
ArmeniaD02AF 12419
11.08.2013
11.08.2018OTC
Arpimed LLC,
Kotayk Marz,
Abovyan, 2nd Micro-
District, 19 Building,
Republic of Armenia
323Anti-Angin
Formula
chlorhexidine
(chlorhexidine
bigluconate),
tetracaine
(tetracaine
hydrochloride)
dosed spray for
topical use
0,24mg/dose (1,2mg/g) +
0,12mg/dose (0,6mg/g),
25ml plastic container
(100 doses)
Natur Produkt
Europe
B.V.,Tweeberg 17,
5246XL Rosmalen
(bulk manufacturer -
Herkel
B.V.,Nobelweg 6,3899
BN Zeewold, the
Netherlands)
the Netherlands R02AA20 13568/125.12.2014
10.06.2019OTC
Valeant LLC,
Shabolovka st. 31,
building 5, 115162,
Moscow, Russia
324Anti-Angin
Formula
chlorhexidine
(chlorhexidine
diacetate),
tetracaine
(tetracaine
hydrochloride),
ascorbic acid
lozenges2mg+0,2mg+50mg, in
blister (20/2x10/)
Herkel
B.V.,Nobelweg 6,3899
BN Zeewold
the Netherlands R02AA20 1636930.12.2016
30.12.2021OTC
VALEANT LLC,
Shabolovka st. 31,
building 5, 115162,
Moscow, Russia
325 Anticol disulfiram tablets500mg,
in plastic container (30)
Warsaw
Pharmaceutical
Works "Polfa" S.A.,
Karolkowa 22/24 str.,
01-207 Warsaw
Poland P03AA04 1420406.02.2015
06.02.2020PoM
Warsaw
Pharmaceutical
Works "Polfa" S.A.,
Karolkowa 22/24 str.,
01-207 Warsaw,
Poland
326 Anti-Cold
acetaminophen,
chlorpheniramine
(chlorpheniramine
maleate),
phenylpropanol-
amine
hydrochloride
syrup with orange
flavour
160mg+1mg+5mg, 60ml
plastic bottle
Arpimed LLC, Kotayk
Marz, Abovyan, 2nd
Micro-District, 19
Building
Republic of
ArmeniaR05X 12192
01.02.2013
01.02.2018OTC
Arpimed LLC,
Kotayk Marz,
Abovyan, 2nd Micro-
District, 19 Building,
Republic of Armenia
66
327 Anti-Cold
paracetamol,
phenylephrine
(phenylephrine
hydrochloride),
chlorpheniramine
(chlorpheniramine
maleate)
tablets325mg+5mg+2mg, in
blister (20/2x10/)
Arpimed LLC, Kotayk
Marz, Abovyan, 2nd
Micro-District, 19
Building
Republic of
ArmeniaN02BE51 17191
28.11.2017
28.11.2022OTC
Arpimed LLC,
Kotayk Marz,
Abovyan, 2nd Micro-
District, 19 Building,
Republic of Armenia
328 Anti-Cold
paracetamol,
chlorpheniramine
(chlorpheniramine
maleate),
phenylpropanolami
ne
(phenylpropanolam
ine hydrochloride)
syrup with orange
flavour
32mg/ml+
0,2mg/ml+1mg/ml, 60ml
glass bottle
Arpimed LLC, Kotayk
Marz, Abovyan, 2nd
Micro-District, 19
Building
Republic of
ArmeniaN02BE51 17257
12.12.2017
12.12.2022OTC
Arpimed LLC,
Kotayk Marz,
Abovyan, 2nd Micro-
District, 19 Building,
Republic of Armenia
329 Antiflu
acetaminophen,
phenylephrine
(phenylephrine
hydrochloride),
chlorpheniramine
(chlorpheniramine
maleate)
tablets film-coated325mg+5mg+2mg, in
blister (12/1x12/)
Contract Pharmacal
Corporation, 135
Adams avenue,
Hauppauge, New
York 11788-batch
releaser, packager,
Contract Pharmacal
Corporation, 160
Commerce Drive
Hauppauge, New
York 11788, USA-
bulk manufacturer
USA N02BE51 1615323.11.2016
23.11.2021OTC
Bayer Consumer Care
AG, Peter Merian-
Strasse 84, 4052 Basel,
Switzerland
67
330 Antiflu
acetaminophen,
phenylephrine
(phenylephrine
hydrochloride),
chlorpheniramine
(chlorpheniramine
maleate)
powder for oral
solution with lemon
flavour
650mg+10mg+4mg
sachets (5)
Contract Pharmacal
Corporation, 135
Adams avenue,
Hauppauge, New
York 11788-batch
releaser, packager,
Contract Pharmacal
Corporation, 160
Commerce Drive
Hauppauge, New
York 11788, USA-
bulk manufacturer
USA N02BE51 1615423.11.2016
23.11.2021OTC
for Bayer Consumer
Care AG, Peter
Merian-Strasse 84,
4052 Basel,
Switzerland
331 Antiflu Kids
paracetamol,
ascorbic acid,
chlorpheniramine
(chlorpheniramine
maleate)
powder for oral
solution with
raspberry flavour
160mg+50mg+ 1mg,
sachets (5)
Contract Pharmacal
Corporation, 135
Adams avenue,
Hauppauge, New
York 11788-batch
releaser, packager,
Contract Pharmacal
Corporation, 160
Commerce Drive
Hauppauge, New
York 11788, USA-
bulk manufacturer
USA N02BE51 1615523.11.2016
23.11.2021OTC
AO BAYER, 3rd
Rybinskaya St., 18,
build. 2, 107113
Moscow, Russia
332 Antigrippin
paracetamol,
chlorphenamine
(chlorphenamine
maleate), ascorbic
acid
tablets effervescent
500mg+10mg+ 200mg,
in plastic container (10),
in strip (30/5x6/)
Natur Produkt
Pharma Sp. z o.o., ul.
Podstoczysko 30, 07-
300 Ostrow
Mazowiecka
Poland N02BE51 1495422.10.2015
22.10.2020OTC
VALEANT LLC,
Shabolovka st. 31,
building 5, 115162,
Moscow, Russia
333 Antigrippin
paracetamol,
chlorphenamine
(chlorphenamine
maleate), ascorbic
acid
tablets effervescent
250mg+3mg+ 50mg,
in plastic container (10),
in strip (30/5x6/)
Natur Produkt
Pharma Sp. z o.o., ul.
Podstoczysko 30, 07-
300 Ostrow
Mazowiecka
Poland N02BE51 1495522.10.2015
22.10.2020OTC
VALEANT LLC,
Shabolovka st. 31,
building 5, 115162,
Moscow, Russia
68
334 Antigrippin
paracetamol,
chlorphenamine
(chlorphenamine
maleate), ascorbic
acid
powder for oral
solution with
chamomile flavour
500mg+10mg+ 200mg,
5g sachets (6, 10)
Natur Produkt
Pharma Sp. z o.o., ul.
Podstoczysko 30, 07-
300 Ostrow
Mazowiecka
Poland N02BE51 1532304.02.2016
04.02.2021OTC
VALEANT LLC,
Shabolovka st. 31,
building 5, 115162,
Moscow, Russia
335 Antigrippin
paracetamol,
chlorphenamine
(chlorphenamine
maleate), ascorbic
acid
powder for oral
solution with honey
and lemon flavour
500mg+10mg+ 200mg,
5g sachets (6, 10)
Natur Produkt
Pharma Sp. z o.o., ul.
Podstoczysko 30, 07-
300 Ostrow
Mazowiecka
Poland N02BE51 1532404.02.2016
04.02.2021OTC
VALEANT LLC,
Shabolovka st. 31,
building 5, 115162,
Moscow, Russia
336 Antigrippin
paracetamol,
chlorphenamine
(chlorphenamine
maleate), ascorbic
acid
tablets effervescent
250mg+3mg+ 50mg, in
plastic container (10),
(30/5x6/) in strip
Natur Produkt
Europe
B.V.,Tweeberg 17,
5246 XL Rosmalen-
batch releaser, Natur
Produkt Pharma Sp. z
o.o., ul. Podstoczysko
30, 07-300 Ostrow
Mazowiecka, Poland-
bulk manufacturer,
packager
the Netherlands N02BE51 1547002.04.2016
02.04.2021OTC
VALEANT LLC,
Shabolovka st. 31,
building 5, 115162,
Moscow, Russia
337 Antigrippin
paracetamol,
chlorphenamine
(chlorphenamine
maleate), ascorbic
acid
tablets effervescent
500mg+10mg+ 200mg,
in plastic container (10),
in strip (30/5x6/)
Natur Produkt
Europe
B.V.,Tweeberg 17,
5246 XL Rosmalen-
batch releaser, Natur
Produkt Pharma Sp. z
o.o., ul. Podstoczysko
30, 07-300 Ostrow
Mazowiecka, Poland-
bulk manufacturer,
packager
the Netherlands N02BE51 1550419.04.2016
19.04.2021OTC
VALEANT LLC,
Shabolovka st. 31,
building 5, 115162,
Moscow, Russia
69
338 Antilice
pyrethrins
(permethrin+
tetramethrin),
piperonyl butoxide
shampoo1,65mg/ml+ 16,5mg/ml,
100ml plastic bottle
Arpimed LLC, Kotayk
Marz, Abovyan, 2nd
Micro-District, 19
Building
Republic of
ArmeniaP03AC54 13763
14.08.2014
14.08.2019OTC
Arpimed LLC,
Kotayk Marz,
Abovyan, 2nd Micro-
District, 19 Building,
Republic of Armenia
339 Antimyk-Neu clotrimazole cream10mg/g,
20g aluminium tube
"NOKI" JV LTD Co.,
Nor-Kharberd, Ararat
region
Republic of
ArmeniaD01AC01 16142
10.11.2016
10.11.2021OTC
"NOKI" JV LTD Co.,
Nor-Kharberd, Ararat
region, Republic of
Armenia
340 Anusol
xeroform,
belladonna extract,
zinc (zinc sulfate)
suppositories rectal100mg+20mg+ 50mg,
(10/2x5/)
Nizhpharm JSC,
603950, Nizhny
Novgorod,
Salganskaya st., 7
Russia C05AX03 1695105.09.2017
05.09.2022OTC
Nizhpharm JSC,
603950, Nizhny
Novgorod,
Salganskaya st., 7,
Russia
341 AnviRem
paracetamol,
ascorbic acid,
calcium gluconate
(calcium gluconate
monohydrate),
rimantadine
(rimantadine
hydrochloride),
rutoside (rutin),
loratadine
powder for oral
solution with lemon
flavour
360mg+300mg+
100mg+50mg+
20mg+3mg,
sachets (3, 6, 12 and 24)
Pharmproject JSC,
bld. 14, lit. A,
Sofiyskaya str., Saint
Petersburg, 192236
Russia R05X 1708623.10.2017
23.10.2022OTC
"AnviLab" LLC,
141302 Sergiev Posad,
Festival street, 10,
Sergiev Posad
municipal district,
urban settlement
Sergiev Posad,
Moscow region,
Russia
342 AnviRem
paracetamol,
ascorbic acid,
calcium gluconate
(calcium gluconate
monohydrate),
rimantadine
(rimantadine
hydrochloride),
rutoside (rutin),
loratadine
powder for oral
solution with lemon
and honey flavour
360mg+300mg+
100mg+50mg+
20mg+3mg,
sachets (3, 6, 12)
Pharmproject JSC,
bld. 14, lit. A,
Sofiyskaya str., Saint
Petersburg, 192236
Russia R05X 1708723.10.2017
23.10.2022OTC
"AnviLab" LLC,
141302 Sergiev Posad,
Festival street, 10,
Sergiev Posad
municipal district,
urban settlement
Sergiev Posad,
Moscow region,
Russia
70
343 AnviRem
paracetamol,
ascorbic acid,
calcium gluconate
(calcium gluconate
monohydrate),
rimantadine
(rimantadine
hydrochloride),
rutoside (rutin),
loratadine
powder for oral
solution with
raspberry flavour
360mg+300mg+
100mg+50mg+
20mg+3mg,
sachets (3, 6, 12, 24)
Pharmproject JSC,
bld. 14, lit. A,
Sofiyskaya str., Saint
Petersburg, 192236
Russia R05X 1708823.10.2017
23.10.2022OTC
"AnviLab" LLC,
141302 Sergiev Posad,
Festival street, 10,
Sergiev Posad
municipal district,
urban settlement
Sergiev Posad,
Moscow region,
Russia
344 AnviRem
paracetamol,
ascorbic acid,
calcium gluconate
(calcium gluconate
monohydrate),
rimantadine
(rimantadine
hydrochloride),
rutoside (rutin),
loratadine
powder for oral
solution with
blackcurrant flavour
360mg+300mg+
100mg+50mg+
20mg+3mg,
sachets (3, 6, 12, 24)
Pharmproject JSC,
bld. 14, lit. A,
Sofiyskaya str., Saint
Petersburg, 192236
Russia R05X 1708923.10.2017
23.10.2022OTC
"AnviLab" LLC,
141302 Sergiev Posad,
Festival street, 10,
Sergiev Posad
municipal district,
urban settlement
Sergiev Posad,
Moscow region,
Russia
345 Apaurin diazepamsolution for i/v and
i/m injection
5mg/ml,
2ml ampoule,
in blister (10/2x5/)
KRKA d.d., Novo
mesto, Smarjeska
cesta 6, 8501 Novo
Mesto
Slovenia N05BA01 1669223.05.2017
23.05.2022PoM/UC
KRKA d.d., Novo
mesto, Smarjeska
cesta 6, 8501 Novo
Mesto, Slovenia
346 Apaurin diazepam tablets coated5mg,
in blister (30/2x15/)
KRKA d.d., Novo
mesto, Smarjeska
cesta 6, 8501 Novo
Mesto-batch releaser,
Merck KGaA & Co.,
Werk Spittal,
Hosslgasse 20, 9800
Spittal an der Drau,
Austria- bulk
manufacturer,
packager
Slovenia N05BA01 1683810.07.2017
10.07.2022PoM/UC
KRKA d.d., Novo
mesto, Smarjeska
cesta 6, 8501 Novo
Mesto, Slovenia
71
347
Apidra solution for
injection in a pre-
filled pen
insulin glulisinesolution for s/c
injection
100U/ml,
3ml Solostar pre-filled
pens (5)
Sanofi-Aventis
Deutschland GmbH,
Industriepark
Hoechst,
Bruningstrasse 50, D-
65926 Frankfurt am
Main
Germany A10AB06 1376014.08.2014
14.08.2019PoM
Sanofi-Aventis
Deutschland GmbH,
Industriepark
Hoechst,
Bruningstrasse 50, D-
65926 Frankfurt am
Main, Germany
348 Apilac royal jelly tablets sublingual
10mg,
in blister, (10/1x10/,
30/3x10/)
VIFITEH CJSC,
SCRAM, Obolensk v.,
corp. 84, corp. 87,
build. 90, Serpukhov
district, Moscow
region,142279
Russia A13A 1537126.02.2016
26.02.2021OTC
VIFITEH CJSC,
SCRAM, Obolensk v.,
Serpukhov district,
Moscow
region,142279, Russia
349 Apilac Grindeks royal jellyointment for
external use
10mg/g,
50g aluminium tube
Tallinn
Pharmaceutical Plant
JSC, Tondi 33, 11316
Tallinn
Estonia D11AX 1640510.02.2017
10.02.2022OTC
Grindeks JSC,
Krustpils street 53,
LV-1057, Riga, Latvia
350 Apilac Grindeks royal jelly tablets sublingual
10mg,
in blister (25/1x25/,
50/2x25/)
Grindeks JSC,
Krustpils street 53, LV-
1057, Riga
Latvia A13A 1640610.02.2017
10.02.2022OTC
Grindeks JSC,
Krustpils street 53,
LV-1057, Riga, Latvia
351 Apisarthron
bee venom
standardized, allyl
isothiocyanate,
methyl salicylate
ointment
0,03mg/g+10mg/g+100mg
/g,
20g aluminium tube
Esparma GmbH,
Werner-von-Siemens-
Ring 8, 39116
Magdeburg Saxony-
Anhalt - batch
releaser (Lichtenheldt
GmbH, Werk I -
Industriestraasse 7-
1123812 Wahlstedt,
Germany, bulk
manufacturer,
packager)
Germany M02AC 1369624.07.2014
24.07.2019OTC
Esparma GmbH,
Seepark 7 339116
Magdeburg, Germany
72
352 Apo-Amoxi Clav
amoxicillin
(amoxicillin
trihydrate),
clavulanic acid
(potassium
clavulanate)
tablets875mg+125mg,
in plastic container (100)
Apotex Inc., 3701
Weston Road,
Weston, Ontario,
M9L 2S8-batch
releaser, Apotex Inc.,
20 Kenhar Drive,
Weston, Ontario,
M9L 1N1, Canada-
bulk manufacturer,
packager
Canada J01CR02 1454909.06.2015
09.06.2020PoM
Apotex Inc., 150
Signet Drive,
Toronto, Ontario,
M9L 1T9, Canada
353 Apo-Amoxi Clav
amoxicillin
(amoxicillin
trihydrate),
clavulanic acid
(potassium
clavulanate)
tablets250mg+125mg,
in plastic container (100)
Apotex Inc., 3701
Weston Road,
Weston, Ontario,
M9L 2S8-batch
releaser, Apotex Inc.,
20 Kenhar Drive,
Weston, Ontario,
M9L 1N1, Canada-
bulk manufacturer,
packager
Canada J01CR02 1455009.06.2015
09.06.2020PoM
Apotex Inc., 150
Signet Drive,
Toronto, Ontario,
M9L 1T9, Canada
354 Apo-Amoxi Clav
amoxicillin
(amoxicillin
trihydrate),
clavulanic acid
(potassium
clavulanate)
tablets500mg+125mg,
in plastic container (100)
Apotex Inc., 3701
Weston Road,
Weston, Ontario,
M9L 2S8-batch
releaser, Apotex Inc.,
20 Kenhar Drive,
Weston, Ontario,
M9L 1N1, Canada-
bulk manufacturer,
packager
Canada J01CR02 1455109.06.2015
09.06.2020PoM
Apotex Inc., 150
Signet Drive,
Toronto, Ontario,
M9L 1T9, Canada
73
355 Apo-Atenol atenolol tablets
50mg,
in blister (30/3x10/),
in plastic container (100)
Apotex Inc., 150
Signet Drive, Toronto,
Ontario, M9L 1T9-
batch releaser, bulk
manufacturer, Apotex
Inc., 4100 Weston
Road, Toronto,
Ontario, M9L 2Y6,
Canada -packager
Canada C07AB03 1672205.06.2017
05.06.2022PoM
Apotex Inc., 150
Signet Drive,
Toronto, Ontario,
M9L 1T9, Canada
356 Apo-Atenol atenolol tablets
100mg,
in blister (30/3x10/),
in plastic container (100)
Apotex Inc., 150
Signet Drive, Toronto,
Ontario, M9L 1T9-
batch releaser, bulk
manufacturer, Apotex
Inc., 4100 Weston
Road, Toronto,
Ontario, M9L 2Y6,
Canada -packager
Canada C07AB03 1672305.06.2017
05.06.2022PoM
Apotex Inc., 150
Signet Drive,
Toronto, Ontario,
M9L 1T9, Canada
357 Apo-Celecoxib celecoxib capsules100mg,
in plastic container (100)
Apotex Inc., 150
Signet Drive, Toronto,
Ontario, M9L 1T9 -
batch releaser, Apotex
Research Private
Limited, Plot no.1
and 2, Bommasandra
lndustrial area, 4th
Phase, Jigani Link
Road, Bangalore - 560
099, India -bulk
manufacturer,
packager
Canada M01AH01 1721008.12.2017
08.12.2022PoM
Apotex Inc., 150
Signet Drive,
Toronto, Ontario,
M9L 1T9, Canada
74
358 Apo-Celecoxib celecoxib capsules200mg,
in plastic container (100)
Apotex Inc., 150
Signet Drive, Toronto,
Ontario, M9L 1T9 -
batch releaser, Apotex
Research Private
Limited, Plot no.1
and 2, Bommasandra
lndustrial area, 4th
Phase, Jigani Link
Road, Bangalore - 560
099, India -bulk
manufacturer,
packager
Canada M01AH01 1721108.12.2017
08.12.2022PoM
Apotex Inc., 150
Signet Drive,
Toronto, Ontario,
M9L 1T9, Canada
359 Apo-Cephalex cefalexin tablets250mg,
plastic container (100)
Apotex Inc., 400
Ormont Drive
Weston, Ontario,
M9L 1N9
Canada J01DB01 1440916.04.2015
16.04.2020PoM
Apotex Inc., 150
Signet Drive,
Toronto, Ontario,
M9L 1T9, Canada
360 Apo-Cephalex cefalexin tablets500mg, plastic container
(100)
Apotex Inc., 400
Ormont Drive
Weston, Ontario,
M9L 1N9
Canada J01DB01 1441016.04.2015
16.04.2020PoM
Apotex Inc., 150
Signet Drive,
Toronto, Ontario,
M9L 1T9, Canada
361 Apo-Clopidogrel
clopidogrel
(clopidogrel
bisulfate)
tablets75mg,
in blister (30/3x10/)
Apotex Inc., 150
Signet Drive, Toronto,
Ontario, M9L 1T9 -
batch releaser, Apotex
Inc., 50 Steinway
Blvd., Etobicoke,
Ontario, M9W 6Y3,
Canada-bulk
manufacturer, Apotex
Inc., 4100 Weston
Road, Weston,
Ontario, M9L 2Y6,
Canada-packager
Canada B01AC04 1435825.03.2015
25.03.2020PoM
Apotex Inc., 150
Signet Drive,
Toronto, Ontario,
M9L 1T9, Canada
75
362 Apo-Desmopressin
desmopressin
(desmopressin
acetate)
tablets0,1mg,
in plastic container (100)
Apotex Inc., 150
Signet Drive, Toronto,
Ontario, M9L 1T9 -
batch releaser, Apotex
Inc., 50 Steinway
Blvd., Etobicoke,
Ontario, M9W 6Y3,
Canada-bulk
manufacturer, Apotex
Inc., 4100 Weston
Road, Toronto,
Ontario, M9L 2Y6,
Canada-packager
Canada H01BA02 1677722.06.2017
22.06.2022PoM
Apotex Inc., 150
Signet Drive,
Toronto, Ontario,
M9L 1T9, Canada
363 Apo-Desmopressin
desmopressin
(desmopressin
acetate)
tablets0,2mg,
in plastic container (100)
Apotex Inc., 150
Signet Drive, Toronto,
Ontario, M9L 1T9 -
batch releaser, Apotex
Inc., 50 Steinway
Blvd., Etobicoke,
Ontario, M9W 6Y3,
Canada-bulk
manufacturer, Apotex
Inc., 4100 Weston
Road, Toronto,
Ontario, M9L 2Y6,
Canada-packager
Canada H01BA02 1677822.06.2017
22.06.2022PoM
Apotex Inc., 150
Signet Drive,
Toronto, Ontario,
M9L 1T9, Canada
364 Apo-Esomeprazole
esomeprazole
(esomeprazole
magnesium)
tablets delayed-
release
40mg,
in blister (30/3x10/)
Apotex Inc., 150
Signet Drive, Toronto,
Ontario, M9L 1T9 -
batch releaser, bulk
manufacturer, Apotex
Inc., 4100 Weston
Road, Toronto,
Ontario, M9L 2Y6,
Canada -packager
Canada A02BC05 1438516.04.2015
16.04.2020PoM
Apotex Inc., 150
Signet Drive,
Toronto, Ontario,
M9L 1T9, Canada
76
365 Apo-Esomeprazole
esomeprazole
(esomeprazole
magnesium)
tablets delayed-
release
20mg,
in blister (30/3x10/)
Apotex Inc., 150
Signet Drive, Toronto,
Ontario, M9L 1T9-
batch releaser, bulk
manufacturer, Apotex
Inc., 4100 Weston
Road, Toronto,
Ontario, M9L 2Y6,
Canada -packager
Canada A02BC05 1458609.06.2015
09.06.2020PoM
Apotex Inc., 150
Signet Drive,
Toronto, Ontario,
M9L 1T9, Canada
366 Apo-Lansoprazole lansoprazolecapsules delayed-
release
30mg,
in plastic container (100)
Apotex Inc., 50
Steinway Blvd.,
Etobicoke, Ontario,
M9W 6Y3
Canada A02BC03 1438616.04.2015
16.04.2020PoM
Apotex Inc., 150
Signet Drive,
Toronto, Ontario,
M9L 1T9, Canada
367 Apo-Lansoprazole lansoprazolecapsules delayed-
release
15mg,
in plastic container (100)
Apotex Inc., 50
Steinway Blvd.,
Etobicoke, Ontario,
M9W 6Y3
Canada A02BC03 1438716.04.2015
16.04.2020PoM
Apotex Inc., 150
Signet Drive,
Toronto, Ontario,
M9L 1T9, Canada
368 Apo-Letrozole letrozole tablets2,5mg,
in blister (30/3x10/)
Apotex Inc., 150
Signet Drive, Toronto,
Ontario, M9L 1T9 -
batch releaser, bulk
manufacturer, Apotex
Inc., 4100 Weston
Road, Toronto,
Ontario, M9L 2Y6,
Canada-packager
Canada L02BG04 1700926.09.2017
26.09.2022PoM
Apotex Inc., 150
Signet Drive,
Toronto, Ontario,
M9L 1T9, Canada
77
369 Apo-Levocarb carbidopa, levodopa tablets25mg+100mg,
in plastic container (100)
Apotex Inc., 150
Signet Drive, Toronto,
Ontario, M9L 1T9 -
batch releaser, bulk
manufacturer, Apotex
Inc., 4100 Weston
Road, Toronto,
Ontario, M9L 2Y6,
Canada-packager
Canada N04BA02 1709723.10.2017
23.10.2022PoM
Apotex Inc., 150
Signet Drive,
Toronto, Ontario,
M9L 1T9, Canada
370 Apo-Levocarb carbidopa, levodopa tablets25mg+250mg,
in plastic container (100)
Apotex Inc., 150
Signet Drive, Toronto,
Ontario, M9L 1T9 -
batch releaser, bulk
manufacturer, Apotex
Inc., 4100 Weston
Road, Toronto,
Ontario, M9L 2Y6,
Canada-packager
Canada N04BA02 1709823.10.2017
23.10.2022PoM
Apotex Inc., 150
Signet Drive,
Toronto, Ontario,
M9L 1T9, Canada
371 Apo-Omeprazole omeprazolecapsules delayed-
release
20mg,
in plastic container (100)
Apotex Inc., 50
Steinway Blvd.,
Etobicoke, Ontario,
M9W 6Y3-batch
releaser, bulk
manufacturer, Apotex
Inc., 4100 Weston
Road, Weston,
Ontario, M9L 2Y6,
Canada- packager
Canada A02BC01 1438416.04.2015
16.04.2020PoM
Apotex Inc., 150
Signet Drive,
Toronto, Ontario,
M9L 1T9, Canada
372 Apo-Omeprazole omeprazolecapsules delayed-
release
20mg,
in plastic container (100)
Apotex Inc., 50
Steinway Blvd.,
Etobicoke, Ontario,
M9W 6Y3
Canada A02BC01 1488124.09.2015
24.09.2020PoM
Apotex Inc., 150
Signet Drive,
Toronto, Ontario,
M9L 1T9, Canada
78
373 Apo-Pantoprazole
pantoprazole
(pantoprazole
sodium
sesquihydrate)
tablets enteric-
coated
40mg,
plastic container (100)
Apotex Inc., 150
Signet Drive, Toronto,
Ontario, M9L 1T9-
batch releaser, bulk
manufacturer, Apotex
Inc., 4100 Weston
Road, Toronto,
Ontario, M9L 2Y6,
Canada -packager
Canada A02BC02 1435425.03.2015
25.03.2020PoM
Apotex Inc., 150
Signet Drive,
Toronto, Ontario,
M9L 1T9, Canada
374 Apo-Pantoprazole
pantoprazole
(pantoprazole
sodium
sesquihydrate)
tablets enteric coated20mg,
plastic container (100)
Apotex Inc., 150
Signet Drive, Toronto,
Ontario, M9L 1T9-
batch releaser, bulk
manufacturer, Apotex
Inc., 4100 Weston
Road, Toronto,
Ontario, M9L 2Y6,
Canada -packager
Canada A02BC02 1435525.03.2015
25.03.2020PoM
Apotex Inc., 150
Signet Drive,
Toronto, Ontario,
M9L 1T9, Canada
375 Apo-Rabeprazole
rabeprazole
(rabeprazole
sodium)
tablets enteric-
coated
10mg,
plastic container (100)
Apotex Inc., 150
Signet Drive, Toronto,
Ontario, M9L 1T9 -
batch releaser, bulk
manufacturer, Apotex
Inc., 4100 Weston
Road, Toronto,
Ontario, M9L 2Y6,
Canada -packager
Canada A02BC04 1437816.04.2015
16.04.2020PoM
Apotex Inc., 150
Signet Drive,
Toronto, Ontario,
M9L 1T9, Canada
79
376 Apo-Rabeprazole
rabeprazole
(rabeprazole
sodium)
tablets enteric-
coated
20mg,
plastic container (100)
Apotex Inc., 150
Signet Drive, Toronto,
Ontario, M9L 1T9 -
batch releaser, bulk
manufacturer, Apotex
Inc., 4100 Weston
Road, Toronto,
Ontario, M9L 2Y6,
Canada -packager
Canada A02BC04 1437916.04.2015
16.04.2020PoM
Apotex Inc., 150
Signet Drive,
Toronto, Ontario,
M9L 1T9, Canada
377 Apo-Salventsalbutamol
(salbutamol sulfate)tablets
2mg,
in plastic container (100)
Apotex Inc., 150
Signet Drive, Toronto,
Ontario, M9L 1T9 -
batch releaser, bulk
manufacturer, Apotex
Inc., 4100 Weston
Road, Weston,
Ontario, M9L 2Y6,
Canada -packager
Canada R03AC02 1473603.08.2015
03.08.2020PoM
Apotex Inc., 150
Signet Drive,
Toronto, Ontario,
M9L 1T9, Canada
378 Apo-Salventsalbutamol
(salbutamol sulfate)tablets
4mg,
in plastic container (100)
Apotex Inc., 150
Signet Drive, Toronto,
Ontario, M9L 1T9 -
batch releaser, bulk
manufacturer, Apotex
Inc., 4100 Weston
Road, Weston,
Ontario, M9L 2Y6,
Canada -packager
Canada R03AC02 1473703.08.2015
03.08.2020PoM
Apotex Inc., 150
Signet Drive,
Toronto, Ontario,
M9L 1T9, Canada
80
379 Apo-Sildenafilsildenafil (sildenafil
citrate)tablets
50mg,
in blister (4/1x4/)
Apotex Inc., 150
Signet Drive, Toronto,
Ontario, M9L 1T9-
batch releaser, bulk
manufacturer, Apotex
Inc., 4100 Weston
Road, Toronto,
Ontario, M9L 2Y6,
Canada -packager
Canada G04BE03 1435625.03.2015
25.03.2020PoM
Apotex Inc., 150
Signet Drive,
Toronto, Ontario,
M9L 1T9, Canada
380 Apo-Sildenafilsildenafil (sildenafil
citrate)tablets
25mg,
in blister (4/1x4/)
Apotex Inc., 150
Signet Drive, Toronto,
Ontario, M9L 1T9-
batch releaser, bulk
manufacturer, Apotex
Inc., 4100 Weston
Road, Toronto,
Ontario, M9L 2Y6,
Canada -packager
Canada G04BE03 1435725.03.2015
25.03.2020PoM
Apotex Inc., 150
Signet Drive,
Toronto, Ontario,
M9L 1T9, Canada
381 Apo-Sucralfate sucralfate tablets1000mg,
in plastic container (100)
Apotex Inc., 150
Signet Drive, Toronto,
Ontario, M9L 1T9 -
batch releaser, bulk
manufacturer, Apotex
Inc., 4100 Weston
Road, Toronto,
Ontario, M9L 2Y6,
Canada -packager
Canada A02BX02 1455209.06.2015
09.06.2020PoM
Apotex Inc., 150
Signet Drive,
Toronto, Ontario,
M9L 1T9, Canada
81
382 Apo-Sulfatrim-DSsulfamethoxazole,
trimethoprimtablets
800mg+160mg,
in plastic container (100)
Apotex Inc., 150
Signet Drive, Toronto,
Ontario, M9L 1T9 -
batch releaser, bulk
manufacturer, Apotex
Inc., 4100 Weston
Road, Weston,
Ontario, M9L 2Y6,
Canada -packager
Canada J01EE01 1454809.06.2015
09.06.2020PoM
Apotex Inc., 150
Signet Drive,
Toronto, Ontario,
M9L 1T9, Canada
383 Apo-Tamoxtamoxifen
(tamoxifen citrate)tablets
10mg,
in plastic container (100)
Apotex Inc., 3701
Weston Road,
Weston, Ontario,
M9L 2S8-batch
releaser (Apotex Inc.,
285 Gary Ray Drive,
Weston, Ontario,
M9L 1P3, Canada-
bulk manufacturer,
packager)
Canada L02BA 1451315.05.2015
15.05.2020PoM
Apotex Inc., 150
Signet Drive,
Toronto, Ontario,
M9L 1T9, Canada
384 Apo-Tamoxtamoxifen
(tamoxifen citrate)tablets
20mg,
in plastic container (100)
Apotex Inc., 3701
Weston Road,
Weston, Ontario,
M9L 2S8-batch
releaser (Apotex Inc.,
285 Gary Ray Drive,
Weston, Ontario,
M9L 1P3, Canada-
bulk manufacturer,
packager)
Canada L02BA 1451415.05.2015
15.05.2020PoM
Apotex Inc., 150
Signet Drive,
Toronto, Ontario,
M9L 1T9, Canada
82
385 Apo-Valacyclovir
valacyclovir
(valacyclovir
hydrochloride
monohydrate)
tablets (caplet)1000mg,
in blister (21/7x3/)
Apotex Inc., 150
Signet Drive, Toronto,
Ontario, M9L 1T9 -
batch releaser, bulk
manufacturer, Apotex
Inc., 4100 Weston
Road, Toronto,
Ontario, M9L 2Y6,
Canada -packager
Canada J05AB11 1435225.03.2015
25.03.2020PoM
Apotex Inc., 150
Signet Drive,
Toronto, Ontario,
M9L 1T9, Canada
386 Apo-Valacyclovir
valacyclovir
(valacyclovir
hydrochloride
monohydrate)
tablets (caplet)
500mg,
in blister (8/1x8/,
30/3x10)
Apotex Inc., 150
Signet Drive, Toronto,
Ontario, M9L 1T9 -
batch releaser, bulk
manufacturer, Apotex
Inc., 4100 Weston
Road, Toronto,
Ontario, M9L 2Y6,
Canada -packager
Canada J05AB11 14395/102.08.2016
16.04.2020PoM
Apotex Inc., 150
Signet Drive,
Toronto, Ontario,
M9L 1T9, Canada
387 Aqua Maris adriatic sea water spray throat30ml/100ml,
30ml glass bottle
Jadran Galenski
Laboratorij d.d.,
51000 Rijeka, Pulac
b.b.
Croatia R02A 1321131.01.2014
31.01.2019OTC
Jadran Galenski
Laboratorij d.d.,
51000 Rijeka, Pulac
b.b., Croatia
388 Aquadetrim plusvitamin A, vitamin
D3drops oral
20000IU/ml+
10000IU/ml,
10ml glass bottle
Medana Pharma JSC,
98-200 Sieradz, W.
Lokietka 10 - batch
releaser (dosage form
manufacturer,
packager - Medana
Pharma JSC, str.
Polskiej Organizacji
Wojskowej 57,98-200
Sieradz, Poland)
Poland A11CB 1328104.03.2014
04.03.2019PoM
Medana Pharma JSC,
98-200 Sieradz, W.
Lokietka 10, Poland
83
389
Aquadetrim
Vitamin D3
Medana
cholecalciferol drops oral15000IU/ml,
10ml glass bottle
Medana Pharma S.A.,
98-200 Sieradz, W.
Lokietka 10- batch
releaser, Medana
Pharma S.A., str.
Polskiej Organizacji
Wojskowej 57, 98-200
Sieradz, Poland- bulk
manufacturer,
packager
Poland A11CC05 1667111.05.2017
11.05.2022PoM
Medana Pharma S.A.,
98-200 Sieradz, W.
Lokietka 10, Poland
390 Aquavit-D3 cholecalciferol solution oral
375 mkg/ml(15000
IU/ml),
10ml glass vial-dropper
PJSC "Technolog",
Manuilskogo str. 8,
20300
Uman,Cherkassy
region
Ukraine AC11CC05 1479704.09.2015
04.09.2020PoM
PJSC "Technolog",
Manuilskogo str. 8,
20300
Uman,Cherkassy
region, Ukraine
391 Arbidol
umifenovir
(umifenovir
hydrochloride)
capsules
100mg,
blister (10/1x10/,
20/2x10/, 40/4x10/)
Pharmstandard-
Leksredstva JSC,
305022, Kursk,
Agregatnaya 2nd str.,
1a/18
Russia J05AX 14281/121.04.2016
19.03.2020OTC
OTCPharm PJSC,
123317, Moscow,
Testovskaya str., 10,
Russia
392 Arbidol
umifenovir
(umifenovir
hydrochloride)
tablets film-coated
50mg,
blisters (10/1x10/,
20/2x10/)
Pharmstandard-
Tomskchimpharm
OJSC, 634009, Tomsk,
R.Luxemburg str. 89-
batch releaser,
Pharmstandard-
Tomskchimpharm
OJSC, 634009, Tomsk,
avenue Lenina, 211,
Russia-bulk
manufacturer,
packager
Russia J05AX 14608/102.02.2017
03.07.2020OTC
OTCPharm PJSC,
123317, Moscow,
Testovskaya str., 10,
Russia
84
393 Arcoxia etoricoxib tablets film-coated120mg,
in blister (7/1x7/, 28/4x7/)
Merck Sharp &
Dohme B.V.
Waarderweg 39, 2031
BN Haarlem-batch
releaser, packager,
Frosst Iberica S.A.,
Via Complutense 140,
28805 Alcala de
Henares, Madrid,
Spain- bulk
manufacturer
the Netherlands M01AH05 1549919.04.2016
19.04.2021PoM
Schering-Plough
Central East AG,
Weystrasse 20, 6000
Lucerne 6,
Switzerland
394 Arcoxia etoricoxib tablets film-coated60mg,
in blister (7/1x7/, 28/4x7/)
Merck Sharp &
Dohme B.V.
Waarderweg 39, 2031
BN Haarlem-batch
releaser, packager,
Frosst Iberica S.A.,
Via Complutense 140,
28805 Alcala de
Henares, Madrid,
Spain- bulk
manufacturer
the Netherlands M01AH05 1550019.04.2016
19.04.2021PoM
Schering-Plough
Central East AG,
Weystrasse 20, 6000
Lucerne 6,
Switzerland
395 Arcoxia etoricoxib tablets film-coated90mg,
in blister (7/1x7/, 28/4x7/)
Merck Sharp &
Dohme B.V.
Waarderweg 39, 2031
BN Haarlem-batch
releaser, packager,
Frosst Iberica S.A.,
Via Complutense 140,
28805 Alcala de
Henares, Madrid,
Spain- bulk
manufacturer
the Netherlands M01AH05 1550119.04.2016
19.04.2021PoM
Schering-Plough
Central East AG,
Weystrasse 20, 6000
Lucerne 6,
Switzerland
85
396 Arduanpipecuronium
bromide
powder lyophilized
and solvent for
solution for injection
4mg, 10ml glass vial, in
blister (25/5x5/) and 2ml
solvent in ampoules, in
blister (25/5x5/)
Gedeon Richter PLC,
Gyomroi ut 19-21,
1103 Budapest
Hungary M03AC06 1450115.05.2015
15.05.2020PoM
Gedeon Richter PLC,
Gyomroi ut 19-21,
1103 Budapest,
Hungary
397 Aremed anastrozole tablets film-coated1mg,
in blisters (28/2x14/)
Remedica Ltd,
Aharnon street,
Limassol Industrial
Estate, 3056 Limassol
Cyprus L02BG03 14684/113.03.2017
29.06.2020PoM
Remedica Ltd,
Aharnon street,
Limassol Industrial
Estate, 3056 Limassol,
Cyprus
398 Arginine-Liqvoarginine (arginine
hydrochloride)
concentrate for
solution for infusion
210,7mg/ml,
20ml glass vial
Liqvor CJSC, 0089,
Yerevan, str.
Kochinyan, 7/9
Republic of
ArmeniaB05XB01 14938
20.10.2015
20.10.2020PoM
Liqvor CJSC, 0089,
Yerevan, str.
Kochinyan, 7/9,
Republic of Armenia
399 Argosulfan silver sulfathiazole cream for external
use
20mg/g,
15g, 40g aluminium tube,
400g plastic container
Pharmaceutical
Company Jelfa S.A.,
ul. Wincentego Pola
21, 58-500 Jelenia
Gora
Poland D06BA02 1611410.11.2016
10.11.2021OTC
VALEANT LLC,
Shabolovka st. 31,
building 5, 115162,
Moscow, Russia
400 Aricardesmolol (esmolol
hydrochloride)
solution for i/v
injection
10mg/ml,
10ml glass vial (5)
Liqvor CJSC, 0089,
Yerevan, str.
Kochinyan, 7/9
Republic of
ArmeniaC07AB09 15378
26.02.2016
26.02.2021PoM
Liqvor CJSC, 0089,
Yerevan, str.
Kochinyan, 7/9,
Republic of Armenia
401Arifam
1.5mg/10mg
indapamide,
amlodipine
(amlodipine
besilate)
tablets modified-
release
1,5mg+10mg,
in blister (30/2x15/)
Les Laboratoires
Servier Industrie, 905,
route de Saran, 45520
Gidy
France C08GA02 1383018.09.2014
18.09.2019PoM
Les Laboratoires
Servier, 50, rue
Carnot, 92284
Suresnes cedex,
France
402 Arifam 1.5mg/5mg
indapamide,
amlodipine
(amlodipine
besilate)
tablets modified-
release
1,5mg+5mg,
in blister (30/2x15/)
Les Laboratoires
Servier Industrie, 905,
route de Saran, 45520
Gidy
France C08GA02 1382918.09.2014
18.09.2019PoM
Les Laboratoires
Servier, 50, rue
Carnot, 92284
Suresnes cedex,
France
86
403 ARIFON Retard indapamidetablets prolonged-
release film-coated
1,5mg,
in blister (30/2x15/)
Les Laboratoires
Servier Industrie (905,
route de Saran, 45520
Gidy)
France C03BA11 1295928.10.2013
28.10.2018PoM
Les Laboratoires
Servier (50, rue
Carnot, 92284
Suresnes cedex,
France)
404 Aripegis aripiprazole tablets
10mg,
in blister (14/1x14/,
28/2x14/, 56/4x14/)
Nobelfarma Ilac
Sanayii Ve Tic. A.S.,
81100 Sancaklar,
Duzce
Turkey N05AX12 1393029.10.2014
29.10.2019PoM
Egis Pharmaceuticals
PLC, 1106 Budapest,
Kereszturi st. 30-38,
Hungary
405 Aripegis aripiprazole tablets
15mg,
in blister (14/1x14/,
28/2x14/, 56/4x14/)
Nobelfarma Ilac
Sanayii Ve Tic. A.S.,
81100 Sancaklar,
Duzce
Turkey N05AX12 1393129.10.2014
29.10.2019PoM
Egis Pharmaceuticals
PLC, 1106 Budapest,
Kereszturi st. 30-38,
Hungary
406 Aripegis aripiprazole tablets
30mg,
in blister (14/1x14/,
28/2x14/, 56/4x14/)
Nobelfarma Ilac
Sanayii Ve Tic. A.S.,
81100 Sancaklar,
Duzce
Turkey N05AX12 1393229.10.2014
29.10.2019PoM
Egis Pharmaceuticals
PLC, 1106 Budapest,
Kereszturi st. 30-38,
Hungary
407 Aripegis aripiprazole tablets
10mg,
in blister (14/1x14/,
28/2x14/, 56/4x14/)
Egis Pharmaceuticals
PLC, 1165 Budapest,
Bokenyfoldi st. 118-
120
Hungary N05AX12 1484704.09.2015
04.09.2020PoM
Egis Pharmaceuticals
PLC, 1106 Budapest,
Kereszturi st. 30-38,
Hungary
408 Aripegis aripiprazole tablets
15mg,
in blister (14/1x14/,
28/2x14/, 56/4x14/)
Egis Pharmaceuticals
PLC, 1165 Budapest,
Bokenyfoldi st. 118-
120
Hungary N05AX12 1484804.09.2015
04.09.2020PoM
Egis Pharmaceuticals
PLC, 1106 Budapest,
Kereszturi st. 30-38,
Hungary
409 Arixtra
fondaparinux
(fondaparinux
sodium)
solution for injection
5մգ/մլ,
0.5մլ նախալցված
ներարկիչ(10)
Aspen Notre Dame de
Bondeville, 1 rue de
l’Abbaye, 76960
Notre Dame de
Bondeville, France
France B01AX05 14272/131.07.2015
26.02.2020PoM
Aspen Pharma
Trading Limited,
3016 Lake Drive,
Citywest Business
Campus, Dublin 24,
Ireland
87
410 Arlevertcinnarizine,
dimenhydrinatetablets
20mg+40mg,
in blister (20/1x20/,
50/2x25/)
Hennig Arzneimittel
GmbH & Co. KG,
Liebigstrasse 1 - 2,
65439 Floersheim-am-
Main
Germany N07CA52 1576304.07.2016
04.07.2021PoM
Menarini
International
Operations
Luxembourg S.A.,1,
avenue de la Gare,
1611, Luxembourg
411 Armalgon methyl salicylate ointment300mg/g,
25g aluminium tube
Arpimed LLC, Kotayk
Marz, Abovyan, 2nd
Micro-District, 19
Building
Republic of
ArmeniaM02AC 14351
25.03.2015
25.03.2020OTC
Arpimed LLC,
Kotayk Marz,
Abovyan, 2nd Micro-
District, 19 Building,
Republic of Armenia
412 Armenicum
iodine, potassium
iodide, lithium
chloride, polyvinyl
alcohol, dextrin,
sodium chloride
capsules
28,76mg+
43,14mg+0,72mg+10,79m
g+ 359,53mg+ 32,36mg,
in blister (40/4x10/) and
in plastic container (40)
Arpimed LLC, Kotayk
Marz, Abovyan, 2nd
Micro-District, 19
Building
Republic of
ArmeniaJ05AX 13877
23.09.2014
23.09.2019PoM
"Armenicum+" CJSC,
37 Nalbandayan,
Yerevan 0001,
Republic of Armenia
413 Armenicum
iodine, potassium
iodide, lithium
chloride, polyvinyl
alcohol, dextrin,
sodium chloride
paste
13,6mg/g+ 20,4mg/g+
0,3mg/g+ 5,1mg/g+
170,3mg/g+ 15,3mg/g,
25g, 50g aluminium tube
Arpimed LLC, Kotayk
Marz, Abovyan, 2nd
Micro-District, 19
Building
Republic of
Armenia- 14822
04.09.2015
04.09.2020PoM
Armenicum+' CJSC,
37 Nalbandayan,
Yerevan 0001,
Republic of Armenia
414 Armenicum
iodine, potassium
iodide, lithium
chloride, polyvinyl
alcohol, dextrin,
sodium chloride
concentrate for
solution for infusion
0,16g/20ml+ 0,24g/20ml+
0,004g/20ml+
0,06g/20ml+ 2g/20ml+
0,18g/20ml,
20ml glass vial (1)
"Armenicum+" CJSC,
37 Nalbandyan,
Yerevan, 0001
Republic of
ArmeniaJ05AX 14911
02.10.2015
02.10.2020PoM
"Armenicum+" CJSC,
37 Nalbandyan,
Yerevan, 0001,
Republic of Armenia
415 Aromasin exemestane tablets coated25mg,
in blister (30/2x15/)
Pfizer Italia S.R.L.,
Localita Marino del
Tronto 63100 Ascoli
Piceno, Italy
Italy L02BG06 1218901.02.2013
01.02.2018PoM
Pfizer Italia S.R.L.,
Localita Marino del
Tronto 63100 Ascoli
Piceno, Italy
88
416 Arthrinal 20 tenoxicam tablets film-coated20mg,
in blister (10/1x10/)
Remedica Ltd.,
Limassol Industrial
Estate, Aharnon
street, 3056 Limassol
Cyprus M01AC02 1375705.08.2014
05.08.2019PoM
Remedica Ltd.,
Limassol Industrial
Estate,Aharnon
street,P.O. Box
51706, 3508 Limassol,
Cyprus
417 Articaine 1:100000
articaine (articaine
hydrochloride),
epinephrine
(epinephrine
hydrotartrate)
solution for injection40mg/ml+ 10mcg/ml,
1.8ml cartridges (50)
DFL Industria e
Comercio S.A.,
Estrada do
Guerengue, 2059,
Jacarepagua, Rio de
Janeiro-RJ
Brazil N01BB58 1495923.10.2015
23.10.2020PoM
DFL Industria e
Comercio S.A.,
Estrada do
Guerengue, 2059,
Jacarepagua, Rio de
Janeiro-RJ, Brazil
418 Articaine-Liqvo
articaine (articaine
hydrochloride),
epinephrine
(epinephrine
hydrotartrate)
solution for injection40mg/ml+ 0.01mg/ml,
20ml glass vial
Liqvor CJSC, 0089,
Yerevan, str.
Kochinyan, 7/9
Republic of
ArmeniaN01BB58 15510
19.04.2016
19.04.2021PoM
Liqvor CJSC, 0089,
Yerevan, str.
Kochinyan, 7/9,
Republic of Armenia
419 Articaine-Liqvo
articaine (articaine
hydrochloride),
epinephrine
(epinephrine
hydrotartrate)
solution for injection40mg/ml+ 0.005mg/ml,
20ml glass vial
Liqvor CJSC, 0089,
Yerevan, str.
Kochinyan, 7/9
Republic of
ArmeniaN01BB58 15511
19.04.2016
19.04.2021PoM
Liqvor CJSC, 0089,
Yerevan, str.
Kochinyan, 7/9,
Republic of Armenia
420 Artinibsa
articaine (articaine
hydrochloride),
epinephrine
(epinephrine
tartrate)
solution for injection40mg/ml+ 0.01mg/ml,
1.8ml cartridges (50)
Laboratories Inibsa
S.A., Ctra. Sabadell a
Granollers, km 14.5,
08185 Llica de Vall,
Barcelona
Spain N01BB58 1459808.06.2015
08.06.2020PoM
Inibsa Dental S.L.U.,
Ctra. Sabadell a
Granollers, km 14.5,
08185 Llica de Vall,
Barcelona, Spain
421 Artmeloc meloxicam tablets15mg,
in blister (20/2x10/)
Pharmtechnology
LLC, Korzhenevskogo
str., 22, 220024,
Minsk
Belarus M01AC06 1671723.05.2017
23.05.2022PoM
Giga Pharm LLC,
Gogunca str.3/5,
Gyumri, Republic of
Armenia
89
422 Artra
chondroitin sulfate
(chondroitin sulfate
sodium),
glucosamine
(glucosamine
hydrochloride)
tablets film-coated
500mg+500mg,
in plastic container (30,
60, 100, 120)
Unipharm, Inc., 200
Hick str., Westbury,
New York 11590
USAM01AX05,
M01AX25 13175
10.01.2014
10.01.2019OTC
Unipharm, Inc., 350,
5th avenue, suite
6701, New York,
10118, USA
423 Artra MSM Forte
chondroitin sulfate
(chondroitin sulfate
sodium),
glucosamine
hydrochloride,
methyl sulfonyl
methane,
hyaluronic acid
tablets film-coated
400mg+500mg+
300mg+10mg,
in plastic container (60)
Unipharm Inc., 75
Progress Lane,
Waterbury,
Connecticut(CT),
06705
USA M09AX 1399826.11.2014
26.11.2019OTC
Unipharm, Inc., 350,
5th avenue, suite
6701, New York,
10118, USA
424 Artrozan meloxicam tablets15mg,
in blister (20)
Pharmstandard-
Leksredstva OJSC,
305022, Kursk,
Agregatnaya 2nd str.,
1a/18
Russia M01AC06 1272923.07.2013
23.07.2018PoM
Pharmstandard-
Leksredstva OJSC,
305022, Kursk,
Agregatnaya 2nd str.,
1a/18, Russia
425 Artrozan meloxicam solution for injection
6mg/ml,
2,5ml ampoules (10/2x5/,
3/1x3/)
Pharmstandard-
UfaVITA OJSC,
450077, Ufa, str.
Khudajberdina 28
Russia M01AC06 1354230.05.2014
30.05.2019PoM
Pharmstandard-
UfaVITA OJSC,
450077, Ufa, str.
Khudajberdina 28,
Russia
426 Artrum ketoprofensolution for i/v and
i/m injection
50mg/ml,
2ml ampoules, in blister
(10/2x5/)
Biosintez OJSC,
Druzhby st. 4,
440033, Penza
Russia M01AE03 1484304.09.2015
04.09.2020PoM
Biosintez OJSC,
Druzhby st. 4,
440033, Penza, Russia
427 Artrum ketoprofen suppositories rectal100mg,
(10/2x5/)
Biosintez OJSC,
Druzhby st. 4,
440033, Penza
Russia M01AE03 1484404.09.2015
04.09.2020PoM
Biosintez OJSC,
Druzhby st. 4,
440033, Penza, Russia
90
428 Artrum ketoprofen gel for external use25mg/g,
30g aluminium tube
Biosintez OJSC,
Druzhby st. 4,
440033, Penza
Russia M02AA10 1484504.09.2015
04.09.2020PoM
Biosintez OJSC,
Druzhby st. 4,
440033, Penza, Russia
429 Artrum ketoprofen gel for external use50mg/g,
30g aluminium tube
Biosintez OJSC,
Druzhby st. 4,
440033, Penza
Russia M02AA10 1484604.09.2015
04.09.2020PoM
Biosintez OJSC,
Druzhby st. 4,
440033, Penza, Russia
430 Ascophen-Arpi
acetylsalicylic acid,
paracetamol,
caffeine
tablets
200mg+200mg+ 40mg,
in blister (6/1x6/,
10/1x10/)
Arpimed LLC, Kotayk
Marz, Abovyan, 2nd
Micro-District, 19
Building
Republic of
ArmeniaN02BA51 13970
21.11.2014
21.11.2019OTC
Arpimed LLC,
Kotayk Marz,
Abovyan, 2nd Micro-
District, 19 Building,
Republic of Armenia
431 Ascophen-Darnitsa
acetylsalicylic acid,
paracetamol,
caffeine
tablets
200mg+200mg+ 40mg,
in blister (6 and 10),
(6/1x6/ and 10/1x10/)
Darnitsa
Pharmaceutical Firm
PrJSC, 02093, Kyiv,
Boryspilska Str.,13
Ukraine N02BA51 1706405.10.2017
05.10.2022OTC
Darnitsa
Pharmaceutical Firm
PrJSC, 02093, Kyiv,
Boryspilska Str.,13,
Ukraine
432 Ascophen-P
paracetamol,
acetylsalicylic acid,
caffeine
tablets
200mg+200mg+ 40mg,
blister (10/1x10/,
20/2x10/)
Pharmstandard-
Leksredstva OJSC,
305022, Kursk,
Agregatnaya 2nd str.,
1a/18
Russia N02BA71 12612/206.09.2016
21.06.2018OTC
OTCPharm PJSC,
123317, Moscow,
Testovskaya str., 10,
Russia
433 Ascorbic acid ascorbic acid tablets chewable25mg,
in parafine paper (10)
Marbiopharm JSC,
424006,The Republic
of Mari El,Yoshkar-
Ola, st. Karl Marx 121
Russia A11GA01 1276314.08.2013
14.08.2018OTC
Marbiopharm JSC,
424006,The Republic
of Mari El,Yoshkar-
Ola, st. Karl Marx
121, Russia
434 Ascorbic acid ascorbic acid tablets chewable50mg,
in parafine paper (10)
Marbiopharm JSC,
424006,The Republic
of Mari El,Yoshkar-
Ola, st. Karl Marx 121
Russia A11GA01 1276414.08.2013
14.08.2018OTC
Marbiopharm JSC,
424006,The Republic
of Mari El,Yoshkar-
Ola, st. Karl Marx
121, Russia
91
435 Ascorbic acid ascorbic acid tablets chewable75mg,
in parafine paper (10)
Marbiopharm JSC,
424006,The Republic
of Mari El,Yoshkar-
Ola, st. Karl Marx 121
Russia A11GA01 1276514.08.2013
14.08.2018OTC
Marbiopharm JSC,
424006,The Republic
of Mari El,Yoshkar-
Ola, st. Karl Marx
121, Russia
436 Ascorbic acid ascorbic acid solution for injection
50mg/ml,
1ml ampoules (10), 1ml
ampoules, label banderol
(10), 1ml ampoules,
dividella (10)
Open Joint Stock
Company
"Borisovskiy zavod
Medicinskikh
Preparatov" (64/27,
Chapayev str., Borisov
222120, Minsk oblast)
Belarus A11GA01 1297528.10.2013
28.10.2018PoM
Open Joint Stock
Company
"Borisovskiy zavod
medicinskikh
preparatov" (64/27,
Chapayev str.,
Borisov 222120,
Minsk oblast, Belarus)
437 Ascorbic acid ascorbic acid solution for injection
50mg/ml,
2ml ampoules (10), 2ml
ampoules, label banderol
(10), 2ml ampoules,
dividella (10)
Open Joint Stock
Company
"Borisovskiy zavod
Medicinskikh
Preparatov" (64/27,
Chapayev str., Borisov
222120, Minsk oblast)
Belarus A11GA01 1297628.10.2013
28.10.2018PoM
Open Joint Stock
Company
"Borisovskiy zavod
medicinskikh
preparatov" (64/27,
Chapayev str.,
Borisov 222120,
Minsk oblast, Belarus)
438 Ascorbic acid ascorbic acid dragee50mg,
in plastic container (200)
Pharmstandard-
UfaVITA OJSC,
450077, Ufa, str.
Khudaiberdina 28
Russia A11GA 1368725.07.2014
25.07.2019OTC
Pharmstandard-
UfaVITA OJSC,
450077, Ufa, str.
Khudaiberdina 28,
Russia
439 Ascorbic acid ascorbic acid solution for injection
100mg/ml,
2ml ampoules (10) and
2ml ampoules, in blister
(10/2x5/)
Lekhim-Kharkiv JSC,
36, 17-go Partsyezda
str., 61115 Kharkov
Ukraine A11GA01 1460703.07.2015
03.07.2020PoM
Lekhim-Kharkiv JSC,
36, 17-go Partsyezda
str., 61115 Kharkov,
Ukraine
440 Ascorbic acid ascorbic acid solution for injection
50mg/ml, 2ml ampoules
(10) and (2ml ampoules,
in blister 10/2x5/)
Lekhim-Kharkiv JSC,
36, 17-go Partsyezda
str., 61115 Kharkov
Ukraine A11GA01 1462803.07.2015
03.07.2020PoM
Lekhim-Kharkiv JSC,
36, 17-go Partsyezda
str., 61115 Kharkov,
Ukraine
92
441 Ascorbic acid ascorbic acid solution for injection50mg/ml,
5ml ampoules (10)
Yerevan Chemical-
Pharmaceutical firm
OJSC, Yerevan,
Ajaryan street, 2 Line,
No6
Republic of
ArmeniaA11GA01 16681
31.05.2017
31.05.2022PoM
Yerevan Chemical-
Pharmaceutical firm
OJSC, Yerevan,
Ajaryan street, 2
Line, No6, Republic
of Armenia
442 Ascorbic acid ascorbic acid solution for injection50mg/ml,
2ml ampoules (10)
Yerevan Chemical-
Pharmaceutical firm
OJSC, Yerevan,
Ajaryan street, 2 Line,
No6
Republic of
ArmeniaA11GA01 16682
31.05.2017
31.05.2022PoM
Yerevan Chemical-
Pharmaceutical firm
OJSC, Yerevan,
Ajaryan street, 2
Line, No6, Republic
of Armenia
443Ascorbic acid with
glucose
ascorbic acid,
dextrose (dextrose
monohydrate)
tablets
100mg+877mg,
in blister (10/1x10/),
in plastic container (40)
Pharmstandard-
UfaVITA OJSC,
450077, Ufa, str.
Khudajberdina 28
Russia A11GB 1218801.02.2013
01.02.2018OTC
Pharmstandard-
UfaVITA OJSC,
450077, Ufa, str.
Khudajberdina 28,
RUSSIA
444Ascorbic acid with
glucose
ascorbic acid,
glucose (glucose
monohydrate)
tablets100mg+ 877mg,
in blister (10)
Open Joint Stock
Company
<Borisovskiy zavod
Medicinckikh
Preparatov>, 64/27,
Chapayev str., Borisov
222120, Minsk oblast
Belarus A11GB 1244002.10.2013
02.10.2018OTC
Open Joint Stock
Company
<Borisovskiy zavod
Medicinckikh
Preparatov>, 64/27,
Chapayev str.,
Borisov 222120,
Minsk oblast, Belarus
445 Ascorutin
ascorbic acid,
rutoside ( rutoside
trihydrate)
tablets50mg+50mg,
in blister (50/5x10/)
Marbiopharm JSC,
424006,The Republic
of Mari El,Yoshkar-
Ola, st. Karl Marx 121
Russia C05CA51 1302925.11.2013
25.11.2018OTC
Marbiopharm JSC,
424006,The Republic
of Mari El,Yoshkar-
Ola, st. Karl Marx
121, Russia
446 Ascorutinascorbic acid,
rutosidetablets
50mg+50mg,
in container (50)
Pharmstandard-
UfaVITA OJSC,
450077, Ufa, str.
Khudaiberdina 28
Russia C05CA51 1360620.06.2014
20.06.2019OTC
Pharmstandard-
UfaVITA OJSC,
450077, Ufa, str.
Khudaiberdina 28,
Russia
93
447 Ascorutin
ascorbic acid,
rutoside (rutoside
trihydrate)
tablets50mg+50mg,
in blister (50/5x10/)
PJSC "Technolog",
Manuylskogo str. 8,
20300
Uman,Cherkassy
region
Ukraine C05CA51 1727613.12.2017
13.12.2022OTC
PJSC "Technolog",
Manuylskogo str. 8,
20300
Uman,Cherkassy
region, Ukraine
448 Ascovet clotrimazole solution
32mg/ml,
0.5ml ampoules (50), 1ml
ampoules (50)
Agrobioprom CJSC,
143985, Moscow,
Balashikhinski
district, Novo-Milet
r/d, Poltevskoe shosse,
4
Russia
QJ02AB90;
veterinary
drug
1676602.06.2017
02.06.2022OTC
Agrobioprom CJSC,
107139, Moscow,
pereulok
Orlikov,house 3,
Russia
449 Asentrasertraline (sertraline
hydrochloride)tablets film-coated
50mg,
in blister (28/4x7/)
KRKA d.d., Novo
mesto, Smarjeska
cesta 6, 8501 Novo
Mesto
Slovenia N06AB06 1563924.05.2016
24.05.2021PoM
KRKA d.d., Novo
mesto, Smarjeska
cesta 6, 8501 Novo
Mesto, Slovenia
450 Askophen-Extra
acetylsalicylic acid,
paracetamol,
caffeine
tablets300mg+100mg+ 50mg,
blister (10, 10/1x10/)
Lubnypharm' PJSC,
37500, Poltava obl.,
Lubny, Petrovskogo
str., 16
Ukraine N02BA51 13637/217.08.2016
27.06.2019OTC
Lubnypharm' PJSC,
37500, Poltava obl.,
Lubny, Petrovskogo
str., 16, Ukraine
451 Asomex-2,5
amlodipine
(amlodipine
besilate)
tablets2,5mg,
in blister (30/3x10/)
Emcure
Pharmaceuticals Ltd.,
Lane No. 3, Phase II,
SIDCO Industrial
Complex, Bari-
Brahmana, Jammu
(J&K)-181 133
India C08CA01 1327604.03.2014
04.03.2019PoM
Emcure
Pharmaceuticals Ltd.,
T-184, M.I.D.C.,
Bhosari, Pune-
411026, Maharashtra,
India
452 Asomex-5
amlodipine
(amlodipine
besilate)
tablets5mg,
in blister (30/3x10/)
Emcure
Pharmaceuticals Ltd.,
Lane No. 3, Phase II,
SIDCO Industrial
Complex, Bari-
Brahmana, Jammu
(J&K)-181 133
India C08CA01 1327704.03.2014
04.03.2019PoM
Emcure
Pharmaceuticals Ltd.,
T-184, M.I.D.C.,
Bhosari, Pune-
411026, Maharashtra,
India
94
453 Asomex-D
amlodipine
(amlodipine
besilate),
hydrochloro-
thiazide
tablets2,5mg+12,5mg,
in blister (30/3x10/)
Emcure
Pharmaceuticals Ltd.,
Lane No. 3, Phase II,
SIDCO Industrial
Complex, Bari-
Brahmana, Jammu
(J&K)-181 133
India C08CA01 1363327.06.2014
27.06.2019PoM
Emcure
Pharmaceuticals Ltd.,
T-184, M.I.D.C.,
Bhosari, Pune-
411026, Maharashtra,
India
454Asparaginase
medacl-asparaginase
powder lyophilized
for solution for
injection
10000U,
glass vial
Medac GmbH,
Theaterstrasse 6,
22880 Wedel-
secondary packager,
batch releaser (bulk
manufacturer,
primary packager -
Kyowa Hakko Kirin
Co., Ltd, Fuji Plant
1188 Shimotogari,
Nagaizumi-cho Sunto-
gun, Shizuoka, Japan)
Germany L01XX02 13007/106.12.2016
13.11.2018PoM
Medac GmbH,
Theaterstrasse 6,
22880 Wedel,
Germany
455Asparaginase
medacl-asparaginase
powder lyophilized
for solution for
injection
5000U,
glass vial
Medac GmbH,
Theaterstrasse 6,
22880 Wedel-
secondary packager,
batch releaser (bulk
manufacturer,
primary packager -
Kyowa Hakko Kirin
Co., Ltd, Fuji Plant
1188 Shimotogari,
Nagaizumi-cho Sunto-
gun, Shizuoka, Japan)
Germany L01XX02 13104/106.12.2016
02.12.2018PoM
Medac GmbH,
Theaterstrasse 6,
22880 Wedel,
Germany
456Asparkam-
Zdorovye
magnesium
asparaginate
tetrahydrate,
potassium
asparaginate
hemihydrate
tablets
175mg+175mg,
in blister (50/5x10/,
50/1x50/)
Zdorovye
Pharmaceutical
Company LLC, str.
Shevchenko 22,
Kharkov
Ukraine A12CX 1305425.11.2013
25.11.2018OTC
Zdorovye
Pharmaceutical
Company LLC, str.
Shevchenko 22,
Kharkov, Ukraine
95
457 Aspicor 100 acetylsalicylic acidtablets gastro-
resistant
100mg,
in blister (1000/100x10/)
Coral Laboratories
Ltd., Plot No. 57/1
(16), Bhenslore,
Dunetha, Nani
Daman 396 210
India B01AC06 1638710.02.2017
10.02.2022OTC
Coral Laboratories
Ltd., 503, Dalamal
House, 5th floor, J.B.
Marg, Nariman Point,
Mumbai 400 021,
India
458 Aspicor 300 acetylsalicylic acidtablets gastro-
resistant
300mg,
in blister (1000/100x10/)
Coral Laboratories
Ltd., Plot No. 57/1
(16), Bhenslore,
Dunetha, Nani
Daman 396 210
India B01AC06 1483804.09.2015
04.09.2020OTC
Coral Laboratories
Ltd., 503, Dalamal
House, 5th floor, J.B.
Marg, Nariman Point,
Mumbai 400 021,
India
459 Aspirin Cacetylsalicylic acid,
ascorbic acidtablets effervescent
400mg+240mg,
in strip (10/5x2/)
Bayer Bitterfeld
GmbH, Ortsteil
Greppin Salegaster
Chaussee 1, 06803
Bitterfeld-Wolfen
Germany N02BA51 1499316.11.2015
16.11.2020OTC
Bayer Consumer Care
AG, Peter Merian-
Strasse 84, 4052 Basel,
Switzerland
460 Aspirin cardio acetylsalicylic acidtablets enteric-
coated
100mg,
in blister (20/2x10/)
Bayer Bitterfeld
GmbH, Ortsteil
Greppin Salegaster
Chaussee 1, 06803
Bitterfeld-Wolfen -
batch releaser,
primary and
secondary packager
(dosage form
manufacturer - Bayer
Bitterfeld GmbH,
Ortsteil Greppin
Salegaster Chaussee 1,
06803 Bitterfeld-
Wolfen)
Germany N02BA01 1219301.02.2013
01.02.2018OTC
Bayer Vital GmbH,
51368 Leverkusen,
Germany
96
461 Aspirin cardio acetylsalicylic acidtablets enteric-
coated
300mg,
in blister (20/2x10/)
Bayer Bitterfeld
GmbH, Ortsteil
Greppin Salegaster
Chaussee 1, 06803
Bitterfeld-Wolfen -
batch releaser,
primary and
secondary packager
(dosage form
manufacturer - Bayer
Bitterfeld GmbH,
Ortsteil Greppin
Salegaster Chaussee 1,
06803 Bitterfeld-
Wolfen)
Germany N02BA01 1219401.02.2013
01.02.2018OTC
Bayer Vital GmbH,
51368 Leverkusen,
Germany
462 Aspirin Cardio acetylsalicylic acidtablets gastro-
resistant
100mg,
in blister (28/2x14/)
Bayer Bitterfeld
GmbH, Ortsteil
Greppin, Salegaster
Chaussee 1, 06803
Bitterfeld-Wolfen-
batch releaser,
packager, Bayer
Pharma AG, Kaiser-
Wilhelm-Allee, 51368
Leverkusen, Germany-
bulk manufacturer
Germany B01AC06 1701426.09.2017
26.09.2022OTC
Bayer Consumer Care
AG, Peter Merian-
Strasse 84, 4052 Basel,
Switzerland
463 Astradez-Light
N,N-bis(3-
aminopropyl)dodec
ylamine, N,N-
didecyl-N,N-
dimethyl amonium
chloride
solution
7,1+/-0,1%+
3,5+/-0,3%,
1l in plastic container
Gigiena-Med JSC
Prophylaxis Centre,
241004, Karachevskoe
road, 4th km, Bryansk
Russia 1244707.05.2013
07.05.2018OTC
Gigiena-Med JSC
Prophylaxis
Centre,119361,
Ozernaya str., 42,
Moscow, Russia
464 Asvitol ascorbic acid tablets chewable200mg,
in blister (20/1x20/)
Pharmstandard-
Leksredstva JSC,
305022, Kursk,
Agregatnaya 2nd str.,
1a/18
Russia A11GA01 1705205.10.2017
05.10.2022OTC
OTCPharm PJSC,
123317, Moscow,
Testovskaya str., 10,
Russia
97
465 Atarax
hydroxyzine
(hydroxyzine
hyrochloride)
tablets film-coated25mg,
in blister (25/1x25/)
UCB Pharma S.A.,
Chemin du Foriest, B-
1420 Braine
Belgium N05BB01 15024/113.03.2017
02.12.2020PoM
l'Alleud
GlaxoSmithKline
Export Ltd., 980
Great West Road,
Brentford, Middlesex,
TW8 9GS, UK
466 Atenolol atenolol tablets film-coated25mg,
in blister (28)
CP Pharmaceuticals
Ltd., Ash Road North,
Wrexham LL13 9UF -
batch releaser ( dosage
form manufacturer,
packager - Wockhardt
Limited, H-14/2
MIDC, Waluj,
Aurangabad,
Maharashtra, IN-
431136, India)
UK C07AB03 1232703.04.2013
03.04.2018PoM
Wockhardt UK Ltd.,
Ash Road North,
Wrexham Industrial
Estate, LL13 9 UF,
UK
467 Atenolol atenolol tablets film-coated50mg,
in blister (28)
CP Pharmaceuticals
Ltd., Ash Road North,
Wrexham LL13 9UF -
batch releaser ( dosage
form manufacturer,
packager - Wockhardt
Limited, H-14/2
MIDC, Waluj,
Aurangabad,
Maharashtra, IN-
431136, India)
UK C07AB03 1232803.04.2013
03.04.2018PoM
Wockhardt UK Ltd.,
Ash Road North,
Wrexham Industrial
Estate, LL13 9 UF,
UK
98
468 Atenolol atenolol tablets film-coated100mg,
in blister (28)
CP Pharmaceuticals
Ltd., Ash Road North,
Wrexham LL13 9UF -
batch releaser ( dosage
form manufacturer,
packager - Wockhardt
Limited, H-14/2
MIDC, Waluj,
Aurangabad,
Maharashtra, IN-
431136, India)
UK C07AB03 1232903.04.2013
03.04.2018PoM
Wockhardt UK Ltd.,
Ash Road North,
Wrexham Industrial
Estate, LL13 9 UF,
UK
469 Atenolol atenolol tablets50mg,
in blisters (30/2x15/)
Tatchempharmpre-
paraty JSC, 420091
Kazan, str.
Belomorskaya 260
Russia C07AB03 14276/103.04.2017
19.03.2020PoM
Tatchempharmpre-
paraty JSC, 420091
Kazan, str.
Belomorskaya 260,
Russia
470 Atenolol atenolol tablets50mg,
in blister (30/3x10/)
Open joint stock
company "Borisovskiy
zavod medicinskikh
preparatov" 64,
Chapaev str., Borisov
222518, Minsk region
Belarus C07AB03 1558512.05.2016
12.05.2021PoM
Open joint stock
company "Borisovskiy
zavod medicinskikh
preparatov" 64,
Chapaev str., Borisov
222518, Minsk
region, Belarus
471 Atenolol atenolol tablets100mg, (30/3x10/), in
blister
Open joint stock
company "Borisovskiy
zavod medicinskikh
preparatov" 64,
Chapaev str., Borisov
222518, Minsk region
Belarus C07AB03 1558612.05.2016
12.05.2021PoM
Open joint stock
company "Borisovskiy
zavod medicinskikh
preparatov" 64,
Chapaev str., Borisov
222518, Minsk
region, Belarus
99
472Atenolol 100mg
Tabletsatenolol tablets
100mg,
in blister (28/2x14/)
Accord Healthcare
Limited, Sage House,319
Pinner Road, North
Harrow, Middlesex, HA1
4HF- batch releaser, Intas
Pharmaceuticals Limited,
Plot No 5/6/7, Pharmez,
Near Village Matoda,
Sarkhej-Bavla Highway,
NH-8A, Matoda, District-
Ahmedabad, 382 210,
Gujarat, India- bulk
manufacturer, Accord
Healthcare Limited, Unit C
& D, Homefield Business
Park, Homefield Road,
Haverhill, CB9 8QP, UK-
primary and secondary
packager
UK C07AB03 1525613.01.2016
13.01.2021PoM
Accord Healthcare
Limited, Sage
House,319 Pinner
Road, North Harrow,
Middlesex, HA1 4HF,
UK
473Atenolol 100mg
Tabletsatenolol tablets
100mg,
in blister (28/2x14/)
Accord Healthcare
Limited, Sage House, 319
Pinner Road, North
Harrow, Middlesex, HA1
4HF - batch releaser, Intas
Pharmaceuticals Limited,
Plot No 457 & 458 &
191/218 P, Sarkhej-Bavla
Highway, Matoda Village,
Sanand, District-
Ahmedabad, 382 210,
Gujarat, India- bulk
manufacturer, Accord
Healthcare Limited, Unit C
& D, Homefield Business
Park, Homefield Road,
Haverhill, CB9 8QP, UK-
primary and secondary
packager
UK C07AB03 1525813.01.2016
13.01.2021PoM
Accord Healthcare
Limited, Sage
House,319 Pinner
Road, North Harrow,
Middlesex, HA1 4HF,
UK
100
474Atenolol 25mg
Tabletsatenolol tablets
25mg,
in blister (28/2x14/)
Accord Healthcare
Limited, Sage House,319
Pinner Road, North
Harrow, Middlesex, HA1
4HF- batch releaser, Intas
Pharmaceuticals Limited,
Plot No 5/6/7, Pharmez,
Near Village Matoda,
Sarkhej-Bavla Highway,
NH-8A, Matoda, District-
Ahmedabad, 382 210,
Gujarat, India- bulk
manufacturer, Accord
Healthcare Limited, Unit C
& D, Homefield Business
Park, Homefield Road,
Haverhill, CB9 8QP, UK-
primary and secondary
packager
UK C07AB03 1525513.01.2016
13.01.2021PoM
Accord Healthcare
Limited, Sage
House,319 Pinner
Road, North Harrow,
Middlesex, HA1 4HF,
UK
475Atenolol 25mg
Tabletsatenolol tablets
25mg,
in blister (28/2x14/)
Accord Healthcare
Limited, Sage House, 319
Pinner Road, North
Harrow, Middlesex, HA1
4HF - batch releaser, Intas
Pharmaceuticals Limited,
Plot No 457 & 458 &
191/218 P, Sarkhej-Bavla
Highway, Matoda Village,
Sanand, District-
Ahmedabad, 382 210,
Gujarat, India- bulk
manufacturer, Accord
Healthcare Limited, Unit C
& D, Homefield Business
Park, Homefield Road,
Haverhill, CB9 8QP, UK-
primary and secondary
packager
UK C07AB03 1525913.01.2016
13.01.2021PoM
Accord Healthcare
Limited, Sage
House,319 Pinner
Road, North Harrow,
Middlesex, HA1 4HF,
UK
101
476Atenolol 50mg
Tabletsatenolol tablets
50mg,
in blister (28/2x14/)
Accord Healthcare
Limited, Sage House,319
Pinner Road, North
Harrow, Middlesex, HA1
4HF- batch releaser, Intas
Pharmaceuticals Limited,
Plot No 5/6/7, Pharmez,
Near Village Matoda,
Sarkhej-Bavla Highway,
NH-8A, Matoda, District-
Ahmedabad, 382 210,
Gujarat, India- bulk
manufacturer, Accord
Healthcare Limited, Unit C
& D, Homefield Business
Park, Homefield Road,
Haverhill, CB9 8QP, UK-
primary and secondary
packager
UK C07AB03 1525713.01.2016
13.01.2021PoM
Accord Healthcare
Limited, Sage
House,319 Pinner
Road, North Harrow,
Middlesex, HA1 4HF,
UK
477Atenolol 50mg
Tabletsatenolol tablets
50mg,
in blister (28/2x14/)
Accord Healthcare
Limited, Sage House, 319
Pinner Road, North
Harrow, Middlesex, HA1
4HF - batch releaser, Intas
Pharmaceuticals Limited,
Plot No 457 & 458 &
191/218 P, Sarkhej-Bavla
Highway, Matoda Village,
Sanand, District-
Ahmedabad, 382 210,
Gujarat, India- bulk
manufacturer, Accord
Healthcare Limited, Unit C
& D, Homefield Business
Park, Homefield Road,
Haverhill, CB9 8QP, UK-
primary and secondary
packager
UK C07AB03 1526013.01.2016
13.01.2021PoM
Accord Healthcare
Limited, Sage
House,319 Pinner
Road, North Harrow,
Middlesex, HA1 4HF,
UK
478
Atenolol Sopharma
25mg film-coated
tablets
atenolol tablets film-coated25mg,
in blister (30/3x10/)
Sopharma JSC, str.
Iliensko shosse 16,
1220 Sofia
Bulgaria C07AB03 1537326.02.2016
26.02.2021PoM
Sopharma JSC, str.
Iliensko shosse 16,
1220 Sofia, Bulgaria
479
Atenolol Sopharma
50mg film-coated
tablets
atenolol tablets film-coated50mg,
in blister (30/3x10/)
Sopharma JSC, str.
Iliensko shosse 16,
1220 Sofia
Bulgaria C07AB03 1537426.02.2016
26.02.2021PoM
Sopharma JSC, str.
Iliensko shosse 16,
1220 Sofia, Bulgaria
102
480 Atoris
atorvastatin
(atorvastatin
calcium)
tablets film-coated40mg,
in blister (30/3x10/)
KRKA d.d., Novo
mesto, Smarjeska
cesta 6, 8501 Novo
Mesto
Slovenia C10AA05 1465203.07.2015
03.07.2020PoM
KRKA d.d., Novo
mesto, Smarjeska
cesta 6, 8501 Novo
Mesto, Slovenia
481 Atoris
atorvastatin
(atorvastatin
calcium)
tablets film-coated30mg,
in blister (30/3x10/)
KRKA d.d., Novo
mesto, Smarjeska
cesta 6, 8501 Novo
Mesto
Slovenia C10AA05 1478203.08.2015
03.08.2020PoM
KRKA d.d., Novo
mesto, Smarjeska
cesta 6, 8501 Novo
Mesto, Slovenia
482 Atoris
atorvastatin
(atorvastatin
calcium)
tablets film-coated60mg,
in blister (30/3x10/)
KRKA d.d., Novo
mesto, Smarjeska
cesta 6, 8501 Novo
Mesto
Slovenia C10AA05 1478303.08.2015
03.08.2020PoM
KRKA d.d., Novo
mesto, Smarjeska
cesta 6, 8501 Novo
Mesto, Slovenia
483 Atoris
atorvastatin
(atorvastatin
calcium)
tablets film-coated20mg,
in blister (30/3x10/)
KRKA d.d., Novo
mesto, Smarjeska
cesta 6, 8501 Novo
Mesto
Slovenia C10AA05 1561724.05.2016
24.05.2021PoM
KRKA d.d., Novo
mesto, Smarjeska
cesta 6, 8501 Novo
Mesto, Slovenia
484 Atoris
atorvastatin
(atorvastatin
calcium)
tablets film-coated10mg,
in blister (30/3x10/)
KRKA d.d., Novo
mesto, Smarjeska
cesta 6, 8501 Novo
Mesto
Slovenia C10AA05 1561824.05.2016
24.05.2021PoM
KRKA d.d., Novo
mesto, Smarjeska
cesta 6, 8501 Novo
Mesto, Slovenia
485 Atortonus
atorvastatin
(atorvastatin
calcium trihydrate)
tablets film-coated20mg,
in blister (30/3x10/)
Arpimed LLC, Kotayk
Marz, Abovyan, 2nd
Micro-District, 19
Building
Republic of
ArmeniaC10AA05 15720
22.06.2016
22.06.2021PoM
Arpimed LLC,
Kotayk Marz,
Abovyan, 2nd Micro-
District, 19 Building,
Republic of Armenia
103
486 Atorvastatin
atorvastatin
(atorvastatin
calcium
hemihydrate)
tablets film-coated10mg,
in blister (28)
Dexcel-Pharma Ltd., 7
Sopwith Way, Drayton
Fields Industrial Estate,
Daventry,
Northamptonshire,
NN11 8PB - batch
releaser (dosage form
manufacturer - Dexcel
Pharma Technologies
Limited, 10 Hakidma
Street, Northern Hi-
tech City Park,
Yokneam, Israel)
(packager - Dexcel Ltd.,
1 Dexcel St., Or-Akiva
30600, Israel)
UK C10AA05 1253222.05.2013
22.05.2018PoM
Dexcel-Pharma Ltd.,
7 Sopwith Way,
Drayton Fields
Industrial Estate,
Daventry,
Northamptonshire,
NN11 8PB, UK
487 Atorvastatin
atorvastatin
(atorvastatin
calcium
hemihydrate)
tablets film-coated20mg,
in blister (28)
Dexcel-Pharma Ltd., 7
Sopwith Way, Drayton
Fields Industrial Estate,
Daventry,
Northamptonshire,
NN11 8PB - batch
releaser (dosage form
manufacturer - Dexcel
Pharma Technologies
Limited, 10 Hakidma
Street, Northern Hi-
tech City Park,
Yokneam, Israel)
(packager - Dexcel Ltd.,
1 Dexcel St., Or-Akiva
30600, Israel)
UK C10AA05 1253322.05.2013
22.05.2018PoM
Dexcel-Pharma Ltd.,
7 Sopwith Way,
Drayton Fields
Industrial Estate,
Daventry,
Northamptonshire,
NN11 8PB, UK
104
488 Atorvastatin
atorvastatin
(atorvastatin
calcium
hemihydrate)
tablets film-coated40mg,
in blister (28)
Dexcel-Pharma Ltd., 7
Sopwith Way, Drayton
Fields Industrial Estate,
Daventry,
Northamptonshire,
NN11 8PB - batch
releaser (dosage form
manufacturer - Dexcel
Pharma Technologies
Limited, 10 Hakidma
Street, Northern Hi-
tech City Park,
Yokneam, Israel)
(packager - Dexcel Ltd.,
1 Dexcel St., Or-Akiva
30600, Israel)
UK C10AA05 1253422.05.2013
22.05.2018PoM
Dexcel-Pharma Ltd.,
7 Sopwith Way,
Drayton Fields
Industrial Estate,
Daventry,
Northamptonshire,
NN11 8PB, UK
489 Atorvastatin
atorvastatin
(atorvastatin
calcium)
tablets film-coated
20mg,
in blister (10/1x10/,
30/3x10/)
Belmedpreparaty
RUE, 220007, Minsk,
Fabritsius St., 30
Belarus C10AA05 1314310.01.2014
10.01.2019PoM
Belmedpreparaty
RUE, 220007, Minsk,
Fabritsius St., 30,
Belarus
490 Atorvastatin
atorvastatin
(atorvastatin
calcium)
tablets coated
10mg,
in blister (10/1x10/,
30/3x10/)
Belmedpreparaty
RUE, 220007, Minsk,
Fabritsius St., 30
Belarus C10AA05 1322524.02.2014
24.02.2019PoM
Belmedpreparaty
RUE, 220007, Minsk,
Fabritsius St., 30,
Belarus
491 Atorvastatin
atorvastatin
(atorvastatin
calcium trihydrate)
tablets film-coated10mg,
in blister (30/3x10/)
Replek Farm Ltd.-
Skopje, 188 str. Kozle,
1000 Skopje
Macedonia C10AA05 1329104.03.2014
04.03.2019PoM
Replek Farm Ltd.-
Skopje, 188 str. Kozle,
1000 Skopje,
Macedonia
492 Atorvastatin
atorvastatin
(atorvastatin
calcium trihydrate)
tablets film-coated20mg,
in blister (30/3x10/)
Replek Farm Ltd.-
Skopje, 188 str. Kozle,
1000 Skopje
Macedonia C10AA05 1329204.03.2014
04.03.2019PoM
Replek Farm Ltd.-
Skopje, 188 str. Kozle,
1000 Skopje,
Macedonia
493 Atorvastatin
atorvastatin
(atorvastatin
calcium trihydrate)
tablets film-coated40mg,
in blister(30/3x10/)
Replek Farm Ltd.-
Skopje, 188 str. Kozle,
1000 Skopje
Macedonia C10AA05 1329304.03.2014
04.03.2019PoM
Replek Farm Ltd.-
Skopje, 188 str. Kozle,
1000 Skopje,
Macedonia
105
494 Atorvastatin
atorvastatin
(atorvastatin
calcium trihydrate)
tablets film-coated80mg,
in blister (30/3x10/)
Replek Farm Ltd.-
Skopje, 188 str. Kozle,
1000 Skopje
Macedonia C10AA05 1329404.03.2014
04.03.2019PoM
Replek Farm Ltd.-
Skopje, 188 str. Kozle,
1000 Skopje,
Macedonia
495Atracurium
Besylate Injection
atracurium
(atracurium
besylate)
solution for injection10mg/ml,
5ml ampoules (5)
Swiss Parenterals Pvt.
Ltd., 809 Kerala
Industrial Estate ,
G.I.D.C, Near Bavla,
Dist. Ahmedabad-382
220,Gujarat
India M03AC04 1701126.09.2017
26.09.2022PoM
Swiss Parenterals Pvt.
Ltd., 809 Kerala
Industrial Estate ,
G.I.D.C, Near Bavla,
Dist. Ahmedabad-382
220,Gujarat, India
496
Atracurium
Besylate Injection
10mg/ml
atracurium
(atracurium
besylate)
solution for injection10mg/ml,
2,5ml ampoules (5)
Swiss Parenterals Pvt.
Ltd., 809 Kerala
Industrial Estate ,
G.I.D.C, Near Bavla,
Dist. Ahmedabad-382
220,Gujarat
India M03AC04 1342714.04.2014
14.04.2019PoM
Swiss Parenterals Pvt.
Ltd., 809 Kerala
Industrial Estate ,
G.I.D.C, Near Bavla,
Dist. Ahmedabad-382
220,Gujarat, India
497 Atrican 250 tenonitrozolecapsules gastro-
resistant
250mg,
in blister (8/1x8/)
Innothera Chouzy,
Rue Rene Chantereau
"Lisle Vert", 41150
Chouzy-Sur-Cisse
France P01AX08 1354923.05.2014
23.05.2019PoM
Laboratoire Innotech
International, 22,
Avenue Aristide
Briand, 94110
Arcueil, France
498 Atropine sulfateatropine (atropine
sulfate)drops eye
10mg/ml,
5ml glass vial and dropper
Experimental plant
GNCLS LLC, 61057,
Kharkov, Vorobeva
str., 8
Ukraine S01FA01 1301025.11.2013
25.11.2018PoM
Experimental plant
GNCLS LLC, 61057,
Kharkov, Vorobeva
str., 8, Ukraine
499 Atropine sulfateatropine (atropine
sulfate)
solution for i/m, i/v
and s/c injection
1mg/ml,
1ml ampoules (10)
Pharmaceutical
Company "Zdorovye"
LLC, 61013, Kharkov,
Shevchenko str., 22
Ukraine A03BA01 1589623.08.2016
23.08.2021PoM
Experimental Plant
"GNCLS" LLC, 61057,
Kharkov, Vorobyova
str., 8, Ukraine
106
500 Atropine sulfateatropine (atropine
sulfate)drops eye
10mg/ml,
5ml glass vial and dropper
"PHARMEX GROUP"
LLC, 100, Shevchenka
str.,08300, Kyiv
region, Boryspil
Ukraine S01FA01 1709023.10.2017
23.10.2022PoM
Experimental Plant
"GNCLS" LLC, 61057,
Kharkov, Vorobyova
str., 8, Ukraine
501 Atrovent N
ipratropium
bromide
(ipratropium
bromide
monohydrate)
aerosol for
inhalation, dosed
20mcg/dose,
10ml (200doses)
aluminium container
with measuring pump
Boehringer Ingelheim
Pharma GmbH & Co.
KG, Binger Strasse
173, 55216 Ingelheim
am Rhein
Germany R03BB01 1641710.02.2017
10.02.2022PoM
Boehringer Ingelheim
International GmbH,
Binger Strasse 173,
55216 Ingelheim am
Rhein, Germany
502 Augmentin
amoxicillin
(amoxicillin
trihydrate),
clavulanic acid
(potassium
clavulanate)
tablets film-coated250mg+125mg,
in blister (20/2x10/)
SmithKline Beecham
Limited, Clarendon
road, Worthing, West
Sussex, BN14 8QH
UK J01CR02 12472/121.03.2014
13.05.2018PoM
Beecham Group PLC,
980 Great West Road,
Brentford, Middlesex,
TW8 9GS, UK
503 Augmentin
amoxicillin
(amoxicillin
trihydrate),
clavulanic acid
(potassium
clavulanate)
tablets film-coated500mg+125mg,
in blister (14/2x7/)
SmithKline Beecham
Limited, Clarendon
road, Worthing, West
Sussex, BN14 8QH
UK J01CR02 12473/121.03.2014
13.05.2018PoM
Beecham Group PLC,
980 Great West Road,
Brentford, Middlesex,
TW8 9GS, UK
504 Augmentin
amoxicillin
(amoxicillin
trihydrate),
clavulanic acid
(potassium
clavulanate)
tablets film-coated875mg+125mg,
in blister (14/2x7/)
SmithKline Beecham
Limited, Clarendon
road, Worthing, West
Sussex, BN14 8QH
UK J01CR02 12474/121.03.2014
13.05.2018PoM
Beecham Group PLC,
980 Great West Road,
Brentford, Middlesex,
TW8 9GS, UK
505 Augmentin
amoxicillin
(amoxicillin
trihydrate),
clavulanic acid
(potassium
clavulanate)
powder for oral
suspension
125mg/5ml+
31,25mg/5ml, 100ml glass
bottle
SmithKline Beecham
Limited, Clarendon
road, Worthing, West
Sussex, BN14 8QH
UK J01CR02 12475/121.03.2014
13.05.2018PoM
Beecham Group PLC,
980 Great West Road,
Brentford, Middlesex,
TW8 9GS, UK
107
506 Augmentin
amoxicillin
(amoxicillin
trihydrate),
clavulanic acid
(potassium
clavulanate)
powder for oral
suspension
200mg/5ml+ 28,5mg/5ml,
70ml glass bottle
SmithKline Beecham
Limited, Clarendon
road, Worthing, West
Sussex, BN14 8QH
UK J01CR02 12476/121.03.2014
13.05.2018PoM
Beecham Group PLC,
980 Great West Road,
Brentford, Middlesex,
TW8 9GS, UK
507 Augmentin
amoxicillin
(amoxicillin
trihydrate),
clavulanic acid
(potassium
clavulanate)
powder for oral
suspension
250mg/5ml+ 62,5mg/5ml,
100ml glass bottle
SmithKline Beecham
Limited, Clarendon
road, Worthing, West
Sussex, BN14 8QH
UK J01CR02 12477/121.03.2014
13.05.2018PoM
Beecham Group PLC,
980 Great West Road,
Brentford, Middlesex,
TW8 9GS, UK
508 Augmentin
amoxicillin
(amoxicillin
trihydrate),
clavulanic acid
(potassium
clavulanate)
powder for oral
suspension
400mg/5ml+ 57mg/5ml,
70ml glass bottle
SmithKline Beecham
Limited, Clarendon
road, Worthing, West
Sussex, BN14 8QH
UK J01CR02 12478/121.03.2014
13.05.2018PoM
Beecham Group PLC,
980 Great West Road,
Brentford, Middlesex,
TW8 9GS, UK
509 Augmentin ES
amoxicillin
(amoxicillin
trihydrate),
clavulanic acid
(potassium
clavulanate)
powder for oral
suspension with
strawberry flavour
600mg/5ml+ 42.9mg/5ml,
100ml glass bottle and
5ml measuring spoon
Glaxo Wellcome
Production, Z.I. de la
Peyenniere, 53100
Mayenne
France J01C R02 1480204.09.2015
04.09.2020PoM
Laboratoire
GlaxoSmithKline,
100, route de
Versailles, 78163
Marly-Le-Roi cedex,
France
510Augmentin
intravenous
amoxicillin
(amoxicillin
sodium), clavulanic
acid (potassium
clavulanate)
powder for solution
for injection
1000mg+200mg, glass
vials (10)
SmithKline Beecham
Limited, Clarendon
road, Worthing, West
Sussex, BN14 8QH
UK J01CR02 12802/121.03.2014
23.08.2018PoM
Beecham Group PLC,
980 Great West Road,
Brentford, Middlesex,
TW8 9GS, UK
108
511 Avamigran
propyphenazone,
caffeine, camylofin
(camylofin
hydrochloride),
mecloxamine
(mecloxamine
citrate), ergotamine
(ergotamine
tartrate)
tablets film-coated
200mg+80mg+
25mg+20mg+ 0,75mg,
in plastic container (10)
Bosnalijek d.d.,
Jukiceva 53, 71000
Sarajevo
Bosnia And
HerzegovinaN02CA52 17201
08.12.2017
08.12.2022PoM
Bosnalijek d.d.,
Jukiceva 53, 71000
Sarajevo, Bosnia And
Herzegovina
512 Avamysfluticasone
(fluticasone furoate)
spray nasal
(suspension)
27,5mcg/dose, plastic
bottle
Glaxo Operations UK
Limited, Harmire
Road, Barnard Castle,
Co Durham DL12
8DT
UK R01AD12 1442614.04.2015
14.04.2020PoM
Glaxo Group Ltd, 980
Great West Road,
Brentford, Middlesex,
TW8 9GS, UK
513 Avastin bevacizumabconcentrate for
solution for infusion
25mg/ml,
4ml glass vial (1)
Roche Diagnostics
GmbH, Sandhofer
Strasse 116, D-68305
Mannheim-batch
releaser, bulk
manufacturer,
primary packager, F.
Hoffmann-La Roche
Ltd. Wurmisweg CH-
4303 Kaiseraugst,
Switzerland-
secondary packager
Germany
L01XC07;
new
indication
14359/125.03.2015
25.03.2020PoM
F. Hoffmann-La
Roche Ltd.,
Grenzacherstrasse,
124, CH-4070, Basel,
Switzerland
514 Avastin bevacizumabconcentrate for
solution for infusion
25mg/ml,
16ml glass vial (1)
Roche Diagnostics
GmbH, Sandhofer
Strasse 116, D-68305
Mannheim-batch
releaser, bulk
manufacturer,
primary packager, F.
Hoffmann-La Roche
Ltd. Wurmisweg CH-
4303 Kaiseraugst,
Switzerland-
secondary packager
Germany
L01XC07;
new
indication
14360/125.03.2015
25.03.2020PoM
F. Hoffmann-La
Roche Ltd.,
Grenzacherstrasse,
124, CH-4070, Basel,
Switzerland
109
515 Avecor 10-Aversi
bisoprolol
(bisoprolol
fumarate)
tablets film-coated10mg,
in blister (30/3x10/)
Aversi-Rational Ltd,
0198 Tbilisi,
Chirnakhuli str. 14
Georgia C07AB07 1313710.01.2014
10.01.2019PoM
Aversi-Rational Ltd,
0198 Tbilisi,
Chirnakhuli str. 14,
Georgia
516 Avelox
moxifloxacin
(moxifloxacin
hydrochloride)
solution for infusion1.6mg/ml,
250ml glass vial
Bayer Pharma AG, D-
51368 , LeverkusenGermany J01MA14 14948
20.10.2015
20.10.2020PoM
Bayer Pharma AG, D-
51368 , Leverkusen,
Germany
517 Avelox moxifloxacin tablets coated400mg,
in blister (5/1x5/)
Bayer Pharma AG, D-
51368 LeverkusenGermany J01MA14 16379
30.12.2016
30.12.2021PoM
Bayer Pharma AG, D-
51368 Leverkusen,
Germany
518 Avexon-Rational
ceftriaxone
(ceftriaxone
sodium)
powder for solution
for i/m and i/v
injection
1000mg,
glass vial
Aversi-Rational Ltd,
Chirnakhuli str. 14,
0198 Tbilisi-
secondary packager,
batch releaser (bulk
manufacturer,
primary packager-
Reyoung
Pharmaceutical Co.
Ltd., No 6 Erlangshan
Road, Yiyuan County,
Shandong Province,
China)
Georgia J01DD04 1579720.07.2016
20.07.2021PoM
Aversi-Rational Ltd,
Chirnakhuli str. 14,
0198 Tbilisi, Georgia
519 Avia-More
veratrum album ,
anamirta cocculus
(Cocculus), natrium
tetraboracicum
(Borax)
tablets
C200+C200+ C200,
in blister (20/1x20/,
40/2x20/)
NPF Materia Medica
Holding Ltd., 54,
Buguruslanskaya st.,
Chelyabinsk 454139
Russiahomeopathic
drug12510
01.06.2013
01.06.2018OTC
NPF Materia Medica
Holding Ltd., 9 bld.,
3rd Samotyochny
per., Moscow 127473,
Russia
520 Avodart dutasteride capsules0,5mg,
in blister (30/3x10/)
GlaxoSmithKline
Pharmaceuticals
S.A.,189 Grunwaldzka
street, 60-322 Poznan
Poland G04CB02 1224607.03.2013
07.03.2018PoM
GlaxoSmithKline
Export Ltd, 980 Great
West Road,
Brentford, Middlesex,
TW8 9GS, UK
110
521 Axetine
cefuroxime
(cefuroxime
sodium)
powder for solution
for injection/infusion
750mg,
glass vial (10)
Medochemie Ltd., 2
Michael Eracleous
Street, Agios
Athanasios Industrial
Area, 4101, Agios
Athanassios, Limassol
Cyprus J01DC02 1221407.03.2013
07.03.2018PoM
Medochemie Ltd.,
P.O. Box 51409, 3505
Limassol, Cyprus
522 Axetine
cefuroxime
(cefuroxime
sodium)
powder for solution
for injection/infusion
1500mg,
glass vial (10)
Medochemie Ltd., 2
Michael Eracleous
Street, Agios
Athanasios Industrial
Area, 4101, Agios
Athanassios, Limassol
Cyprus J01DC02 1221507.03.2013
07.03.2018PoM
Medochemie Ltd.,
P.O. Box 51409, 3505
Limassol, Cyprus
523Axol Liquid
3mg/ml
ambroxol
(ambroxol
hydrochloride)
liquid3mg/ml,
100ml plastic bottle
Y.S.P. Industries (M)
SDN. BHD., Lot 3,5 &
7, Jalan P/7, Section
13, Kawasan
Perindustrian Bandar
Baru Bangi, 43000
Kajang, Selangor
Darul Ehsan
Malaysia R05CB06 1315210.01.2014
10.01.2019OTC
Y.S.P. Industries (M)
SDN. BHD., 16th
Floor, Plaza VADS,
No.1, Jalan Tun
Mohd. Fuad, Taman
Tun Dr. Ismail, 60000
Kuala Lumpur,
Malaysia
524 Azaleptine clozapine tablets25mg,
in blister (48/2x24/)
Arpimed LLC, Kotayk
Marz, Abovyan, 2nd
Micro-District, 19
Building
Republic of
ArmeniaN05AH02 12847
17.09.2013
17.09.2018PoM/UC
Arpimed LLC,
Kotayk Marz,
Abovyan, 2nd Micro-
District, 19 Building,
Republic of Armenia
525 Azaleptine 100mg clozapine tablets100mg,
in blister (50/5x10/)
Arpimed LLC, Kotayk
Marz, Abovyan, 2nd
Micro-District, 19
Building
Republic of
ArmeniaN05AH02 13867
18.09.2014
18.09.2019PoM/UC
Arpimed LLC,
Kotayk Marz,
Abovyan, 2nd Micro-
District, 19 Building,
Republic of Armenia
111
526 Azaleptol clozapine tablets100mg,
in blister (50/5x10/)
PJSC "Technolog"
(Manuylskogo str. 8,
20300
Uman,Cherkassy
region)
Ukraine N05AH02 1295328.10.2013
28.10.2018PoM/UC
PJSC "Technolog"
(Manuylskogo str. 8,
20300
Uman,Cherkassy
region, Ukraine)
527 Azarga
brinzolamide,
timolol (timolol
maleate)
drops eye
(suspension)
10mg/ml+5mg/ml, 5ml
vial
S.A. Alcon-Couvreur
N.V., Rijksweg 14
2870 Puurs
Belgium S01ED51 1360220.06.2014
20.06.2019PoM
S.A. Alcon-Couvreur
N.V., Rijksweg 14
2870 Puurs, Belgium
528 Azastrole anastrozole tablets film-coated1mg,
in blister (30/2x15/)
Douglas
Manufacturing Ltd,
Corner Te Pai Place
and Central Park
Drive, Lincoln
Auckland
New Zealand L02BG03 1393329.10.2014
29.10.2019PoM
Eris Pharmaceuticals
Pty LTD, 6 Eastern
road South
Melbourne, Victoria,
3205, Australia
529 Azatril 100mg/5ml
azithromycin
(azithromycin
dihydrate)
powder for oral
suspension
100mg/5ml,
20ml glass bottle, double-
ended measuring spoon
and an oral dosing syringe
Balkanpharma-
Razgrad AD, 68
Aprilsko Vastanie
Blvd, 7200 Razgrad
Bulgaria J01FA10 1229922.03.2013
22.03.2018PoM
Balkanpharma-
Razgrad
AD(ACTAVIS
GROUP), 68 Aprilsko
Vastanie Blvd, 7200
Razgrad, Bulgaria
530 Azatril 200mg/5ml
azithromycin
(azithromycin
dihydrate)
powder for oral
suspension
200mg/5ml,
20ml glass bottle, double-
ended measuring spoon
and an oral dosing syringe
Balkanpharma-
Razgrad AD, 68
Aprilsko Vastanie
Blvd, 7200 Razgrad
Bulgaria J01FA10 1230022.03.2013
22.03.2018PoM
Balkanpharma-
Razgrad
AD(ACTAVIS
GROUP), 68 Aprilsko
Vastanie Blvd, 7200
Razgrad, Bulgaria
531 Azibiot
azithromycin
(azithromycin
dihydrate)
tablets film-coated500mg,
in blister (3/1x3/)
KRKA d.d., Novo
mesto, Smarjeska
cesta 6, 8501 Novo
Mesto
Slovenia J01FA10 1489224.09.2015
24.09.2020PoM
KRKA d.d., Novo
mesto, Smarjeska
cesta 6, 8501 Novo
Mesto, Slovenia
112
532 Aziflam D.S.
azithromycin
(azithromycin
dihydrate)
powder for oral
suspension
40mg/ml,
15ml plastic container
and 5ml measuring
syringe
Flamingo
Pharmaceuticals Ltd,
R-662,T.T.C. Ind.
Area, Rabale, Navi
Mumbai 400 701
India J01FA10 1238319.04.2013
19.04.2018PoM
Flamingo
Pharmaceuticals Ltd,
P.O. Box No
27257,Mumbai 400
071, India
533 Azimac azithromycin capsules250mg,
in blister (6/2x3/)
GM Pharmaceuticals
Ltd, PSP group 65,
Qvemo Phonichala
str., Tbilisi
Georgia J01FA10 1374524.07.2014
24.07.2019PoM
GM Pharmaceuticals
Ltd, PSP group 65,
Qvemo Phonichala
str., Tbilisi, Georgia
534 Azimac azithromycin capsules500mg,
in blister (3/1x3/)
GM Pharmaceuticals
Ltd, PSP group 65,
Qvemo Phonichala
str., Tbilisi
Georgia J01FA10 1374624.07.2014
24.07.2019PoM
GM Pharmaceuticals
Ltd, PSP group 65,
Qvemo Phonichala
str., Tbilisi, Georgia
535 Azimac 200mg/5ml
azithromycin
(azithromycin
dihydrate)
powder for oral
suspension
40mg/ml,
15ml glass bottle, and
measuring syringe
GM Pharmaceuticals
Ltd, PSP group 65,
Qvemo Phonichala
str., Tbilisi (dosage
form manufacturer -
Arafarma Group, S.A.,
C/Fray Gabriel de San
Antonio, 6-10, Pol.
Ind. Del Henares,
19180, Marchamalo,
Guadalajara, Spain)
Georgia J01FA10 1218201.02.2013
01.02.2018PoM
GM Pharmaceuticals
Ltd, PSP group 65,
Qvemo Phonichala
str., Tbilisi, Georgia
536 Azimed
azithromycin
(azithromycin
dihydrate)
capsules250mg,
in blister (6/1x6/)
Kievmedpreparat
OJSC, 01032, Kiev,
Saksaganskogo street,
139
Ukraine J01FA10 1337904.04.2014
04.04.2019PoM
Kievmedpreparat
OJSC, 01032, Kiev,
Saksaganskogo street,
139, Ukraine
537 Azirex azithromycin tablets film-coated500mg,
in plastic container (30)
Pharmtechnology
LLC, Korzhenevskogo
str., 22, 220024,
Minsk
Belarus J01FA10 1677922.06.2017
22.06.2022PoM
Giga Farm LLC,
Gogunca str.3/5,
Gyumri, Republic of
Armenia
113
538 Azithromycin azithromycin tablets film-coated500mg,
in blister (3/1x3/)
Open joint stock
company "Borisovskiy
zavod medicinskikh
preparatov" 64,
Chapaev str., Borisov
222518, Minsk region
Belarus J01FA10 1576804.07.2016
04.07.2021PoM
Open joint stock
company "Borisovskiy
zavod medicinskikh
preparatov" 64,
Chapaev str., Borisov
222518, Minsk
region, Belarus
539 Azithromycin azithromycin capsules250mg,
in blister (6/1x6/)
Open joint stock
company "Borisovskiy
zavod medicinskikh
preparatov" 64, ul.
Chapaeva, Borisov
222518, Minsk region
Belarus J01FA10 1621708.12.2016
08.12.2021PoM
Open joint stock
company "Borisovskiy
zavod medicinskikh
preparatov" 64, ul.
Chapaeva, Borisov
222518, Minsk
region, Belarus
540Azithromycin
500mg
azithromycin
(azithromycin
monohydrate)
tablets film-coated500mg,
in blister (3)
Sandoz S.R.L., str.
Livezeni nr. 7A,
540472, Targu Mures
Romania J01FA10 1227222.03.2013
22.03.2018PoM
Lek d.d., Verovskova
57, Ljubljana,
Slovenia
541 Azithromycin ABR
azithromycin
(azithromycin
dihydrate)
capsules hard500mg,
in blister (3/1x3/)
Balkanpharma-
Razgrad AD, 68
Aprilsko Vastanie
Blvd, 7200 Razgrad
Bulgaria J01FA10 1724608.12.2017
08.12.2022PoM
Antibiotic-Razgrad
AD, 68, Aprilsko
vastanie Blvd,
Razgrad, 7200,
Bulgaria, Bulgaria
542AZITHROMYCIN-
ASTRAPHARMazithromycin capsules
500mg,
in blister (3)
'ASTRAPHARM' Ltd,
6, Kievskaya Str.,
Vishnevoye, Kiev-
Svyatoshinskiyy
district, Kiev region,
08132
Ukraine J01FA10 1469616.07.2015
16.07.2020PoM
ASTRAPHARM' Ltd,
6, Kievskaya Str.,
Vishnevoye, Kiev-
Svyatoshinskiyy
district, Kiev region,
08132, Ukraine
543 Azitrom-Replek
azithromycin
(azithromycin
dihydrate)
tablets film-coated500mg,
blister (3)
Replek Farm Ltd.-
Skopje, 188 str. Kozle,
1000 Skopje
Macedonia J01FA10 13290/111.07.2016
04.03.2019PoM
Replek Farm Ltd.-
Skopje, 188 str. Kozle,
1000 Skopje
114
544 Azitrox
azithromycin
(azithromycin
dihydrate)
capsules250mg,
blister (6/1x6/)
Pharmstandard-
Leksredstva OJSC,
305022, Kursk,
Agregatnaya 2nd str.,
1a/18
Russia J01FA10 14180/103.10.2016
21.01.2020PoM
OTCPharm PJSC,
123317, Moscow,
Testovskaya str., 10,
Russia
545 Azitrox
azithromycin
(azithromycin
dihydrate)
capsules500mg,
blister (2/1x2/, 3/1x3/)
Pharmstandard-
Leksredstva OJSC,
305022, Kursk,
Agregatnaya 2nd str.,
1a/18
Russia J01FA10 14215/103.10.2016
12.02.2020PoM
OTCPharm PJSC,
123317, Moscow,
Testovskaya str., 10,
Russia
546 Azitrox
azithromycin
(azithromycin
dihydrate)
powder for oral
suspension
100mg/5ml,
50ml glass bottle with
15.9g powder (for 20ml
prepared suspension),
measuring spoon and
dropper
Pharmstandard-
Leksredstva JSC,
305022, Kursk,
Agregatnaya 2nd str.,
1a/18
Russia J01FA10 14935/125.07.2016
20.10.2020PoM
OTCPharm PJSC,
123317, Moscow,
Testovskaya str., 10,
Russia
547 Azitrox
azithromycin
(azithromycin
dihydrate)
powder for oral
suspension
200mg/5ml,
50ml glass bottle with
15.9g powder (for 20ml
prepared suspension),
measuring spoon and
dropper
Pharmstandard-
Leksredstva JSC,
305022, Kursk,
Agregatnaya 2nd str.,
1a/18
Russia J01FA10 14936/125.07.2016
20.10.2020PoM
OTCPharm PJSC,
123317, Moscow,
Testovskaya str., 10,
Russia
548 Azopt brinzolamide drops eye10mg/ml,
5ml plastic vial
S.A. Alcon-Couvreur
N.V., Rijksweg 14,
2870 Puurs
Belgium S01EC04 1280423.08.2013
23.08.2018PoM
Alcon
Pharmaceuticals Ltd,
Route des Arsenaux
41 Case Postale 1701
Fribourg, Switzerland
549 BC Benzogel benzocaine gel200mg/g,
6g syringe
“Bio-Chem” LTD,
Manandyan, 33, 1/1,
Yerevan
Republic of
ArmeniaC05AD03 14149
29.12.2014
29.12.2019OTC
“Bio-Chem” LTD,
Manandyan, 33, 1/1,
Yerevan, Republic of
Armenia
115
550 Bactox 250mg/5ml
amoxicillin
(amoxicillin
trihydrate)
powder for oral
suspension
250mg/5ml,
60ml glass bottle and
measuring spoon
Innothera Chouzy,
Rue Rene Chantereau
L` lsle Vert 41150,
Chouzy sur Cisse
France J01CA04 1416124.12.2014
24.12.2019PoM
Laboratoire Innotech
International, 22
Avenue Aristide
Brand 94110 Arcueil,
France
551 Bactrimsulfamethoxazole,
trimethoprimsuspension
200mg/5ml+ 40mg/5ml,
100ml bottle
Cenexi SAS, Rue
Marcel et Jacques
Gaucher, 52,
Fontenay sous Bois,
94120
France J01EE01 1241802.06.2013
02.06.2018PoM
F. Hoffmann-La
Roche Ltd,
Greenzacherstrasse
124, 4070 Basel,
Switzerland
552 Bactrim fortesulfamethoxazole,
trimethoprimtablets
800mg+160mg,
in blister (10/1x10/)
F. Hoffmann-La
Roche Ltd.,
Grenzacherstrasse,
124, CH-4070, Basel -
batch releaser,
Productos Roche S.A.
de C.V., Via Isidro
Fabela Norte N 1536-
B, Parque Industrial
Toluca (Estado de
Mexico) 50030,
Mexico, Mexico-bulk
manufacturer, F.
Hoffmann-La Roche
Ltd, Betriebsstandort
Kaiseraugst, 4303
Kaiseraugst,
Switzerland-primary
and secondary
packager
Switzerland J01EE01 1538822.02.2016
22.02.2021PoM
F. Hoffmann-La
Roche Ltd.,
Grenzacherstrasse,
124, CH-4070, Basel,
Switzerland
553Bactroban 2%
creammupirocin cream
20mg/g,
15g aluminium tube
Glaxo Operations UK
Limited (trading as:
Glaxo Wellcome
Operations) Harmire
Road, Barnard Castle,
Durham, DL12 8DT
UK D06AX09 13207/131.07.2015
21.01.2019PoM
Beecham Group PLC,
Stockley Park West,
Uxbridge, Middlesex
UB11 1BT, UK
116
554Bactroban 2%
ointmentmupirocin ointment
20mg/g,
15g aluminium tube
Glaxo Operations UK
Limited (trading as:
Glaxo Wellcome
Operations) Harmire
Road, Barnard Castle,
Durham, DL12 8DT
UK D06AX09 13208/111.12.2014
21.01.2019PoM
Beecham Group PLC,
Stockley Park West,
Uxbridge, Middlesex
UB11 1BT, UK
555 BacTRONNsulfamethoxazole,
trimethoprimsuspension oral
200mg/5ml+ 40mg/5ml,
50ml, 55ml, 60ml, 80ml,
100ml, 120ml glass bottle
and measuring cup
Medicon
Pharmaceuticals Ltd,
Industral Plot
No.17/A-1, Block-D,
Section-10, Mirpur,
Dhaka
Bangladesh J01EE01 1236309.04.2013
09.04.2018PoM
Medicon
Pharmaceuticals Ltd,
Industral Plot
No.17/A-1, Block-D,
Section-10, Mirpur,
Dhaka, Bangladesh
556 Bagodilol 12,5 carvedilol tablets12,5mg,
in blister (28/2x14/)
Laboratorios Bago
S.A.,1429 4th str.,La
Plata,Buenos Aires
Argentina C07AG02 12700/126.03.2014
23.07.2018PoM
Laboratorios Bago
S.A.,248 Bernardo de
Irigoyen str.,Buenos
Aires,Argentina
557 Bagodilol 25 carvedilol tablets25mg,
in blister (28/2x14/)
Laboratorios Bago
S.A.,1429 4th str.,La
Plata,Buenos Aires
Argentina C07AG02 12701/126.03.2014
23.07.2018PoM
Laboratorios Bago
S.A.,248 Bernardo de
Irigoyen str.,Buenos
Aires,Argentina
558 Bagodilol 6,25 carvedilol tablets6,25mg,
in blister (28/2x14/)
Laboratorios Bago
S.A.,1429 4th str.,La
Plata,Buenos Aires
Argentina C07AG02 12699/126.03.2014
23.07.2018PoM
Laboratorios Bago
S.A.,248 Bernardo de
Irigoyen str.,Buenos
Aires,Argentina
559 Bagomet 500
metformin
(metformin
hydrochloride)
tablets film-coated
500mg,
in blister (30/3x10/,
60/6x10/, 100/10x10/)
Quimica Montpellier
S.A., Virrey Liniers
673, Ciudad
Autonoma de Buenos
Aires
Argentina A10BD02 1319510.01.2014
10.01.2019PoM
Quimica Montpellier
S.A., Virrey Liniers
673, Ciudad
Autonoma de Buenos
Aires, Argentina
117
560Bagomet Plus
500/2,5
metformin
(metformin
hydrochloride),
glibenclamide
tablets film-coated
500mg+2,5mg,
in blister (30/3x10/,
60/6x10/)
Quimica Montpellier
S.A. (Virrey Liniers
673, Ciudad
Autonoma de Buenos
Aires)
Argentina A10BD02 1289207.10.2013
07.10.2018PoM
Quimica Montpellier
S.A. (Virrey Liniers
673, Ciudad
Autonoma de Buenos
Aires, Argentina)
561Bagomet Plus
500/5
metformin
(metformin
hydrochloride),
glibenclamide
tablets film-coated
500mg+5mg,
in blister (30/3x10/,
60/6x10/)
Quimica Montpellier
S.A. (Virrey Liniers
673, Ciudad
Autonoma de Buenos
Aires)
Argentina A10BD02 1289307.10.2013
07.10.2018PoM
Quimica Montpellier
S.A. (Virrey Liniers
673, Ciudad
Autonoma de Buenos
Aires, Argentina)
562Balzamic liniment
of Vishnevskybirch tar, xeroform liniment
30mg/g+30mg/g, 40g
aluminium tube
Open joint stock
company "Borisovskiy
zavod medicinskikh
preparatov" 64,
Chapaev str., Borisov
222518, Minsk region
Belarus D08AX 1389306.10.2014
06.10.2019OTC
Open joint stock
company "Borisovskiy
zavod medicinskikh
preparatov" 64,
Chapaev str., Borisov
222518, Minsk
region, Belarus
563 Baneocin
bacitracin zinc,
neomycin
(neomycine sulfate)
powder for external
use
250IU/g+5000IU/g, 10g in
plastic container
Sandoz GmbH,
Biochemiestrasse 10,
A-6250 Kundl-batch
releaser;
(Pharmazeutische
Fabrik Montavit
GmbH, Salzbergstr.
96, 6067Absam Tirol,
Austria- bulk
manufacturer,
packager)
Austria D06AX 1335104.04.2014
04.04.2019OTC
Sandoz GmbH,
Biochemiestrasse 10,
A-6250 Kundl,
Austria
118
564 Baneocin
bacitracin zinc,
neomycin
(neomycine sulfate)
ointment250IU/g+5000IU/g, 20g
aluminum tube
Sandoz GmbH,
Biochemiestrasse 10,
A-6250 Kundl - batch
releaser; (Merck
KGaA & Co., Plant
Spittal, Hosslgasse 20,
9800 Spittal/Drau,
Austria - bulk
manufacturer,
packager)
Austria D06AX 1335204.04.2014
04.04.2019OTC
Sandoz GmbH,
Biochemiestrasse 10,
A-6250 Kundl,
Austria
565
Bars
Insectoacaricide for
dogs
fipronil drops50mg/ml; (4) container-
dropper 1,4ml
NVTS
Agrovetzashchita S-P,
OOO, oblast
Moskovskaya,
Sergiyev Posad, ulitsa
Tsentralnaya
Russia
QP53AX65
veterinary
drug
1214301.02.2013
01.02.2018PoM
NVTS
Agrovetzashchita S-P,
OOO, oblast
Moskovskaya,
Sergiyev Posad, ulitsa
Tsentralnaya, RUSSIA
566BC Dentahex
Solution
chlorhexidine
(chlorhexidine
gluconate)
solution20mg/ml,
100ml glass vial (1)
Bio-Chem Ltd., 0046,
Erevan, Manandyan
str. 33, 1/1
Republic of
ArmeniaA01AB03 13438
14.04.2014
14.04.2019OTC
Bio-Chem Ltd., 0046,
Erevan, Manandyan
str. 33, 1/1, Republic
of Armenia
567 BCG vaccine
BCG
vaccine(Bacillus
Calmette Guerin
Strain)
powder lyophilized
for solution for
injection
between 2x10^5 and
8x10^5 CFU/0,1ml; (50)
10/20 dose glass vial/
(50/5x10/) sodium
chloride 0.9% 1ml
ampoules with solvent in
blister, (300/6 box/)(50)
10/20 dose glass vial/
(50/5x10/) sodium
chloride 0.9% 1ml
ampoules with solvent in
blister
Serum Institute of
India Pvt. Ltd., 212/2,
Hadapsar, Pune
411028
IndiaJ07AN01;
vaccine17092
23.10.2017
23.10.2022PoM
Serum Institute of
India Pvt. Ltd., 212/2,
Hadapsar, Pune
411028, India
568 Be-Bo benzyl benzoate emulsion
200mg/ml,
100ml glass or plastic
bottle
Esco-Pharm LLC, Nor-
Norq, Mikoyan 13,
Yerevan
Republic of
ArmeniaP03AX01 12529
01.06.2013
01.06.2018OTC
Esco-Pharm LLC, Nor-
Norq, Mikoyan 13,
Yerevan, Armenia
119
569Befungin-
Tatpharm
chaga, cobalt
chloride
hexahydrate
solution oral1000mg/ml+ 1,76mg/ml,
100ml glass bottle
Tatchempharmpre-
paraty JSC, 420091
Kazan, str.
Belomorskaya 260
Russia A13A 15542/108.02.2017
19.04.2021PoM
Tatchempharmpre-
paraty JSC, 420091
Kazan, str.
Belomorskaya 260,
Russia
570 Belara
chlormadinone
(chlormadinone
acetate),
ethinylestradiol
tablets film-coated
2mg+0,03mg,
in blister (21/1x21/,
63/3x21/)
Gedeon Richter PLC,
Gyomroi ut 19-21,
1103 Budapest
Hungary G03AA 1425820.02.2015
20.02.2020PoM
Gedeon Richter PLC,
Gyomroi ut 19-21,
1103 Budapest,
Hungary
571
Bendamustine
Moosmann
2,5mg/ml
bendamustine
(bendamustine
hydrochloride)
powder for
concentrate for
solution for infusion
25mg,
glass vial (1)
Thymoorgan
Pharmazie GmbH,
Schiffgraben 23,
38690 Goslar
Germany L01AA09 1677222.06.2017
22.06.2022PoM
Moosmann
Pharmaceuticals LLC,
Vanahovit 8,
Proshyan v., Ashtarak
Ave., Kotayk Marz
2413, Republic of
Armenia
572
Bendamustine
Moosmann
2,5mg/ml
bendamustine
(bendamustine
hydrochloride)
powder for
concentrate for
solution for infusion
100mg,
glass vial (1)
Thymoorgan
Pharmazie GmbH,
Schiffgraben 23,
38690 Goslar
Germany L01AA09 1677322.06.2017
22.06.2022PoM
Moosmann
Pharmaceuticals LLC,
Vanahovit 8,
Proshyan v., Ashtarak
Ave., Kotayk Marz
2413, Republic of
Armenia
573 Bendaz 300 albendazole bolus (tablets)300mg,
in blister (50/10x5/)
Agio Pharmaceuticals
Limited, T-82,
M.I.D.C., Bhosari,
Pune 411026
Maharashtra State
India
QP52AC11;
veterinary
drug
1438916.04.2015
16.04.2020PoM
Agio Pharmaceuticals
Limited, A-38,
Nandjyot Industrial
Estate, Kurla -
Andheri Road,
Safedpool, Mumbai -
400 072, India
120
574 Bendaz 600 albendazole bolus (tablets)600mg,
in blister (50/10x5/)
Agio Pharmaceuticals
Limited, T-82,
M.I.D.C., Bhosari,
Pune 411026
Maharashtra State
India
QP52AC11;
veterinary
drug
1438816.04.2015
16.04.2020PoM
Agio Pharmaceuticals
Limited, A-38,
Nandjyot Industrial
Estate, Kurla -
Andheri Road,
Safedpool, Mumbai -
400 072, India
575 BeneFix nonacog alfapowder for solution
for injection
250IU,
glass vial, 5ml solvent in
pre-filled syringe, vial
adapter, sterile infusion
set, (2) alcohol swabs,
plaster, gauze pad
Wyeth Farma S.A.,
Autovia del Norte A-
1 Km 23, Desvio
Algete Km 1, 28700
San Sebastian de los
Reyes, Madrid
Spain B02BD09 1330204.03.2014
04.03.2019PoM
Pfizer Limited,
Ramsgate Road,
Sandwich, Kent CT13
9NJ, UK
576 BeneFix nonacog alfapowder for solution
for injection
500IU,
glass vial, 5ml solvent in
pre-filled syringe, vial
adapter, sterile infusion
set, (2) alcohol swabs,
plaster, gauze pad
Wyeth Farma S.A.,
Autovia del Norte A-
1 Km 23, Desvio
Algete Km 1, 28700
San Sebastian de los
Reyes, Madrid
Spain B02BD09 1330304.03.2014
04.03.2019PoM
Pfizer Limited,
Ramsgate Road,
Sandwich, Kent CT13
9NJ, UK
577 BeneFix nonacog alfapowder for solution
for injection
1000IU,
glass vial, 5ml solvent in
pre-filled syringe, vial
adapter, sterile infusion
set, (2) alcohol swabs,
plaster, gauze pad
Wyeth Farma S.A.,
Autovia del Norte A-
1 Km 23, Desvio
Algete Km 1, 28700
San Sebastian de los
Reyes, Madrid
Spain B02BD09 1330404.03.2014
04.03.2019PoM
Pfizer Limited,
Ramsgate Road,
Sandwich, Kent CT13
9NJ, UK
578 BeneFix nonacog alfapowder for solution
for injection
2000IU,
glass vial, 5ml solvent in
pre-filled syringe, vial
adapter, sterile infusion
set, (2) alcohol swabs,
plaster, gauze pad
Wyeth Farma S.A.,
Autovia del Norte A-
1 Km 23, Desvio
Algete Km 1, 28700
San Sebastian de los
Reyes, Madrid
Spain B02BD09 1330504.03.2014
04.03.2019PoM
Pfizer Limited,
Ramsgate Road,
Sandwich, Kent CT13
9NJ, UK
121
579 Bengaymethyl salicylate,
racementholcream
150mg/g+ 100mg/g,
50g aluminium tube
Janssen-Cilag,
Domaine de
Maigremont, 27100
Val De Reuil
France M02AC 1306609.12.2013
09.12.2018OTC
Johnson & Johnson
LLC, 121614,
Moscow, Krylatskaya
str., 17, building 2,
Russia
580 Benzonal benzobarbital tablets100mg,
in blister (48/2x24/)
Arpimed LLC, Kotayk
Marz, Abovyan, 2nd
Micro-District, 19
Building
Republic of
ArmeniaN03AA 13965
04.11.2014
04.11.2019PoM
Arpimed LLC,
Kotayk Marz,
Abovyan, 2nd Micro-
District, 19 Building,
Republic of Armenia
581Benzonal-
Tatpharmbenzobarbital tablets
100mg,
blisters (50/5x10/)
Tatchempharmpre-
paraty JSC, 420091
Kazan, str.
Belomorskaya 261
Russia N03AA 12931/108.02.2017
07.10.2018PoM
Tatchempharmpre-
paraty JSC, 420091
Kazan, str.
Belomorskaya 260,
Russia
582 Benzyl benzoate benzyl benzoate emulsion topical250mg/ml,
120ml glass bottle
Arpimed LLC, Kotayk
Marz, Abovyan, 2nd
Micro-District, 19
Building
Republic of
ArmeniaP03AX01 12483
02.10.2013
02.10.2018OTC
Arpimed LLC,
Kotayk Marz,
Abovyan, 2nd Micro-
District, 19 Building,
Republic of Armenia
583Benzylbenzoate
Grindeksbenzylbenzoate
ointment for
external use
200mg/g,
30g aluminium tube
Tallinn
Pharmaceutical Plant
JSC, Tondi 33, 11316
Tallinn
Estonia P03AX01 1629730.12.2016
30.12.2021OTC
Grindeks JSC,
Krustpils street 53,
LV-1057, Riga, Latvia
584 Benzylpenicillin
benzylpenicillin
(benzylpenicillin
sodium)
powder for solution
for injection
1000000IU,
glass vial (40)
Kievmedpreparat
PJSC, 01032, Kiev,
Saksaganskogo street,
139
Ukraine J01CE01 1596015.09.2016
15.09.2021PoM
Kievmedpreparat
PJSC, 01032, Kiev,
Saksaganskogo street,
139, Ukraine
122
585Benzylpenicillin
sodium
benzylpenicillin
(benzylpenicillin
sodium)
powder for solution
for injection
1000000IU,
glass vial (50),
(1000/20box /50/)
Harbin
Pharmaceutical
Group Co., Ltd.,
General
Pharmaceutical
Factory,No 388 Hahei
Road, Hulan District.,
Harbin
China J01CE01 1695405.09.2017
05.09.2022PoM
Harbin
Pharmaceutical
Group Co., Ltd.,
General
Pharmaceutical
Factory, No 109
Xuefu Road, Nangang
District., Harbin,
China
586Benzylpenicillin
sodium salt
benzylpenicillin
(benzylpenicillin
sodium)
powder for solution
for i/m injection
1000000IU,
10ml glass vials (50)
"Sintez" OJSC, Pr.
Konstitutsii, No. 7,
Kurgan, 640008
Russia J01CE01 1557412.05.2016
12.05.2021PoM
"Sintez" OJSC, Pr.
Konstitutsii, No. 7,
Kurgan, 640008,
Russia
587 Bepanthen cream dexpanthenol cream50mg/g,
30g aluminium tube
GP Grenzach
Produktions GmbH,
Emil-Barell-Strasse 7,
D-79639 Grenzach-
Wyhlen
Germany D03AX03 1389830.09.2014
30.09.2019OTC
Bayer Consumer Care
AG, Peter Merian-
Strasse 84, 4052 Basel,
Switzerland
588Bepanthen
ointmentdexpanthenol ointment
50mg/g,
30g aluminium tube
GP Grenzach
Produktions GmbH,
Emil-Barell-Strasse 7,
D-79639 Grenzach-
Wyhlen
Germany D03AX03 1389730.09.2014
30.09.2019OTC
Bayer Consumer Care
AG, Peter Merian-
Strasse 84, 4052 Basel,
Switzerland
589 Bepanthen Plus
dexpanthenol,
chlorhexidine
(chlorhexidine
dihydrochloride)
cream50mg/g+5mg/g, 30g
aluminium tube
GP Grenzach
Produktions GmbH,
Emil-Barell-Strasse 7,
D-79639 Grenzach-
Wyhlen
Germany D08AC52 1271323.07.2013
23.07.2018OTC
Bayer Consumer
Care AG, Peter
Merian-Strasse 84,
4052 Basel,
Switzerland
590 Bepanthen Plus
dexpanthenol,
chlorhexidine
(chlorhexidine
digluconate)
spray
50mg/ml+5mg/ml, 30ml
plastic container with
pump dispenser
Lichtenheldt GmbH
Pharmazeutische
Fabrik,
Industriestrasse 7-11,
Schleswig-Holstein,
Wahlstedt, 23812
Germany D08AC02 1481604.09.2015
04.09.2020OTC
Bayer Consumer Care
AG, Peter Merian-
Strasse 84, 4052 Basel,
Switzerland
123
591 Beriate 1000
human blood
coagulation factor
VIII
powder and solvent
for solution for
injection/ infusion
1000IU,
glass vial (1), 10ml glass
vial with solvent,
transfer/filter set (1)
CSL Behring GmbH,
Emil-von-Behring-
Strasse 76, 35041
Marburg
Germany B02BD02 1483104.09.2015
04.09.2020PoM
CSL Behring GmbH,
Emil-von-Behring-
Strasse 76, 35041
Marburg, Germany
592 Beriate 500
human blood
coagulation factor
VIII
powder and solvent
for solution for
injection/ infusion
500IU,
glass vial (1), 5ml glass
vial with solvent,
transfer/filter set (1)
CSL Behring GmbH,
Emil-von-Behring-
Strasse 76, 35041
Marburg
Germany B02BD02 1483004.09.2015
04.09.2020PoM
CSL Behring GmbH,
Emil-von-Behring-
Strasse 76, 35041
Marburg, Germany
593 Berlipril 10enalapril (enalapril
maleate)tablets
10mg,
in blister (30/3x10/)
Berlin-Chemie
A.G.,Glienicker Weg
125, D-12489 Berlin-
batch releaser,
packager, Berlin-
Chemie A.G.,
Tempelhofer Weg 83,
D-12347
Berlin,Germany-bulk
manufacturer
Germany C09AA02 1655703.04.2017
03.04.2022PoM
Berlin-Chemie A.G.,
Glienicker Weg 125,
12489 Berlin,
Germany
594 Berlipril 20enalapril (enalapril
maleate)tablets
20mg,
in blister (30/3x10/)
Berlin-Chemie
A.G.,Glienicker Weg
125, D-12489 Berlin-
batch releaser,
packager, Berlin-
Chemie A.G.,
Tempelhofer Weg 83,
D-12347
Berlin,Germany-bulk
manufacturer
Germany C09AA02 1655603.04.2017
03.04.2022PoM
Berlin-Chemie A.G.,
Glienicker Weg 125,
12489 Berlin,
Germany
124
595 Berlipril plus
enalapril (enalapril
maleate),
hydrochlorothia-
zide
tablets10mg+25mg,
in blister (30/3x10/)
Berlin-Chemie
A.G.,Glienicker Weg
125, D-12489 Berlin-
packager,batch
releaser Berlin-
Chemie A.G.,
Tempelhofer Weg 83,
D-12347
Berlin,Germany-bulk
manufacturer
Germany C09BA02 1530104.02.2016
04.02.2021PoM
Berlin-Chemie A.G.,
Glienicker Weg 125,
D-12489 Berlin,
Germany
596Berlithion 600
capsulesthioctic acid capsules soft
600mg,
in blister (15/1x15/,
30/2x15/)
Berlin-Chemie AG,
Glienicker Weg 125,
12489 Berlin-batch
releaser, Catalent
Germany Eberbach
GmbH,
Gammelsbacherstrass
e 2, D-69412
Eberbach, Germany-
bulk manufacturer,
Catalent Germany
Schorndorf GmbH,
Steinbeisstrasse 1und
2, 73614, Schorndorf,
Germany-packager
Germany A16AX01 1597215.09.2016
15.09.2021PoM
Berlin-Chemie AG,
Glienicker Weg 125,
12489 Berlin,
Germany
597 Berlithion 600 ED thioctic acid
concentrate for
solution for i/v
infusion
25mg/ml,
25ml ampoules (24ml
concentrate) (5, 10)
Berlin-Chemie AG,
Glienicker Weg 125,
12489 Berlin - batch
releaser, Hameln
Pharmaceuticals
GmbH, Langes Feld
13, Hameln, 31789,
Germany- bulk
manufacturer,
packager
Germany A16AX01 1597315.09.2016
15.09.2021PoM
Berlin-Chemie AG,
Glienicker Weg 125,
12489 Berlin,
Germany
125
598 Berodual
fenoterol (fenoterol
hydrobromide),
ipratropium
bromide
(ipratropium
bromide
monohydrate)
solution inhalation500mcg/ml+ 261mcg/ml,
20ml glass container
Istituto de Angeli
S.R.L. Loc. Prulli,
103/C 50066 Reggello,
Firenze
Italy R03AL01 1643606.03.2017
06.03.2022PoM
Boehringer Ingelheim
International GmbH,
Binger Strasse 173,
55216 Ingelheim am
Rhein, Germany
599 Berodual N
ipratropium
bromide
(ipratropium
bromide
monohydrate),
fenoterol (fenoterol
hydrobromide)
aerosol for
inhalation, dosed
20mcg/dose+ 50mcg/dose,
10ml (200doses)
aluminium container
with measuring pump
Boehringer Ingelheim
Pharma GmbH & Co.
KG, Binger Strasse
173, 55216 Ingelheim
am Rhein
Germany R03AL01 1641810.02.2017
10.02.2022PoM
Boehringer Ingelheim
International GmbH,
Binger Strasse 173,
55216 Ingelheim am
Rhein, Germany
600 Berotec Nfenoterol (fenoterol
hydrobromide)aerosol for inhalation
100mcg/dose,
10ml aluminium bottle
Boehringer Ingelheim
Pharma GmbH & Co.
KG, Binger Strasse
173, D-55216
Ingelheim am Rhein
Germany R03AC04 12208/131.03.2017
07.03.2018PoM
Boehringer Ingelheim
International GmbH,
Binger Strasse 173,
55216 Ingelheim am
Rhein, Germany
601 Betacid
betamethasone
(betamethasone
dipropionat),
salicylic acid
lotion0,5mg/ml+ 20mg/ml,
30ml glass bottle
Arpimed LLC, Kotayk
Marz, Abovyan, 2nd
Micro-District, 19
Building
Republic of
ArmeniaD07XC01 12468
11.08.2013
11.08.2018PoM
Arpimed LLC,
Kotayk Marz,
Abovyan, 2nd Micro-
District, 19 Building,
Republic of Armenia
602 Betacid
betamethasone
(betamethasone
dipropionat),
salicylic acid
ointment for topical
use
0,5mg/g+30mg/g, 15g
aluminium tube
Arpimed LLC, Kotayk
Marz, Abovyan, 2nd
Micro-District, 19
Building
Republic of
ArmeniaD07XC01 12469
11.11.2013
11.11.2018PoM
Arpimed LLC,
Kotayk Marz,
Abovyan, 2nd Micro-
District, 19 Building,
Republic of Armenia
126
603 Betaderm
betamethasone
(betamethasone
dipropionate),
gentamicin
(gentamicin sulfate)
ointment for
external use
0,5mg/g+1mg/g, 15g
aluminium tube
Pharmaceutical
Company Jelfa S.A.,
ul. Wincentego Pola
21, 58-500 Jelenia
Gora
Poland D07CC01 1491820.10.2015
20.10.2020PoM
VALEANT LLC,
Shabolovka st. 31,
building 5, 115162,
Moscow, Russia
604 Betadina povidone-iodinesolution for external
use
100mg/ml,
20ml, 30ml and 50ml
plastic vial
Pharmaceutical
Company "NOKA"
Ltd, Davtashen 2nd
block 21/1, Yerevan
Republic of
ArmeniaD08AG02 16613
10.04.2017
10.04.2022OTC
Pharmaceutical
Company "NOKA"
Ltd, Davtashen 2nd
block 21/1, Yerevan,
Republic of Armenia
605 Betadine povidone-iodine ointment100mg/g,
20g aluminium tube
Egis Pharmaceuticals
PLC, 9900, Kormend,
Matyas kiraly st. 65
Hungary D08AG02 12757/122.06.2015
14.08.2018OTC
Egis Pharmaceuticals
PLC, 1106 Budapest,
Kereszturi st. 30-38,
Hungary
606 Betadine povidone-iodine suppositories vaginal200mg,
in blister (7, 14/2x7/)
Egis Pharmaceuticals
PLC, 9900, Kormend,
Matyas kiraly st. 65
Hungary G01AX11 12852/122.06.2015
17.09.2018OTC
Egis Pharmaceuticals
PLC, 1106 Budapest,
Kereszturi st. 30-38,
Hungary
607 Betadine povidone-iodine suppositories vaginal200mg,
(14/2x7/)
Alkaloid AD-Skopje,
Blvd. Aleksandar
Makedonski 12, 1000
Skopje
Macedonia G01AX11 1559624.05.2016
24.05.2021OTC
Alkaloid AD-Skopje,
Blvd. Aleksandar
Makedonski 12, 1000
Skopje, Macedonia
608 Betadine povidone-iodinesolution for external
use
100mg/ml,
100ml plastic bottle-
dropper
Alkaloid AD-Skopje,
Blvd. Aleksandar
Makedonski 12, 1000
Skopje
Macedonia D08AG02 1559724.05.2016
24.05.2021OTC
Alkaloid AD-Skopje,
Blvd. Aleksandar
Makedonski 12, 1000
Skopje, Macedonia
127
609 Betadine povidone-iodinesolution for external
use
100mg/ml,
30ml, 120ml, 1000ml
plastic bottle-dropper
Egis Pharmaceuticals
PLC, 9900, Kormend,
Matyas Kiraly u. 65
Hungary D08AG02 1595415.09.2016
15.09.2021OTC
Egis Pharmaceuticals
PLC, 1106 Budapest,
Kereszturi ut 30-38,
Hungary
610 Betadinok povidone-iodinesolution for external
use
100mg/ml,
20ml, 30ml, 75ml plastic
vial
"NOKI" JV LTD Co.,
Nor-Kharberd, Ararat
region
Republic of
ArmeniaD08AG02 14054
19.12.2014
19.12.2019OTC
"NOKI" JV LTD Co.,
Nor-Kharberd, Ararat
region, Republic of
Armenia
611 Betafucin
fusidic acid,
betamethasone
(betamethasone
valerate)
cream20mg/g+1mg/g, 15g
aluminium tube
Delta Pharma,
Industrial Zone
B4,10th of Ramadan
city
Egypt D07BC01 1425120.02.2015
20.02.2020PoM
Delta Pharma,
Industrial Zone
B4,10th of Ramadan
city, Egypt
612
Betahistine
dihydrochloride
16mg Tablets
betahistine
(betahistine
dihydrochloride)
tablets16mg,
in blister (84/6x14/)
Accord Healthcare
Limited, Sage House,319
Pinner Road, North
Harrow, Middlesex, HA1
4HF- batch releaser, Intas
Pharmaceuticals Limited,
Plot No 5/6/7, Pharmez,
Near Village Matoda,
Sarkhej-Bavla Highway,
NH-8A, Matoda, District-
Ahmedabad, 382 210,
Gujarat, India- bulk
manufacturer, Accord
Healthcare Limited, Unit C
& D, Homefield Business
Park, Homefield Road,
Haverhill, CB9 8QP, UK-
primary and secondary
packager
UK N07CA01 1526113.01.2016
13.01.2021PoM
Accord Healthcare
Limited, Sage
House,319 Pinner
Road, North Harrow,
Middlesex, HA1 4HF,
UK
128
613
Betahistine
dihydrochloride
16mg Tablets
betahistine
(betahistine
dihydrochloride)
tablets16mg,
in blister (84/6x14/)
Accord Healthcare
Limited, Sage House, 319
Pinner Road, North
Harrow, Middlesex, HA1
4HF - batch releaser, Intas
Pharmaceuticals Limited,
Plot No 457 & 458 &
191/218 P, Sarkhej-Bavla
Highway, Matoda Village,
Sanand, District-
Ahmedabad, 382 210,
Gujarat, India- bulk
manufacturer, Accord
Healthcare Limited, Unit C
& D, Homefield Business
Park, Homefield Road,
Haverhill, CB9 8QP, UK-
primary and secondary
packager
UK N07CA01 1526213.01.2016
13.01.2021PoM
Accord Healthcare
Limited, Sage
House,319 Pinner
Road, North Harrow,
Middlesex, HA1 4HF,
UK
614
Betahistine
dihydrochloride
8mg Tablets
betahistine
(betahistine
dihydrochloride)
tablets8mg,
in blister (84/6x14/)
Accord Healthcare
Limited, Sage House, 319
Pinner Road, North
Harrow, Middlesex, HA1
4HF - batch releaser, Intas
Pharmaceuticals Limited,
Plot No 457 & 458 &
191/218 P, Sarkhej-Bavla
Highway, Matoda Village,
Sanand, District-
Ahmedabad, 382 210,
Gujarat, India- bulk
manufacturer, Accord
Healthcare Limited, Unit C
& D, Homefield Business
Park, Homefield Road,
Haverhill, CB9 8QP, UK-
primary and secondary
packager
UK N07CA01 1526313.01.2016
13.01.2021PoM
Accord Healthcare
Limited, Sage
House,319 Pinner
Road, North Harrow,
Middlesex, HA1 4HF,
UK
129
615
Betahistine
dihydrochloride
8mg Tablets
betahistine
(betahistine
dihydrochloride)
tablets8mg,
in blister (84/6x14/)
Accord Healthcare
Limited, Sage House,319
Pinner Road, North
Harrow, Middlesex, HA1
4HF- batch releaser, Intas
Pharmaceuticals Limited,
Plot No 5/6/7, Pharmez,
Near Village Matoda,
Sarkhej-Bavla Highway,
NH-8A, Matoda, District-
Ahmedabad, 382 210,
Gujarat, India- bulk
manufacturer, Accord
Healthcare Limited, Unit C
& D, Homefield Business
Park, Homefield Road,
Haverhill, CB9 8QP, UK-
primary and secondary
packager
UK N07CA01 1526413.01.2016
13.01.2021PoM
Accord Healthcare
Limited, Sage
House,319 Pinner
Road, North Harrow,
Middlesex, HA1 4HF,
UK
616 Betaiodine povidone-iodine solution mouthwash10mg/ml,
100ml, 120ml glass bottle
Arpimed LLC, Kotayk
Marz, Abovyan, 2nd
Micro-District, 19
Building
Republic of
ArmeniaD08AG02 12481
09.12.2013
09.12.2018OTC
Arpimed LLC,
Kotayk Marz,
Abovyan, 2nd Micro-
District, 19 Building,
Republic of Armenia
617 Betaiodine povidone-iodinesolution for external
use
100mg/ml,
30ml, 60ml, 100ml, 1l,
3,6l, 4l plastic bottle
Arpimed LLC, Kotayk
Marz, Abovyan, 2nd
Micro-District, 19
Building
Republic of
ArmeniaD08AG02 12518/2
22.02.2016
01.06.2018OTC
Arpimed LLC,
Kotayk Marz,
Abovyan, 2nd Micro-
District, 19 Building,
Republic of Armenia
618 Betaiodine povidone-iodine soap liquid
75mg/ml,
80ml, 140ml plastic
bottle, 1l, 3l plastic
container
Arpimed LLC, Kotayk
Marz, Abovyan, 2nd
Micro-District, 19
Building
Republic of
ArmeniaD08AG02 12535/1
30.12.2016
29.05.2018OTC
Arpimed LLC,
Kotayk Marz,
Abovyan, 2nd Micro-
District, 19 Building,
Republic of Armenia
619 Betaiodine povidone-iodine cream100mg/g,
15g, 20g aluminium tube
Arpimed LLC, Kotayk
Marz, Abovyan, 2nd
Micro-District, 19
Building
Republic of
ArmeniaD08AG02 14084/1
14.04.2015
16.12.2019OTC
Arpimed LLC,
Kotayk Marz,
Abovyan, 2nd Micro-
District, 19 Building,
Republic of Armenia
130
620 Betamaks sulpiride tablets film-coated50mg,
in plastic container (30)
Grindeks JSC,
Krustpils street 53, LV-
1057, Riga
Latvia N05AL01 1484904.09.2015
04.09.2020PoM
Grindeks JSC,
Krustpils street 53,
LV-1057, Riga, Latvia
621 Betamaks sulpiride tablets film-coated100mg,
in plastic container (30)
Grindeks JSC,
Krustpils street 53, LV-
1057, Riga
Latvia N05AL01 1485004.09.2015
04.09.2020PoM
Grindeks JSC,
Krustpils street 53,
LV-1057, Riga, Latvia
622 Betamaks sulpiride tablets film-coated200mg,
in plastic container (30)
Grindeks JSC,
Krustpils street 53, LV-
1057, Riga
Latvia N05AL01 1485104.09.2015
04.09.2020PoM
Grindeks JSC,
Krustpils street 53,
LV-1057, Riga, Latvia
623 Betamed-N Cream
betamethasone
(betamethasone
valerate), neomycin
(neomycin
sulphate)
cream0.1%+0.5%,
30g aluminium tube
Medpharma Pharm.
& Chem. Inds LLC,
Sharjah, Industrial
Area 13, P.O. Box:
25235
United Arab
EmiratesD07CC01 15003
02.12.2015
02.12.2020PoM
Medpharma Pharm.
& Chem. Inds LLC,
Sharjah, Industrial
Area 13, P.O. Box:
25235, United Arab
Emirates
624Betamed-N
Ointment
betamethasone
(betamethasone
valerate), neomycin
(neomycin
sulphate)
ointment0,1%+0,5%,
30g aluminium tube
Medpharma Pharm.
& Chem. Inds LLC,
Sharjah, Industrial
Area 13, P.O. Box:
25235
United Arab
EmiratesD07CC01 15004
02.12.2015
02.12.2020PoM
Medpharma Pharm.
& Chem. Inds LLC,
Sharjah, Industrial
Area 13, P.O. Box:
25235, United Arab
Emirates
625 Betamethasone
betamethasone
(betamethasone
valerate)
ointment for topical
use
1mg/g,
15g aluminium tube
Arpimed LLC, Kotayk
Marz, Abovyan, 2nd
Micro-District, 19
Building
Republic of
ArmeniaD07AC01 12482
26.12.2013
26.12.2018PoM
Arpimed LLC,
Kotayk Marz,
Abovyan, 2nd Micro-
District, 19 Building,
Republic of Armenia
626Betamethasone
cream
betamethasone
(betamethasone
valerate)
cream1mg/g,
15g aluminium tube
Arpimed LLC, Kotayk
Marz, Abovyan, 2nd
Micro-District, 19
Building
Republic of
ArmeniaD07AC01 14080
16.12.2014
16.12.2019PoM
Arpimed LLC,
Kotayk Marz,
Abovyan, 2nd Micro-
District, 19 Building,
Republic of Armenia
131
627
Betamox LA
150mg/ml
suspension for
injection
amoxicillin
(amoxicillin
trihydrate)
suspension for
injection
150mg/ml,
50ml, 100ml glass bottle
Norbrook
Laboratories Limited,
Station Works
Camlough Road,
Newry, Co. Down,
BT35 6JP
UK
QJ01CA04
veterinary
drug
1281417.09.2013
17.09.2018PoM
Norbrook
Laboratories Limited,
Station Works
Camlough Road,
Newry, Co. Down,
BT35 6JP, UK
628 Betasalic
betamethasone
(betamethasone
dipropionate),
salicylic acid
ointment0,64mg/g+30mg/g, 15g
aluminum tube
Kievmedpreparat
OJSC, 01032, Kiev,
Saksaganskogo street,
139
Ukraine D07XC01 1337804.04.2014
04.04.2019PoM
Kievmedpreparat
OJSC, 01032, Kiev,
Saksaganskogo street,
139, Ukraine
629 Betaserc
betahistine
(betahistine
dihydrochloride)
tablets8mg,
in blister (30/1x30/)
ABBOTT Healthcare
SAS, Route de
Belleville, Lieu-dit
Maillard, 01400
Chatillon Sur
Chalaronne
France N07CA01 1250023.06.2013
23.06.2018PoM
ABBOTT Healthcare
Products B.V., C.J.
van Houtenlaan 36,
1381 CP Weesp, the
Netherlands
630 Betaserc
betahistine
(betahistine
dihydrochloride)
tablets16mg,
in blister (30/2x15/)
ABBOTT Healthcare
SAS, Route de
Belleville, Lieu-dit
Maillard, 01400
Chatillon Sur
Chalaronne
France N07CA01 1250123.06.2013
23.06.2018PoM
ABBOTT Healthcare
Products B.V., C.J.
van Houtenlaan 36,
1381 CP Weesp, the
Netherlands
631 Betaserc
betahistine
(betahistine
dihydrochloride)
tablets
24mg,
in blister (20/1x20/,
60/3x20/)
ABBOTT Healthcare
SAS, Route de
Belleville, Lieu-dit
Maillard, 01400
Chatillon Sur
Chalaronne
France N07CA01 1250223.07.2013
23.07.2018PoM
ABBOTT Healthcare
Products B.V., C.J.
van Houtenlaan 36,
1381 CP Weesp, the
Netherlands
632 Betastin
betahistine
(betahistine
dihydrochloride)
tablets
24mg,
in blister (20/2x10/,
30/3x10/, 100/10x10/)
Pharmacare PLC,
Ramallah, Betunia,
Industrial Zone
Palestine N07CA01 1597415.09.2016
15.09.2021PoM
Pharmacare Int.
Co./German
Palestinian Joint
Venture, Jerusalem,
P.O. box 51621,
Palestine
132
633 Betastin
betahistine
(betahistine
dihydrochloride)
tablets16mg,
in blister (30/3x10/)
Pharmacare PLC,
Ramallah, Betunia,
Industrial Zone
Palestine N07CA01 1597515.09.2016
15.09.2021PoM
Pharmacare Int.
Co./German
Palestinian Joint
Venture, Jerusalem,
P.O. box 51621,
Palestine
634 Betmiga mirabegrontablets film-coated
prolonged-release
25mg,
in blister (10/1x10/,
30/3x10/)
Astellas Pharma
Europe B.V.,
Hogemaat 2, 7942 JG
Meppel - packager,
batch releaser (Avara
Pharmaceutical
Tecnologies Inc., 3300
Marshall Avenue,
Norman, OK 73072,
USA - bulk
manufacturer)
the Netherlands G04BD12 13571/211.09.2017
10.06.2019PoM
Astellas Pharma
Europe B.V.,
Sylviusweg 62, 2333
BE Leiden, the
Netherlands
635 Betmiga mirabegrontablets film-coated
prolonged-release
50mg,
in blister (10/1x10/
30/3x10/)
Astellas Pharma
Europe B.V.,
Hogemaat 2, 7942 JG
Meppel - packager,
batch releaser (Avara
Pharmaceutical
Tecnologies Inc., 3300
Marshall Avenue,
Norman, OK 73072,
USA - bulk
manufacturer)
the Netherlands G04BD12 13572/211.09.2017
10.06.2019PoM
Astellas Pharma
Europe B.V.,
Sylviusweg 62, 2333
BE Leiden, the
Netherlands
636 Betoptic Sbetaxolol (betaxolol
hydrochloride)
drops eye
(suspension)
2,5mg/ml,
5ml vial
S.A. Alcon-Couvreur
N.V., Rijksweg 14
2870 Puurs
Belgium S01ED02 1359906.06.2014
06.06.2019PoM
S.A. Alcon-Couvreur
N.V., Rijksweg 14
2870 Puurs, Belgium
133
637 Bicalox bicalutamide tablets film-coated50mg,
in blister (28/1x28/)
Douglas
Manufacturing Ltd,
Corner Te Pai Place
and Central Park
Drive, Lincoln
Auckland
New Zealand L02BB03 1427719.03.2015
19.03.2020PoM
Eris Pharmaceuticals
Pty LTD, 6 Eastern
road South
Melbourne, Victoria,
3205, Australia
638Bicalutamide 50mg
film-coated tabletsbicalutamide tablets film-coated
50mg,
in blister (28/2x14/)
Accord Healthcare
Limited, Sage House,319
Pinner Road, North
Harrow, Middlesex, HA1
4HF-batch releaser, Intas
Pharmaceuticals Limited,
Plot No 457 & 458 Sarkhej-
Bavla Highway, Matoda
Village, Sanand, District-
Ahmedabad, 382 210,
Gujarat, India-bulk
manufacturer, Accord
Healthcare Limited, Unit C
& D, Homefield Business
Park, Homefield Road,
Haverhill, CB9 8QP, UK-
primary and secondary
packager
UK L02BB03 1443216.04.2015
16.04.2020PoM
Accord Healthcare
Limited, Sage
House,319 Pinner
Road, North Harrow,
Middlesex, HA1 4HF,
UK
639Bicalutamide
Grindeksbicalutamide tablets film-coated
50mg,
in blister (30/3x10/)
Grindeks JSC,
Krustpils street 53, LV-
1057, Riga- batch
releaser, Kocak Farma
Ilac ve Kimya Sanayi
A.S., Cerkezkoy
Organize Sanayi
Bolgesi, Karagac Mah.
11, Sok. No 5,
Kapakli/Tekirdag,
Turkey-bulk
manufacturer,
packager
Latvia L02BB03 1587411.08.2016
11.08.2021PoM
Grindeks JSC,
Krustpils street 53,
LV-1057, Riga, Latvia
134
640Bicalutamide-
TEVAbicalutamide tablets film-coated
150mg,
in blister (28/4x7/,
30/3x10/)
Teva Pharmaceutical
Industries Ltd., 18 Eli
Hurvitz Street,
Industrial Zone, Kfar
Saba 44102
Israel L02BB03 1422320.02.2015
20.02.2020PoM
Teva Pharmaceutical
Industries Ltd. 5,
Basel Street, P.O. Box
3190, 49131 Petach
Tikva, Israel
641Bicalutamide-
TEVAbicalutamide tablets film-coated
50mg,
in blister (28/4x7/,
30/3x10/)
Teva Pharmaceutical
Industries Ltd., 18 Eli
Hurvitz Street,
Industrial Zone, Kfar
Saba 44102 for
Israel L02BB03 1422420.02.2015
20.02.2020PoM
Teva Pharmaceutical
Industries Ltd. 5,
Basel Street, P.O. Box
3190, 49131 Petach
Tikva, Israel
642 Bicillin-3
benzathine
benzylpenicillin,
benzylpenicillin
sodium,
benzylpenicillin
procaine
powder for
suspension for i/m
injection
200000IU+ 200000IU+
200000IU,
10ml glass vial (50)
"Sintez" OJSC, Pr.
Konstitutsii, No. 7,
Kurgan, 640008
Russia J01CE30 1560924.05.2016
24.05.2021PoM
"Sintez" OJSC, Pr.
Konstitutsii, No. 7,
Kurgan, 640008,
Russia
643 Bicillin-3
benzylpenicillin
benzathine,
benzylpenicillin
sodium,
benzylpenicillin
procaine
powder for
suspension for i/m
injection
400000IU+ 400000IU+
400000IU,
10ml glass vial (50)
"Sintez" OJSC, Pr.
Konstitutsii, No. 7,
Kurgan, 640008
Russia J01CE30 1561024.05.2016
24.05.2021PoM
"Sintez" OJSC, Pr.
Konstitutsii, No. 7,
Kurgan, 640008,
Russia
644 Bicillin-3
benzathine
benzylpenicillin,
benzylpenicillin
sodium,
benzylpenicillin
procaine
powder for i/m
suspension for
injection
200000IU+ 200000IU+
200000IU,
glass vial (40)
Kievmedpreparat
PJSC, 01032, Kiev,
Saksaganskogo street,
139
Ukraine J01CE30 1611610.11.2016
10.11.2021PoM
Kievmedpreparat
PJSC, 01032, Kiev,
Saksaganskogo street,
139, Ukraine
645 Bicillin-5
benzathine
benzylpenicillin,
benzylpenicillin
procaine
powder for
suspension for i/m
injection
1200000IU+ 300000IU,
10ml glass vial (50)
"Sintez" OJSC, Pr.
Konstitutsii, No. 7,
Kurgan, 640008
Russia J01CE30 1553119.04.2016
19.04.2021PoM
"Sintez" OJSC, Pr.
Konstitutsii, No. 7,
Kurgan, 640008,
Russia
135
646 Bicillin-5
benzathine
benzylpenicillin,
benzylpenicillin
procaine
powder for i/m
suspension for
injection
1200000IU+ 300000IU,
glass vial (40)
Kievmedpreparat
PJSC, 01032, Kiev,
Saksaganskogo street,
139
Ukraine J01CE30 1611710.11.2016
10.11.2021PoM
Kievmedpreparat
PJSC, 01032, Kiev,
Saksaganskogo street,
139, Ukraine
647 Bidop 10mg
bisoprolol
(bisoprolol
fumarate)
tablets
10mg,
in blister (14/1x14/,
28/2x14/, 56/4x14/)
Gedeon Richter PLC,
Gyomroi ut 19-21,
1103 Budapest - batch
releaser, Niche
Generics Limited,
Unit 5, 151 Baldoyle
Industrial Estate,
Dublin 13, Ireland-
bulk manufacturer,
JSC GEDEON
RICHTER- RUS,
Lesnaya St. 40.,
Shuvoye, Moscow
region, Yegoriyevsky
district, 140342,
Russia-packager
Hungary C07AB07 1628719.12.2016
19.12.2021PoM
Gedeon Richter PLC,
Gyomroi ut 19-21,
1103 Budapest,
Hungary
648 Bidop 2,5mg
bisoprolol
(bisoprolol
fumarate)
tablets
2,5mg,
in blister (14/1x14/,
28/2x14/, 56/4x14/)
Gedeon Richter PLC,
Gyomroi ut 19-21,
1103 Budapest - batch
releaser, Niche
Generics Limited,
Unit 5, 151 Baldoyle
Industrial Estate,
Dublin 13, Ireland-
bulk manufacturer,
JSC GEDEON
RICHTER- RUS,
Lesnaya St. 40.,
Shuvoye, Moscow
region, Yegoriyevsky
district, 140342,
Russia-packager
Hungary C07AB07 1628519.12.2016
19.12.2021PoM
Gedeon Richter PLC,
Gyomroi ut 19-21,
1103 Budapest,
Hungary
136
649 Bidop 5mg
bisoprolol
(bisoprolol
fumarate)
tablets
5mg,
in blister (14/1x14/,
28/2x14/, 56/4x14/)
Gedeon Richter PLC,
Gyomroi ut 19-21,
1103 Budapest - batch
releaser, Niche
Generics Limited,
Unit 5, 151 Baldoyle
Industrial Estate,
Dublin 13, Ireland-
bulk manufacturer,
JSC GEDEON
RICHTER- RUS,
Lesnaya St. 40.,
Shuvoye, Moscow
region, Yegoriyevsky
district, 140342,
Russia-packager
Hungary C07AB07 1628619.12.2016
19.12.2021PoM
Gedeon Richter PLC,
Gyomroi ut 19-21,
1103 Budapest,
Hungary
650 Bifidumbacterin bifidobacteriumpowder lyophilized
for oral solution
107, glass vials (5 dose)
(10/2x5/)
Ecopolis CJSC
(601900
Vladimirskaya oblast,
Kovrov, Kuznechnaya
str. 143, korp. 1)
Russia A07FA 1298528.10.2013
28.10.2018OTC
Ecopolis CJSC
(601900
Vladimirskaya oblast,
Kovrov, Kuznechnaya
str. 143, korp. 1,
Russia)
651 Bifiform
bifidobacterium
longum,
enterococcus
faecium
capsules gastro-
resistant
1x10^7CFU + 1x10^7
CFU,
in aluminium container
(30)
Ferrosan A/S,
Sydmarken 5,
Soeborg,DK- 2860
Denmark A07FA 1573022.06.2016
22.06.2021OTC
Ferrosan A/S,
Sydmarken 5,
Soeborg,DK- 2860,
Denmark
652 Bilobilginkgo biloba folies
dry extractcapsules
40mg,
in blister (20/2x10/)
KRKA d.d., Novo
mesto, Smarjeska
cesta 6, 8501 Novo
Mesto
SloveniaC04AX
herbal drug12789
14.08.2013
14.08.2018OTC
KRKA d.d., Novo
mesto, Smarjeska
cesta 6, 8501 Novo
Mesto, Slovenia
653 Bilobil forteginkgo biloba dry
extractcapsules
80mg,
in blister (20/2x10/,
60/6x10/)
KRKA d.d., Novo
mesto, Smarjeska
cesta 6, 8501 Novo
Mesto
SloveniaN06DX02;
herbal drug15631
24.05.2016
24.05.2021OTC
KRKA d.d., Novo
mesto, Smarjeska
cesta 6, 8501 Novo
Mesto, Slovenia
137
654 Bilobil intenseginkgo biloba folies
dry extractcapsules
120mg,
in blister (20/2x10/)
KRKA d.d., Novo
mesto, Smarjeska
cesta 6, 8501 Novo
Mesto
Slovenia herbal drug 1231522.03.2013
22.03.2018OTC
KRKA d.d., Novo
mesto, Smarjeska
cesta 6, 8501 Novo
Mesto, Slovenia
655 Biogenta
amoxicillin
(amoxicillin
trihydrate),
gentamicin
(gentamicin
sulphate)
suspension for i/m
injection
150mg/ml+ 40mg/ml,
100ml glass bottle
Interchemie werken
De Adelaar Eesti AS,
Vanapere tee 14,
Viimsi, Harju county-
bulk manufacturer,
primary packager,
batch releaser,
Interchemie werken
"De Adelaar" B.V.,
Metaalweg 8, 5804
CG Venray, the
Netherlands-
secondary packager
Estonia
QJ01RA01;
veterinary
drug
1605617.10.2016
17.10.2021PoM
Interchemie werken
"De Adelaar" B.V.,
Metaalweg 8, 5804
CG Venray, the
Netherlands
656 Biokson
ceftriaxone
(ceftriaxone sodium
triseskvihydrate)
powder for solution
for i/v and i/m
injection
1000mg,
glass vial (1)
Biosintez OJSC,
Druzhby st. 4,
440033, Penza
Russia J01DD04 1410629.12.2014
29.12.2019PoM
Biosintez OJSC,
Druzhby st. 4,
440033, Penza, Russia
657Biolectra
Magnesium forte
magnesium
(magnesium oxide)
tablets effervescent
with lemon flavour
243mg,
in plastic container (10)
Hermes Arzneimittel
GmbH, Hans-
Urmiller-Ring 52,
82515 Wolfratshausen
Germany A12CC10 1633930.12.2016
30.12.2021OTC
Alpen Pharma AG,
Cazinoplatz 2, 3011
Bern, Switzerland
658
Biolectra
Magnesium
fortissimum
magnesium
(magnesium oxide,
magnesium
carbonate)
tablets effervescent
with lemon flavour
365mg (342mg-
369.4mg+670mg), in
plastic container (10)
Hermes Arzneimittel
GmbH, Hans-
Urmiller-Ring 52,
82515 Wolfratshausen
Germany A12CC10 1633830.12.2016
30.12.2021OTC
Alpen Pharma AG,
Cazinoplatz 2, 3011
Bern, Switzerland
138
659 Biopassit Syrup
tinospora cordifolia,
withania somnifera,
terminalia arjuna,
celastrus
paniculatus,
nardostachys
jatamansi, centella
asiatica, glycyrrhiza
glabra, adhatoda
vasica
syrup
77,5mg/ml+ 77,5mg/ml+
77,5mg/ml+ 77,5mg/ml+
77,5mg/ml+ 77,5mg/ml+
40mg/ml+40mg/ml,
100ml glass bottle
Multani
Pharmaceuticals Ltd,
C-100, Okhla
Industrial Area, Phase-
I, New Delhi-110020
India 1217301.02.2013
01.02.2018OTC
Multani
Pharmaceuticals Ltd,
C-100, Okhla
Industrial Area, Phase-
I, New Delhi-110020,
INDIA
660 Biosanitoleum rusci,
florfenicol
solution for external
use
125mg/ml+ 43mg/ml,
100ml, 170ml and 350ml
aerosol container
Firma
"BioChimPharm
LLC", 600910,
Vladimirskaya region,
Raduzhny city, block
16, build.23, SP-16,
placement 1-23
Russia
QJ01BA99;
veterinary
drug
1707205.10.2017
05.10.2022PoM
Firma
"BioChimPharm
LLC", 600910,
Vladimirskaya region,
Raduzhny city, block
16, build.23, SP-16,
placement 1-23,
Russia
661 Biotaksim
cefotaxime
(cefotaxime
sodium)
powder for solution
for i/v and i/m
injection
1000mg,
10ml glass vial (1)
Biosintez OJSC,
Druzhby st. 4,
440033, Penza
Russia J01DD01 1385718.09.2014
18.09.2019PoM
Biosintez OJSC,
Druzhby st. 4,
440033, Penza, Russia
662 Biovetalgin
metamizole
(metamizole
sodium)
solution for injection
500mg/ml,
50ml and 100ml glass
bottle
Bioveterinarian
Industry Plant in
Drwalew JSC, 6
Grojecka str., 05-651,
Drwalew
Poland
QN02BB02;
veterinary
drug
1723808.12.2017
08.12.2022PoM
Bioveterinarian
Industry Plant in
Drwalew JSC, 6
Grojecka str., 05-651,
Drwalew, Poland
663 Bipin-T amitrasesolution for external
use
12,5%,
0,5ml ampoule (1), 1ml
ampoule (1), 1ml glass
vials (5)
Agrobioprom CJSC,
143980, Moscow,
Balashikhinski
district,,Novo-Milet
r/d , Poltevskoe shosse
, 4
Russia
QP53AD01
veterinary
drug
12267/114.04.2015
22.02.2018PoM
Agrobioprom CJSC,
107139, Moscow,
pereulok
Orlikov,house 3,
Russia
139
664 Biprol
bisoprolol
(bisoprolol
fumarate)
tablets film-coated5mg,
blisters (30/3x10/)
Makiz-Pharma LLC,
109029, Moscow, 6-5
Avtomobilny proezd
Russia C07AB07 12923/115.06.2016
07.10.2018PoM
Nizhpharm JSC,
603950, Nizhny
Novgorod, GSP-459,
Salganskaya st., 7,
Russia
665 Biprol
bisoprolol
(bisoprolol
fumarate)
tablets film-coated10mg,
blisters (30/3x10/)
Makiz-Pharma LLC,
109029, Moscow, 6-5
Avtomobilny proezd
Russia C07AB07 12924/115.06.2016
07.10.2018PoM
Nizhpharm JSC,
603950, Nizhny
Novgorod, GSP-459,
Salganskaya st., 7,
Russia
666 Biprol
bisoprolol
(bisoprolol
fumarate)
tablets film-coated5mg,
blisters (30/3x10/)
Hemofarm LLC,
249030, Obninsk,
Kaluga Region, 62
Kievskoye shosse St.
Russia C07AB07 13092/115.06.2016
09.12.2018PoM
Nizhpharm JSC,
603950, Nizhny
Novgorod, GSP-459,
Salganskaya st., 7,
Russia
667 Biprol
bisoprolol
(bisoprolol
fumarate)
tablets film-coated10mg,
blisters (30/3x10/)
Hemofarm LLC,
249030, Obninsk,
Kaluga Region, 62
Kievskoye shosse St.
Russia C07AB07 13093/115.06.2016
09.12.2018PoM
Nizhpharm JSC,
603950, Nizhny
Novgorod, GSP-459,
Salganskaya st., 7,
Russia
668 Biprol
bisoprolol
(bisoprolol
fumarate)
tablets film-coated2,5mg,
in blister (30/3x10/)
Hemofarm LLC,
249030, Obninsk,
Kaluga Region, 62
Kievskoye shosse
Russia C07AB07 1625019.12.2016
19.12.2021PoM
Nizhpharm JSC,
603950, Nizhny
Novgorod, GSP-459,
Salganskaya st., 7,
Russia
669 Bisacodyl bisacodyl suppositories rectal10mg
(10/2x5/)
Farmaprim SRL,
Crinilor str., 5,
Porumbeni, Criuleni
dis.,MD-4829
Moldova A06AB02 1250801.06.2013
01.06.2018OTC
Farmaprim SRL,
Crinilor str., 5,
Porumbeni, Criuleni
dis.,MD-4829,
Moldova
140
670 Bisacodyl bisacodyl
tablets gastro-
resistant enteric-
coated
5mg,
in blister (30/3x10/)
Open Joint Stock
Company, Borisovskiy
zavod Medicinskikh
Preparatov, 64/27,
Chapayev str., Borisov
222120, Minsk oblast
Belarus A06AB02 1323624.02.2014
24.02.2019OTC
Open Joint Stock
Company,
Borisovskiy zavod
Medicinskikh
Preparatov, 64/27,
Chapayev str.,
Borisov 222120,
Minsk oblast, Belarus
671 Bisacodyl bisacodyltablets gastro-
resistant
5mg,
in blister (30/3x10/)
Balkanpharma-
Razgrad AD, 68,
Aprilsko vastanie
Blvd, 7200 Razgrad
Bulgaria A06AB02 1682810.07.2017
10.07.2022OTC
Balkanpharma-
Dupnitsa AD,
(ACTAVIS GROUP),
str."Samokovsko
Shosse" N3, Dupnitsa
2600, Bulgaria
672 Bisacodyl bisacodyl suppositories rectal10mg,
in blister (10/2x5/)
Lekhim-Kharkiv JSC,
36,Severyna
Pototskoho str.,
61115, Kharkiv
region, Kharkiv
Ukraine A06AB02 1704526.09.2017
26.09.2022OTC
Lekhim-Kharkiv JSC,
36,Severyna
Pototskoho str.,
61115, Kharkiv
region, Kharkiv,
Ukraine
673 Bisacodyl Grindeks bisacodyltablets enteric-
coated
5mg,
in blister (40/4x10/)
Grindeks JSC,
Krustpils street 53, LV-
1057, Riga
Latvia A06AB02 1507707.12.2015
07.12.2020OTC
Grindeks JSC,
Krustpils street 53,
LV-1057, Riga, Latvia
674Bisacodyl-
Hemofarmbisacodyl
tablets gastro-
resistant
5mg,
in blister (30/3x10/)
Hemofarm A.D.,
26300, Vrsac,
Beogradskii put bb
Serbia A06AB02 1627519.12.2016
19.12.2021OTC
Hemofarm A.D.,
26300, Vrsac,
Beogradskii put bb,
Serbia
675Bisacodyl-
Nizhpharmbisacodyl suppositories rectal
10mg
(10/2x5/)
Nizhpharm OJSC,
603950, Nizhny
Novgorod, GSP-459,
Salganskaya st., 7
Russia A06AB02 1343214.04.2014
14.04.2019OTC
Nizhpharm OJSC,
603950, Nizhny
Novgorod, GSP-459,
Salganskaya st., 7,
Russia
141
676 Biseptolsulfamethoxazole,
trimethoprimtablets
100mg+20mg,
in blister (20)
Pharmaceutical
Works Polfa in
Pabianice JSC, 5
Marszalka J.
Pilsudskiego Str., 95-
200 Pabianice
Poland J01EE01 1302725.11.2013
25.11.2018PoM
Pharmaceutical
Works Polfa in
Pabianice JSC, 5
Marszalka J.
Pilsudskiego Str., 95-
200 Pabianice, Poland
677 Biseptolsulfamethoxazole,
trimethoprimtablets
400mg+80mg,
in blister (20, 28/2x14/)
Pharmaceutical
Works Polfa in
Pabianice JSC, 5
Marszalka J.
Pilsudskiego Str., 95-
200 Pabianice
Poland J01EE01 13028/126.09.2014
25.11.2018PoM
Pharmaceutical
Works Polfa in
Pabianice JSC, 5
Marszalka J.
Pilsudskiego Str., 95-
200 Pabianice, Poland
678 Biseptolsulfamethoxazole,
trimethoprimsuspension oral
40mg/ml+8mg/ml, 80ml
glass bottle and measuring
cup
Medana Pharma JSC,
98-200 Sieradz, W.
Lokietka 10 - batch
releaser (dosage form
manufacturer,
packager - Medana
Pharma JSC, str.
Polskiej Organizacji
Wojskowej 57,98-200
Sieradz, Poland)
Poland J01EE01 1327904.03.2014
04.03.2019PoM
Medana Pharma JSC,
98-200 Sieradz, W.
Lokietka 10, Poland
679 Bisoprolol
bisoprolol
(bisoprolol
fumarate)
tablets coated5mg,
in blister (30/3x10/)
Arpimed LLC, Kotayk
Marz, Abovyan, 2nd
Micro-District, 19
Building
Republic of
ArmeniaC07AB07 12294
22.03.2013
22.03.2018PoM
Arpimed LLC,
Kotayk Marz,
Abovyan, 2nd Micro-
District, 19 Building,
Republic of Armenia
680 Bisoprolol
bisoprolol
(bisoprolol
fumarate)
tablets coated2,5mg,
in blister (30/3x10/)
Open joint stock
company, Borisovskiy
zavod medicinskikh
preparatov, 64/27,
Chapaev str., Borisov
222120, Minsk region
Belarus C07AB07 1330704.03.2014
04.03.2019PoM
Open joint stock
company, Borisovskiy
zavod medicinskikh
preparatov, 64/27,
Chapaev str., Borisov
222120, Minsk
region, Belarus
142
681 Bisoprolol
bisoprolol
(bisoprolol
fumarate)
tablets coated5mg,
in blister (30/3x10/)
Open joint stock
company, Borisovskiy
zavod medicinskikh
preparatov, 64/27,
Chapaev str., Borisov
222120, Minsk region
Belarus C07AB07 1330804.03.2014
04.03.2019PoM
Open joint stock
company, Borisovskiy
zavod medicinskikh
preparatov, 64/27,
Chapaev str., Borisov
222120, Minsk
region, Belarus
682 Bisoprolol
bisoprolol
(bisoprolol
fumarate)
tablets coated10mg,
in blister (30/3x10/)
Open joint stock
company, Borisovskiy
zavod medicinskikh
preparatov, 64/27,
Chapaev str., Borisov
222120, Minsk region
Belarus C07AB07 1330904.03.2014
04.03.2019PoM
Open joint stock
company, Borisovskiy
zavod medicinskikh
preparatov, 64/27,
Chapaev str., Borisov
222120, Minsk
region, Belarus
683 Bisoprolol
bisoprolol
(bisoprolol
fumarate)
tablets film-coated2,5mg,
in blister (30/3x10/)
Replek Farm Ltd.-
Skopje, 188 str. Kozle,
1000 Skopje
Macedonia C07AB07 1371624.07.2014
24.07.2019PoM
Replek Farm Ltd.-
Skopje, 188 str. Kozle,
1000 Skopje,
Macedonia
684 Bisoprolol
bisoprolol
(bisoprolol
fumarate)
tablets film-coated5mg,
in blister (30/3x10/)
Replek Farm Ltd.-
Skopje, 188 str. Kozle,
1000 Skopje
Macedonia C07AB07 1371724.07.2014
24.07.2019PoM
Replek Farm Ltd.-
Skopje, 188 str. Kozle,
1000 Skopje,
Macedonia
685 Bisoprolol
bisoprolol
(bisoprolol
fumarate)
tablets film-coated10mg,
in blister (30/3x10/)
Replek Farm Ltd.-
Skopje, 188 str. Kozle,
1000 Skopje
Macedonia C07AB07 1371824.07.2014
24.07.2019PoM
Replek Farm Ltd.-
Skopje, 188 str. Kozle,
1000 Skopje,
Macedonia
686Bisoprolol 10mg
film-coated tablets
bisoprolol
(bisoprolol
fumarate)
tablets film-coated10mg,
in blister (100/4x25/)
Lek S.A.,16 Podlipie
Str., 95-010 Strykow Poland C07AB07 16756
05.06.2017
05.06.2022PoM
Sandoz
Pharmaceuticals d.d.,
Verovskova Str. 57,
1000 Ljubljana,
Slovenia
143
687Bisoprolol 2,5mg
film-coated tablets
bisoprolol
(bisoprolol
fumarate)
tablets film-coated2,5mg,
in blister (30/2x15/)
Lek S.A.,16 Podlipie
Str., 95-010 StrykowPoland C07AB07 16754
05.06.2017
05.06.2022PoM
Sandoz
Pharmaceuticals d.d.,
Verovskova Str. 57,
1000 Ljubljana,
Slovenia
688Bisoprolol 5mg
film-coated tablets
bisoprolol
(bisoprolol
fumarate)
tablets film-coated5mg,
in blister (100/4x25/)
Lek S.A., ul.
Domaniewska 50C,
Warszawa, 02-672-
batch releaser, Lek
S.A.,16 Podlipie Str.,
95-010 Strykow,
Poland-bulk
manufacturer,
packager
Poland C07AB07 1675505.06.2017
05.06.2022PoM
Sandoz
Pharmaceuticals d.d.,
Verovskova Str. 57,
1000 Ljubljana,
Slovenia
689Bisoprolol
Fumarate
bisoprolol
(bisoprolol
fumarate)
tablets2,5mg,
in blister (30/3x10/)
Chanelle Medical,
Loughrea, Co. Galway Ireland C07AB07 12720
23.07.2013
23.07.2018PoM
Ritm Farm LTD, 11/2
Totovents Street,
Apartment 34,
Yerevan, Republic of
Armenia
690Bisoprolol
Fumarate
bisoprolol
(bisoprolol
fumarate)
tablets
5mg,
in blister (30/3x10/,
100/10x10/)
Chanelle Medical,
Loughrea, Co. Galway Ireland C07AB07 12721
23.07.2013
23.07.2018PoM
Ritm Farm LTD, 11/2
Totovents Street,
Apartment 34,
Yerevan, Republic of
Armenia
691Bisoprolol
Fumarate
bisoprolol
(bisoprolol
fumarate)
tablets
10mg,
in blister (30/3x10/,
100/10x10/)
Chanelle Medical,
Loughrea, Co. Galway Ireland C07AB07 12722
23.07.2013
23.07.2018PoM
Ritm Farm LTD, 11/2
Totovents Street,
Apartment 34,
Yerevan, Republic of
Armenia
144
692 Blemaren
citric acid,
potassium
hydrogencarbo-
nate, sodium citrate
tablets effervescent
1197mg+ 967,5mg+
835,5mg,
in plastic container
(80/4x20/)
Esparma GmbH,
Seepark 7, 39116
Magdeburg - batch
releaser (Allphamed
Pharbil Arzneimittel
GmbH Hildebrandstr.
12, 37081 Gottingen,
Germany - bulk
manufacturer,
packager)
Germany G04BC 1387423.09.2014
23.09.2019PoM
Esparma GmbH,
Seepark 7, 39116
Magdeburg, Germany
693 Blestar 24
betahistine
(betahistine
hydrochloride)
tablets24mg,
in strip (20/2x10/)
Aversi-Rational Ltd,
0198 Tbilisi,
Chirnakhuli str. 14 -
secondary packager,
batch releaser (dosage
form manufacturer,
primary packager -
Omega
Pharmaceuticals, Plot
No 119 to 123, 149 to
151, G.I.D.C.,
Wadhwan city
363035, Dist.
Surendranagar,
Gujarat, India)
Georgia N07CA01 1266904.07.2013
04.07.2018PoM
Aversi-Rational Ltd,
0198 Tbilisi,
Chirnakhuli str. 14,
Georgia
694 Bobotic simethicone drops oral66,66mg/ml,
30ml glass bottle
Medana Pharma JSC,
98-200 Sieradz, W.
Lokietka 10-batch
releaser; (Medana
Pharma JSC, str.
Polskiej Organizacji
Wojskowej 57,98-200
Sieradz, Poland-bulk
manufacturer,
packager)
Poland A03AX13 1336104.04.2014
04.04.2019OTC
Medana Pharma JSC,
98-200 Sieradz, W.
Lokietka 10, Poland
145
695 Boncur zoledronic acidconcentrate for
solution for infusion
4mg/5ml,
5ml glass vial (1)
Liqvor CJSC, 0089,
Yerevan, str.
Kochinyan, 7/9
Republic of
ArmeniaM05BA08 15452
02.04.2016
02.04.2021PoM
Liqvor CJSC, 0089,
Yerevan, str.
Kochinyan, 7/9,
Republic of Armenia
696 Bonjigar
eclipta
alba,picrorrhiza
kurrooa,solanum
nigrum,cichorium
intybus,glycyrrhiza
glabra,tamarix
gallica,raphanus
sativus,berberis
aristata,silbyum
marianum,spherant
us indica,boerhavia
diffusa
capsules
250mg+100mg+
50mg+175mg+
200mg+100mg+
50mg+150mg+
200mg+50mg+ 100mg,
in plastic container (20,
60)
Herbion Pakistan Pvt.
Ltd., 30/28, Korangi
Industrial
Area,Karachi-74900
PakistanA05C;
herbal drug12678
12.07.2013
12.07.2018OTC
Herbion Pakistan Pvt.
Ltd., 30/28, Korangi
Industrial
Area,Karachi-74900,
Pakistan
697 Bonjigar
eclipta
alba,picrorrhiza
kurrooa,solanum
nigrum,cichorium
intybus,glycyrrhiza
glabra,tamarix
gallica,raphanus
sativus,berberis
aristata,silbyum
marianum,spherant
us indica,boerhavia
diffusa
syrup
8,3mg/ml+ 3,3mg/ml+
1,7mg/ml+ 5,8mg/ml+
6,7mg/ml+ 3,3mg/ml+
1,7mg/ml+ 5mg/ml+
6,7mg/ml+ 1,7mg/ml+
3,3mg/ml,
in glass container (90,
120, 150)
Herbion Pakistan Pvt.
Ltd., 30/28, Korangi
Industrial area,
Karachi-74900
PakistanHA05BA
herbal drug 14030
26.11.2014
26.11.2019PoM
Herbion Pakistan Pvt.
Ltd., 30/28, Korangi
Industrial area,
Karachi-74900,
Pakistan
698 Bonviva
ibandronic acid
(ibandronic acid
monosodium
monohydrate)
tablets film-coated150mg,
in blister (1, 3)
F. Hoffmann-La
Roche Ltd.,
Grenzacherstrasse,
124, CH-4070, Basel -
batch releaser, bulk
manufacturer, F.
Hoffmann-La Roche
Ltd., Wurmisweg, CH-
4303, Kaiseraugst,
Switzerland-packager
Switzerland M05BA06 1517517.12.2015
17.12.2020PoM
F. Hoffmann-La
Roche Ltd.,
Grenzacherstrasse,
124, CH-4070, Basel,
Switzerland
146
699 Bonviva ibandronic acidsolution for i/v
injection
1mg/ml,
3ml pre-filled glass
syringe (1) and needle (1)
Roche Diagnostics
GmbH, Sandhofer
Strasse 116, D-68305
Mannheim - batch
releaser, secondary
packager, Vetter
Pharma-Fertigung
GmbH & Co. KG,
Eisenbahn strasse 2-4,
88085 Langenargen,
Germany- bulk
manufacturer,
primary packager
Germany M05BA06 1599716.09.2016
16.09.2021PoM
F. Hoffmann La
Roche Ltd.,
Grenzacherstrasse 124
Basel, CH-4070,
Switzerland
700Boric acid
ointment 5%boric acid ointment
50mg/g,
25g in aluminium tube
Esco-Pharm LLC, Nor-
Norq, Mikoyan 13,
Yerevan
Republic of
ArmeniaD08AD 12522
01.06.2013
01.06.2018OTC
Esco-Pharm LLC, Nor-
Norq, Mikoyan 13,
Yerevan, Armenia
701 BoriVit
thiamine (thiamine
hydrochloride),
pyridoxine
(pyridoxine
hydrochloride),
cyanocobalamin,
lidocaine (lidocaine
hydrochloride)
solution for injection
100mg/2ml+ 100mg/2ml+
1mg/2ml+ 20mg/2ml,
2ml ampoules, blister
(10/1x10/), 2ml ampoules
(10)
Open joint stock
company "Borisovskiy
zavod medicinskikh
preparatov" 64,
Chapaev str., Borisov
222518, Minsk region
Belarus A11DB 12160/123.03.2016
01.02.2018PoM
Open joint stock
company "Borisovskiy
zavod medicinskikh
preparatov" 64,
Chapaev str., Borisov
222518, Minsk
region, Belarus
702 BoriVit
thiamine (thiamine
hydrochloride),
pyridoxine
(pyridoxine
hydrochloride),
cyanocobalamin,
lidocaine (lidocaine
hydrochloride)
solution for i/m
injection
100mg/2ml+ 100mg/2ml+
1mg/2ml+ 20mg/2ml,
2ml ampoules
(10, 10/1x10/ )
Open joint stock
company "Borisovskiy
zavod medicinskikh
preparatov" 64,
Chapaev str., Borisov
222518, Minsk region
Belarus A11DB 1697805.09.2017
05.09.2022PoM
Open joint stock
company "Borisovskiy
zavod medicinskikh
preparatov" 64,
Chapaev str., Borisov
222518, Minsk
region, Belarus
147
703 Borizol riluzole tablets film-coated50mg,
in blister (60/6x10/)
SIC Borshchahivskiy
Chemical-
Pharmaceutical Plant
PJSC, 17, Mira St,
Kiev 03134
Ukraine N07XX02 1410929.12.2014
29.12.2019PoM
SIC Borshchahivskiy
Chemical-
Pharmaceutical Plant
PJSC, 17, Mira St,
Kiev 03134, Ukraine
704 Bovaclox DC
cloxacillin
(cloxacillin
benzathine),
ampicillin
(ampicillin
trihydrate)
suspension for
administration into
the milk duct
500mg/4,5g+ 250mg/4,5g,
4,5g plastic syringes (24,
120)
Norbrook
Laboratories Limited,
Station Works
Camlough Road,
Newry, Co. Down,
BT35 6JP
UK
J01CA51
veterinary
drug
1271623.07.2013
23.07.2018PoM
Norbrook
Laboratories Limited,
Station Works
Camlough Road,
Newry, Co. Down,
BT35 6JP, UK
705 Bravadin
ivabradine
(ivabradine
hydrobromide)
tablets film-coated7,5mg,
in blister (28/2x14/)
Krka-RUS LLC, 50
Moskovskaya str.,
Istra, Moscow region
143500
Russia C01EB17 1598515.09.2016
15.09.2021PoM
Krka-RUS LLC, 50
Moskovskaya str.,
Istra, Moscow region
143500, Russia
706 Bravadin
ivabradine
(ivabradine
hydrobromide)
tablets film-coated5mg,
in blister (28/2x14/)
Krka-RUS LLC, 50
Moskovskaya str.,
Istra, Moscow region
143500
Russia C01EB17 1598615.09.2016
15.09.2021PoM
Krka-RUS LLC, 50
Moskovskaya str.,
Istra, Moscow region
143500, Russia
707Bretaris Genuair
322mcg
aclidinium
(aclidinium
bromide)
powder for
inhalation
322mcg/dose; (1) inhaler
(30 unit doses), (1) inhaler
(60 unit doses), (3) inhaler
(180/3x60/ unit doses)
Industrias
Farmaceuticas
Almirall S.A., Ctra.
Nacional II, Km. 593,
08740 Sant Andreu de
la Barca, Barcelona
Spain R03BB05 13779/116.02.2016
05.09.2019PoM
Berlin-Chemie AG
(Menarini Group),
Glienicker Weg 125,
12489 Berlin,
Germany
708 Breviprost travoprost drops eye0,04mg/ml,
2.5ml plastic vial (1, 10)
Liqvor CJSC, 0089,
Yerevan, str.
Kochinyan, 7/9
Republic of
ArmeniaS01EE04 16786
22.06.2017
22.06.2022PoM
Liqvor CJSC, 0089,
Yerevan, str.
Kochinyan, 7/9,
Republic of Armenia
148
709 Bridion
sugammadex
(sugammadex
sodium)
solution for i/v
injection
100mg/ml,
2ml glass vial (10)
N.V. Organon,
Molenstraat 110, 5342
CC Oss
the Netherlands V03AB35 1452215.05.2015
15.05.2020PoM
Schering-Plough
Central East AG,
Weystrasse 20, 6000
Lucerne 6,
Switzerland
710 Bridion
sugammadex
(sugammadex
sodium)
solution for i/v
injection
100mg/ml,
5ml glass vial (10)
N.V. Organon,
Molenstraat 110, 5342
CC Oss
the Netherlands V03AB35 1452315.05.2015
15.05.2020PoM
Schering-Plough
Central East AG,
Weystrasse 20, 6000
Lucerne 6,
Switzerland
711 Brilliant green brilliant greensolution for external
use
10mg/ml,
10ml glass bottle
ESCO-PHARM LLC,
Nor-Norq V block,
Mikoyan 13, Yerevan
0079
Republic of
ArmeniaD08AX 13477
06.05.2014
06.05.2019OTC
ESCO-PHARM LLC,
Nor-Norq V block,
Mikoyan 13, Yerevan
0079, Republic of
Armenia
712 Brimica Genuair
aclidinium
(aclidinium
bromide),
formoterol
fumarate dihydrate
powder for
inhalation
340mcg/dose+
12mcg/dose, (1) inhaler
with 60 unit doses, (3)
inhalers with 180(3x60)
unit doses
Industrias
Farmaceuticas
Almirall S.A., Ctra.
Nacional II, Km. 593,
08740 Sant Andreu de
la Barca, Barcelona
Spain R03AL05 1572222.06.2016
22.06.2021PoM
Berlin-Chemie AG,
Glienicker Weg 125,
12489 Berlin,
Germany
713 Brimoptic
brimonidine
(brimonidine
tartrate), timolol
(timolol maleate)
drops eye2mg/ml+6,8mg/ml, 10ml
vial-dropper
Liqvor CJSC, 0089,
Yerevan, str.
Kochinyan, 7/9
Republic of
ArmeniaS01EX 13643
27.06.2014
27.06.2019PoM
Liqvor CJSC, 0089,
Yerevan, str.
Kochinyan, 7/9,
Republic of Armenia
714 Britomar torasemidetablets prolonged-
release
5mg,
in blister (30/2x15/)
Ferrer International,
S.A., Joan Buscalla,1-9
08173 Sant Cugat del
Valles, Barcelona
Spain C03CA04 1639910.02.2017
10.02.2022PoM
Ferrer International,
S.A., Gran Via Carlos
III, 94, 08028,
Barcelona, Spain
149
715 Britomar torasemidetablets prolonged-
release
10mg,
in blister (30/2x15/)
Ferrer Internacional,
S.A., Joan Buscalla, 1-
9 08173 Sant Cugat
del Valles, Barcelona
Spain C03CA04 1640010.02.2017
10.02.2022PoM
Ferrer International,
S.A., Gran Via Carlos
III, 94, 08028,
Barcelona, Spain
716 Bromhexin
bromhexine
(bromhexine
hydrochloride)
syrup with apricot
flavour
4mg/5ml,
100ml glass bottle and
measuring spoon
Pharmstandard-
Leksredstva OJSC,
305022, Kursk,
Agregatnaya 2nd str.,
1a/18
Russia R05CB02 1269423.07.2013
23.07.2018OTC
Pharmstandard-
Leksredstva OJSC,
305022, Kursk,
Agregatnaya 2nd str.,
1a/18, Russia
717 Bromhexin
bromhexine
(bromhexine
hydrochloride)
syrup with pear
flavour
4mg/5ml,
100ml glass bottle and
measuring spoon
Pharmstandard-
Leksredstva JSC,
305022, Kursk,
Agregatnaya 2nd str.,
1a/18
Russia R05CB02 1322624.02.2014
24.02.2019OTC
Pharmstandard-
Leksredstva JSC,
305022, Kursk,
Agregatnaya 2nd str.,
1a/18, Russia
718 Bromhexin
bromhexine
(bromhexine
hydrochloride)
syrup with cherry
flavour
4mg/5ml,
100ml glass bottle and
measuring spoon or
measuring syringe
Pharmstandard-
Leksredstva JSC,
305022, Kursk,
Agregatnaya 2nd str.,
1a/18
Russia R05CB02 1322724.02.2014
24.02.2019OTC
Pharmstandard-
Leksredstva JSC,
305022, Kursk,
Agregatnaya 2nd str.,
1a/18, Russia
719 Bromhexin
bromhexine
(bromhexine
hydrochloride)
tablets8mg,
in blister (20/1x20/)
Pharmstandard-
Leksredstva JSC,
305022, Kursk,
Agregatnaya 2nd str.,
1a/18
Russia R05CB02 1703026.09.2017
26.09.2022OTC
Pharmstandard-
Leksredstva JSC,
305022, Kursk,
Agregatnaya 2nd str.,
1a/18, Russia
720Bromhexin 4
Berlin-Chemie
bromhexine
(bromhexine
hydrochloride)
solution oral
0,8mg/ml,
60ml glass bottle and
measuring spoon
Berlin-Chemie A.G.,
Glienicker Weg 125 D-
12489 Berlin
Germany R05CB02 1377605.09.2014
05.09.2019OTC
Berlin-Chemie A.G.,
Glienicker Weg 125
D-12489 Berlin,
Germany
150
721Bromhexin 8
Berlin-Chemie
bromhexine
(bromhexine
hydrochloride)
tablets8mg,
in blister (25/1x25/)
Berlin-Chemie
A.G.Glienicker Weg
125 D-12489 Berlin -
packager, batch
releaser (Berlin-
Chemie A.G.,
Tempelhofer Weg 83
D-12347 Berlin,
Germany - bulk
manufacturer)
Germany R05CB02 1377505.09.2014
05.09.2019OTC
Berlin-Chemie A.G.
Glienicker Weg 125
D-12489 Berlin,
Germany
722Bromhexin 8
Berlin-Chemie
bromhexine
(bromhexine
hydrochloride)
tablets coated8mg,
in blister (25/1x25/)
Berlin-Chemie
A.G.,Glienicker Weg
125 D-12489 Berlin-
batch releaser, SWISS
CAPS GmbH,
Grassingerstrasse 9,
83043 Bad Aibling,
Germany-packager,
Dragenopharm
Apotheker Puschl
GmbH, Gollstrasse 1,
84529 Tittmoning,
Germany- bulk
manufacturer
Germany R05CB02 1429219.03.2015
19.03.2020OTC
Berlin-Chemie
A.G.,Glienicker Weg
125 D-12489 Berlin,
Germany
723 Bromhexine
bromhexine
(bromhexine
hydrochloride)
tablets8mg,
in blister (50/5x10/)
Open joint stock
company "Borisovskiy
zavod medicinskikh
preparatov" 64, ul.
Chapaeva, Borisov
222518, Minsk region
Belarus R05CB02 1661925.04.2017
25.04.2022OTC
Open joint stock
company "Borisovskiy
zavod medicinskikh
preparatov" 64, ul.
Chapaeva, Borisov
222518, Minsk
region, Belarus
724Bromocriptin-
Richter
bromcriptine
(bromocriptine
mesylate)
tablets2,5mg,
in glass bottle (30)
Gedeon Richter OJSC,
Gyomroi ut 19-21,
1103 Budapest
Hungary G02CB01 1414729.12.2014
29.12.2019PoM
Gedeon Richter
OJSC, Gyomroi ut 19-
21, 1103 Budapest,
Hungary
151
725 Bronchicum Sthyme liquid
extractsyrup
150mg/ml,
100ml glass bottle and
measuring cup
A. Nattermann & Cie.
GmbH,
Nattermannallee 1, D-
50829 Kolne
GermanyR05CA
herbal drug 13915
29.10.2014
29.10.2019OTC
A. Nattermann & Cie.
GmbH,
Nattermannallee 1, D-
50829 Kolne,
Germany
726 Bronchicum TP
thyme liquid
extract, primula
root liquid extract
elixir50mg/g+25mg/g, 130g
(100ml) glass bottle
A. Nattermann & Cie.
GmbH,
Nattermannallee 1, D-
50829 Kolne
GermanyR05CA10;
herbal drug13697
24.07.2014
24.07.2019OTC
A. Nattermann & Cie.
GmbH,
Nattermannallee 1, D-
50829 Kolne,
Germany
727 Bronchobos carbocisteine syrup
250mg/5ml,
250ml glass bottle (200ml
syrup) and measuring
spoon
Bosnalijek d.d.,
Jukiceva 53, 71000
Sarajevo
Bosnia And
HerzegovinaR05CB03 15944
30.08.2016
30.08.2021OTC
Bosnalijek d.d.,
Jukiceva 53, 71000
Sarajevo, Bosnia And
Herzegovina
728 Bronchobos carbocisteine syrup
125mg/5ml,
250ml glass bottle (200ml
syrup) and measuring
spoon
Bosnalijek d.d.,
Jukiceva 53, 71000
Sarajevo
Bosnia And
HerzegovinaR05CB03 15945
30.08.2016
30.08.2021OTC
Bosnalijek d.d.,
Jukiceva 53, 71000
Sarajevo, Bosnia And
Herzegovina
729 Bronchobos carbocisteine capsules375mg,
in blister (30/3x10/)
Bosnalijek d.d.,
Jukiceva 53, 71000
Sarajevo
Bosnia And
HerzegovinaR05CB03 15946
30.08.2016
30.08.2021OTC
Bosnalijek d.d.,
Jukiceva 53, 71000
Sarajevo, Bosnia And
Herzegovina
730Bronchobru Dextro
syrup
guaifenesin,
dextromethorphan
hydrobromide
syrup10mg/ml+ 1,5mg/ml,
125ml glass bottle
Bruphamexport
SPRL, Rue de la
Grotte, 14, Bruxelles,
1020 - batch releaser
(dosage form
manufacturer,
packager -
Laboratoires Sterop
NV, Scheutlaan 46-
50, Anderlecht, B-
1070, Belgium)
Belgium R05FB 1273223.07.2013
23.07.2018OTC
Bruphamexport
SPRL, Rue de la
Grotte, 14, Bruxelles,
1020, Belgium
152
731 Broncholytin
glaucine (glaucine
hydrobromide),
ephedrine
(ephedrine
hydrochloride)
syrup
5,75mg/5ml+ 4,6mg/5ml,
125ml glass or plastic
bottle and measuring cup
Sopharma JSC, str.
Iliensko shosse 16,
1220 Sofia-batch
releaser, Sopharma
JSC, Vrabevo vlg.
5660, district of
Lovetch, Bulgaria-
bulk manufacturer,
packager
Bulgaria R05DB20 1723208.12.2017
08.12.2022PoM
Sopharma JSC, str.
Iliensko shosse 16,
1220 Sofia, Bulgaria
732 Broncho-munallyophilized
bacterial lysatecapsules hard
7mg,
in blister (10/1x10/)
Lek Pharmaceuticals
d.d., Verovskova Str.
57, 1526 Ljubljana-
batch releaser,
primary and
secondary packager,
OM Pharma SA, 22,
rue du Bois-du-Lan,
1217 Meyrin
2/Geneva,
Switzerland-bulk
manufacturer
Slovenia R07AX 1466103.07.2015
03.07.2020PoM
Lek Pharmaceuticals
d.d., Verovskova Str.
57, 1526 Ljubljana,
Slovenia
733 Broncho-munal Plyophilized
bacterial lysatecapsules hard
3,5mg,
in blister (10/1x10/)
Lek Pharmaceuticals
d.d., Verovskova Str.
57, 1526 Ljubljana-
batch releaser,
primary and
secondary packager,
OM Pharma SA, 22,
rue du Bois-du-Lan,
1217 Meyrin
2/Geneva,
Switzerland-bulk
manufacturer
Slovenia R07AX 1466203.07.2015
03.07.2020PoM
Lek Pharmaceuticals
d.d., Verovskova Str.
57, 1526 Ljubljana,
Slovenia
734 Brovanol-plus
praziquantel,
ivermectin,
levamisole
(levamisole
hydrochloride)
tablets50mg+2mg+38mg, in
blister (10/1x10/)
"Brovafarma" Ltd,18-
a, Nezalezhnosti
blvd., Brovary, Kyiv
region, 07400
Ukraine
QP52AA51;
veterinary
drug
1418106.02.2015
06.02.2020PoM
"Brovafarma" Ltd,18-
a, Nezalezhnosti
blvd., Brovary, Kyiv
region, 07400,
Ukraine
153
735 Brovin syrup levodropropizine syrup
6mg/ml,
60ml and 120ml glass or
plastic bottle
Osoth Inter
Laboratories Co. Ltd.,
600/9 Moo 11,
Sukhaphiban 8 Road,
Nong Kham, Si Racha,
Chonburi 20230
Thailand R05DB27 15286/107.02.2017
04.02.2021PoM
Eurodrug
Laboratories S.A.,
Assesteenweg 117/7,
B-1740 Ternat,
Belgium
736 Brucor 20mg simvastatin tablets film-coated20mg,
in blister (60/3x20/)
Brupharmexport sprl,
Rue de la Grotte, 14,
B-1020, Brussels -
batch releaser
(Farmalabor Produtos
Farmaceuticos, S.A,
Zona Industrial de
Condeixa-a-Nova,
Sebal Grande 3150-
194 Condeixa-a-Nova,
Portugal - bulk
manufacturer,
packager)
Belgium C10AA01 1341714.04.2014
14.04.2019PoM
Brupharmexport sprl,
Rue de la Grotte, 14,
B-1020, Brussels,
Belgium
737 Brucor 40mg simvastatin tablets film-coated40mg,
in blister (60/6x10/)
Brupharmexport sprl,
Rue de la Grotte, 14,
B-1020, Brussels -
batch releaser
(Farmalabor Produtos
Farmaceuticos, S.A,
Zona Industrial de
Condeixa-a-Nova,
Sebal Grande 3150-
194 Condeixa-a-Nova,
Portugal - bulk
manufacturer,
packager)
Belgium C10AA01 1341814.04.2014
14.04.2019PoM
Brupharmexport sprl,
Rue de la Grotte, 14,
B-1020, Brussels,
Belgium
738 Brufen ibuprofen syrup
20mg/ml,
100ml plastic container
and 5ml measuring
syringe
Abbott Laboratories
GmbH, Freundallee
9A, 30173 Hannover
Germany M01AE01 13922/113.05.2015
29.10.2019OTC
Abbott Laboratories
GmbH, Freundallee
9A, 30173 Hannover,
Germany
154
739 Brulium domperidone suspension oral
1mg/ml,
100ml, 200ml glass bottle,
measuring spoon and
measuring dropper
Brupharmexport sprl,
Rue de la Grotte, 14,
B-1020, Brussels -
batch releaser
(Farmalabor Produtos
Farmaceuticos, S.A,
Zona Industrial de
Condeixa-a-Nova,
Sebal Grande 3150-
194 Condeixa-a-Nova,
Portugal - bulk
manufacturer,
packager)
Belgium A03FA03 1341614.04.2014
14.04.2019PoM
Brupharmexport sprl,
Rue de la Grotte, 14,
B-1020, Brussels,
Belgium
740Brulium
Linguatabsdomperidone tablets orodispersible
10mg,
in blister (20/2x10/)
Brupharmexport sprl,
Rue de la Grotte, 14,
B-1020, Brussels
Belgium A03FA03 1446922.04.2015
22.04.2020PoM
Brupharmexport sprl,
Rue de la Grotte, 14,
B-1020, Brussels,
Belgium
741Brumipril 10mg
capsulesramipril capsules
10mg,
in blister (56/8x7)
Brupharmexport
SPRL, Rue de la
Grotte, 14, Brussels,
1020 - batch releaser
(dosage form
manufacturer,
packager -
Laboratoires Sterop
NV, Scheutlaan 46-
50, Anderlecht, B-
1070, Belgium)
Belgium C09AA05 1283217.09.2013
17.09.2018PoM
Brupharmexport
SPRL, Rue de la
Grotte, 14, Brussels,
1020, Belgium
742Brumipril 2,5mg
capsulesramipril capsules
2,5mg,
in blister (56/8x7)
Brupharmexport
SPRL, Rue de la
Grotte, 14, Brussels,
1020 - batch releaser
(dosage form
manufacturer,
packager -
Laboratoires Sterop
NV, Scheutlaan 46-
50, Anderlecht, B-
1070, Belgium)
Belgium C09AA05 1283017.09.2013
17.09.2018PoM
Brupharmexport
SPRL, Rue de la
Grotte, 14, Brussels,
1020, Belgium
155
743Brumipril 5mg
capsulesramipril capsules
5mg,
in blister (56/8x7)
Brupharmexport
SPRL, 14 Rue De la
Grotte, B-1020
Brussels - batch
releaser (doage form
manufacturer,
packager - Farmalabor
Produtos
Farmaceuticos, S.A,
Zona Industrial de
Condeixa-a-Nova,
Sebal Grande 3150-
194 Condeixa-a-Nova,
Portugal)
Belgium C09AA05 1283117.09.2013
17.09.2018PoM
Brupharmexport
SPRL, Rue de la
Grotte, 14, B-1020,
Brussels, Belgium
744 Brusartan 100mglosartan (losartan
potassium)tablets film-coated
100mg,
in blister (56/8x7/)
Brupharmexport sprl,
14 Rue De la Grotte,
B-1020 Brussels -
batch releaser
(Farmalabor Produtos
Farmaceuticos, S.A,
Zona Industrial de
Condeixa-a-Nova,
Sebal Grande 3150-
194 Condeixa-a-Nova,
Portugal - bulk
manufacturer,
packager)
Belgium C09CA01 1350230.05.2014
30.05.2019PoM
Brupharmexport sprl,
14 Rue De la Grotte,
B-1020 Brussels,
Belgium
745 Brusartan 50mglosartan (losartan
potassium)tablets film-coated
50mg,
in blister (28/4x7/,
56/8x7/)
Brupharmexport sprl,
14 Rue De la Grotte,
B-1020 Brussels -
batch releaser
(Farmalabor Produtos
Farmaceuticos, S.A,
Zona Industrial de
Condeixa-a-Nova,
Sebal Grande 3150-
194 Condeixa-a-Nova,
Portugal - bulk
manufacturer,
packager)
Belgium C09CA01 1350130.05.2014
30.05.2019PoM
Brupharmexport sprl,
14 Rue De la Grotte,
B-1020 Brussels,
Belgium
156
746 Brusartan HTZ
losartan (losartan
potassium),
hydrochlorothia-
zide
tablets film-coated
50mg+12,5mg,
in blister (28/4x7/,
56/8x7/)
Brupharmexport
SPRL, 14 Rue De la
Grotte, B-1020
Brussels - batch
releaser (doage form
manufacturer,
packager - Farmalabor
Produtos
Farmaceuticos, S.A,
Zona Industrial de
Condeixa-a-Nova,
Sebal Grande 3150-
194 Condeixa-a-Nova,
Portugal)
Belgium C09DA01 1313510.01.2014
10.01.2019PoM
Brupharmexport
SPRL, Rue de la
Grotte, 14, B-1020,
Brussels, Belgium
747 Brustin
betahistine
(betahistine
dihydrochloride)
tablets16mg,
in blister (60/6x10/)
Brupharmexport sprl,
Rue de la Grotte, 14,
B-1020, Brussels -
batch releaser
(Farmalabor Produtos
Farmaceuticos, S.A,
Zona Industrial de
Condeixa-a-Nova,
Sebal Grande 3150-
194 Condeixa-a-Nova,
Portugal - bulk
manufacturer,
packager)
Belgium N07CA01 1361527.06.2014
27.06.2019PoM
Brupharmexport sprl,
Rue de la Grotte, 14,
B-1020, Brussels,
Belgium
748 Bruzepam diazepam solution for injection
10mg/2ml,
2ml ampoules
(100/10x10/)
Brupharmexport
SPRL, Rue de la
Grotte, 14, Brussels,
1020
Belgium N05BA01 1311124.12.2013
24.12.2018PoM/UC
Brupharmexport
SPRL, Rue de la
Grotte, 14, Brussels,
1020, Belgium
749
Bupivacaine
hydrochloride
0,5%
bupivacaine
(bupivacaine
hydrochloride)
solution for injection5mg/ml,
10ml ampoules (10)
Warsaw
Pharmaceutical
Works "Polfa" S.A.,
Karolkowa 22/24 str.,
01-207 Warsaw
Poland N01BB01 1663625.04.2017
25.04.2022PoM
Warsaw
Pharmaceutical
Works "Polfa" S.A.,
Karolkowa 22/24 str.,
01-207 Warsaw,
Poland
157
750Bupivacaine WPW
Spinal 0,5% Heavy
bupivacaine
(bupivacaine
hydrochloride)
solution for injection5mg/ml,
4ml ampoules (5)
Warsaw
Pharmaceutical
Works "Polfa" S.A.,
Karolkowa 22/24 str.,
01-207 Warsaw
Poland N01BB01 1456109.06.2015
09.06.2020PoM
Warsaw
Pharmaceutical
Works "Polfa" S.A.,
Karolkowa 22/24 str.,
01-207 Warsaw,
Poland
751 Buscopanhyoscine
butylbromidetablets coated
10mg,
in blister (20/1x20/)
Delpharm Reims, 10
rue Colonel
Charbonneaux,
Reims, 51100
France A03BB01 1699305.09.2017
05.09.2022PoM
Boehringer Ingelheim
International GmbH,
Binger Strasse 173,
55216 Ingelheim am
Rhein, Germany
752 Butadion phenylbutazone ointment50mg/g,
20g aluminium tube
Gedeon Richter PLC,
Gyomroi ut 19-21,
1103 Budapest
Hungary M02AA01 1531604.02.2016
04.02.2021OTC
Gedeon Richter PLC,
Gyomroi ut 19-21,
1103 Budapest,
Hungary
753 Butasal-100butafosfan, vitamin
B12solution for injection
100mg/ml+ 50mcg/ml,
100ml glass bottle
Interchemie werken
De Adelaar Eesti AS,
Vanapere tee 14,
Viimsi, Harju county-
bulk manufacturer,
primary packager,
batch releaser,
Interchemie werken
De Adelaar B.V.,
Metaalweg 8, 5804
CG Venray, the
Netherlands-
secondary packager
Estonia
QA13A;
veterinary
drug
1458109.06.2015
09.06.2020PoM
Interchemie werken
De Adelaar B.V.,
Metaalweg 8, 5804
CG Venray, the
Netherlands
754 Caduet
amlodipine
(amlodipine
besilate),
atorvastatin
(atorvastatin
calcium)
tablets film-coated5mg+10mg,
in blister (30/3x10/)
Pfizer Manufacturing
Deutschland GmbH,
Betriebsstatte
Freiburg,
Mooswaldallee 1,
79090 Frieburg
Germany C10AA55 1526922.01.2016
22.01.2021PoM
Pfizer H.C.P.
Corporation, 235,
East 42nd street New
York 10017, USA
158
755 Caduet
amlodipine
(amlodipine
besilate),
atorvastatin
(atorvastatin
calcium)
tablets film-coated10mg+10mg,
in blister (30/3x10/)
Pfizer Manufacturing
Deutschland GmbH,
Betriebsstatte
Freiburg,
Mooswaldallee 1,
79090 Frieburg
Germany C10AA55 1527022.01.2016
22.01.2021PoM
Pfizer H.C.P.
Corporation, 235,
East 42nd street New
York 10017, USA
756Caffeine Citrate
Injection, USPcaffeine
solution for i/v
injection
20mg/ml,
3ml glass vial (1)
Cadila Healthcare
Ltd., Sarkhej-Bavla
National Highway No
8A, Moraiya, Tal.
Sanand, Dist.
Ahmedabad 382 210
India N06BC01 1453120.05.2015
20.05.2020PoM
Sagent
Pharmaceuticals Inc.,
1901 N. Roselle Road,
Suite 700,
Schaumburg, Illinois
60195, USA
757Caffeine-benzoate
sodium
caffeine (caffeine-
benzoate sodium)tablets
100mg,
strip (6, 10), blister (10,
10/1x10/, 20/2x10/)
Tatchempharmpre-
paraty JSC, 420091
Kazan, str.
Belomorskaya 262
Russia N06BC01 14027/108.06.2017
26.11.2019PoM
Tatchempharmpre-
paraty JSC, 420091
Kazan, str.
Belomorskaya 260,
Russia
758 Caffetin
paracetamol,
propyphenazone,
caffeine, codeine
(codeine phosphate)
tablets
250mg+210mg+
50mg+7,1mg,
in strip (6/1x6/, 12/2x6/,
10/1x10/)
Alkaloid AD Skopje,
Blvd. Aleksandar
Makedonski 12, 1000
Skopje
Macedonia N02BE51 1638410.02.2017
10.02.2022PoM/UC
Alkaloid AD Skopje,
Blvd. Aleksandar
Makedonski 12, 1000
Skopje, Macedonia
759 Caffetin Cold
paracetamol,
pseudoephedrine
(pseudoephedrine
hydrochloride),
dextromethorphan
(dextromethorphan
hydrobromide),
ascorbic acid
tablets film-coated
500mg+30mg+
15mg+60mg,
in blister (10)
Alkaloid-INT d.o.o.,
Slandrova ulica 4,
1231 Ljubljana-
Crnuce - batch
releaser (dosage form
manufacturer,
packager - Alkaloid
AD-Skopje, bul.
Aleksandar
Makedonski 12, 1000,
Skopje, Macedonia )
Slovenia N02BE51 1253122.05.2013
22.05.2018OTC
Alkaloid Ltd,
Motopista 2, 2
"Ricardo Vakarini"
str., fl. 3, ap. 10 Sofia
1404, Bulgaria
159
760 Caffetin COLD
paracetamol,
pseudoephedrine
(pseudoephedrine
hydrochloride),
dextromethorphan
(dextromethorphan
hydrobromide),
ascorbic acid
tablets film-coated
500mg+30mg+
15mg+60mg,
in blister (10/1x10/)
Alkaloid AD Skopje,
Blvd. Aleksandar
Makedonski 12, 1000
Skopje
Macedonia N02BE51 1721808.12.2017
08.12.2022OTC
Alkaloid AD Skopje,
Blvd. Aleksandar
Makedonski 12, 1000
Skopje, Macedonia
761 Caffetin COLDmax
paracetamol,
phenylephrine
(phenylephrine
hydrochloride)
powder for oral
solution
1000mg+12,2mg, 5,15g
sachets (10)
Alkaloid-INT d.o.o.,
Slandrova ulica 4,
1231 Ljubljana-
Crnuce - batch
releaser (dosage form
manufacturer,
packager - Hermes
Pharma Ges.m.b.H,
Allgau 36 9400
Wolfsberg, Austria)
Slovenia N02BE51 1258811.06.2013
11.06.2018OTC
Alkaloid-INT d.o.o.,
Slandrova ulica 4,
1231 Ljubljana-
Crnuce, Slovenia
762 Caffetin COLDmax
paracetamol,
phenylephrine
hydrochloride
powder for oral
solution
1000mg+12,2mg, sachets
(10)
Alkaloid AD Skopje,
Blvd. Aleksandar
Makedonski 12, 1000
Skopje-batch releaser,
Hermes Pharma
Ges.m.b.H., Allgau
36, 9400 Wolfsberg,
Austria - bulk
manufacturer,
packager
Macedonia N02BE51 1721608.12.2017
08.12.2022OTC
Alkaloid AD Skopje,
Blvd. Aleksandar
Makedonski 12, 1000
Skopje, Macedonia
763 Caffetin Ladyibuprofen
(ibuprofen lysinate)tablets film-coated
200mg,
in blister (10/1x10/)
Alkaloid AD Skopje,
Blvd. Aleksandar
Makedonski 12, 1000
Skopje
Macedonia M01AE01 1645806.03.2017
06.03.2022OTC
Alkaloid AD Skopje,
Blvd. Aleksandar
Makedonski 12, 1000
Skopje
160
764 Caffetin SC
paracetamol,
propyphenazone,
caffeine
tablets
250mg+210mg+ 50mg,
in strip
(6/1x6/, 12/2x6/)
Alkaloid-INT d.o.o.,
Slandrova ulica 4,
1231 Ljubljana-
Crnuce - batch
releaser (dosage form
manufacturer,
packager - Alkaloid
AD-Skopje, bul.
Aleksandar
Makedonski 12, 1000,
Skopje, Macedonia )
Slovenia N02BE51 1253022.05.2013
22.05.2018OTC
Alkaloid Ltd,
Motopista 2, 2
"Ricardo Vakarini"
str., fl. 3, ap. 10 Sofia
1404, Bulgaria
765 Caffetin SC
paracetamol,
propyphenazone,
caffeine
tablets250mg+210mg+ 50mg,
in strip (6/1x6/, 12/2x6/)
Alkaloid AD Skopje,
Blvd. Aleksandar
Makedonski 12, 1000
Skopje
Macedonia N02BE51 1721708.12.2017
08.12.2022OTC
Alkaloid AD Skopje,
Blvd. Aleksandar
Makedonski 12, 1000
Skopje, Macedonia
766 Cafin caffeine tablets chewable55mg,
in blister (10)
IBN AL-Haytham
Pharma Industries
Co., P.O.Box 16232,
Al Mansoura-Aleppo
Syria N06BC01 1402826.11.2014
26.11.2019PoM
IBN AL-Haytham
Pharma Industries
Co., P.O.Box 16232,
Al Mansoura-Aleppo,
Syria
767 Calcemin
calcium, vitamin
D3, zinc(zinc
oxide), copper
(copper oxide),
manganese
(manganese sulfate),
boron (sodium
borate)
tablets coated
250mg+50IU+
2mg+0,5mg+
0,5mg+50mcg,
in plastic container (30,
60, 120)
Contract Pharmacal
Corporation, 135
Adams avenue,
Hauppauge, New
York 11788-batch
releaser, packager,
Contract Pharmacal
Corporation, 150
&160 Commerce
Drive Hauppauge,
New York 11788,
USA -bulk
manufacturer
USA A12AX 1501402.12.2015
02.12.2020OTC
Bayer Consumer Care
AG, Peter Merian-
Strasse 84, 4052 Basel,
Switzerland
161
768 Calcemin Advance
calcium, vitamin
D3, magnesium,
zinc, copper,
manganese, boron
tablets film-coated
500mg+200IU+
40mg+7,5mg+
1mg+1,8mg+ 250mcg,
in plastic container (30,
60, 120)
Contract Pharmacal
Corporation, 135
Adams avenue,
Hauppauge, New
York 11788-batch
releaser, packager,
Contract Pharmacal
Corporation, 160
Commerce Drive
Hauppauge, New
York 11788, USA-
bulk manufacturer
USA A12AX 1703126.09.2017
26.09.2022OTC
Bayer Consumer Care
AG, Peter Merian-
Strasse 84, 4052 Basel,
Switzerland
769 Calcemin Silver
calcium, vitamin
D3, magnesium,
zinc, copper,
manganese, boron
tablets film-coated
500mg+400IU+
40mg+7,5mg+
1mg+1,8mg+ 250mcg,
in plastic container (30,
60)
Contract Pharmacal
Corporation, 135
Adams avenue,
Hauppauge, New
York 11788-batch
releaser, packager,
Contract Pharmacal
Corporation, 160
Commerce Drive
Hauppauge, New
York 11788, USA-
bulk manufacturer for
Bayer Consumer Care
AG, Peter Merian-
Strasse 84, 4052 Basel,
Switzerland
USA A12AX 1684310.07.2017
10.07.2022OTC
770 CalciD-Denk
calcium (calcium
carbonate),
cholecalciferol
tablets effervescent1000mg+22mcg(880IU),
in plastic container (20)
Losan Pharma GmbH,
Otto- Hahn-Strasse
13,15, 79395
Neuenburg
Germany A12AX 1683110.07.2017
10.07.2022PoM
Denk Pharma GmbH
& Co. KG,
Prinzregentenstr. 79,
81675 Muenchen,
Germany
771 Calcium chloride calcium chloride solution for injection100mg/ml,
5ml ampoules (10)
Yerevan Chemical-
Pharmaceutical firm
OJSC, Yerevan,
Ajaryan street, 2 Line,
No6
Republic of
ArmeniaB05XA07 16684
31.05.2017
31.05.2022PoM
Yerevan Chemical-
Pharmaceutical firm
OJSC, Yerevan,
Ajaryan street, 2
Line, No6, Republic
of Armenia
162
772Calcium chloride-
Darnitsa
calcium chloride
(calcium chloride
hexahydrate)
solution for injection
100mg/ml,
10ml ampoules,
in blister (10/2x5/)
Darnitsa
Pharmaceutical Firm
PrJSC, 02093, Kiev,
Borisopolskaya Str.,13
Ukraine B05XA07 1235109.04.2013
09.04.2018PoM
Darnitsa
Pharmaceutical Firm
PrJSC, 02093, Kiev,
Borisopolskaya
Str.,13, Ukraine
773Calcium chloride-
Darnitsa
calcium chloride
(calcium chloride
hexahydrate)
solution for injection
100mg/ml,
5ml ampoules,
in blister (10)(10/2x5/)
Darnitsa
Pharmaceutical Firm
PrJSC, 02093, Kiev,
Borisopolskaya Str.,13
Ukraine B05XA07 1235209.04.2013
09.04.2018PoM
Darnitsa
Pharmaceutical Firm
PrJSC, 02093, Kiev,
Borisopolskaya
Str.,13, Ukraine
774Calcium D3
Nycomed
calcium (calcium
carbonate),
cholecalciferol
tablets chewable
with orange flavour
500mg+5mcg (200IU),
in plastic container (20,
50, 100)
Takeda AS,
Drammensveien 852
No-1383 Asker
Norway A12AX 15983/2 30.08.2017
15.09.2021OTC
Takeda AS,
Drammensveien 852
No-1383 Asker,
Norway
775Calcium D3
Nycomed Forte
calcium (calcium
carbonate),
cholecalciferol
tablets chewable
with lemon flavour
500mg+10mcg (400IU),
in plastic container (30,
60, 120)
Takeda AS,
Drammensveien 852
No-1383 Asker
Norway A12AX 15984/2 30.08.2017
15.09.2021OTC
Takeda AS,
Drammensveien 852
No-1383 Asker,
Norway
776 Calcium gluconate
calcium gluconate
(calcium gluconate
monohydrate)
tablets
500mg,
in blister (10/1x10/,
20/2x10/), in strip (10)
Pharmstandard-
Leksredstva JSC,
305022, Kursk,
Agregatnaya 2nd str.,
1a/18
Russia A12AA03 12880/121.11.2013
25.09.2018OTC
Pharmstandard-
Leksredstva JSC,
305022, Kursk,
Agregatnaya 2nd str.,
1a/18, Russia
777Calcium gluconate
stabilizedcalcium gluconate solution for injection
100mg/ml,
5ml ampoules (5, 10)
PJSC "Farmak",
04080, Kiev, Frunze
str. 74
Ukraine A12AA03 1236519.04.2013
19.04.2018PoM
PJSC "Farmak",
04080, Kiev, Frunze
str. 63, Ukraine
778Calcium gluconate
stabilizedcalcium gluconate solution for injection
100mg/ml,
10ml ampoules (5, 10)
PJSC "Farmak",
04080, Kiev, Frunze
str. 74
Ukraine A12AA03 1236619.04.2013
19.04.2018PoM
PJSC "Farmak",
04080, Kiev, Frunze
str. 63, Ukraine
163
779Calcium gluconate
Tatpharmcalcium gluconate tablets
500mg,
strip (10/1x10/), blisters
(10/1x10/, 20/2x10/)
Tatchempharmpre-
paraty JSC, 420091
Kazan, str.
Belomorskaya 260
Russia A12AA03 14295/108.02.2017
19.03.2020OTC
Tatchempharmpre-
paraty JSC, 420091
Kazan, str.
Belomorskaya 260,
Russia
780
Calcium gluconate-
Darnitsa
(stabilized)
calcium gluconate solution for injection
100mg/ml,
5ml ampoules,
in blister (10, 10/2x5/)
Darnitsa
Pharmaceutical Firm
PrJSC, 02093, Kiev,
Borisopolskaya Str.,13
Ukraine A12AA03 1235909.04.2013
09.04.2018PoM
Darnitsa
Pharmaceutical Firm
PrJSC, 02093, Kiev,
Borisopolskaya
Str.,13, Ukraine
781
Calcium gluconate-
Darnitsa
(stabilized)
calcium gluconate solution for injection
100mg/ml,
10ml ampoules,
in blister (10/2x5/)
Darnitsa
Pharmaceutical Firm
PrJSC, 02093, Kiev,
Borisopolskaya Str.,13
Ukraine A12AA03 1236009.04.2013
09.04.2018PoM
Darnitsa
Pharmaceutical Firm
PrJSC, 02093, Kiev,
Borisopolskaya
Str.,13, Ukraine
782Calcium+Vitamin
D3 Vitrum
calcium, vitamin
D3tablets film-coated
500mg+200IU,
in plastic container (30,
60, 100)
Unipharm, Inc., 200
Hick str., Westbury,
New York 11590
USA A12AX 1317910.01.2014
10.01.2019OTC
Unipharm, Inc., 350,
5th avenue, suite
6701, New York,
10118, USA
783
Calciumfolinate
"EBEWE"
100mg/10ml
calcium folinatesolution for
injection/infusion
10mg/ml,
10ml ampoules (5)
EBEWE Pharma Ges.
m.b.H. Nfg. KG,
Mondseestrasse 11, At-
4866 Unterach am
Attersee
Austria V03AF03 1223607.03.2013
07.03.2018PoM
EBEWE Pharma Ges.
m.b.H. Nfg. KG,
Mondseestrasse 11, At-
4866 Unterach am
Attersee, Austria
784
Calciumfolinate
"EBEWE"
30mg/3ml
calcium folinatesolution for
injection/infusion
10mg/ml,
3ml ampoules (5)
EBEWE Pharma Ges.
m.b.H. Nfg. KG,
Mondseestrasse 11, At-
4866 Unterach am
Attersee
Austria V03AF03 1223507.03.2013
07.03.2018PoM
EBEWE Pharma Ges.
m.b.H. Nfg. KG,
Mondseestrasse 11, At-
4866 Unterach am
Attersee, Austria
164
785 Calciveyxol 38
calcium gluconate
(calcium gluconate
monohydrate),
magnesium
chloride
(magnesium
chloride
hexahydrate), boric
acid
solution for infusion
380mg/ml+
60mg/ml+50mg/ml,
500ml plastic bottle (1,
12)
Veyx-Pharma GmbH,
Sohreweg 6, 34639
Schwarzenborn-
batch releaser,
secondary packager,
Bela-Pharma GmbH
& Co.KG, Lohner Str.
19, Vechta,
Niedersachsen, 49377,
Germany- bulk
manufacturer,
primary packager
Germany
QA12;
veterinary
drug
1651217.03.2017
17.03.2022PoM
Veyx-Pharma
GmbH, Sohreweg 6,
34639
Schwarzenborn,
Germany
786 Calendulatinctura calendulae
D1suppositories rectal
57mg,
in blister (10/2x5/)
Moscow
Pharmaceutical
Works CJSC, 125239,
Pharmaceutical
driveway 1, Moscow
Russiahomeopathic
drug12201
07.03.2013
07.03.2018OTC
Moscow
Pharmaceutical
Works CJSC, 125239,
Pharmaceutical
driveway 1, Moscow,
RUSSIA
787 Calendulatinctura calendulae
D1ointment
100mg/g,
30g aluminium tube
Moscow
Pharmaceutical
Works CJSC, 125239,
Pharmaceutical
driveway 1, Moscow
Russiahomeopathic
drug12202
07.03.2013
07.03.2018OTC
Moscow
Pharmaceutical
Works CJSC, 125239,
Pharmaceutical
driveway 1, Moscow,
RUSSIA
788 Calgel
lidocaine (lidocaine
hydrochloride),
cetylpyridinum
(cetylpyridinum
chloride)
gel3,3mg/g+1mg/g, 10g
aluminium tube
GlaxoSmithKline
Pharmaceuticals S.A.,
189 Grunwaldzka
street, 60-322 Poznan
Poland N01BB52 1274723.07.2013
23.07.2018PoM
Glaxo Wellcome UK
Limited, Stockley
Park, Middlesex, UB
11 1BT, UK
789 Calumid bicalutamide tablets film-coated50mg,
in blister (30/2x15/)
Gedeon Richter OJSC,
Gyomroi ut 19-21,
1103 Budapest
Hungary L02BB03 1231122.03.2013
22.03.2018PoM
Gedeon Richter
OJSC, Gyomroi ut 19-
21, 1103 Budapest,
Hungary
165
790 Calypsolketamine (ketamine
hydrochloride)solution for injection
500mg/10ml,
10ml glass vials (5)
Gedeon Richter PLC,
Gyomroi ut 19-21,
1103 Budapest
Hungary N01AX03 1408716.12.2014
16.12.2019PoM/UC
Gedeon Richter PLC,
Gyomroi ut 19-21,
1103 Budapest,
Hungary
791 Camphor oil camphorsolution for external
use
100mg/ml,
30ml glass bottle
ESCO-PHARM LLC
(Nor-Norq V block,
Mikoyan 13, Yerevan
0079)
Republic of
ArmeniaM01AX10 12991
28.10.2013
28.10.2018OTC
ESCO-PHARM LLC
(Nor-Norq V block,
Mikoyan 13, Yerevan
0079, Republic of
Armenia)
792 Campto
irinotecan
(irinotecan
hydrochloride
trihydrate)
concentrate for
solution for i/v
infusion
20mg/ml vial,
2ml plastic vial
Pfizer (Perth) Pty
Limited, 15 Brodie
Hall Drive
Technology Park
Bentley WA 6102
Australia L01XX19 1333617.03.2014
17.03.2019PoM
Pfizer H.C.P.
Corporation, 235,
East 42nd Street, New
York 10017, USA
793 Campto
irinotecan
(irinotecan
hydrochloride
trihydrate)
concentrate for
solution for i/v
infusion
20mg/ml vial,
5ml plastic vial
Pfizer (Perth) Pty
Limited, 15 Brodie
Hall Drive
Technology Park
Bentley WA 6102
Australia L01XX19 1333717.03.2014
17.03.2019PoM
Pfizer H.C.P.
Corporation, 235,
East 42nd Street, New
York 10017, USA
794 Campto
irinotecan
(irinotecan
hydrochloride
trihydrate)
concentrate for
solution for i/v
infusion
20mg/ml vial,
15ml plastic vial
Pfizer (Perth) Pty
Limited, 15 Brodie
Hall Drive
Technology Park
Bentley WA 6103
Australia L01XX19 1333817.03.2014
17.03.2019PoM
Pfizer H.C.P.
Corporation, 235,
East 42nd Street, New
York 10017, USA
795 Candida candida albicans tablets6C,
in blister (72/3x24/)
A Nelson and Co
Limited, 5 Endeavour
Way, Wimbledon,
London SW19 8UH
UK
J02AX
homeopathic
drug
1351430.05.2014
30.05.2019PoM
A Nelson and Co
Limited, 5 Endeavour
Way, Wimbledon,
London SW19 8UH,
UK
166
796 Canephron N
centauri herba,
levistici radix,
rosmarini folia
tablets coated18mg+18mg+ 18mg,
in blister (60/3x20/)
Bionorica SE,
Kerschensteinerstr. 11-
15, 92318 Neumarkt
GermanyG04BX;
herbal drug14576
09.06.2015
09.06.2020PoM
Bionorica SE,
Kerschensteinerstr.
11-15, 92318
Neumarkt, Germany
797 Canephron N
centauri herba,
levistici radix,
rosmarini folia
drops oral
6mg/g+6mg/g+ 6mg/g,
100ml glass container-
dropper
Bionorica SE,
Kerschensteinerstr. 11-
15, 92318 Neumarkt
GermanyG04BX;
herbal drug14577
09.06.2015
09.06.2020PoM
Bionorica SE,
Kerschensteinerstr.
11-15, 92318
Neumarkt, Germany
798 Caniverm tablets
fenbendazole,
praziquantel,
pyrantel (pyrantel
embonate)
tablets
150mg+50mg+ 144mg,
in blister (6/1x6/), sachets
(100)
Bioveta a.s.,
Komenskeho 212,
68323 Ivanovice na
Hane
Czech Republic
QP52AC30;
veterinary
drug
1530204.02.2016
04.02.2021PoM
Bioveta a.s.,
Komenskeho 212,
68323 Ivanovice na
Hane, Czech
Republic
799
Capecitabine
Accord 150mg film-
coated tablets
capecitabine tablets film-coated150mg,
in blister (60/1x60/)
Accord Healthcare
Limited, Sage House,319
Pinner Road, North
Harrow, Middlesex, HA1
4HF- batch releaser, Intas
Pharmaceuticals Limited,
Plot No 457 & 458 &
191/218 P, Sarkhej-Bavla
Highway, Matoda Village,
Sanand, District-
Ahmedabad, 382 210,
Gujarat, India- bulk
manufacturer, Accord
Healthcare Limited, Unit C
& D, Homefield Business
Park, Homefield Road,
Haverhill, CB9 8QP, UK-
primary and secondary
packager
UK L01BC06 1512911.12.2015
11.12.2020PoM
Accord Healthcare
Limited, Sage
House,319 Pinner
Road, North Harrow,
Middlesex, HA1 4HF,
UK
167
800
Capecitabine
Accord 150mg film-
coated tablets
capecitabine tablets film-coated150mg,
in blister (60/1x60/)
Accord Healthcare
Limited, Sage House,319
Pinner Road, North
Harrow, Middlesex, HA1
4HF- batch releaser, Intas
Pharmaceuticals Limited,
Plot No 5/6/7, Pharmez,
Near Village Matoda,
Sarkhej-Bavla Highway,
NH-8A, Matoda, District-
Ahmedabad, 382 210,
Gujarat, India- bulk
manufacturer, Accord
Healthcare Limited, Unit C
& D, Homefield Business
Park, Homefield Road,
Haverhill, CB9 8QP, UK-
primary and secondary
packager
UK L01BC06 1513011.12.2015
11.12.2020PoM
Accord Healthcare
Limited, Sage
House,319 Pinner
Road, North Harrow,
Middlesex, HA1 4HF,
UK
801
Capecitabine
Accord 150mg film-
coated tablets
capecitabine tablets film-coated150mg,
in blister (60/1x60/)
Pharmacare Premium
Limited, HHF 003, Hal
Far Industrial Estate,
Birzebbugia BBg 3000-
batch releaser, Intas
Pharmaceuticals
Limited, Plot No 457 &
458 &191/218P, Sarkhej-
Bavla Highway, Matoda
Village, Sanand, District-
Ahmedabad, 382 210,
Gujarat- bulk
manufacturer, Accord
Healthcare Limited,
Unit C & D, Homefield
Business Park,
Homefield Road,
Haverhill, CB9 8QP-
primary and secondary
packager
Malta L01BC06 1513211.12.2015
11.12.2020PoM
Accord Healthcare
Limited, Sage
House,319 Pinner
Road, North Harrow,
Middlesex, HA1 4HF,
UK
168
802
Capecitabine
Accord 150mg film-
coated tablets
capecitabine tablets film-coated150mg,
in blister (60/1x60/)
Pharmacare Premium
Limited, HHF 003, Hal
Far Industrial Estate,
Birzebbugia BBg 3000-
batch releaser, Intas
Pharmaceuticals
Limited, Plot No 5/6/7,
Pharmez, Near Village
Matoda, Sarkhej-Bavla
Highway, NH-8A,
Matoda, District-
Ahmedabad, 382 210,
Gujarat- bulk
manufacturer, Accord
Healthcare Limited,
Unit C & D, Homefield
Business Park,
Homefield Road,
Haverhill, CB9 8QP-
primary and secondary
packager
Malta L01BC06 1513411.12.2015
11.12.2020PoM
Accord Healthcare
Limited, Sage
House,319 Pinner
Road, North Harrow,
Middlesex, HA1 4HF,
UK
803
Capecitabine
Accord 300mg film-
coated tablets
capecitabine tablets film-coated300mg,
in blister (60/1x60/)
Accord Healthcare
Limited, Sage House,319
Pinner Road, North
Harrow, Middlesex, HA1
4HF- batch releaser, Intas
Pharmaceuticals Limited,
Plot No 5/6/7, Pharmez,
Near Village Matoda,
Sarkhej-Bavla Highway,
NH-8A, Matoda, District-
Ahmedabad, 382 210,
Gujarat, India- bulk
manufacturer, Accord
Healthcare Limited, Unit C
& D, Homefield Business
Park, Homefield Road,
Haverhill, CB9 8QP, UK-
primary and secondary
packager
UK L01BC06 1512811.12.2015
11.12.2020PoM
Accord Healthcare
Limited, Sage
House,319 Pinner
Road, North Harrow,
Middlesex, HA1 4HF,
UK
169
804
Capecitabine
Accord 300mg film-
coated tablets
capecitabine tablets film-coated300mg, (60/1x60/), in
blister
Accord Healthcare
Limited, Sage House,319
Pinner Road, North
Harrow, Middlesex, HA1
4HF- batch releaser, Intas
Pharmaceuticals Limited,
Plot No 457 & 458 &
191/218 P, Sarkhej-Bavla
Highway, Matoda Village,
Sanand, District-
Ahmedabad, 382 210,
Gujarat, India- bulk
manufacturer, Accord
Healthcare Limited, Unit C
& D, Homefield Business
Park, Homefield Road,
Haverhill, CB9 8QP, UK-
primary and secondary
packager
UK L01BC06 1513111.12.2015
11.12.2020PoM
Accord Healthcare
Limited, Sage
House,319 Pinner
Road, North Harrow,
Middlesex, HA1 4HF,
UK
805
Capecitabine
Accord 300mg film-
coated tablets
capecitabine tablets film-coated300mg,
in blister (60/1x60/)
Pharmacare Premium
Limited, HHF 003, Hal
Far Industrial Estate,
Birzebbugia BBg 3000-
batch releaser, Intas
Pharmaceuticals
Limited, Plot No 457 &
458 &191/218P, Sarkhej-
Bavla Highway, Matoda
Village, Sanand, District-
Ahmedabad, 382 210,
Gujarat- bulk
manufacturer, Accord
Healthcare Limited,
Unit C & D, Homefield
Business Park,
Homefield Road,
Haverhill, CB9 8QP-
primary and secondary
packager
Malta L01BC06 1513611.12.2015
11.12.2020PoM
Accord Healthcare
Limited, Sage
House,319 Pinner
Road, North Harrow,
Middlesex, HA1 4HF,
UK
170
806
Capecitabine
Accord 300mg film-
coated tablets
capecitabine tablets film-coated300mg,
in blister (60/1x60/)
Pharmacare Premium
Limited, HHF 003, Hal
Far Industrial Estate,
Birzebbugia BBg 3000-
batch releaser, Intas
Pharmaceuticals
Limited, Plot No 5/6/7,
Pharmez, Near Village
Matoda, Sarkhej-Bavla
Highway, NH-8A,
Matoda, District-
Ahmedabad, 382 210,
Gujarat- bulk
manufacturer, Accord
Healthcare Limited,
Unit C & D, Homefield
Business Park,
Homefield Road,
Haverhill, CB9 8QP-
primary and secondary
packager
Malta L01BC06 1513711.12.2015
11.12.2020PoM
Accord Healthcare
Limited, Sage
House,319 Pinner
Road, North Harrow,
Middlesex, HA1 4HF,
UK
807
Capecitabine
Accord 500mg film-
coated tablets
capecitabine tablets film-coated500mg,
in blister (120/1x120/)
Accord Healthcare
Limited, Sage House,319
Pinner Road, North
Harrow, Middlesex, HA1
4HF- batch releaser, Intas
Pharmaceuticals Limited,
Plot No 5/6/7, Pharmez,
Near Village Matoda,
Sarkhej-Bavla Highway,
NH-8A, Matoda, District-
Ahmedabad, 382 210,
Gujarat, India- bulk
manufacturer, Accord
Healthcare Limited, Unit C
& D, Homefield Business
Park, Homefield Road,
Haverhill, CB9 8QP, UK-
primary and secondary
packager
UK L01BC06 1512611.12.2015
11.12.2020PoM
Accord Healthcare
Limited, Sage
House,319 Pinner
Road, North Harrow,
Middlesex, HA1 4HF,
UK
171
808
Capecitabine
Accord 500mg film-
coated tablets
capecitabine tablets film-coated500mg,
in blister (120/1x120/)
Accord Healthcare
Limited, Sage House,319
Pinner Road, North
Harrow, Middlesex, HA1
4HF- batch releaser, Intas
Pharmaceuticals Limited,
Plot No 457 & 458 &
191/218 P, Sarkhej-Bavla
Highway, Matoda Village,
Sanand, District-
Ahmedabad, 382 210,
Gujarat, India- bulk
manufacturer, Accord
Healthcare Limited, Unit C
& D, Homefield Business
Park, Homefield Road,
Haverhill, CB9 8QP, UK-
primary and secondary
packager
UK L01BC06 1512711.12.2015
11.12.2020PoM
Accord Healthcare
Limited, Sage
House,319 Pinner
Road, North Harrow,
Middlesex, HA1 4HF,
UK
809
Capecitabine
Accord 500mg film-
coated tablets
capecitabine tablets film-coated500mg,
in blister (120/1x120/)
Pharmacare Premium
Limited, HHF 003, Hal
Far Industrial Estate,
Birzebbugia BBg 3000-
batch releaser, Intas
Pharmaceuticals
Limited, Plot No 5/6/7,
Pharmez, Near Village
Matoda, Sarkhej-Bavla
Highway, NH-8A,
Matoda, District-
Ahmedabad, 382 210,
Gujarat- bulk
manufacturer, Accord
Healthcare Limited,
Unit C & D, Homefield
Business Park,
Homefield Road,
Haverhill, CB9 8QP-
primary and secondary
packager
Malta L01BC06 1513311.12.2015
11.12.2020PoM
Accord Healthcare
Limited, Sage
House,319 Pinner
Road, North Harrow,
Middlesex, HA1 4HF,
UK
172
810
Capecitabine
Accord 500mg film-
coated tablets
capecitabine tablets film-coated500mg,
in blister (120/1x120/)
Pharmacare Premium
Limited, HHF 003, Hal
Far Industrial Estate,
Birzebbugia BBg 3000-
batch releaser, Intas
Pharmaceuticals
Limited, Plot No 457 &
458 &191/218P, Sarkhej-
Bavla Highway, Matoda
Village, Sanand, District-
Ahmedabad, 382 210,
Gujarat- bulk
manufacturer, Accord
Healthcare Limited,
Unit C & D, Homefield
Business Park,
Homefield Road,
Haverhill, CB9 8QP-
primary and secondary
packager
Malta L01BC06 1513511.12.2015
11.12.2020PoM
Accord Healthcare
Limited, Sage
House,319 Pinner
Road, North Harrow,
Middlesex, HA1 4HF,
UK
811 Capotril captopril tablets25mg,
in blister (24)
Arpimed LLC, Kotayk
Marz, Abovyan, 2nd
Micro-District, 19
Building
Republic of
ArmeniaC09AA01 13125
10.01.2014
10.01.2019PoM
Arpimed LLC,
Kotayk Marz,
Abovyan, 2nd Micro-
District, 19 Building,
Republic of Armenia
812 Capotril 50mg captopril tablets50mg,
in blister (24/2x12/)
Arpimed LLC, Kotayk
Marz, Abovyan, 2nd
Micro-District, 19
Building
Republic of
ArmeniaC09AA01 15868
03.08.2016
03.08.2021PoM
Arpimed LLC,
Kotayk Marz,
Abovyan, 2nd Micro-
District, 19 Building,
Republic of Armenia
173
813 Caproferr
ferric chloride (III),
epsilon-
aminocaproic acid
solution947mg/ml+ 24mg/ml,
20ml, 30ml plastic vial
The Scientific
Technological Center
of Organic and
Pharmaceutical
Chemistry, A.L.
Mndjoyan Institute of
Fine Organic
Chemistry NAS RA ,
Erevan, Azatutyun
avenue 26
Republic of
ArmeniaB02BC 13317
04.03.2014
04.03.2019OTC
The Scientific
Technological Center
of Organic and
Pharmaceutical
Chemistry, A.L.
Mndjoyan Institute of
Fine Organic
Chemistry NAS RA ,
Erevan, Azatutyun
avenue 26, Republic
of Armenia
814 Capsicam
dimethyl sulfoxide,
camphor racemic,
turpentine oil,
benzyl nicotinate,
nonivamide
ointment for
external use
50mg/g+30mg/g+
30mg/g+20mg/g+ 2mg/g,
30g, 50g aluminium tube
and applicator
Grindex JSC, Krustpils
street 53, LV-1057,
Riga
Latvia M02AX 1384818.09.2014
18.09.2019OTC
Grindex JSC,
Krustpils street 53,
LV-1057, Riga, Latvia
815 Capsicam
dimethyl sulfoxide,
camphor racemic,
turpentine oil,
benzyl nicotinate,
nonivamide
ointment for
external use
50mg/g+30mg/g+
30mg/g+20mg/g+ 2mg/g,
30g and 50g aluminium
tube and applicator
Tallinn
Pharmaceutical Plant
JSC, Tondi 33, 11316
Tallinn
Estonia M02AX92 1568108.06.2016
08.06.2021OTC
Grindeks JSC,
Krustpils street 53,
LV-1057, Riga, Latvia
816 Captopril captopril tablets25mg,
in blister (40/4x10/)
Open Joint Stock
Company , 64/27,
Chapayev str., Borisov
222120, Minsk oblast
Belarus C09AA01 1283617.09.2013
17.09.2018PoM
Open Joint Stock
Company , 64/27,
Chapayev str.,
Borisov 222120,
Minsk oblast, Belarus
817 Captopril captopril tablets25mg,
in blister (20/2x10/)
Kievmedpreparat
PJSC, 01032, Kiev,
Saksaganskogo street,
139
Ukraine C09AA01 1402226.11.2014
26.11.2019PoM
Kievmedpreparat
PJSC, 01032, Kiev,
Saksaganskogo street,
139, Ukraine
174
818Captopril 12.5mg
Tabletscaptopril tablets
12,5mg,
in blister (56/4x14/)
Accord Healthcare
Limited, Sage House,319
Pinner Road, North
Harrow, Middlesex, HA1
4HF- batch releaser, Intas
Pharmaceuticals Limited,
Plot No 5/6/7, Pharmez,
Near Village Matoda,
Sarkhej-Bavla Highway,
NH-8A, Matoda, District-
Ahmedabad, 382 210,
Gujarat, India- bulk
manufacturer, Accord
Healthcare Limited, Unit C
& D, Homefield Business
Park, Homefield Road,
Haverhill, CB9 8QP, UK-
primary and secondary
packager
UK C09AA01 1514717.12.2015
17.12.2020PoM
Accord Healthcare
Limited, Sage
House,319 Pinner
Road, North Harrow,
Middlesex, HA1 4HF,
UK
819Captopril 12.5mg
Tabletscaptopril tablets
12,5mg,
in blister (56/4x14/)
Accord Healthcare
Limited, Sage House,319
Pinner Road, North
Harrow, Middlesex, HA1
4HF- batch releaser, Intas
Pharmaceuticals Limited,
Plot No 457 & 458 &
191/218 P, Sarkhej-Bavla
Highway, Matoda Village,
Sanand, District-
Ahmedabad, 382 210,
Gujarat, India- bulk
manufacturer, Accord
Healthcare Limited, Unit C
& D, Homefield Business
Park, Homefield Road,
Haverhill, CB9 8QP, UK-
primary and secondary
packager
UK C09AA01 1514817.12.2015
17.12.2020PoM
Accord Healthcare
Limited, Sage
House,319 Pinner
Road, North Harrow,
Middlesex, HA1 4HF,
UK
175
820Captopril 25mg
Tabletscaptopril tablets
25mg,
in blister (56/4x14/)
Accord Healthcare
Limited, Sage House,319
Pinner Road, North
Harrow, Middlesex, HA1
4HF- batch releaser, Intas
Pharmaceuticals Limited,
Plot No 457 & 458 &
191/218 P, Sarkhej-Bavla
Highway, Matoda Village,
Sanand, District-
Ahmedabad, 382 210,
Gujarat, India- bulk
manufacturer, Accord
Healthcare Limited, Unit C
& D, Homefield Business
Park, Homefield Road,
Haverhill, CB9 8QP, UK-
primary and secondary
packager
UK C09AA01 1514617.12.2015
17.12.2020PoM
Accord Healthcare
Limited, Sage
House,319 Pinner
Road, North Harrow,
Middlesex, HA1 4HF,
UK
821Captopril 25mg
Tabletscaptopril tablets
25mg,
in blister (56/4x14/)
Accord Healthcare
Limited, Sage House,319
Pinner Road, North
Harrow, Middlesex, HA1
4HF- batch releaser, Intas
Pharmaceuticals Limited,
Plot No 5/6/7, Pharmez,
Near Village Matoda,
Sarkhej-Bavla Highway,
NH-8A, Matoda, District-
Ahmedabad, 382 210,
Gujarat, India- bulk
manufacturer, Accord
Healthcare Limited, Unit C
& D, Homefield Business
Park, Homefield Road,
Haverhill, CB9 8QP, UK-
primary and secondary
packager
UK C09AA01 1514917.12.2015
17.12.2020PoM
Accord Healthcare
Limited, Sage
House,319 Pinner
Road, North Harrow,
Middlesex, HA1 4HF,
UK
176
822Captopril 50mg
Tabletscaptopril tablets
50mg,
in blister (56/4x14/)
Accord Healthcare
Limited, Sage House,319
Pinner Road, North
Harrow, Middlesex, HA1
4HF- batch releaser, Intas
Pharmaceuticals Limited,
Plot No 457 & 458 &
191/218 P, Sarkhej-Bavla
Highway, Matoda Village,
Sanand, District-
Ahmedabad, 382 210,
Gujarat, India- bulk
manufacturer, Accord
Healthcare Limited, Unit C
& D, Homefield Business
Park, Homefield Road,
Haverhill, CB9 8QP, UK-
primary and secondary
packager
UK C09AA01 1514517.12.2015
17.12.2020PoM
Accord Healthcare
Limited, Sage
House,319 Pinner
Road, North Harrow,
Middlesex, HA1 4HF,
UK
823Captopril 50mg
Tabletscaptopril tablets
50mg,
in blister (56/4x14/)
Accord Healthcare
Limited, Sage House,319
Pinner Road, North
Harrow, Middlesex, HA1
4HF- batch releaser, Intas
Pharmaceuticals Limited,
Plot No 5/6/7, Pharmez,
Near Village Matoda,
Sarkhej-Bavla Highway,
NH-8A, Matoda, District-
Ahmedabad, 382 210,
Gujarat, India- bulk
manufacturer, Accord
Healthcare Limited, Unit C
& D, Homefield Business
Park, Homefield Road,
Haverhill, CB9 8QP, UK-
primary and secondary
packager
UK C09AA01 1515017.12.2015
17.12.2020PoM
Accord Healthcare
Limited, Sage
House,319 Pinner
Road, North Harrow,
Middlesex, HA1 4HF,
UK
824 Captopril Denk 25 captopril tablets
25mg,
in blister (20/2x10/,
100/10x10)
Denk Pharma GmbH
& Co. KG, Gollstr. 1,
84529 Tittmoning
Germany C09AA01 12731/120.05.2014
23.07.2018PoM
Denk Pharma GmbH
& Co. KG,
Prinzregentenstr. 79,
81675 Munchen,
Germany
177
825Captopril+HCT
Denk 50/25
captopril,
hydrochloro-
thiazide
tablets
50mg+25mg,
in blister (30/3x10/,
100/10x10/)
Denk Pharma GmbH
& Co. KG, Gollstr. 1,
84529 Tittmoning
Germany C09BA01 12249/120.05.2014
07.03.2018PoM
Denk Pharma GmbH
& Co. KG,
Prinzregentenstr. 79,
81675 Munchen,
Germany
826 Carbalex 200mg carbamazepine tablets
200mg,
in blister (50/5x10/,
100/10x10/)
G.L. Pharma GmbH,
Schlossplatz 1, 8502
Lannach -batch
releaser, G.L. Pharma
GmbH,
Industriestrasse 1,
8502 Lannach,
Austria -bulk
manufacturer,
packager
Austria N03AF01 1575404.07.2016
04.07.2021PoM
VALEANT LLC,
Shabolovka st. 31,
building 5, 115162,
Moscow, Russia
827Carbalex 300mg
retardcarbamazepine
tablets prolonged-
release
300mg,
in blister (50/5x10/,
100/10x10/)
G.L. Pharma GmbH,
Schlossplatz 1, 8502
Lannach -batch
releaser, G.L. Pharma
GmbH,
Industriestrasse 1,
8502 Lannach,
Austria -bulk
manufacturer,
packager
Austria N03AF01 1575504.07.2016
04.07.2021PoM
VALEANT LLC,
Shabolovka st. 31,
building 5, 115162,
Moscow, Russia
828Carbalex 600mg
retardcarbamazepine
tablets prolonged-
release
600mg,
in blister (50/5x10/,
100/10x10/)
G.L. Pharma GmbH,
Schlossplatz 1, 8502
Lannach -batch
releaser, G.L. Pharma
GmbH,
Industriestrasse 1,
8502 Lannach,
Austria -bulk
manufacturer,
packager
Austria N03AF01 1575604.07.2016
04.07.2021PoM
VALEANT LLC,
Shabolovka st. 31,
building 5, 115162,
Moscow, Russia
178
829 Carbamazepine carbamazepine tablets200mg,
in blister (50/5x10/)
Marbiopharm JSC,
424006,The Republic
of Mari El,Yoshkar-
Ola, st. Karl Marx 121
Russia N03AF01 1346906.05.2014
06.05.2019PoM
Marbiopharm JSC,
424006,The Republic
of Mari El,Yoshkar-
Ola, st. Karl Marx
121, Russia
830 Carbamazepine carbamazepine tablets200mg,
in blister (50/5x10/)
Arpimed LLC, Kotayk
Marz, Abovyan, 2nd
Micro-District, 19
Building
Republic of
ArmeniaN03AF01 13960
28.10.2014
28.10.2019PoM
Arpimed LLC,
Kotayk Marz,
Abovyan, 2nd Micro-
District, 19 Building,
Republic of Armenia
831Carbamazepine-
Zdorovyecarbamazepine tablets
200mg,
in blister (20/1x20/,
20/2x10/)
Pharmaceutical
Company "Zdorovye"
LLC, 61013, Kharkov,
Shevchenko str., 22
Ukraine N03AF01 1674205.06.2017
05.06.2022PoM
Pharmaceutical
Company "Zdorovye"
LLC, 61013, Kharkov,
Shevchenko str., 22,
Ukraine
832Carbidopa and
Levodopa-TEVAcarbidopa, levodopa tablets
25mg+250mg,
in blister (50/5x10/,
100/10x10/)
TEVA
Pharmaceutical
Industries Ltd., 18 Eli
Hurvitz str.,
Industrial Zone, Kfar
Saba 44102
Israel N04BA02 1388506.10.2014
06.10.2019PoM
TEVA
Pharmaceutical
Industries Ltd., 5
Basel str., P.O. Box
3190, 49131 Petach
Tikva, Israel
833 Carbo activatus activated charcoal tablets250mg,
in blister (10), strip (10)
SIC Borshchahivskiy
chemical-
pharmaceutical plant
PJSC 17, Mira St, Kiev
03134
Ukraine A07BA01 1285817.09.2013
17.09.2018OTC
SIC Borshchahivskiy
chemical-
pharmaceutical plant
PJSC 17, Mira St, Kiev
03134, Ukraine
834Carbocisteine 2%
syrup for childrencarbocisteine syrup
100mg/5ml,
120ml bottle
Arpimed LLC, Kotayk
Marz, Abovyan, 2nd
Micro-District, 19
Building
Republic of
ArmeniaR05CB03 13762
14.08.2014
14.08.2019OTC
Arpimed LLC,
Kotayk Marz,
Abovyan, 2nd Micro-
District, 19 Building,
Republic of Armenia
179
835Carbocisteine 5%
syrup for adultscarbocisteine syrup
250mg/5ml,
120ml bottle
Arpimed LLC, Kotayk
Marz, Abovyan, 2nd
Micro-District, 19
Building
Republic of
ArmeniaR05CB03 13761
14.08.2014
14.08.2019OTC
Arpimed LLC,
Kotayk Marz,
Abovyan, 2nd Micro-
District, 19 Building,
Republic of Armenia
836
Carboplatin
10mg/ml
concentrate for
solution for
infusion
carboplatinconcentrate for
solution for infusion
10mg/ml,
45ml glass vial
Accord Healthcare
Limited, Sage House,319
Pinner Road, North
Harrow, Middlesex, HA1
4HF-batch releaser, Intas
Pharmaceuticals Limited,
Plot No 457 & 458 Sarkhej-
Bavla Highway, Matoda
Village, Sanand, District-
Ahmedabad, 382 210,
Gujarat, India-bulk
manufacturer, Accord
Healthcare Limited, Unit C
& D, Homefield Business
Park, Homefield Road,
Haverhill, CB9 8QP, UK-
primary and secondary
packager
UK L01XA02 1443316.04.2015
16.04.2020PoM
Accord Healthcare
Limited, Sage
House,319 Pinner
Road, North Harrow,
Middlesex, HA1 4HF,
UK
837
Carboplatin
10mg/ml
concentrate for
solution for
infusion
carboplatinconcentrate for
solution for infusion
10mg/ml,
15ml glass vial
Accord Healthcare
Limited, Sage House,319
Pinner Road, North
Harrow, Middlesex, HA1
4HF-batch releaser, Intas
Pharmaceuticals Limited,
Plot No 457 & 458 Sarkhej-
Bavla Highway, Matoda
Village, Sanand, District-
Ahmedabad, 382 210,
Gujarat, India-bulk
manufacturer, Accord
Healthcare Limited, Unit C
& D, Homefield Business
Park, Homefield Road,
Haverhill, CB9 8QP, UK-
primary and secondary
packager
UK L01XA02 1443416.04.2015
16.04.2020PoM
Accord Healthcare
Limited, Sage
House,319 Pinner
Road, North Harrow,
Middlesex, HA1 4HF,
UK
180
838
Carboplatin
10mg/ml
concentrate for
solution for
infusion
carboplatinconcentrate for
solution for infusion
10mg/ml,
60ml glass vial
Accord Healthcare
Limited, Sage House,319
Pinner Road, North
Harrow, Middlesex, HA1
4HF-batch releaser, Intas
Pharmaceuticals Limited,
Plot No 457 & 458 Sarkhej-
Bavla Highway, Matoda
Village, Sanand, District-
Ahmedabad, 382 210,
Gujarat, India-bulk
manufacturer, Accord
Healthcare Limited, Unit C
& D, Homefield Business
Park, Homefield Road,
Haverhill, CB9 8QP, UK-
primary and secondary
packager
UK L01XA02 1443516.04.2015
16.04.2020PoM
Accord Healthcare
Limited, Sage
House,319 Pinner
Road, North Harrow,
Middlesex, HA1 4HF,
UK
839
Carboplatin
10mg/ml
concentrate for
solution for
infusion
carboplatinconcentrate for
solution for infusion
10mg/ml,
15ml glass vial
Accord Healthcare
Limited, Sage House,319
Pinner Road, North
Harrow, Middlesex, HA1
4HF -batch releaser, Intas
Pharmaceuticals Limited,
Plot No 5/6/7, Pharmez,
Near Village Matoda,
Sarkhej-Bavla Highway,
NH-8A, Matoda, District-
Ahmedabad, 382 210,
Gujarat, India-bulk
manufacturer, Accord
Healthcare Limited, Unit C
& D, Homefield Business
Park, Homefield Road,
Haverhill, CB9 8QP, UK-
primary and secondary
packager
UK L01XA02 1443616.04.2015
16.04.2020PoM
Accord Healthcare
Limited, Sage
House,319 Pinner
Road, North Harrow,
Middlesex, HA1 4HF,
UK
181
840
Carboplatin
10mg/ml
concentrate for
solution for
infusion
carboplatinconcentrate for
solution for infusion
10mg/ml,
45ml glass vial
Accord Healthcare
Limited, Sage House,319
Pinner Road, North
Harrow, Middlesex, HA1
4HF -batch releaser, Intas
Pharmaceuticals Limited,
Plot No 5/6/7, Pharmez,
Near Village Matoda,
Sarkhej-Bavla Highway,
NH-8A, Matoda, District-
Ahmedabad, 382 210,
Gujarat, India-bulk
manufacturer, Accord
Healthcare Limited, Unit C
& D, Homefield Business
Park, Homefield Road,
Haverhill, CB9 8QP, UK-
primary and secondary
packager
UK L01XA02 1443716.04.2015
16.04.2020PoM
Accord Healthcare
Limited, Sage
House,319 Pinner
Road, North Harrow,
Middlesex, HA1 4HF,
UK
841
Carboplatin
10mg/ml
concentrate for
solution for
infusion
carboplatinconcentrate for
solution for infusion
10mg/ml,
5ml glass vial
Accord Healthcare
Limited, Sage House,319
Pinner Road, North
Harrow, Middlesex, HA1
4HF-batch releaser, Intas
Pharmaceuticals Limited,
Plot No 457 & 458 Sarkhej-
Bavla Highway, Matoda
Village, Sanand, District-
Ahmedabad, 382 210,
Gujarat, India-bulk
manufacturer, Accord
Healthcare Limited, Unit C
& D, Homefield Business
Park, Homefield Road,
Haverhill, CB9 8QP, UK-
primary and secondary
packager
UK L01XA02 1443816.04.2015
16.04.2020PoM
Accord Healthcare
Limited, Sage
House,319 Pinner
Road, North Harrow,
Middlesex, HA1 4HF,
UK
182
842
Carboplatin
10mg/ml
concentrate for
solution for
infusion
carboplatinconcentrate for
solution for infusion
10mg/ml,
60ml glass vial
Accord Healthcare
Limited, Sage House,319
Pinner Road, North
Harrow, Middlesex, HA1
4HF -batch releaser, Intas
Pharmaceuticals Limited,
Plot No 5/6/7, Pharmez,
Near Village Matoda,
Sarkhej-Bavla Highway,
NH-8A, Matoda, District-
Ahmedabad, 382 210,
Gujarat, India-bulk
manufacturer, Accord
Healthcare Limited, Unit C
& D, Homefield Business
Park, Homefield Road,
Haverhill, CB9 8QP, UK-
primary and secondary
packager
UK L01XA02 1443916.04.2015
16.04.2020PoM
Accord Healthcare
Limited, Sage
House,319 Pinner
Road, North Harrow,
Middlesex, HA1 4HF,
UK
843
Carboplatin
10mg/ml
concentrate for
solution for
infusion
carboplatinconcentrate for
solution for infusion
10mg/ml,
5ml glass vial
Accord Healthcare
Limited, Sage House,319
Pinner Road, North
Harrow, Middlesex, HA1
4HF -batch releaser, Intas
Pharmaceuticals Limited,
Plot No 5/6/7, Pharmez,
Near Village Matoda,
Sarkhej-Bavla Highway,
NH-8A, Matoda, District-
Ahmedabad, 382 210,
Gujarat, India-bulk
manufacturer, Accord
Healthcare Limited, Unit C
& D, Homefield Business
Park, Homefield Road,
Haverhill, CB9 8QP, UK-
primary and secondary
packager
UK L01XA02 1444016.04.2015
16.04.2020PoM
Accord Healthcare
Limited, Sage
House,319 Pinner
Road, North Harrow,
Middlesex, HA1 4HF,
UK
844
Carboplatin-
Asteria Inj.
450mg/45ml
carboplatin solution for injection10mg/ml,
45ml glass bottle
Hankook Korus
Pharm Co., Ltd, 78
Daepungsandan-ro,
Daeso-myeon,
Eumseong-gun,
Chungcheongbuk-do
Korea Sourth L01XA02 12654/120.08.2015
04.07.2018PoM
GL Corporation,
Woori Venture
Tower #201, 70,
Seonyu-ro,
Yeongdeungpo-ku,
Seoul, Korea South
183
845
Carboplatin-
Asteria Inj.
450mg/45ml
carboplatinsolution for i/v
injection
10mg/ml,
45ml glass vial
Hankook Korus
Pharm Co., Ltd, 78
Daepungsandan-ro,
Daeso-myeon,
Eumseong-gun,
Chungcheongbuk-do
Korea South L01XA02 1679022.06.2017
22.06.2022PoM
GL Corporation,
Woori Venture
Tower 201, 70,
Seonyu-ro,
YoungDeungPo-Ku,
Seoul, Korea South
846 Carbosin carboplatinconcentrate for
solution for infusion
10mg/ml,
15ml glass vial
Pharmachemie
B.V.,Swensweg 5, NL
2031 GA Haarlem
the Netherlands L01XA02 12291/104.04.2014
22.03.2018PoM
Pharmachemie
B.V.,Swensweg 5, NL
2031 GA Haarlem,
the Netherlands
847 Carbosin carboplatinconcentrate for
solution for infusion
10mg/ml,
45ml glass vial
Pharmachemie
B.V.,Swensweg 5, NL
2031 GA Haarlem
the Netherlands L01XA02 12292/104.04.2014
22.03.2018PoM
Pharmachemie
B.V.,Swensweg 5, NL
2031 GA Haarlem,
the Netherlands
848Cardibru 25mg
tabletscarvedilol tablets
25mg,
in blister (28/4x7/)
Brupharmexport
SPRL, 14 Rue De la
Grotte, B-1020
Brussels - batch
releaser (doage form
manufacturer,
packager - Farmalabor
Produtos
Farmaceuticos, S.A,
Zona Industrial de
Condeixa-a-Nova,
Sebal Grande 3150-
194 Condeixa-a-Nova,
Portugal)
Belgium C07AG02 1283417.09.2013
17.09.2018PoM
Brupharmexport
SPRL, Rue de la
Grotte, 14, B-1020,
Brussels, Belgium
184
849Cardibru 6,25mg
tabletscarvedilol tablets
6,25mg,
in blister (28/4x7/)
Brupharmexport
SPRL, 14 Rue De la
Grotte, B-1020
Brussels - batch
releaser (doage form
manufacturer,
packager - Farmalabor
Produtos
Farmaceuticos, S.A,
Zona Industrial de
Condeixa-a-Nova,
Sebal Grande 3150-
194 Condeixa-a-Nova,
Portugal)
Belgium C07AG02 1283317.09.2013
17.09.2018PoM
Brupharmexport
SPRL, Rue de la
Grotte, 14, B-1020,
Brussels, Belgium
850 Cardilopin
amlodipine
(amlodipine
besilate)
tablets10mg,
in blister (30/3x10/)
Egis Pharmaceuticals
PLC, 1165 Budapest,
Bokenyfoldi st. 118-
120
Hungary C08CA01 1700405.09.2017
05.09.2022PoM
Egis Pharmaceuticals
PLC, 1106 Budapest,
Kereszturi st. 30-38,
Hungary
851 Cardilopin
amlodipine
(amlodipine
besilate)
tablets5mg,
in blister (30/3x10/)
Egis Pharmaceuticals
PLC, 1165 Budapest,
Bokenyfoldi st. 118-
120
Hungary C08CA01 1700505.09.2017
05.09.2022PoM
Egis Pharmaceuticals
PLC, 1106 Budapest,
Kereszturi st. 30-38,
Hungary
852 Cardilopin
amlodipine
(amlodipine
besilate)
tablets2,5mg,
in blister (30/3x10/)
Egis Pharmaceuticals
PLC, 1165 Budapest,
Bokenyfoldi st. 118-
120
Hungary C08CA01 1700605.09.2017
05.09.2022PoM
Egis Pharmaceuticals
PLC, 1106 Budapest,
Kereszturi st. 30-38,
Hungary
853 Cardio-AS acetylsalicylic acid tablets100mg,
in blister (20/2x10/)
NOKI JV LTD Co.,
Nor-Kharberd, Ararat
region
Republic of
ArmeniaB01AC06 15315
04.02.2016
04.02.2021OTC
NOKI JV LTD Co.,
Nor-Kharberd, Ararat
region, Republic of
Armenia
185
854 Cardiolife
acetylsalicylic acid,
magnesium
hydroxide
tablets coated75mg+15,2mg,
in blister (96/4x24/)
Arpimed LLC, Kotayk
Marz, Abovyan, 2nd
Micro-District, 19
Building
Republic of
ArmeniaB01AC30 15179
17.12.2015
17.12.2020OTC
Arpimed LLC,
Kotayk Marz,
Abovyan, 2nd Micro-
District, 19 Building,
Republic of Armenia
855 Cardiomagnyl
acetylsalicylic acid,
magnesium
hydroxide
tablets film-coated
75mg+15.2mg,
in glass container (30,
100)
Takeda GmbH,
Production Site
Oranienburg, Lehnitz
str. 70-98, 16515
Oranienburg
Germany B01AC30 12251/118.08.2015
07.03.2018OTC
Takeda
Pharmaceuticals LLC,
Usatcheva str 2 bld. 1,
Moscow 119048,
Russia
856 Cardiomagnyl
acetylsalicylic acid,
magnesium
hydroxide
tablets film-coated150mg+30,39mg, in glass
container (30, 100)
Takeda GmbH,
Production Site
Oranienburg, Lehnitz
str. 70-98, 16515
Oranienburg
Germany B01AC30 12252/118.08.2015
07.03.2018OTC
Takeda
Pharmaceuticals LLC,
Usatcheva str 2 bld. 1,
Moscow 119048,
Russia
857 Cardionat
meldonium
(meldonuim
dihydrate)
solution for injection
100mg/ml,
5ml ampoules, blisters
(10/2x5/)
Moscow Endocrine
Plant FSUE, 25, bld 1,
bld 2,
Novokhokhlovskaya
st., Moscow, 109052
Russia C01EB 14182/127.01.2017
06.02.2020PoM
Nizhpharm JSC,
603950, Nizhny
Novgorod, GSP-459,
Salganskaya st., 7,
Russia
858 Carditon levocarnitine solution oral100mg/ml,
10ml glass vials (10)
GM Pharmaceuticals
Ltd, PSP group 65,
Qvemo Phonichala
str., Tbilisi-batch
releaser, secondary
packager, Anfarm
Hellas S.A., Sximatari
Viotias, 32009, Greece-
bulk manufacturer,
primary packager
Georgia A16AA01 1474203.08.2015
03.08.2020PoM
GM Pharmaceuticals
Ltd, PSP group 65,
Qvemo Phonichala
str., Tbilisi, Georgia
186
859 Caripazimlatex exsicco
papayaeae
powder lyophilized
for solution for
external use
350PU/ml,
10ml glass vial
LEPL Tbilisi State
Medical University
Iovel Kutateladze
Institute of
Pharmacochemistry,
P.Sarajishvili St. 36,
0159, Tbilisi
GeorgiaG03B;
herbal drug14036/1
22.01.2015
19.12.2019PoM
LEPL Tbilisi State
Medical University
Iovel Kutateladze
Institute of
Pharmacochemistry,
P.Sarajishvili St. 36,
0159, Tbilisi, Georgia
860
Carminativum
Babynos colic
drops
fennel (foeniculi
amari fructus),
coriander (coriandri
fructus), chamomile
(matricariae flos)
drops oral
320mg/g+ 200mg/g+
200mg/g,
30ml glass bottle
Dentinox Company Germany A03AX 1253801.06.2013
01.06.2018OTC
Pharmaceutical
Products Lenk &
Schuppan KG,
Nunsdorfer Ring
1912277, Berlin,
Germany
861Carsil 22,5mg
coated tabletssilymarin tablets coated
22,5mg,
in blister (80/8x10/)
Sopharma JSC, str.
Iliensko shosse 16,
1220 Sofia
BulgariaA05BA03;
herbal drug16728
05.06.2017
05.06.2022OTC
Sopharma JSC, str.
Iliensko shosse 16,
1220 Sofia, Bulgaria
862 Carsil Forte silymarin capsules hard90mg,
in blister (30/5x6/)
Sopharma JSC, str.
Iliensko shosse 16,
1220 Sofia-batch
releaser, Sopharma
JSC, 110, 23rd
Pehoten Shipchenski
Polk Blvd., 6100
Kazanlak, Bulgaria-
bulk manufacturer,
primary and
secondary packager
Bulgaria
A05BA03;
բուսական
ծագման դեղ
1494120.10.2015
20.10.2020PoM
Sopharma JSC, str.
Iliensko shosse 16,
1220 Sofia, Bulgaria
863 Carvedi-Denk 25 carvedilol tablets25mg,
in blister (30/3x10/)
Artesan Pharma
GmbH & Co. KG,
Wendlandstrasse 1,
29439 Luechow
Germany C07AG02 1269623.07.2013
23.07.2018PoM
Denk Pharma GmbH
& Co. KG,
Prinzregentenstr. 79,
81675 Muenchen,
Germany
187
864 Carvedi-Denk 6,25 carvedilol tablets6,25mg,
in blister (30/3x10/)
Artesan Pharma
GmbH & Co. KG,
Wendlandstrasse 1,
29439 Luechow
Germany C07AG02 1269523.07.2013
23.07.2018PoM
Denk Pharma GmbH
& Co. KG,
Prinzregentenstr. 79,
81675 Muenchen,
Germany
865 Carvedigamma carvedilol tablets film-coated
12,5mg,
in blister (30/3x10/,
50/5x10/, 100/10x10/)
Woerwag Pharma
GmbH & Co. KG,
Calwer Str. 7, 71034
Boblingen-batch
releaser, S.C. Magistra
C & C S.R.L., 82A
Aurel Vlaicu Blvd.,
900055 Constanta,
Romania-bulk
manufacturer,
packager
Germany C07AG02 1493920.10.2015
20.10.2020PoM
Woerwag Pharma
GmbH & Co. KG,
Calwer Str. 7, 71034
Boblingen, Germany
866 Carvedigamma carvedilol tablets film-coated
25mg,
in blister (30/3x10/,
50/5x10/, 100/10x10/)
Woerwag Pharma
GmbH & Co. KG,
Calwer Str. 7, 71034
Boblingen-batch
releaser, S.C. Magistra
C & C S.R.L., 82A
Aurel Vlaicu Blvd.,
900055 Constanta,
Romania-bulk
manufacturer,
packager
Germany C07AG02 1494420.10.2015
20.10.2020PoM
Woerwag Pharma
GmbH & Co. KG,
Calwer Str. 7, 71034
Boblingen, Germany
867 Carvedilol carvedilol tablets6,25mg,
in blister (40)
Arpimed LLC, Kotayk
Marz, Abovyan, 2nd
Micro-District, 19
Building
Republic of
ArmeniaC07AG02 12165
01.02.2013
01.02.2018PoM
Arpimed LLC,
Kotayk Marz,
Abovyan, 2nd Micro-
District, 19 Building,
Republic of Armenia
188
868 Carvedilol carvedilol tablets25mg,
in blister (40)
Arpimed LLC, Kotayk
Marz, Abovyan, 2nd
Micro-District, 19
Building
Republic of
ArmeniaC07AG02 12166
01.02.2013
01.02.2018PoM
Arpimed LLC,
Kotayk Marz,
Abovyan, 2nd Micro-
District, 19 Building,
Republic of Armenia
869 Carvedilol carvedilol tablets12,5mg,
in blister (40/1x40/)
Arpimed LLC, Kotayk
Marz, Abovyan, 2nd
Micro-District, 19
Building
Republic of
ArmeniaC07AG02 15694
08.06.2016
08.06.2021PoM
Arpimed LLC,
Kotayk Marz,
Abovyan, 2nd Micro-
District, 19 Building,
Republic of Armenia
870 Carvedilol carvedilol tablets25mg,
in blister (40/1x40/)
Arpimed LLC, Kotayk
Marz, Abovyan, 2nd
Micro-District, 19
Building
Republic of
ArmeniaC07AG02 17286
26.12.2017
26.12.2021PoM
Arpimed LLC,
Kotayk Marz,
Abovyan, 2nd Micro-
District, 19 Building,
Republic of Armenia
871 Carvedilol carvedilol tablets6,25mg,
in blister (40/1x40/)
Arpimed LLC, Kotayk
Marz, Abovyan, 2nd
Micro-District, 19
Building
Republic of
ArmeniaC07AG02 17287
26.12.2017
26.12.2021PoM
Arpimed LLC,
Kotayk Marz,
Abovyan, 2nd Micro-
District, 19 Building,
Republic of Armenia
872Carvedilol Sandoz
12,5mgcarvedilol tablets
12,5mg,
in blister (30/3x10/)
Salutas Pharma
GmbH, Otto-von-
Guericke-Alle-1,
39179 Barleben
Germany C07AG02 1447330.04.2015
30.04.2020PoM
Sandoz
Pharmaceuticals d.d.,
Verovskova Str. 57,
1000 Ljubljana,
Slovenia
873Carvedilol Sandoz
25mgcarvedilol tablets
25mg,
in blister (30/3x10/)
Salutas Pharma
GmbH, Otto-von-
Guericke-Alle-1,
39179 Barleben
Germany C07AG02 1447430.04.2015
30.04.2020PoM
Sandoz
Pharmaceuticals d.d.,
Verovskova Str. 57,
1000 Ljubljana,
Slovenia
189
874Carvedilol Sandoz
6,25mgcarvedilol tablets
6,25mg,
in blister (30/3x10/)
Salutas Pharma
GmbH, Otto-von-
Guericke-Alle-1,
39179 Barleben
Germany C07AG02 1447230.04.2015
30.04.2020PoM
Sandoz
Pharmaceuticals d.d.,
Verovskova Str. 57,
1000 Ljubljana,
Slovenia
875 Carvedilol-Mic carvedilol capsules6,25mg,
in blister (30/3x10/)
Minskintercaps UE,
220075-Minsk, 26
Inzhenernaya St,
P.B.113
Belarus C07AG02 1304025.11.2013
25.11.2018PoM
Minskintercaps UE,
220075-Minsk, 26
Inzhenernaya St,
P.B.112, Belarus
876 Carvedilol-Mic carvedilol capsules12,5mg,
in blister (30/3x10/)
Minskintercaps UE,
220075-Minsk, 26
Inzhenernaya St,
P.B.114
Belarus C07AG02 1304125.11.2013
25.11.2018PoM
Minskintercaps UE,
220075-Minsk, 26
Inzhenernaya St,
P.B.112, Belarus
877 Carvedilol-Mic carvedilol capsules25mg,
in blister (30/3x10/)
Minskintercaps UE,
220075-Minsk, 26
Inzhenernaya St,
P.B.112
Belarus C07AG02 1304225.11.2013
25.11.2018PoM
Minskintercaps UE,
220075-Minsk, 26
Inzhenernaya St,
P.B.112, Belarus
878 Carvilex 12,5mg carvedilol tablets12,5mg,
in blister (30/3x10/)
Balkanpharma-
Dupnitsa AD,
(ACTAVIS GROUP),
str."Samokovsko
Shosse" N3, Dupnitsa
2600, Bulgaria
Bulgaria C07AG02 1699005.09.2017
05.09.2022PoM
Balkanpharma-
Dupnitsa AD,
(ACTAVIS GROUP),
str."Samokovsko
Shosse" N3, Dupnitsa
2600, Bulgaria,
Bulgaria
879 Carvilex 25mg carvedilol tablets25mg,
in blister (30/3x10/)
Balkanpharma-
Dupnitsa AD,
(ACTAVIS GROUP),
str."Samokovsko
Shosse" N3, Dupnitsa
2600, Bulgaria
Bulgaria C07AG02 1698805.09.2017
05.09.2022PoM
Balkanpharma-
Dupnitsa AD,
(ACTAVIS GROUP),
str."Samokovsko
Shosse" N3, Dupnitsa
2600, Bulgaria,
Bulgaria
190
880 Carvilex 6,25mg carvedilol tablets6,25mg,
in blister (30/3x10/)
Balkanpharma-
Dupnitsa AD,
(ACTAVIS GROUP),
str."Samokovsko
Shosse" N3, Dupnitsa
2600, Bulgaria
Bulgaria C07AG02 1698905.09.2017
05.09.2022PoM
Balkanpharma-
Dupnitsa AD,
(ACTAVIS GROUP),
str."Samokovsko
Shosse" N3, Dupnitsa
2600, Bulgaria,
Bulgaria
881 Catafast
diclofenac
(diclofenac
potassium)
powder for oral
solution
50mg,
sachets (3, 9, 21)
Mipharm S.p.A., VIA
Bernardo Quaranta,
12, 20141 Milano (MI)
Italy M01AB05 1332110.03.2014
10.03.2019PoM
Novartis Pharma AG,
Lichstrasse 35, 4056
Basel, Switzerland
882 Cavinton vinpocetine solution for injection
5mg/ml,
2ml ampoules, in plastic
tray (10/2x5/)
Gedeon Richter PLC,
Gyomroi ut 19-21,
1103 Budapest
Hungary N06BX18 1511415.12.2015
15.12.2020PoM
Gedeon Richter PLC,
Gyomroi ut 19-21,
1103 Budapest,
Hungary
883 Cavinton vinpocetine solution for injection
5mg/ml,
5ml ampoules in plastic
tray (10/2x5/)
Gedeon Richter PLC,
Gyomroi ut 19-21,
1103 Budapest
Hungary N06BX18 1511515.12.2015
15.12.2020PoM
Gedeon Richter PLC,
Gyomroi ut 19-21,
1103 Budapest,
Hungary
884 Cavinton vinpocetine tablets5mg,
in blister (50/2x25/)
Gedeon Richter PLC,
Gyomroi ut 19-21,
1103 Budapest
Hungary N06BX18 1511715.12.2015
15.12.2020PoM
Gedeon Richter PLC,
Gyomroi ut 19-21,
1103 Budapest,
Hungary
885 Cavinton Forte vinpocetine tablets
10mg,
in blister (30/2x15/,
90/6x15/)
Gedeon Richter PLC,
Gyomroi ut 19-21,
1103 Budapest
Hungary N06BX18 1511615.12.2015
15.12.2020PoM
Gedeon Richter PLC,
Gyomroi ut 19-21,
1103 Budapest,
Hungary
191
886 Cedax ceftibuten capsules hard400mg,
sachets (5/5x1/)
Merck Sharp &
Dohme Corp.13900
North West 57th
Court, Miami Lakes
FL 33014
USA J01DD14 13342/128.04.2014
17.03.2019PoM
Schering-Plough
Central East AG,
Weystrasse 20, P.O.
Box CH-6000
Lucerne 6,
Switzerland
887 Cedax ceftibutenpowder for oral
suspension
36mg/ml,
30ml glass bottle and
measuring cup
Merck Sharp &
Dohme Corp.13900
North West 57th
Court, Miami Lakes
FL 33014
USA J01DD14 1349730.05.2014
30.05.2019PoM
Schering-Plough
Central East AG,
Weystrasse 20, CH-
6000 Lucerne 6,
Switzerland
888 Cefalexincefalexin (cefalexin
monohydrate)
granules for oral
suspension
250mg/5ml,
100ml glass bottle and
measuring spoon
Hemofarm A.D.
26300, Vrsac,
Beogradskii put bb-
batch releaser,
Hemomont D.O.O.,
Montenegro 81000,
Podgorica, 8 marta
55a, Montenegro-
bulk manufacturer,
packager
Serbia J01DB01 1557312.05.2016
12.05.2021PoM
Hemofarm A.D.,
26300, Vrsac,
Beogradskii put bb,
Serbia
889 Cefalexincefalexin (cefalexin
monohydrate)capsules
500mg,
in blister (16/2x8/)
Hemofarm A.D.
26300, Vrsac,
Beogradskii put bb-
batch releaser,
Hemomont D.O.O.,
Montenegro 81000,
Podgorica, 8 marta
55a, Montenegro-
bulk manufacturer,
packager
Serbia J01DB01 1566208.06.2016
08.06.2021PoM
Hemofarm A.D.,
26300, Vrsac,
Beogradskii put bb,
Serbia
192
890 Cefamezincefazolin (cefazolin
sodium)
powder for solution
for injection
1000mg,
glass vial (1)
KRKA d.d., Novo
mesto, Smarjeska
cesta 6, 8501 Novo
Mesto-batch releaser,
Labesfal-Laboratorios
Almiro, S.A, Santiago
de Besteiros, 3465-
157, Portugal-bulk
manufacturer,
packager
Slovenia J01DB04 1619708.12.2016
08.12.2021PoM
KRKA d.d., Novo
mesto, Smarjeska
cesta 6, 8501 Novo
Mesto, Slovenia
891 Cefazim-100cefixime (cefixime
trihydrate)tablets film-coated
100mg,
in blister (30/3x10/)
Zim Laboratories Ltd.,
B-21/22, MIDC Area,
Kalmeshwar-441 501,
Dist. Nagpur (M.S.)
India J01DD08 1476703.08.2015
03.08.2020PoM
Zim Laboratories
Ltd., Ground Floor,
Sadoday Gyan,
Nelson Square,
Chhindwara Road,
Nagpur-440 013,
India
892 Cefazim-200cefixime (cefixime
trihydrate)tablets film-coated
200mg,
in blister (30/3x10/)
Zim Laboratories Ltd.,
B-21/22, MIDC Area,
Kalmeshwar-441 501,
Dist. Nagpur (M.S.)
India J01DD08 1476603.08.2015
03.08.2020PoM
Zim Laboratories
Ltd., Ground Floor,
Sadoday Gyan,
Nelson Square,
Chhindwara Road,
Nagpur-440 013,
India
893 Cefazolincefazolin (cefazolin
sodium)
powder for solution
for i/v and i/m
injection
1000mg,
10ml glass vials (50)
Biosintez OJSC,
Druzhby st. 4,
440033, Penza
Russia J01DB04 1385918.09.2014
18.09.2019PoM
Biosintez OJSC,
Druzhby st. 4,
440033, Penza, Russia
894 Cefazolin cefazolinpowder for solution
for injection
500mg,
glass vials (10)
Kievmedpreparat
PJSC, 01032, Kiev,
Saksaganskogo street,
139
Ukraine J01DB04 1596215.09.2016
15.09.2021PoM
Kievmedpreparat
PJSC, 01032, Kiev,
Saksaganskogo street,
139, Ukraine
193
895 Cefazolin cefazolinpowder for solution
for injection
1000mg,
glass vials (10)
Kievmedpreparat
PJSC, 01032, Kiev,
Saksaganskogo street,
139
Ukraine J01DB04 1596315.09.2016
15.09.2021PoM
Kievmedpreparat
PJSC, 01032, Kiev,
Saksaganskogo street,
139, Ukraine
896 Cefazolincefazolin (cefazolin
sodium)
powder for solution
for i/m and i/v
injection
1000mg,
glass vial (1, 5, 10, 50)
"Biohimik " PJSC,
Republic of Mordovia,
430030, Saransk,
Vasenko str., 15A
Russia J01DB04 1685010.07.2017
10.07.2022PoM
"PROMOMED RUS "
LLC, 101000,
Moscow, Arkhangelsk
pereulok,1, build.1,
Russia
897 Cefazolin cefazolin (cefazolin
sodium)
powder for solution
for injection
1000mg,
in glass vials
(1, 10, 50, 270)
Open joint stock
company "Borisovskiy
zavod medicinskikh
preparatov", 64/3,ul.
Chapaeva, Borisov
222518, Minsk region
Belarus J01DB04 1689208.08.2017
08.08.2022PoM
Open joint stock
company "Borisovskiy
zavod medicinskikh
preparatov" 64, ul.
Chapaeva, Borisov
222518, Minsk
region, Belarus
898Cefazolin-Asteria
Inj. 0,5g
cefazolin (cefazolin
sodium)
powder for solution
for i/m and i/v
injection
500mg,
vials (10)
Hankook Korus
Pharm Co., Ltd, 30,
Gangjeo-ro, Jecheon-
si, Chungcheongbuk-
do Seoul, South Korea
Korea Sourth J01DB04 13488/106.07.2015
15.05.2019PoM
GL Corporation,
Woori Venture
Tower #201, 70,
Seonyu-ro,
Yeongdeungpo-ku,
899Cefazolin-Asteria
Inj. 1g
cefazolin (cefazolin
sodium)
powder for solution
for i/m and i/v
injection
1000mg,
vials (10)
Hankook Korus
Pharm Co., Ltd, 30,
Gangjeo-ro, Jecheon-
si, Chungcheongbuk-
do
Korea Sourth J01DB04 13489/106.07.2015
15.05.2019PoM
GL Corporation,
Woori Venture
Tower #201, 70,
Seonyu-ro,
Yeongdeungpo-ku,
Seoul, South Korea
900 Cefazolin-Belmedcefazolin (cefazolin
sodium)
powder for solution
for i/m and i/v
injection
500mg,
glass vial (1, 20)
Belmedpreparaty
RUE, 220007, Minsk,
Fabritsius St., 30
Belarus J01DB04 14809/121.12.2016
04.09.2020PoM
Belmedpreparaty
RUE, 220007, Minsk,
Fabritsius St., 30,
Belarus
194
901 Cefazolin-Belmedcefazolin (cefazolin
sodium)
powder for solution
for i/m and i/v
injection
1000mg,
glass vial (1, 20)
Belmedpreparaty
RUE, 220007, Minsk,
Fabritsius St., 30
Belarus J01DB04 14810/121.12.2016
04.09.2020PoM
Belmedpreparaty
RUE, 220007, Minsk,
Fabritsius St., 30,
Belarus
902 Cefecon D paracetamol suppositories rectal250mg,
(10/2x5/)
Nizhpharm JSC,
603950, Nizhny
Novgorod,
Salganskaya st., 7
Russia N02BE01 1670023.05.2017
23.05.2022OTC
Nizhpharm JSC,
603950, Nizhny
Novgorod,
Salganskaya st., 7,
Russia
903 Cefecon D paracetamol suppositories rectal100mg,
(10/2x5/)
Nizhpharm JSC,
603950, Nizhny
Novgorod,
Salganskaya st., 7
Russia N02BE01 1670123.05.2017
23.05.2022OTC
Nizhpharm JSC,
603950, Nizhny
Novgorod,
Salganskaya st., 7,
Russia
904 Cefecon D paracetamol suppositories rectal50mg,
(10/2x5/)
Nizhpharm JSC,
603950, Nizhny
Novgorod,
Salganskaya st., 7
Russia N02BE01 1670223.05.2017
23.05.2022OTC
Nizhpharm JSC,
603950, Nizhny
Novgorod,
Salganskaya st., 7,
Russia
905 Cefepimcefepime (cefepime
hydrochloride)
powder for solution
for injection
1000mg,
glass vial (1, 10), glass vial
(dividella) (10/1x10/)
Open Joint Stock
Company , 64/27,
Chapayev str., Borisov
222120, Minsk oblast
Belarus J01DE01 1285117.09.2013
17.09.2018PoM
Open Joint Stock
Company , 64/27,
Chapayev str.,
Borisov 222120,
Minsk oblast, Belarus
906 Cefepime cefepimepowder for solution
for injection
1000mg,
glass vial (1, 10), glass
vial dividella (10)
Open joint stock
company "Borisovskiy
zavod medicinskikh
preparatov", 64/3, ul.
Chapaeva,Borisov,
Minsk region
Belarus J01DE01 1621108.12.2016
08.12.2021PoM
Open joint stock
company "Borisovskiy
zavod medicinskikh
preparatov" 64,ul.
Chapaeva, Borisov
222518, Minsk
region, Belarus
195
907Cefepime-Asteria
Inj. 1g
cefepime (cefepime
hydrochloride)
powder for solution
for injection
1000mg,
glass vial (1, 10)
Hankook Korus
Pharm Co., Ltd, 78
Daepungsandan-ro,
Daeso-myeon,
Eumseong-gun,
Chungcheongbuk-do
Korea South J01DE01 1612610.11.2016
10.11.2021PoM
GL Corporation,
Woori Venture
Tower 201, 70,
Seonyu-ro,
Yeongdeungpo-ku,
Seoul, Korea South
908 Cefichewcefixime (cefixime
trihydrate)tablets chewable
200mg,
in blister (10/1x10/)
SRS Pharmaceuticals
Pvt. Ltd., Plot No.11
& 12 Kumar
Industrial Estate, Gat
No. 1251-1261,
Alandi-Markal Road,
Markal, Pune 412 105
India J01DD08 1421720.02.2015
20.02.2020PoM
SRS Pharmaceuticals
Pvt. Ltd., 602, 6th
Floor, Marathon Max
Bldg. No 2, Mulund
Goreagon Link Road
L.B.S. Marg, Mulund,
Mumbai,400 080,
India
909 Cefichewcefixime (cefixime
trihydrate)tablets chewable
400mg,
in blister (10/1x10/)
SRS Pharmaceuticals
Pvt. Ltd., Plot No.11
& 12 Kumar
Industrial Estate, Gat
No. 1251-1261,
Alandi-Markal Road,
Markal, Pune 412 105
India J01DD08 1421820.02.2015
20.02.2020PoM
SRS Pharmaceuticals
Pvt. Ltd., 602, 6th
Floor, Marathon Max
Bldg. No 2, Mulund
Goreagon Link Road
L.B.S. Marg, Mulund,
Mumbai,400 080,
India
196
910 Cefort
ceftriaxone
(ceftriaxone
sodium)
powder for solution
for injection/infusion
1000mg,
glass vials (10)
Antibiotice S.A., 1
Valea Lupului str.,
707410 lasi-secondary
packager, batch
releaser (bulk
manufacturer,
primary packager-
Sinopharm Zhijun
(Shenzhen)
Pharmaceutical Co.,
Ltd, No. 16, Lanqing
Yilu, Hi-tech zone,
Guanlan, Longhua
New District,
Shenzhen,
Guangdong, 518110,
China)
Romania J01DD04 1580520.07.2016
20.07.2021PoM
Antibiotice S.A., 1
Valea Lupului str.,
707410 lasi, Romania
911 Cefotaxime
cefotaxime
(cefotaxime
sodium)
powder for solution
for injection
500mg,
glass vial (10)
Open joint stock
company "Borisovskiy
zavod medicinskikh
preparatov" 64,
Chapaev str., Borisov
222518, Minsk region
Belarus J01DD01 1561224.05.2016
24.05.2021PoM
Open joint stock
company "Borisovskiy
zavod medicinskikh
preparatov" 64,
Chapaev str., Borisov
222518, Minsk
region, Belarus
912 Cefotaxime
cefotaxime
(cefotaxime
sodium)
powder for solution
for injection
1000mg,
glass vials (10)
Open joint stock
company "Borisovskiy
zavod medicinskikh
preparatov" 64,
Chapaev str., Borisov
222518, Minsk region
Belarus J01DD01 1561324.05.2016
24.05.2021PoM
Open joint stock
company "Borisovskiy
zavod medicinskikh
preparatov" 64,
Chapaev str., Borisov
222518, Minsk
region, Belarus
197
913 Cefotaxime Atb 1g
cefotaxime
(cefotaxime
sodium)
powder for solution
for injection/infusion
1000mg,
glass vial (1, 10, 50)
Antibiotice S.A., 1
Valea Lupului str.,
707410 lasi-batch
releaser, Facta
Farmaceutici S.p.A.,
Nucleo Industriale S.
Atto, 64100
TERAMO (TE), Italy-
bulk manufacturer,
packager
Romania J01DD01 1590223.08.2016
23.08.2021PoM
Antibiotice S.A., 1
Valea Lupului str.,
707410 lasi, Romania
914 Cefotaxime Atb 1g
cefotaxime
(cefotaxime
sodium)
powder for solution
for injection/infusion
1000mg,
glass vial (1, 10, 50)
Antibiotice S.A., 1
Valea Lupului str.,
707410 lasi - batch
releaser, secondary
packager, Facta
Farmaceutici S.p.A.,
Nucleo Industriale S.
Atto, 64100
TERAMO (TE), Italy-
bulk manufacturer,
primary packager
Romania J01DD01 1596115.09.2016
15.09.2021PoM
Antibiotice S.A., 1
Valea Lupului str.,
707410 lasi, Romania
915Cefotaxime sodium
for injection 1,0g
cefotaxime
(cefotaxime
sodium)
powder for solution
for injection
1000mg,
glass vial and 5ml solvent
in ampoule
Harbin
Pharmaceutical
Group Co., Ltd.,
(General
Pharmaceutical
Factory, No 109
Xuefu Road,Nangang
District., Harbin)
China J01DD10 1289807.10.2013
07.10.2018PoM
Harbin
Pharmaceutical
Group Co., Ltd.,
(General
Pharmaceutical
Factory, No 109
Xuefu Road,Nangang
District., Harbin,
China)
916 Cefrobactum
cefoperazone
(cefoperazone
sodium), sulbactam
(sulbactam sodium)
powder for solution
for injection
1000mg+1000mg, 20ml
glass vial (1)
Sanjivani Paranteral
Limited R-40, T.T.C.
Rabale, Thane-
Belapur Road, Navi
Mumbai 400 701
India J01DD62 1618823.11.2016
23.11.2021PoM
S.P. Incomed Pvt.
Ltd., H-680, Palam
Extn.-1, New Delhi
110 045, India
198
917 Ceftionel-50ceftiofur (ceftiofur
hydrochloride)
suspension for
injection
50mg/ml,
100ml glass bottle
Interchemie werken
De Adelaar Eesti AS,
Vanapere tee 14,
Viimsi, Harju county-
bulk manufacturer,
primary packager,
batch releaser,
Interchemie werken
De Adelaar B.V.,
Metaalweg 8, 5804
CG Venray, the
Netherlands-
secondary packager
Estonia
QJ01DD90;
veterinary
drug
1528904.02.2016
04.02.2021PoM
Interchemie werken
De Adelaar B.V.,
Metaalweg 8, 5804
CG Venray, the
Netherlands
918 Ceftonus
ceftriaxone
(ceftriaxone
sodium)
powder for solution
for injection
1000mg,
glass vials (25)
Panpharma Z.I., du
Clairay-Luitre 35133,
Fougeres
France J01DD04 1217201.02.2013
01.02.2018PoM
Panpharma Z.I., du
Clairay-Luitre 35133,
Fougeres, France
919 Ceftriaxon
ceftriaxone
(ceftriaxone
sodium)
powder for solution
for injection
500mg,
glass vials (10)
Kievmedpreparat
OJSC, 01032, Kiev,
Saksaganskogo street,
139
Ukraine J01DD04 1233109.04.2013
09.04.2018PoM
Kievmedpreparat
OJSC, 01032, Kiev,
Saksaganskogo street,
139, Ukraine
920 Ceftriaxon
ceftriaxone
(ceftriaxone
sodium)
powder for solution
for injection
1000mg,
glass vials (10)
Kievmedpreparat
OJSC, 01032, Kiev,
Saksaganskogo street,
139
Ukraine J01DD04 1233209.04.2013
09.04.2018PoM
Kievmedpreparat
OJSC, 01032, Kiev,
Saksaganskogo street,
139, Ukraine
921 Ceftriaxone
ceftriaxone
(ceftriaxone
sodium)
powder for solution
for i/m and i/v
injection
1g,
glass vial (1, 10, 270)
Open joint stock
company "Borisovskiy
zavod medicinskikh
preparatov" 64,
Chapaev str., Borisov
222518, Minsk region
Belarus J01DD04 15409/105.04.2017
09.03.2021PoM
Open joint stock
company "Borisovskiy
zavod medicinskikh
preparatov" 64,
Chapaev str., Borisov
222518, Minsk
region, Belarus
199
922 Ceftriaxone
ceftriaxone
(ceftriaxone
sodium)
powder for solution
for i/m and i/v
injection
500mg,
glass vial (1, 10, 270)
Open joint stock
company "Borisovskiy
zavod medicinskikh
preparatov" 64,
Chapaev str., Borisov
222518, Minsk region
Belarus J01DD04 15416/105.04.2017
09.03.2021PoM
Open joint stock
company "Borisovskiy
zavod medicinskikh
preparatov" 64,
Chapaev str., Borisov
222518, Minsk
region, Belarus
923 Ceftriaxone
ceftriaxone
(ceftriaxone
sodium)
powder for solution
for i/m and i/v
injection
1000mg,
glass vial (1)
"Sintez" OJSC, Pr.
Konstitutsii, No. 7,
Kurgan, 640008
Russia J01DD04 1554419.04.2016
19.04.2021PoM
"Sintez" OJSC, Pr.
Konstitutsii, No. 7,
Kurgan, 640008,
Russia
924 Ceftriaxone
ceftriaxone
(ceftriaxone
sodium)
powder for solution
for i/m and i/v
injection
500mg,
glass vial (1)
"Sintez" OJSC, Pr.
Konstitutsii, No. 7,
Kurgan, 640008
Russia J01DD04 1554519.04.2016
19.04.2021PoM
"Sintez" OJSC, Pr.
Konstitutsii, No. 7,
Kurgan, 640008,
Russia
925Ceftriaxone
1000mg
ceftriaxone
(ceftriaxone
sodium)
powder for solution
for injection/infusion
1000mg,
glass vial (10)
Arpimed LLC, Kotayk
Marz, Abovyan, 2nd
Micro-District, 19
Building
Republic of
ArmeniaJ01DD04 16294
26.12.2016
26.12.2021PoM
Arpimed LLC,
Kotayk Marz,
Abovyan, 2nd Micro-
District, 19 Building,
Republic of Armenia
926
Ceftriaxone 1g
powder for
solution for
injection
ceftriaxone
(ceftriaxone
sodium)
powder for solution
for injection
1000mg,
glass vials (1, 10)
CP Pharmaceuticals
Ltd., Ash Road North,
Wrexham, LL13 9UF
UK J01DD04 1396329.10.2014
29.10.2019PoM
Wockhardt UK Ltd
Ash Road North,
Wrexham, LL13 9UF,
UK
927 Ceftriaxone 500mg
ceftriaxone
(ceftriaxone
sodium)
powder for solution
for injection/infusion
500mg,
glass vial (10)
Arpimed LLC, Kotayk
Marz, Abovyan, 2nd
Micro-District, 19
Building
Republic of
ArmeniaJ01DD04 16295
26.12.2016
26.12.2021PoM
Arpimed LLC,
Kotayk Marz,
Abovyan, 2nd Micro-
District, 19 Building,
Republic of Armenia
200
928Ceftriaxone
ALPHAceftriaxone
powder for solution
for injection
1g/vial,
10ml glass vial
ALPHA_Aleppo
Pharmaceutical
Industries, Mansoura,
Aleppo
Syria J01DD04 1279514.08.2013
14.08.2018PoM
ALPHA-Aleppo
Pharmaceutical
Industries, Baron
Street, Aleppo, Syria
929Ceftriaxone for
injection
ceftriaxone
(ceftriaxone
sodium)
powder for solution
for i/m and i/v
injection
1000mg,
glass vial (10)
Reyoung
Pharmaceutical Co.
Ltd., No 6 Erlangshan
Road, Yiyuan County,
Shandong Province
China J01DD04 1714307.11.2017
07.11.2022PoM
Reyoung
Pharmaceutical Co.
Ltd., No 6 Erlangshan
Road, Yiyuan
County, Shandong
Province, China
930Ceftriaxone
sodium
ceftriaxone
(ceftriaxone
sodium)
powder for solution
for i/m and i/v
injection
1000mg,
glass vial (1, 20, 40)
Belmedpreparaty
RUE, Grodninsky
region, Lida, str.
Kachana,19/8
Belarus J01DD04 1663525.04.2017
25.04.2022PoM
Belmedpreparaty
RUE, 220007, Minsk,
Fabritsius St., 30,
Belarus
931Ceftriaxone-
Asteria
ceftriaxone
(ceftriaxone
sodium)
powder for solution
for i/m injection
1000mg,
3,5ml glass vial and (1)
solvent in ampoule
Hankook Korus
Pharm Co., Ltd, 78
Daepungsandan-ro,
Daeso-myeon,
Eumseong-gun,
Chungcheongbuk-do
Korea Sourth J01DD04 1517717.12.2015
17.12.2020PoM
GL Corporation,
Woori Venture
Tower #201, 70,
Seonyu-ro,
Yeongdeungpo-ku,
Seoul, Korea South
932Ceftriaxone-
Asteria Inj. 0,5g
ceftriaxone
(ceftriaxone
sodium)
powder for solution
for i/m/i/v injection
500mg,
glass vials (10)
Hankook Korus
Pharm Co., Ltd, 78
Daepungsandan-ro,
Daeso-myeon,
Eumseong-gun,
Chungcheongbuk-do
Korea Sourth J01DD04 12825/120.08.2015
17.09.2018PoM
GL Corporation,
Woori Venture
Tower #201, 70,
Seonyu-ro,
Yeongdeungpo-ku,
Seoul, Korea South
933Ceftriaxone-
Asteria Inj. 0,5g
ceftriaxone
(ceftriaxone
sodium)
powder for solution
for solution for i/m/
and i/v injection
500mg,
glass vial (1) and (10)
Hankook Korus
Pharm Co., Ltd, 78
Daepungsandan-ro,
Daeso-myeon,
Eumseong-gun,
Chungcheongbuk-do
Korea South J01DD04 1674605.06.2017
05.06.2022PoM
GL Corporation,
Woori Venture
Tower 201, 70,
Seonyu-ro,
YoungDeungPo-Ku,
Seoul, Korea South
201
934Ceftriaxone-
Asteria Inj. 1g
ceftriaxone
(ceftriaxone
sodium)
powder for solution
for i/m/i/v injection
1000mg,
glass vials (10)
Hankook Korus
Pharm Co., Ltd, 78
Daepungsandan-ro,
Daeso-myeon,
Eumseong-gun,
Chungcheongbuk-do
Korea Sourth J01DD04 12826/120.08.2015
17.09.2018PoM
GL Corporation,
Woori Venture
Tower #201, 70,
Seonyu-ro,
Yeongdeungpo-ku,
Seoul, Korea South
935Ceftriaxone-
Asteria Inj. 1g
ceftriaxone
(ceftriaxone
sodium)
powder for solution
for i/m and i/v
injection
1000mg,
glass vial (1) and (10)
Hankook Korus
Pharm Co., Ltd, 78
Daepungsandan-ro,
Daeso-myeon,
Eumseong-gun,
Chungcheongbuk-do
Korea South J01DD04 1674705.06.2017
05.06.2022PoM
GL Corporation,
Woori Venture
Tower 201, 70,
Seonyu-ro,
Yeongdeungpo-ku,
Seoul, Korea South
936 Ceftrimo-S
ceftriaxone
(ceftriaxone
sodium), sulbactam
(sulbactam sodium)
powder for solution
for injection1000mg+500mg, glass vial
Klintoz
Pharmaceuticals Pvt.
Ltd., Nalagarh Road
Baddi, 173205, Distt.
Solan, H.P.
India J01DD54 1267104.07.2013
04.07.2018PoM
Klintoz
Pharmaceuticals Pvt.
Ltd., 405, Madhuban
bilding,55,Nehru
Place, New Delhi-
110019, India
937 Celebrex celecoxib capsules100mg,
blisters (20/2x10/)
R-Pharm Germany
GmbH, Heinrich-
Mack-Str. 35, 89257,
Illertissen-batch
releaser, packager,
Neolpharma Inc.,
Caguas 99 Jardines
str., Caguas, Puerto
Rico 00725, USA-bulk
manufacturer
Germany M01AH01 14685/106.09.2016
29.06.2020PoM
Pfizer H.C.P.
Corporation, 235,
East 42nd street, New
York 10017, USA
938 Celebrex celecoxib capsules200mg,
blisters (20/2x10/)
R-Pharm Germany
GmbH, Heinrich-
Mack-Str. 35, 89257,
Illertissen-batch
releaser, packager,
Neolpharma Inc.,
Caguas 99 Jardines
str., Caguas, Puerto
Rico 00725, USA-bulk
manufacturer
Germany M01AH01 14686/106.09.2016
29.06.2020PoM
Pfizer H.C.P.
Corporation, 235,
East 42nd street, New
York 10017, USA
202
939 Celecoxib celecoxib capsules100mg,
in blister (10/1x10/)
Belmedpreparaty
RUP, 220007, Minsk,
Fabritsius St., 30
Belarus M01AH01 1394429.10.2014
29.10.2019PoM
Belmedpreparaty
RUP, 220007, Minsk,
Fabritsius St., 30,
Belarus
940 Celecoxib celecoxib capsules200mg,
in blister (10/1x10/)
Belmedpreparaty
RUP, 220007, Minsk,
Fabritsius St., 30
Belarus M01AH01 1394529.10.2014
29.10.2019PoM
Belmedpreparaty
RUP, 220007, Minsk,
Fabritsius St., 30,
Belarus
941 Celestoderm-V
betamethasone
(betamethasone 17-
valerate)
ointment1mg/g,
30g aluminum tube
Schering-Plough Labo
N.V., Industriepark
30 B-2220, Heist-op-
den-Berg
Belgium D07AC01 1336404.04.2014
04.04.2019PoM
Schering-Plough
Central East AG,
Weystrasse 20, P.O.
Box CH-6000
Lucerne 6,
Switzerland
942
Celestoderm-V
cream with
Garamycin
betamethasone
(betamethasone 17-
valerate),
gentamicin
(gentamicin sulfate)
cream1mg/g+1mg/g,
30g aluminium tube
Schering-Plough Labo
N.V., Industriepark
30 B-2220, Heist-op-
den-Berg
Belgium D07CC01 1350030.05.2014
30.05.2019PoM
Schering-Plough
Central East AG,
Weystrasse 20, CH-
6000 Lucerne 6,
Switzerland
943Celestoderm-V
with Garamycin
betamethasone
(betamethasone
valerate),
gentamicin
(gentamicin sulfate)
ointment1mg/g+1mg/g,
30g aluminium tube
Schering-Plough Labo
N.V., Industriepark
30 B-2220, Heist-op-
den-Berg
Belgium D07CC01 1433225.03.2015
25.03.2020PoM
Schering-Plough
Central East AG,
Weystrasse 20, P.O.
Box CH-6000
Lucerne 6,
Switzerland
944 Celex celecoxib capsules200mg
in blister (10/1x10/)
Tufenkji Group LLC,
Kochinyan 13/16,
Yerevan- batch
releaser, packager,
Zim Laboratories Ltd.,
B-21/22, MIDC Area,
Kalmeshwar-441 501,
Dist. Nagpur (M.S.),
India- bulk
manufacturer
Republic of
ArmeniaM01AH01 16642
25.04.2017
25.04.2022PoM
Tufenkji Group LLC,
Kochinyan 13/16,
Yerevan, Republic of
Armenia
203
945 CellCeptmycophenolate
mofetilcapsules
250mg,
in blister (100/10x10/)
F. Hoffmann-La
Roche Ltd.,
Grenzacherstrasse,
124, CH-4070, Basel-
batch releaser (Roche
S.p.A., Via Morelli 2,
Segrate, 20090, Milan,
Italy-bulk
manufacturer) (F.
Hoffmann-La Roche
Ltd., Wurmisweg, CH-
4303, Kaiseraugst,
Switzerland-primary
and secondary
packager)
Switzerland L04AA06 1448918.05.2015
18.05.2020PoM
F. Hoffmann-La
Roche Ltd.,
Greenzacher-strasse,
124, CH-4070, Basel,
Switzerland
946 Cenipres
enalapril (enalapril
maleate),
nitrendipine
tablets10mg+20mg,
in blister (30/3x10/)
Ferrer Internacional,
S.A., Joan Buscalla, 1-
9 08173 Sant Cugat
del Valles, Barcelona
Spain C09BB06 1274623.07.2013
23.07.2018PoM
Ferrer Internacional,
S.A., Gran Via Carlos
III, 94, 08028,
Barcelona, Spain
947
Ceraxon 1000mg
solution for
injection
citicolinesolution for i/v and
i/m injection
1000mg/4ml,
4ml ampoules (5)
Ferrer International,
S.A., Joan Buscalla,1-9
08173 Sant Cugat del
Valles, Barcelona
Spain N06BX06 13269/102.06.2015
10.03.2019PoM
Ferrer International,
S.A., Joan Gran Via
Carlos III, 94 08028,
Barcelona, Spain
948Ceraxon 100mg/ml
oral solution
citicoline (citicoline
sodium)solution oral
100mg/ml,
30ml glass bottle,
10ml sachets (6, 10)
Ferrer Internacional,
S.A., Gran Via Carlos
III, 94, 08028,
Barcelona
Spain N06BX06 13267/123.06.2014
10.03.2019PoM
Ferrer Internacional,
S.A., Gran Via Carlos
III, 94, 08028,
Barcelona, Spain
949
Ceraxon 500mg
solution for
injection
citicoline (citicoline
sodium)
solution for i/v and
i/m injection
500mg/4ml,
4ml ampoules (5)
Ferrer International,
S.A., Joan Buscalla,1-9
08173 Sant Cugat del
Valles, Barcelona
Spain N06BX06 13268/102.06.2015
10.03.2019PoM
Ferrer International,
S.A., Joan Gran Via
Carlos III, 94 08028,
Barcelona, Spain
204
950 Cerebrolysatecattle or porcine
brain hydrolysatesolution for injection
47-77mg/ml; (10)
ampoules1ml, (10/2x5/)
ampoules 1ml in blister,
(5/1x5/) ampoules 1ml in
blister
Belmedpreparaty
RUE, 220006, Minsk,
Mayakovskogo st. 1
Belarus N06BX 1704026.09.2017
26.09.2022PoM
Belmedpreparaty
RUE, 220007, Minsk,
Fabritsius St., 30,
Belarus
951 Cerebrolysinporcine brain
peptidessolution for injection
215,2mg/ml,
1ml ampoules,
in blister (10/1x10/)
EVER Neuro Pharma
GmbH,
Mondseestrasse 11, At-
4866 Unterach am
Attersee-, bulk
manufacturer, batch
releaser, Ever Pharma
Jena GmbH, Otto-
Schott-Strasse 15,
07745
Jena,Thueringen,
Germany -packager
Austria N06BX 1423720.02.2015
20.02.2020PoM
EVER Neuro Pharma
GmbH,
Mondseestrasse 11, At-
4866 Unterach am
Attersee, Austria
952 Cerebrolysinporcine brain
peptidessolution for injection
215,2mg/ml,
2ml ampoules,
in blister (10/1x10/)
EVER Neuro Pharma
GmbH,
Mondseestrasse 11, At-
4866 Unterach am
Attersee-, bulk
manufacturer, batch
releaser, Ever Pharma
Jena GmbH, Otto-
Schott-Strasse 15,
07745
Jena,Thueringen,
Germany -packager
Austria N06BX 1423820.02.2015
20.02.2020PoM
EVER Neuro Pharma
GmbH,
Mondseestrasse 11, At-
4866 Unterach am
Attersee, Austria
205
953 Cerebrolysinporcine brain
peptidessolution for injection
215,2mg/ml,
5ml ampoules,
in blister (5/1x5/)
EVER Neuro Pharma
GmbH,
Mondseestrasse 11, At-
4866 Unterach am
Attersee-, bulk
manufacturer, batch
releaser, Ever Pharma
Jena GmbH, Otto-
Schott-Strasse 15,
07745
Jena,Thueringen,
Germany -packager
Austria N06BX 1423920.02.2015
20.02.2020PoM
EVER Neuro Pharma
GmbH,
Mondseestrasse 11, At-
4866 Unterach am
Attersee, Austria
954 Cerebrolysinporcine brain
peptidessolution for injection
215,2mg/ml,
10ml ampoules,
in blister (5/1x5/)
EVER Neuro Pharma
GmbH,
Mondseestrasse 11, At-
4866 Unterach am
Attersee-, bulk
manufacturer, batch
releaser, Ever Pharma
Jena GmbH, Otto-
Schott-Strasse 15,
07745
Jena,Thueringen,
Germany -packager
Austria N06BX 1424020.02.2015
20.02.2020PoM
EVER Neuro Pharma
GmbH,
Mondseestrasse 11, At-
4866 Unterach am
Attersee, Austria
955 Cerebrolysinporcine brain
peptidessolution for injection
215,2mg/ml,
1ml ampoules,
in blister (10/1x10/)
EVER Neuro Pharma
GmbH,
Mondseestrasse 11, At-
4866 Unterach am
Attresee - bulk
manufacturer, batch
releaser, Hameln
Pharmaceuticals
GmbH, Langes Feld
13, Hameln,
Niedersachsen, 31789,
Germany- packager
Austria N06BX 1424120.02.2015
20.02.2020PoM
EVER Neuro Pharma
GmbH,
Mondseestrasse 11, At-
4866 Unterach am
Attersee, Austria
206
956 Cerebrolysinporcine brain
peptidessolution for injection
215,2mg/ml,
2ml ampoules,
in blister (10/1x10/)
EVER Neuro Pharma
GmbH,
Mondseestrasse 11, At-
4866 Unterach am
Attresee - bulk
manufacturer, batch
releaser, Hameln
Pharmaceuticals
GmbH, Langes Feld
13, Hameln,
Niedersachsen, 31789,
Germany- packager
Austria N06BX 1424220.02.2015
20.02.2020PoM
EVER Neuro Pharma
GmbH,
Mondseestrasse 11, At-
4866 Unterach am
Attersee, Austria
957 Cerebrolysinporcine brain
peptidessolution for injection
215,2mg/ml,
5ml ampoules,
in blister (5/1x5/)
EVER Neuro Pharma
GmbH,
Mondseestrasse 11, At-
4866 Unterach am
Attresee - bulk
manufacturer, batch
releaser, Hameln
Pharmaceuticals
GmbH, Langes Feld
13, Hameln,
Niedersachsen, 31789,
Germany- packager
Austria N06BX 1424320.02.2015
20.02.2020PoM
EVER Neuro Pharma
GmbH,
Mondseestrasse 11, At-
4866 Unterach am
Attersee, Austria
958 Cerebrolysinporcine brain
peptidessolution for injection
215,2mg/ml,
10ml ampoules,
in blister (5/1x5/)
EVER Neuro Pharma
GmbH,
Mondseestrasse 11, At-
4866 Unterach am
Attresee - bulk
manufacturer, batch
releaser, Hameln
Pharmaceuticals
GmbH, Langes Feld
13, Hameln,
Niedersachsen, 31789,
Germany- packager
Austria N06BX 1424420.02.2015
20.02.2020PoM
EVER Neuro Pharma
GmbH,
Mondseestrasse 11, At-
4866 Unterach am
Attersee, Austria
207
959 Cerebrolysinporcine brain
peptidessolution for injection
215,2mg/ml,
20ml ampoules,
in blister (5/1x5/)
EVER Neuro Pharma
GmbH,
Mondseestrasse 11, At-
4866 Unterach am
Attresee - bulk
manufacturer, batch
releaser, Hameln
Pharmaceuticals
GmbH, Langes Feld
13, Hameln,
Niedersachsen, 31789,
Germany- packager
Austria N06BX 1451715.05.2015
15.05.2020PoM
EVER Neuro Pharma
GmbH,
Mondseestrasse 11, At-
4866 Unterach am
Attersee, Austria
960 Cerebrolysinporcine brain
peptidessolution for injection
215,2mg/ml,
20ml ampoules, in blister
(5/1x5/)
EVER Neuro Pharma
GmbH,
Mondseestrasse 11, At-
4866 Unterach am
Attersee-, bulk
manufacturer, batch
releaser, Ever Pharma
Jena GmbH, Otto-
Schott-Strasse 15,
07745
Jena,Thueringen,
Germany -packager
Austria N06BX 1451815.05.2015
15.05.2020PoM
EVER Neuro Pharma
GmbH,
Mondseestrasse 11, At-
4866 Unterach am
Attersee, Austria
208
961 Cerotex choline alfoscerate capsules
400mg,
in blister (14/1x14/,
28/2x14/), (42/3x14/,
56/4x14/)
"Sotex"PharmFirm"
CJSC, Bld. 11, village
Belikovo, rural
settlement
Bereznjakovskoe,
Sergiev-Posad
municipal district,
Moscow Region,
141345- batch
releaser, primary and
secondarypackager,
"Artlife" Ltd, bld. 8/2
Nahimova str.,
Tomsk, 634034,
Russia- bulk
manufacturer
Russia N07AX02 16409/110.10.2017
10.02.2022PoM
"Sotex"PharmFirm"
CJSC, Bld. 11, village
Belikovo, rural
settlement
Bereznjakovskoe,
Sergiev-Posad
municipal district,
Moscow Region,
141345, Russia
962 Cerotexcholine alfoscerate
polyhydrate
solution for i/m and
i/v injection
250mg/ml,
4ml ampoules (3, 5)
"Sotex"PharmFirm"
CJSC, Bld. 10, 11, 12,
village Belikovo, rural
settlement
Bereznjakovskoe,
Sergiev-Posad
municipal district,
Moscow Region,
141345
Russia N07AX02 1648024.02.2017
24.02.2022PoM
"Sotex"PharmFirm"
CJSC, Bld. 11, village
Belikovo, rural
settlement
Bereznjakovskoe,
Sergiev-Posad
municipal district,
Moscow Region,
141345, Russia
963 Certican everolimus tablets0,25mg,
in blister (60/6x10/)
Novartis Pharma
Stein AG,
Schaffhauserstrasse,
4332 Stein
Switzerland L04AA18 1417316.01.2015
16.01.2020PoM
Novartis Pharma AG,
35, Lichtstrasse, 4056
Basel, Switzerland
964 Certican everolimus tablets0,75mg,
in blister (60/6x10/)
Novartis Pharma
Stein AG,
Schaffhauserstrasse,
4332 Stein
Switzerland L04AA18 1417416.01.2015
16.01.2020PoM
Novartis Pharma AG,
35, Lichtstrasse, 4056
Basel, Switzerland
209
965 Cerucal
metoclopramide
(metoclopramide
hydrochloride
monohydrate)
tablets10mg,
in glass container (50)
Pliva Hrvatska d.o.o.,
Prilaz baruna
Filipovica 25, Zagreb
10000
Croatia A03FA01 1239519.04.2013
19.04.2018PoM
Teva Pharmaceutical
Industries Ltd, 5 Basel
str., P.O. Box 3190,
Petah Tikva, 49131,
Israel
966 Cerucal
metoclopramide
(metoclopramide
hydrochloride
monohydrate)
solution for injection5mg/ml,
2ml ampoules (10)
Teva Pharmaceutical
Works Private
Limited Company, H-
2100 Godollo,
Tancsics Mihaly ut 82
Hungary A03FA01 12496/126.03.2014
01.06.2018PoM
Teva Pharmaceutical
Industries Ltd., 5
Basel str., P.O. Box
3190, Petach Tikva,
49131, Israel
967 Cervarix
human
papillomavirus type
16 L1 protein,
human
papillomavirus type
18 L1 protein
suspension for
injection
20mcg/dose+ 20mcg/dose,
0.5ml pre-filled syringe (1
dose) (1) and needle (1)
GlaxoSmithKline
Biologicals s.a., Rue
de l Institut, 89 B-
1330 Rixensart- batch
releaser,
GlaxoSmithKline
Biologicals SA, Parc
de la Noire Epine Rue
Fleming, 20 1300
Wavre, Belgium-bulk
manufacturer,
packager
BelgiumJ07BM02;
vaccine15382
26.02.2016
26.02.2021PoM
GlaxoSmithKline
Biologicals s.a., Rue
de l Institut, 89 B-
1330 Rixensart,
Belgium
210
968 Cervarix
human
papillomavirus type
16 L1 protein,
human
papillomavirus type
18 L1 protein
suspension for
injection
20mcg/dose+ 20mcg/dose,
0.5ml pre-filled syringe
(1dose) (1) and needle (1)
GlaxoSmithKline
Biologicals s.a., Rue
de l Institut, 89 B-
1330 Rixensart- batch
releaser,
GlaxoSmithKline
Biologicals SA, Parc
de la Noire Epine Rue
Fleming, 20 1300
Wavre, Belgium-bulk
manufacturer,
primary packager,
GlaxoSmithKline
Biologicals SA, Rue
des Aulnois, 637
59230 Saint Amand
Les Eaux, France-
secondary packager
BelgiumJ07BM02;
vaccine15383
26.02.2016
26.02.2021PoM
GlaxoSmithKline
Biologicals s.a., Rue
de l Institut, 89 B-
1330 Rixensart,
Belgium
969 Cetamol paracetamol suppositories rectal80mg,
(10/2x5/)
Medical Horizon Ltd,
Ararat province,
Masis city, Masis
station, Gortsaranain
22
Republic of
ArmeniaN02BE01 13099
09.12.2013
09.12.2018OTC
Medical Horizon Ltd,
Ararat province,
Masis city, Masis
station, Gortsaranain
22, Republic of
Armenia
970 Cetamol paracetamol suppositories rectal150mg
(10/2x5/)
Medical Horizon Ltd,
Ararat province,
Masis city, Masis
station, Gortsaranain
22
Republic of
ArmeniaN02BE01 13100
09.12.2013
09.12.2018OTC
Medical Horizon Ltd,
Ararat province,
Masis city, Masis
station, Gortsaranain
22, Republic of
Armenia
971 Cetamol paracetamol suppositories rectal325mg
(10/2x5/)
Medical Horizon Ltd,
Ararat province,
Masis city, Masis
station, Gortsaranain
22
Republic of
ArmeniaN02BE01 13101
09.12.2013
09.12.2018OTC
Medical Horizon Ltd,
Ararat province,
Masis city, Masis
station, Gortsaranain
22, Republic of
Armenia
211
972 Cetamol paracetamoldrops oral (solution
with cherry flavour)
100mg/ml,
30ml plastic bottle
Medical Horizon Ltd,
Ararat province,
Masis city, Masis
station, Gortsaranain
22
Republic of
ArmeniaN02BE01 13141
10.01.2014
10.01.2019OTC
Medical Horizon Ltd,
Ararat province,
Masis city, Masis
station, Gortsaranain
22, Republic of
Armenia
973 Cetamol paracetamolsyrup (with cherry
flavour)
24mg/ml,
100ml glass bottle
Medical Horizon Ltd,
Ararat province,
Masis city, Masis
station, Gortsaranain
22
Republic of
ArmeniaN02BE01 13142
10.01.2014
10.01.2019OTC
Medical Horizon Ltd,
Ararat province,
Masis city, Masis
station, Gortsaranain
22, Republic of
Armenia
974Cetirizine-Asteria
Tab. 10mg
cetirizine (cetirizine
hydrochloride)tablets film-coated
10mg,
in blister (20/2x10/)
Hankook Korus
Pharm Co., Ltd, 30,
Gangjeo-ro, Jecheon-
Si, Chungcheongbuk-
do
Korea South R06AE07 1679322.06.2017
22.06.2022OTC
GL Corporation,
Woori Venture
Tower 201, 70,
Seonyu-ro,
YoungDeungPo-Ku,
Seoul, South Korea
975 Cetrotidecetrorelix
(cetrorelix acetate)
powder lyophilized
for solution for s/c
injection
0,25mg,
glass vials with powder
(7), 1ml prefilled syringes
with solvent (7), needles
(14), alcohol swabs (14)
Baxter Oncology
GmbH, Kantstrasse 2,
Halle/Westfalen,
33790
Germany H01CC02 1578220.07.2016
20.07.2021PoM
Merck Serono Europe
Ltd., Marsh Wall 56,
London E14 9TP, UK
976 Cevikap ascorbic acid drops oral
100mg/ml,
10ml, 30ml glass bottle-
dropper
Medana Pharma JSC,
98-200 Sieradz, W.
Lokietka 10 - batch
releaser, Medana
Pharma JSC, str.
Polskiej Organizacji
Wojskowej 57, 98-200
Sieradz, Poland-bulk
manufacturer,
packager
Poland A11GA01 1552819.04.2016
19.04.2021OTC
Medana Pharma JSC,
98-200 Sieradz, W.
Lokietka 10, Poland
212
977 Cezera
levocetirizine
(levocetirizine
dihydrochloride)
tablets film-coated5mg,
in blister (30/3x10/)
KRKA d.d., Novo
mesto, Smarjeska
cesta 6, 8501 Novo
Mesto
Slovenia R06AE09 1538526.02.2016
26.02.2021PoM
KRKA d.d., Novo
mesto, Smarjeska
cesta 6, 8501 Novo
Mesto, Slovenia
978 Champix
varenicline
(varenicline
tartrate)
tablets film-coated
0,5mg/1mg,
(11/1x11/)(0,5mg) in
blister, (14/1x14/)(1mg)
in blister
R-Pharm Germany
GmbH, Heinrich-
Mack-Str. 35, 89257,
Illertissen, Bavaria
Germany N07BA03 12129/114.08.2015
01.02.2018PoM
Pfizer H.C.P.
Corporation, 235,
East 42nd street, New
York 10017, USA
979 Champix
varenicline
(varenicline
tartrate)
tablets film-coated
1mg,
in blister (28/2x14/,
56/2x28/)
R-Pharm Germany
GmbH, Heinrich-
Mack-Str. 35, 89257,
Illertissen, Bavaria
Germany N07BA03 12130/114.08.2015
01.02.2018PoM
Pfizer H.C.P.
Corporation, 235,
East 42nd street, New
York 10017, USA
980 Charcoal activated charcoal activated tablets
250mg,
in blister (10/1x10/,
30(/3x10, 50/5x10/),
Pharmstandard-
Leksredstva JSC,
305022, Kursk,
Agregatnaya 2nd str.,
1a/18
Russia A07BA01 1409318.12.2014
18.12.2019OTC
Pharmstandard-
Leksredstva JSC,
305022, Kursk,
Agregatnaya 2nd str.,
1a/18, Russia
981 Chemi Spray
chlortetracycline
(chlortetracycline
hydrochloride),
gentian violet
aerosol for external
use
20mg/ml+5mg/ml, 200ml
container
Invesa Industrial
Veterinaria, S.A.,
08950 Esplugues de
Llobregat, Barcelona,
Esmeralda 19
Spain
QD06AA02;
veterinary
drug
1523723.12.2015
23.12.2020PoM
Invesa Industrial
Veterinaria, S.A.,
08950 Esplugues de
Llobregat, Barcelona,
Esmeralda 19, Spain
213
982 Chicktonic
vitamin A, vitamin
D3, vitamin E,
vitamin B1, vitamin
B2, vitamin B6,
vitamin B12,
vitaminK3, sodium
pantotenat, choline
chloride, D,L-
methionine, L-lysine,
L-triptophane, L-
threonine, inositol,
arginine, valine,
serine, aspartic acid,
glutamic acid,
proline, glycine,
alanine, cystine,
leucine, isoleucine,
phenylalanine,
tyrosine, histidine,
biotin
solution oral
2500000IU/l+
500000IU/l+ 3750mg/l+
3500mg/l+ 4000mg/l+
2000mg/l+
10mg/l+250mg/l+
15000mg/l+ 400mg/l+
5000mg/l+
2500mg/l+75mg/l+
500mg/l+2.5mg/l+
490mg/l+ 1100mg/l+
680mg/l+ 1450mg/l+
1160mg/l+
510mg/l+575mg/l+
975mg/l+150mg/l+
1500mg/l+ 125mg/l+
810mg/l+ 340mg/l+
900mg/l+2mg/l,
1l plastic container
Invesa Industrial
Veterinaria, S.A.,
08950 Esplugues de
Llobregat, Barcelona,
Esmeralda 19
Spain
QA11JC
veterinary
drug
1275414.08.2013
14.08.2018OTC
Invesa Industrial
Veterinaria, S.A.,
08950 Esplugues de
Llobregat, Barcelona,
Esmeralda 19, Spain
983 Chirocaine
levobupivacaine
(levobupivacaine
hydrochloride)
solution for
injection/infusion
5mg/ml,
10ml ampoules (10)
AbbVie S.r.l., S.R. 148
Pontina KM 52, SNC -
Campoverde di
Aprilia 04011 Aprilia
(LT) -batch releaser,
secondary packager,
Curida AS,
Solbaervegen 5,
Elverum, NO-2409,
Norway- bulk
manufacturer,
primary packager
Italy N01BB10 1613710.11.2016
10.11.2021PoM
AbbVie
Biopharmaceuticals
GmbH, Neuhofstrasse
23, Postfach 6341
Baar, Switzerland
984Chlophazolin 150
micrograms tablets
clonidine (clonidine
hydrochloride)tablets
150mcg,
in blister (50/1x50/)
Sopharma JSC, str.
Iliensko shosse 16,
1220 Sofia
Bulgaria C02AC01 1541509.03.2016
09.03.2021PoM/UC
Sopharma JSC, str.
Iliensko shosse 16,
1220 Sofia, Bulgaria
985 Chocolaxcalcium sennosides
A,Btablets chewable
12mg,
chocolate squares
(12/2x6/, 24/4x6/)
Mentholatum
Australasia Pty Ltd,
12-16 Janine
Street,Scoresby Vic
3179
Australia A06AB 1214801.02.2013
01.02.2018OTC
FW Medical LLP, 31
Milndavie Road,
Strathblane, Glasgow
G63 9EW, Scotland,
United Kingdom
214
986Choline
alphoscerate
choline
alphosceratesolution for injection
250mg/ml,
4ml ampoules (5)
Open joint stock
company "Borisovskiy
zavod medicinskikh
preparatov" 64/27,
Chapaev str., Borisov
222120, Minsk region
Belarus N07AX02 1342414.04.2014
14.04.2019PoM
Open joint stock
company "Borisovskiy
zavod medicinskikh
preparatov" 64/27,
Chapaev str., Borisov
222120, Minsk
region, Belarus
987 Cholisal
choline salicylate,
cetalkonium
chloride
gel dental87,1mg/g+ 0,1mg/g,
10g aluminium tube
Pharmaceutical
Company Jelfa S.A.,
ul. Wincentego Pola
21, 58-500 Jelenia
Gora
Poland A01AD 1627419.12.2016
19.12.2021OTC
VALEANT LLC,
Shabolovka st. 31,
building 5, 115162,
Moscow, Russia
988 Chondro-Ritz
chondroitin sulfate
(chondroitin sulfate
sodium),
glucosamine
(glucosamine
sulfate)
capsules200mg+250mg,
in blister (50/5x10/)
GM Pharmaceuticals
Ltd, PSP group 65,
Qvemo Phonichala
str., Tbilisi
Georgia M09A 1518530.12.2015
30.12.2020OTC
GM Pharmaceuticals
Ltd, PSP group 65,
Qvemo Phonichala
str., Tbilisi, Georgia
989 Chondroxid
chondroitin sulfate
(chondroitin sulfate
sodium)
gel for external use
50mg/g,
30g aluminium or plastic
tube
Nizhpharm JSC,
603950, Nizhny
Novgorod, GSP-459,
Salganskaya st., 7
Russia M01AX25 12875/109.09.2016
19.09.2018OTC
Nizhpharm JSC,
603950, Nizhny
Novgorod, GSP-459,
Salganskaya st., 7,
Russia
990 Chondroxid
chondroitin sulfate
(chondroitin sulfate
sodium)
tablets250mg,
in blister (60/6x10/)
Nizhpharm OJSC,
603950, Nizhny
Novgorod, GSP-459,
Salganskaya st., 7
Russia M01AX25 1319310.01.2014
10.01.2019OTC
Nizhpharm OJSC,
603950, Nizhny
Novgorod, GSP-459,
Salganskaya st., 7,
Russia
215
991 Chophytolextractum cynara
scolymustablets coated
200mg,
in blister (60/2x30/,
180/6x30/)
Temmler Pharma
GmbH & Co. KG,
Temmlerstrasse 2,
35039 Marburg -
packager, batch
releaser, (dosage form
manufacturer -
Valpharma
International S.P.A.,
Via G. Morgagni, 2-
47864 Pennabilli
(RN), Italy)
Germany A05AX 1239719.04.2013
19.04.2018OTC
ABBOTT Products
GmbH, Hans-Bockler-
Allee 20, 30173
Hannover, Germany
992 Chophytolcynara scolymus
extractsolution oral
200mg/ml,
120ml glass bottle
Laboratoires Rosa-
Phytopharma, 2
avenue du Traite de
Rome, 78400-Chatou-
batch releaser,
Laboratoires Mayoly
Spindler, 6 avenue de
l`Europe,78400
Chatou Cedex, France-
bulk manufacturer,
packager
FranceA05AX;
herbal drug16751
05.06.2017
05.06.2022OTC
Laboratoires Rosa-
Phytopharma 68, rue
Jean-Jacques
Rousseau 75001
Paris,France
216
993 Choragongonadotrophin
chorionic
powder for solution
for injection
1500IU,
powder, in ampoules (3)
and 1ml solvent, in
ampoules (3)
Ferring GmbH,
Wittland 11, Postfach
21 45, D-24109 Kiel, -
bulk manufacturer,
primary packager,
batch releaser (Haupt
PharmaWulfing
GmbH, Bethelner
Landstr. 18, 31028
Gronau/Leine,
Germany - solvent
manufacturer,
primary packager);
(Ferring International
Center SA, Chemin
de la Vergognausaz
50, 1162 Saint-Prex,
Switzerland -
secondary packager)
Germany G03GA01 1345306.05.2014
06.05.2019PoM
Ferring GmbH,
Wittland 11, Postfach
21 45, D-24109 Kiel,
Germany
994 Choragongonadotrophin
chorionic
powder for solution
for injection
5000IU,
powder, in ampoules (3)
and 1ml solvent, in
ampoules (3)
Ferring GmbH,
Wittland 11, Postfach
21 45, D-24109 Kiel, -
bulk manufacturer,
primary packager,
batch releaser (Haupt
PharmaWulfing
GmbH, Bethelner
Landstr. 18, 31028
Gronau/Leine,
Germany - solvent
manufacturer,
primary packager);
(Ferring International
Center SA, Chemin
de la Vergognausaz
50, 1162 Saint-Prex,
Switzerland -
secondary packager)
Germany G03GA01 1345406.05.2014
06.05.2019PoM
Ferring GmbH,
Wittland 11, Postfach
21 45, D-24109 Kiel,
Germany
217
995 Chymotrypsin chymotrypsin
powder lyophilized
for solution for
injection, local and
external use
10mg,
glass vial (10)
"Samson-Med" LLC,
Moscow highway, 13,
Saint Petersburg,
196158
Russia B06AA04 1573823.06.2016
23.06.2021PoM
"Samson-Med" LLC,
Moscow highway, 13,
Saint Petersburg,
196158, Russia
996Chymotrypsin
Crystallinechymotrypsin
lyophilisate for
solution for injection
10mg,
glass vial (10)
"BIOFARMA" "PP"
LLC, 37, Kyivska Str.,
Bila Tserkva, 09100,
Kyiv region
Ukraine D03B 1657803.04.2017
03.04.2022PoM
"BIOFARMA" "PP"
LLC, 37, Kyivska Str.,
Bila Tserkva, 09100,
Kyiv region, Ukraine
997Chymotrypsin
crystallizedchymotrypsin
powder lyophilized
for solution for
injection and for
external use
10mg,
ampoules (10)
Biopharma PJSC,
03680, Kiev, N.
Amosova str. 9
Ukraine D03B 1367908.07.2014
08.07.2019PoM
Biopharma PJSC,
03680, Kiev, N.
Amosova str. 9,
Ukraine
998 Cialis tadalafil tablets film-coated
20mg,
in blister (1/1x1/, 2/1x2/,
4/2x2/, 8/4x2/)
Lilly S.A., Avda de la
Industria 30, 28108
Alcobendas-Madrid-
primary, secondary
packager, batch
releaser (dosage form
manufacturer - Lilly
del Caribe, Inc.,
Puerto Rico 00985
Industrial Park, 12,6
km 65th Infantry
Road, Carolina, Spain)
Spain G04BE08 1224807.03.2013
07.03.2018PoM
Eli Lilly Nederland
B.V., Grootslag 1-5,
NL-3991 RA, Houten,
the Netherlands
999 Cialis tadalafil tablets film-coated
20mg,
in blister (1, 2), 4/2x2/,
8/4x2)
Lilly S.A., Avda de la
Industria 30, 28108
Alcobendas-Madrid-
batch releaser,
packager, Lilly del
Caribe, Inc., Puerto
Rico 00985, 12,6 km
65th Infantry Road,
Carolina, USA- bulk
manufacturer
Spain G04BE08 1707705.10.2017
05.10.2022PoM
Eli Lilly Nederland
B.V.,Grootslag 1-5,
NL-3991
RA,Houten,the
Netherlands
218
1000 Ciazil
epirubicin
(epirubicin
hydrochloride)
solution for injection2mg/ml,
5ml glass vial
Genepharm S.A., 18th
km Marathonos
Avenue, 153 51
Pallini Attiki
Greece L01DB03 1372524.07.2014
24.07.2019PoM
Genepharm S.A.,
18th km Marathonos
Avenue, 153 51
Pallini Attiki, Greece
1001 Ciazil
epirubicin
(epirubicin
hydrochloride)
solution for injection2mg/ml,
25ml glass vial
Genepharm S.A., 18th
km Marathonos
Avenue, 153 51
Pallini Attiki
Greece L01DB03 1372624.07.2014
24.07.2019PoM
Genepharm S.A.,
18th km Marathonos
Avenue, 153 51
Pallini Attiki, Greece
1002 Cilapenem
imipenem
(imipenem
monohydrate),
cilastatin (cilastatin
sodium)
powder for solution
for infusion
500mg+500mg, glass
bottle (1)
Belmedpreparaty
RUE, 220007, Minsk,
Fabritsius St., 30
Belarus J01DH51 1544802.04.2016
02.04.2021PoM
Belmedpreparaty
RUE, 220007, Minsk,
Fabritsius St., 30,
Belarus
1003 Cilozek cilostazol tablets100mg,
in blister (30/3x10/)
Pharmaceutical
Works Polfa in
Pabianice JSC, 5
Marszalka J.
Pilsudskiego Str., 95-
200 Pabianice
Poland B01AC23 1537926.02.2016
26.02.2021PoM
Adamed Limited
Liability Company,
Pienkow 149, 05-152
Czosnow, Poland
1004 Cinnabsin
cinnabaris trit. D3,
hydrastis trit. D3,
kalium
bichromicum trit.
D3, echinacea
trit.D1
tablets
25mg+25mg+
25mg+25mg,
in blister (100/5x20/)
Deutsche
Homoopathie-Union
DHU-Arzneimittel
GmbH & Co. KG,
Ottostrasse 24 76227
Karlsruhe-batch
releaser, Dr. Willmar
Schwabe GmbH &
Co. KG, Willmar-
Schwabe-Str. 4, 76227
Karlsruhe, Germany-
bulk manufacturer,
packager
Germanyhomeopathic
drug14331
25.03.2015
25.03.2020OTC
Deutsche
Homoopathie-Union
DHU-Arzneimittel
GmbH & Co. KG,
Ottostrasse 24, 76227
Karlsruhe, Germany
219
1005 Cinnarizine cinnarizine tablets25mg,
in blister (50)
Farma AD, 2600
Dupnitsa, Str. "Neofit
Rilski" 13
Bulgaria N07CA02 1262021.06.2013
21.06.2018PoM
Farma AD, 2600
Dupnitsa, Str. "Neofit
Rilski" 13, Bulgaria
1006Cinnarizine
Sopharmacinnarizine tablets
25mg,
in blister (50/1x50/)
Sopharma JSC, str.
Iliensko shosse 16,
1220 Sofia
Bulgaria N07CA02 1651317.03.2017
17.03.2022PoM
Sopharma JSC, str.
Iliensko shosse 16,
1220 Sofia, Bulgaria
1007 CinnoVex interferon beta-1a
powder lyophilized
for solution for i/m
injection
30mcg (6MIU),
(4 /1 glass vial with
powder +1pre-filled
syringe with 1ml solvent+
2 needles/)
CinnaGen Co., West
6th St., 3rd Sq.,
Simindasht Industrial
Area, Karaj, Alborz
Iran L03AB07 1657403.04.2017
03.04.2022PoM
CinnaGen Co., West
6th St., 3rd Sq.,
Simindasht Industrial
Area, Karaj, Alborz,
Iran
1008 Ciprinol ciprofloxacin solution for infusion2mg/ml,
100ml glass vial
KRKA d.d., Novo
mesto, Smarjeska
cesta 6, 8501 Novo
Mesto
Slovenia J01MA02 1612010.11.2016
10.11.2021PoM
KRKA d.d., Novo
mesto, Smarjeska
cesta 6, 8501 Novo
Mesto, Slovenia
1009 Ciprinol
ciprofloxacin
(ciprofloxacin
hydrochloride
monohydrate)
tablets film-coated750mg,
in blister (10/1x10/)
KRKA d.d., Novo
mesto, Smarjeska
cesta 6, 8501 Novo
Mesto
Slovenia J01MA02 1614623.11.2016
23.11.2021PoM
KRKA d.d., Novo
mesto, Smarjeska
cesta 6, 8501 Novo
Mesto, Slovenia
1010 Ciprinol ciprofloxacinconcentrate for
solution for infusion
10mg/ml,
10ml ampoules (5)
KRKA d.d., Novo
mesto, Smarjeska
cesta 6, 8501 Novo
Mesto
Slovenia J01MA02 1640110.02.2017
10.02.2022PoM
KRKA d.d., Novo
mesto, Smarjeska
cesta 6, 8501 Novo
Mesto, Slovenia
1011 Ciprinol
ciprofloxacin
(ciprofloxacin
hydrochloride
monohydrate)
tablets film-coated250mg,
in blister (10/1x10/)
KRKA d.d., Novo
mesto, Smarjeska
cesta 6, 8501 Novo
Mesto
Slovenia J01MA02 1640210.02.2017
10.02.2022PoM
KRKA d.d., Novo
mesto, Smarjeska
cesta 6, 8501 Novo
Mesto, Slovenia
1012 Ciprinol
ciprofloxacin
(ciprofloxacin
hydrochloride
monohydrate)
tablets film-coated500mg,
in blister (10/1x10/)
KRKA d.d., Novo
mesto, Smarjeska
cesta 6, 8501 Novo
Mesto
Slovenia J01MA02 1640310.02.2017
10.02.2022PoM
KRKA d.d., Novo
mesto, Smarjeska
cesta 6, 8501 Novo
Mesto, Slovenia
220
1013 Ciprobay
ciprofloxacin
(ciprofloxacin
hydrochloride
monohydrate)
tablets film-coated500mg,
in blister (10/1x10/)
Bayer Pharma AG, D-
51368 Leverkusen Germany J01MA02 16381
30.12.2016
30.12.2021PoM
Bayer Pharma AG,
Mullerstrasse 178,
13353, Berlin,
Germany
1014 Cipro-Denk 500
ciprofloxacin
(ciprofloxacin
hydrochloride)
tablets film-coated500mg,
in blister (10/1x10/)
Allphamed PHARBIL
Arzneimittel GmbH,
Hildebrandstr. 12,
37081 Gottingen
Germany J01MA02 1613810.11.2016
10.11.2021PoM
Denk Pharma GmbH
& Co. KG,
Prinzregentenstr. 79,
81675 Muenchen,
Germany
1015 Ciprofloxacin
ciprofloxacin
(ciprofloxacin
hydrochloride)
tablets film-coated250mg,
in blister (10)
Borisov Medical
Preparations Plant
OJSC, 64/27,
Chapayev str., Borisov
222120, Minsk oblast
Belarus J01MA02 1221607.03.2013
07.03.2018PoM
Borisov Medical
Preparations Plant
OJSC, 64/27,
Chapayev str.,
Borisov 222120,
Minsk oblast,
BELARUS
1016 Ciprofloxacin
ciprofloxacin
(ciprofloxacin
hydrochloride)
tablets film-coated500mg,
in blister (10)
Borisov Medical
Preparations Plant
OJSC, 64/27,
Chapayev str., Borisov
222120, Minsk oblast
Belarus J01MA02 1221707.03.2013
07.03.2018PoM
Borisov Medical
Preparations Plant
OJSC, 64/27,
Chapayev str.,
Borisov 222120,
Minsk oblast,
BELARUS
1017 Ciprofloxacin
ciprofloxacin
(ciprofloxacin
hydrochloride)
drops eye/ear3mg/ml,
5ml plastic vial-dropper
S.C. Rompharm
Company S.R.L.,
Ilfov, 075100
Otopeni, Str. Eroilor,
Nr. 1A
Romania S01AE03 1603217.10.2016
17.10.2021PoM
S.C. Rompharm
Company S.R.L.,
Ilfov, 075100
Otopeni, Str. Eroilor,
Nr. 1A, Romania
1018 Ciprofloxacin
ciprofloxacin
(ciprofloxacin
hydrochloride)
drops eye3mg/ml,
10ml plastic vial-dropper
Liqvor CJSC, 0089,
Yerevan, str.
Kochinyan, 7/9
Republic of
ArmeniaS01AE03 16148
23.11.2016
23.11.2021PoM
Liqvor CJSC, 0089,
Yerevan, str.
Kochinyan, 7/9,
Republic of Armenia
221
1019 Ciprofloxacin
ciprofloxacin
(ciprofloxacin
hydrochloride)
solution for infusion2mg/ml,
200ml plastic pack
Liqvor CJSC, 0089,
Yerevan, str.
Kochinyan, 7/9
Republic of
ArmeniaJ01MA02 16264
19.12.2016
19.12.2021PoM
Liqvor CJSC, 0089,
Yerevan, str.
Kochinyan, 7/9,
Republic of Armenia
1020 Ciprofloxacin
ciprofloxacin
(ciprofloxacin
hydrochloride)
tablets film-coated250mg,
in blister (10/1x10/)
Open joint stock
company "Borisovskiy
zavod medicinskikh
preparatov" 64, ul.
Chapaeva, Borisov
222518, Minsk region
Belarus J01MA02 1717630.11.2017
30.11.2022PoM
Open joint stock
company "Borisovskiy
zavod medicinskikh
preparatov" 64, ul.
Chapaeva, Borisov
222518, Minsk
region, Belarus
1021 Ciprofloxacin
ciprofloxacin
(ciprofloxacin
hydrochloride)
tablets film-coated500mg,
in blister (10/1x10/)
Open joint stock
company "Borisovskiy
zavod medicinskikh
preparatov" 64, ul.
Chapaeva, Borisov
222518, Minsk region
Belarus J01MA02 1717730.11.2017
30.11.2022PoM
Open joint stock
company "Borisovskiy
zavod medicinskikh
preparatov" 64, ul.
Chapaeva, Borisov
222518, Minsk
region, Belarus
1022Ciprofloxacin
Alkaloidciprofloxacin
concentrate for
solution for infusion
10mg/ml,
10ml ampoules,
in blister (5)
Alkaloid AD Skopje,
Blvd. Aleksandar
Makedonski 12, 1000
Skopje-batch releaser,
secondary packager,
Mefar Ilac Sanayii
A.S., Ramazanoglu,
Mah. Ensar-Cad.
No:20, 34906 Kurtkoy-
Pendik, Istanbul,
Turkey- bulk
manufacturer,
primary packager
Macedonia J01MA02 1634330.12.2016
30.12.2021PoM
Alkaloid AD Skopje,
Blvd. Aleksandar
Makedonski 12, 1000
Skopje, Macedonia
222
1023Ciprofloxacin-
Asteria Tab. 500mg
ciprofloxacin
(ciprofloxacin
hydrochloride)
tablets film-coated
500mg,
in blister (20/2x10/,
100/10x10/)
Hankook Korus
Pharm Co., Ltd, 30,
Gangjeo-ro, Jecheon-
si, Chungcheongbuk-
do
Korea Sourth J01MA02 13669/209.10.2015
08.07.2019PoM
GL Corporation,
Woori Venture
Tower #201, 70,
Seonyu-ro,
Yeongdeungpo-ku,
Seoul, Korea South
1024Ciprofloxacin-
Asteria Tab. 500mg
ciprofloxacin
(ciprofloxacin
hydrochloride)
tablets film-coated
500mg,
in blister (20/2x10/,
100/10x10/)
Hankook Korus
Pharm Co., Ltd, 30,
Gangjeo-ro, Jecheon-
Si, Chungcheongbuk-
do
Korea South J01MA02 1719208.12.2017
08.12.2022PoM
GL Corporation,
Woori Venture
Tower 201, 70,
Seonyu-ro,
YoungDeungPo-Ku,
Seoul, South Korea
1025 Cipro-Tech 0,2%
ciprofloxacin
(ciprofloxacin
hydrochloride)
solution for infusion2mg/ml; 100ml and
200ml plastic pack
PharmaTech CJSC,
0064, Yerevan, Raffi
str. 111
Republic of
ArmeniaJ01MA02 15431
02.04.2016
02.04.2021PoM
PharmaTech CJSC,
0064, Yerevan, Raffi
str. 111, Republic of
Armenia
1026CIPRO-TRO
500mg
ciprofloxacin
(ciprofloxacin
hydrochloride)
tablets film-coated500mg,
in blister (10/1x10/)
S Kant Healthcare
LTD, Plot 1802-1805,
GIDC Phase III, Vapi -
396 195
India J01MA02 1717830.11.2017
30.11.2022PoM
Troge Medical
GmbH, Milchstrasse
19, 20148 Hamburg,
Germany
1027
Cisplatin 1mg/ml
Concentrate for
Solution for
Infusion
cisplatinconcentrate for
solution for infusion
1mg/1ml,
50ml glass vial (1)
Accord Healthcare
Limited, Sage House,319
Pinner Road, North
Harrow, Middlesex, HA1
4HF - batch releaser (bulk
manufacturer, primary
packager- Intas
Pharmaceuticals Limited,
Plot No 457 & 458 &
191/218 P, Sarkhej-Bavla
Highway, Matoda Village,
Sanand, District-
Ahmedabad, 382 210,
Gujarat, India) (secondary
packager- Accord
Healthcare Limited, Unit C
& D, Homefield Business
Park, Homefield Road,
Haverhill, CB9 8QP, UK)
UK L01XA01 14664/109.07.2015
29.06.2020PoM
Accord Healthcare
Limited, Sage
House,319 Pinner
Road, North Harrow,
Middlesex, HA1 4HF,
UK
223
1028
Cisplatin 1mg/ml
Concentrate for
Solution for
Infusion
cisplatinconcentrate for
solution for infusion
1mg/1ml,
25ml glass vial (1)
Accord Healthcare
Limited, Sage House,319
Pinner Road, North
Harrow, Middlesex, HA1
4HF - batch releaser (bulk
manufacturer, primary
packager- Intas
Pharmaceuticals Limited,
Plot No 457 & 458 &
191/218 P, Sarkhej-Bavla
Highway, Matoda Village,
Sanand, District-
Ahmedabad, 382 210,
Gujarat, India) (secondary
packager- Accord
Healthcare Limited, Unit C
& D, Homefield Business
Park, Homefield Road,
Haverhill, CB9 8QP, UK)
UK L01XA01 14665/109.07.2015
29.06.2020PoM
Accord Healthcare
Limited, Sage
House,319 Pinner
Road, North Harrow,
Middlesex, HA1 4HF,
UK
1029
Cisplatin 1mg/ml
Concentrate for
Solution for
Infusion
cisplatinconcentrate for
solution for infusion
1mg/1ml,
10ml glass vial (1)
Accord Healthcare
Limited, Sage House,319
Pinner Road, North
Harrow, Middlesex, HA1
4HF - batch releaser (bulk
manufacturer, primary
packager- Intas
Pharmaceuticals Limited,
Plot No 457 & 458 &
191/218 P, Sarkhej-Bavla
Highway, Matoda Village,
Sanand, District-
Ahmedabad, 382 210,
Gujarat, India) (secondary
packager- Accord
Healthcare Limited, Unit C
& D, Homefield Business
Park, Homefield Road,
Haverhill, CB9 8QP, UK)
UK L01XA01 14666/109.07.2015
29.06.2020PoM
Accord Healthcare
Limited, Sage
House,319 Pinner
Road, North Harrow,
Middlesex, HA1 4HF,
UK
224
1030
Cisplatin 1mg/ml
Concentrate for
Solution for
Infusion
cisplatinconcentrate for
solution for infusion
1mg/1ml,
10ml glass vial (1)
Accord Healthcare
Limited, Sage House,319
Pinner Road, North
Harrow, Middlesex, HA1
4HF - batch releaser (bulk
manufacturer, primary
packager- Intas
Pharmaceuticals Limited,
Plot No 5/6/7, Pharmez,
Near Village Matoda,
Sarkhej-Bavla Highway,
NH-8A, Matoda, District-
Ahmedabad, 382 210,
Gujarat, India) (secondary
packager- Accord
Healthcare Limited, Unit C
& D, Homefield Business
Park, Homefield Road,
Haverhill, CB9 8QP, UK)
UK L01XA01 14667/109.07.2015
29.06.2020PoM
Accord Healthcare
Limited, Sage
House,319 Pinner
Road, North Harrow,
Middlesex, HA1 4HF,
UK
1031
Cisplatin 1mg/ml
Concentrate for
Solution for
Infusion
cisplatinconcentrate for
solution for infusion
1mg/1ml,
25ml glass vial (1)
Accord Healthcare
Limited, Sage House,319
Pinner Road, North
Harrow, Middlesex, HA1
4HF - batch releaser (bulk
manufacturer, primary
packager- Intas
Pharmaceuticals Limited,
Plot No 5/6/7, Pharmez,
Near Village Matoda,
Sarkhej-Bavla Highway,
NH-8A, Matoda, District-
Ahmedabad, 382 210,
Gujarat, India) (secondary
packager- Accord
Healthcare Limited, Unit C
& D, Homefield Business
Park, Homefield Road,
Haverhill, CB9 8QP, UK)
UK L01XA01 14668/109.07.2015
29.06.2020PoM
Accord Healthcare
Limited, Sage
House,319 Pinner
Road, North Harrow,
Middlesex, HA1 4HF,
UK
225
1032
Cisplatin 1mg/ml
Concentrate for
Solution for
Infusion
cisplatinconcentrate for
solution for infusion
1mg/1ml,
100ml glass vial (1)
Accord Healthcare
Limited, Sage House,319
Pinner Road, North
Harrow, Middlesex, HA1
4HF - batch releaser (bulk
manufacturer, primary
packager- Intas
Pharmaceuticals Limited,
Plot No 457 & 458 &
191/218 P, Sarkhej-Bavla
Highway, Matoda Village,
Sanand, District-
Ahmedabad, 382 210,
Gujarat, India) (secondary
packager- Accord
Healthcare Limited, Unit C
& D, Homefield Business
Park, Homefield Road,
Haverhill, CB9 8QP, UK)
UK L01XA01 14669/109.07.2015
29.06.2020PoM
Accord Healthcare
Limited, Sage
House,319 Pinner
Road, North Harrow,
Middlesex, HA1 4HF,
UK
1033
Cisplatin 1mg/ml
Concentrate for
Solution for
Infusion
cisplatinconcentrate for
solution for infusion
1mg/1ml,
50ml glass vial (1)
Accord Healthcare
Limited, Sage House,319
Pinner Road, North
Harrow, Middlesex, HA1
4HF - batch releaser (bulk
manufacturer, primary
packager- Intas
Pharmaceuticals Limited,
Plot No 5/6/7, Pharmez,
Near Village Matoda,
Sarkhej-Bavla Highway,
NH-8A, Matoda, District-
Ahmedabad, 382 210,
Gujarat, India) (secondary
packager- Accord
Healthcare Limited, Unit C
& D, Homefield Business
Park, Homefield Road,
Haverhill, CB9 8QP, UK)
UK L01XA01 14670/109.07.2015
29.06.2020PoM
Accord Healthcare
Limited, Sage
House,319 Pinner
Road, North Harrow,
Middlesex, HA1 4HF,
UK
226
1034
Cisplatin 1mg/ml
Concentrate for
Solution for
Infusion
cisplatinconcentrate for
solution for infusion
1mg/1ml,
100ml glass vial (1)
Accord Healthcare
Limited, Sage House,319
Pinner Road, North
Harrow, Middlesex, HA1
4HF - batch releaser (bulk
manufacturer, primary
packager- Intas
Pharmaceuticals Limited,
Plot No 5/6/7, Pharmez,
Near Village Matoda,
Sarkhej-Bavla Highway,
NH-8A, Matoda, District-
Ahmedabad, 382 210,
Gujarat, India) (secondary
packager- Accord
Healthcare Limited, Unit C
& D, Homefield Business
Park, Homefield Road,
Haverhill, CB9 8QP, UK)
UK L01XA01 14671/109.07.2015
29.06.2020PoM
Accord Healthcare
Limited, Sage
House,319 Pinner
Road, North Harrow,
Middlesex, HA1 4HF,
UK
1035 Cisplatin Ebewe cisplatinconcentrate for
solution for infusion
0,5mg/ml,
100ml glass vial (1)
EBEWE Pharma Ges.
m.b.H. Nfg. KG,
Mondseestrasse 11, A-
4866 Unterach am
Attersee
Austria L01XA01 1391429.10.2014
29.10.2019PoM
EBEWE Pharma Ges.
m.b.H. Nfg. KG,
Mondseestrasse 11, A-
4866 Unterach am
Attersee, Austria
1036Cisplatin-Asteria
Inj. 50mg/50mlcisplatin solution for injection
1mg/ml,
50ml glass bottle
Hankook Korus
Pharm Co., Ltd, 78
Daepungsandan-ro,
Daeso-myeon,
Eumseong-gun,
Chungcheongbuk-do
Korea Sourth L01XA01 12655/120.08.2015
04.07.2018PoM
GL Corporation,
Woori Venture
Tower #201, 70,
Seonyu-ro,
Yeongdeungpo-ku,
Seoul, Korea South
1037Cisplatin-Asteria
Inj. 50mg/50mlcisplatin
solution for i/v
injection
1mg/ml,
50ml glass vial
Hankook Korus
Pharm Co., Ltd, 78
Daepungsandan-ro,
Daeso-myeon,
Eumseong-gun,
Chungcheongbuk-do
Korea South L01XA01 1680422.06.2017
22.06.2022PoM
GL Corporation,
Woori Venture
Tower 201, 70,
Seonyu-ro,
YoungDeungPo-Ku,
Seoul, Korea South
227
1038 Cisplatin-Teva cisplatinconcentrate for
solution for infusion
0,5mg/ml,
20ml, 50ml and 100ml
glass bottle
Pharmachemie B.V.
Swensweg 5, NL 2031
GA Haarlem
the Netherlands L01XA01 1356910.06.2014
10.06.2019PoM
TEVA
Pharmaceutical
Industries LTD, 5
Basel str., P.O. Box
3190, 49131 Petach
Tikva, Israel
1039 Cisplatin-Teva cisplatinconcentrate for
solution for infusion
1mg/ml,
100ml glass bottle
Pharmachemie B.V.
Swensweg 5, NL 2031
GA Haarlem
the Netherlands L01XA01 1357010.06.2014
10.06.2019PoM
TEVA
Pharmaceutical
Industries LTD, 5
Basel str., P.O. Box
3190, 49131 Petach
Tikva, Israel
1040 CITOLEPTciticoline (citicoline
sodium)
solution for i/v and
i/m injection
250mg/ml,
4ml ampoules,
in blister (5/1x5/)
"Sotex"PharmFirm"
CJSC, Bld. 10, 11, 12,
village Belikovo, rural
settlement
Bereznjakovskoe,
Sergiev-Posad
municipal district,
Moscow Region,
141345
Russia N06BX06 1644906.03.2017
06.03.2022PoM
"Sotex"PharmFirm"
CJSC, Bld. 11, village
Belikovo, rural
settlement
Bereznjakovskoe,
Sergiev-Posad
municipal district,
Moscow Region,
141345, Russia
1041 CITOLEPTciticoline (citicoline
sodium)
solution for i/v and
i/m injection
125mg/ml,
4ml ampoules,
in blister (5/1x5/)
"Sotex"PharmFirm"
CJSC, Bld. 10, 11, 12,
village Belikovo, rural
settlement
Bereznjakovskoe,
Sergiev-Posad
municipal district,
Moscow Region,
141345
Russia N06BX06 1645006.03.2017
06.03.2022PoM
"Sotex"PharmFirm"
CJSC, Bld. 11, village
Belikovo, rural
settlement
Bereznjakovskoe,
Sergiev-Posad
municipal district,
Moscow Region,
141345, Russia
1042 Citramon P
acetylsalicylic acid,
paracetamol,
caffeine (caffeine
monohydrate)
tablets240mg+180mg+ 30mg, in
strip (6, 10)
Irbitskiy
himfarmzavod JSC,
643 RU, Irbit, St.
Sverdlovsk, K. Marksa
str., 124
Russia N02BA71 1500702.12.2015
02.12.2020OTC
Irbitskiy
himfarmzavod JSC,
643 RU, Irbit, St.
Sverdlovsk, Kirova
str., 172, Russia
228
1043 Citramon-P
acetylsalicylic acid,
paracetamol,
caffeine (caffeine
monohydrate)
tablets
240mg+180mg+ 30mg,
in blister (10/1x10/,
20/2x10/)
Pharmstandard-
Leksredstva OJSC,
305022, Kursk,
Agregatnaya 2nd str.,
1a/18
Russia N02BA71 12357/104.09.2013
09.04.2018OTC
Pharmstandard-
Leksredstva OJSC,
305022, Kursk,
Agregatnaya 2nd str.,
1a/18, Russia
1044 Clacin-Asteria clarithromycin tablets
500mg,
in blister (10/1x10/,
100/10x10/)
Hankook Korus
Pharm Co., Ltd, 30,
Gangjeo-ro, Jecheon-
si, Chungcheongbuk-
do
Korea Sourth J01FA09 1525329.12.2015
29.12.2020PoM
GL Corporation,
Woori Venture
Tower #201, 70,
Seonyu-ro,
Yeongdeungpo-ku,
Seoul, South Korea
1045 Clafendiclofenac
(diclofenac sodium)gel
50mg/g,
45g aluminium tube
Antibiotice S.A., 1,
Valea Lupului,
707410 lasi
Romania M02AA15 1687031.07.2017
31.07.2022OTC
Antibiotice S.A., 1,
Valea Lupului,
707410 lasi, Romania
1046 Claforan
cefotaxime
(cefotaxime
sodium)
powder and solvent
for solution for
injection
1000mg,
glass vial and 4ml solvent
in ampoule
Zentiva Saglik
Urunleri San.ve Tic.
A.S., Kucukkaristiran
Mahalessi, Merkez
Sokak No:223/A,
39780
Buyukkaristiran,
Luleburgaz, Kirklareli
Turkey J01DD01 1592423.08.2016
23.08.2021PoM
Sanofi Aventis Ilaclari
Ltd. Sti., Buyukdere
Cad. No:193 Levent
34394 Sisli-Istanbul,
Turkey
1047 Clarazole Cream ketoconazole cream20mg/g,
30g aluminium tube
Medpharma Pharm .
& Chem. Inds LLC,
Sharjah, Industrial
Area 13, P.O. Box:
25235
United Arab
EmiratesD01AC08 13668
08.07.2014
08.07.2019OTC
Medpharma Pharm .
& Chem. Inds LLC,
Sharjah, Industrial
Area 13, P.O. Box:
25235, United Arab
Emirates
1048 Clarem 250 clarithromycin tablets film-coated250mg,
in blister (14/2x7/)
Remedica Ltd,
Aharnon street,
Limassol Industrial
Estate, 3056 Limassol
Cyprus J01FA09 1586127.07.2016
27.07.2021PoM
Remedica Ltd,
Aharnon street,
Limassol Industrial
Estate, 3056 Limassol,
Cyprus
229
1049 Clarem 500 clarithromycin tablets film-coated500mg,
in blister (14/2x7/)
Remedica Ltd,
Aharnon street,
Limassol Industrial
Estate, 3056 Limassol
Cyprus J01FA09 1586227.07.2016
27.07.2021PoM
Remedica Ltd,
Aharnon street,
Limassol Industrial
Estate, 3056 Limassol,
Cyprus
1050 Clarithromycin clarithromycin tablets coated250mg,
in blister (10)
Open joint stock
company, Borisovskiy
zavod medicinskikh
preparatov, 64/27,
Chapaev str., Borisov
222120, Minsk region
Belarus J01FA09 1328404.03.2014
04.03.2019PoM
Open joint stock
company, Borisovskiy
zavod medicinskikh
preparatov, 64/27,
Chapaev str., Borisov
222120, Minsk
region, Belarus
1051
Clarithromycin
250mg Film-coated
Tablets
clarithromycin tablets film-coated250mg,
in blister (14/1x14/)
Accord Healthcare
Limited, Sage House, 319
Pinner Road, North
Harrow, Middlesex, HA1
4HF - batch releaser, Intas
Pharmaceuticals Limited,
Plot No 457 & 458 &
191/218 P, Sarkhej-Bavla
Highway, Matoda Village,
Sanand, District-
Ahmedabad, 382 210,
Gujarat, India- bulk
manufacturer, Accord
Healthcare Limited, Unit C
& D, Homefield Business
Park, Homefield Road,
Haverhill, CB9 8QP, UK-
primary and secondary
packager
UK J01FA09 1541822.03.2016
22.03.2021PoM
Accord Healthcare
Limited, Sage
House,319 Pinner
Road, North Harrow,
Middlesex, HA1 4HF,
UK
230
1052
Clarithromycin
250mg Film-coated
Tablets
clarithromycin tablets film-coated250mg; (14/1x14/), in
blister
Accord Healthcare
Limited, Sage House,319
Pinner Road, North
Harrow, Middlesex, HA1
4HF- batch releaser, Intas
Pharmaceuticals Limited,
Plot No 5/6/7, Pharmez,
Near Village Matoda,
Sarkhej-Bavla Highway,
NH-8A, Matoda, District-
Ahmedabad, 382 210,
Gujarat, India- bulk
manufacturer, Accord
Healthcare Limited, Unit C
& D, Homefield Business
Park, Homefield Road,
Haverhill, CB9 8QP, UK-
primary and secondary
packager
UK J01FA09 1541922.03.2016
22.03.2021PoM
Accord Healthcare
Limited, Sage
House,319 Pinner
Road, North Harrow,
Middlesex, HA1 4HF,
UK
1053
Clarithromycin
500mg Film-coated
Tablets
clarithromycin tablets film-coated500mg,
in blister (14/1x14/)
Accord Healthcare
Limited, Sage House,319
Pinner Road, North
Harrow, Middlesex, HA1
4HF- batch releaser, Intas
Pharmaceuticals Limited,
Plot No 5/6/7, Pharmez,
Near Village Matoda,
Sarkhej-Bavla Highway,
NH-8A, Matoda, District-
Ahmedabad, 382 210,
Gujarat, India- bulk
manufacturer, Accord
Healthcare Limited, Unit C
& D, Homefield Business
Park, Homefield Road,
Haverhill, CB9 8QP, UK-
primary and secondary
packager
UK J01FA09 1542022.03.2016
22.03.2021PoM
Accord Healthcare
Limited, Sage
House,319 Pinner
Road, North Harrow,
Middlesex, HA1 4HF,
UK
231
1054
Clarithromycin
500mg Film-coated
Tablets
clarithromycin tablets film-coated500mg,
in blister (14/1x14/)
Accord Healthcare
Limited, Sage House, 319
Pinner Road, North
Harrow, Middlesex, HA1
4HF - batch releaser, Intas
Pharmaceuticals Limited,
Plot No 457 & 458 &
191/218 P, Sarkhej-Bavla
Highway, Matoda Village,
Sanand, District-
Ahmedabad, 382 210,
Gujarat, India- bulk
manufacturer, Accord
Healthcare Limited, Unit C
& D, Homefield Business
Park, Homefield Road,
Haverhill, CB9 8QP, UK-
primary and secondary
packager
UK J01FA09 1542122.03.2016
22.03.2021PoM
Accord Healthcare
Limited, Sage
House,319 Pinner
Road, North Harrow,
Middlesex, HA1 4HF,
UK
1055Clarithromycin
Grindeksclarithromycin tablets film-coated
250mg,
in blister (14/2x7/)
Bluepharma -
Industria
Farmaceutica, S.A., S.
Martinho do Bispo,
Coimbra, 3045-016
Portugal J01FA09 1401626.11.2014
26.11.2019PoM
Grindeks JSC,
Krustpils str. 53, LV-
1057, Riga, Latvia
1056Clarithromycin
Grindeksclarithromycin tablets film-coated
500mg,
in blister (14/2x7/)
Bluepharma -
Industria
Farmaceutica, S.A., S.
Martinho do Bispo,
Coimbra, 3045-016
Portugal J01FA09 1401726.11.2014
26.11.2019PoM
Grindeks JSC,
Krustpils str. 53, LV-
1057, Riga, Latvia
1057 Claritine loratadine syrup
1mg/ml,
60ml and 120ml glass
bottle and measuring
spoon
Schering-Plough Labo
N.V., Industriepark
30 B-2220, Heist-op-
den-Berg
Belgium R06AX13 13614/107.12.2015
27.06.2019OTC
Bayer Consumer Care
AG, Peter Merian-
Strasse 84, 4052 Basel,
Switzerland
1058 Claritine loratadine tablets10mg,
blister (10/1x10/)
Schering-Plough Labo
N.V Industriepark 30,
B-2220 Heist op-den-
Berg
Belgium R06AX13 13707/101.09.2016
24.07.2019OTC
Bayer Consumer Care
AG, Peter Merian-
Strasse 84, 4052 Basel,
Switzerland
232
1059 ClariTRONN clarithromycin tablets film-coated
500mg,
in blister (10/1x10/,
100/10x10/)
Protech Biosystems
Pvt. Ltd., Plot No 145-
146, Pace City-1,
Sector-37, Gurgaon,
Haryana-122001
India J01FA09 13123/104.06.2014
10.01.2019PoM
Protech Biosystems
Pvt. Ltd., Plot No 145-
146, Pace City-1,
Sector-37, Gurgaon,
Haryana-122001,
India
1060 ClariXyz desloratadine tablets film-coated5mg,
in blister (100/10x10/)
Orion Pharma Ltd.,
Orion House, 153-154
Tejgaon Industrial
Area, Dhaka-1208
Bangladesh R06AX27 13674/126.09.2014
08.07.2019OTC
Orion Pharma Ltd.,
Orion House, 153-154
Tejgaon Industrial
Area, Dhaka-1208,
Bangladesh
1061 ClariXyz desloratadine syrup
0,5mg/ml,
60ml glass bottle and
double-ended measuring
spoon (2,5ml/5ml)
Orion Pharma Ltd.,
Orion House, 153-154
Tejgaon Industrial
Area, Dhaka-1208
Bangladesh R06AX27 13675/126.09.2014
08.07.2019OTC
Orion Pharma Ltd.,
Orion House, 153-154
Tejgaon Industrial
Area, Dhaka-1208,
Bangladesh
1062 Clavoton 1g
amoxicillin
(amoxicillin
trihydrate),
clavulanic acid
(potassium
clavulanate)
tablets film-coated875mg+125mg,
in blister (14/2x7/)
Medochemie Ltd-
Factory B, 48 Iapetou
street, Agios
Athanassios Industrial
Area, 4101 Agios
Athanassios, Limassol
Cyprus J01CR02 1498718.11.2015
18.11.2020PoM
Medochemie Ltd., 1-
10
Constantinoupoleos
street, 3011 Limassol,
Cyprus
1063 Clemastin
clemastine
(clemastine
fumarate)
solution for injection
1mg/ml,
2ml ampoules (10), 2ml
ampoules, dividella (10)
Open Joint Stock
Company , 64/27,
Chapayev str., Borisov
222120, Minsk oblast
Belarus R06AA04 1303625.11.2013
25.11.2018PoM
Open Joint Stock
Company , 64/27,
Chapayev str.,
Borisov 222120,
Minsk oblast, Belarus
1064 Clexane
enoxaparin
(enoxaparin
sodium)
solution for injection
20mg/0,2ml,
0,2ml pre-filled syringes
(2)
Sanofi Winthrop
Industrie, 180, rue
Jean Jaures, 94702
Maisons-Alfort Cedex
France B01AB05 12650/127.06.2017
04.07.2018PoM
Sanofi-Aventis
France, 82 avenue
Raspail, 94250
Gentilly, France
233
1065 Clexane
enoxaparin
(enoxaparin
sodium)
solution for injection
40mg/0,4ml,
0,4ml pre-filled syringes
(10/2x5/)
Sanofi Winthrop
Industrie, 180, rue
Jean Jaures, 94702
Maisons-Alfort Cedex
France B01AB05 12651/127.06.2017
04.07.2018PoM
Sanofi-Aventis
France, 82 avenue
Raspail, 94250
Gentilly, France
1066 Clexane
enoxaparin
(enoxaparin
sodium)
solution for injection
60mg/0,6ml,
0,6ml pre-filled syringes
(2)
Sanofi Winthrop
Industrie, 180, rue
Jean Jaures, 94702
Maisons-Alfort Cedex
France B01AB05 12652/127.06.2017
04.07.2018PoM
Sanofi-Aventis
France, 82 avenue
Raspail, 94250
Gentilly, France
1067 Clexane
enoxaparin
(enoxaparin
sodium)
solution for injection
80mg/0,8ml,
0,8ml pre-filled syringes
(10/2x5/)
Sanofi Winthrop
Industrie, 180, rue
Jean Jaures, 94702
Maisons-Alfort Cedex
France B01AB05 12653/127.06.2017
04.07.2018PoM
Sanofi-Aventis
France, 82 avenue
Raspail, 94250
Gentilly, France
1068 Clexepar
enoxaparin
(enoxaparin
sodium)
solution for injection
20mg/0,2ml,
0,2ml pre-filled syringes
(6)
Gland Pharma Ltd,
Survey No: 143 - 148,
150&151, D.P. Pally,
Dundigal Post,
Qutbullapur Mandal,
Ranga Reddy District,
Hyderabad, 500 043,
Telangana State
India B01AB05 1693428.08.2017
28.08.2022PoM
APC Pharmaceuticals
& Chemicals (Europe)
Ltd., 9TH Floor, C P
House, 97-107
Uxbridge Road,
Ealing, London W5
5TL, UK
1069 Clexepar
enoxaparin
(enoxaparin
sodium)
solution for injection
40mg/0,4ml,
0,4ml pre-filled syringes
(6)
Gland Pharma Ltd,
Survey No: 143 - 148,
150&151, D.P. Pally,
Dundigal Post,
Qutbullapur Mandal,
Ranga Reddy District,
Hyderabad, 500 043,
Telangana State
India B01AB05 1693528.08.2017
28.08.2022PoM
APC Pharmaceuticals
& Chemicals (Europe)
Ltd., 9TH Floor, C P
House, 97-107
Uxbridge Road,
Ealing, London W5
5TL, UK
234
1070Climaxan
homeopatic
cimicifuga racemosa
C200, lachesis
mutus C50, apis
mellifica C200
tabletsin blister (20/1x20/,
40/2x20/)
NPF Materia Medica
Holding LLC, 54,
Buguruslanskaya st.,
Chelyabinsk 454139
Russiahomeopathic
drug14296/1
31.07.2015
19.03.2020OTC
NPF Materia Medica
Holding LLC, 9 bld.,
3rd Samotyochny
per., Moscow 127473,
Russia
1071 Clindabiox
clindamycin
(clindamycin
phosphate)
suppositories vaginal100mg
(3/1x3/)
Farmaprim SRL,
Crinilor str., 5,
Porumbeni, Criuleni
dis., MD-4829
Moldova G01AA10 1346306.05.2014
06.05.2019PoM
Farmaprim SRL,
Crinilor str., 5,
Porumbeni, Criuleni
dis., MD-4829,
Moldova
1072 Clindamycin
clindamycin
(clindamycin
hydrochloride)
capsules150mg,
in blister (16)
Chanelle Medical,
Loughrea, Co. Galway Ireland J01FF01 12544
06.06.2013
06.06.2018PoM
Ritm Farm LTD, 11/2
Totovents Street,
Apartment 34,
Yerevan, Armenia
1073 Clindamycin
clindamycin
(clindamycin
hydrochloride)
capsules300mg,
in blister (16)
Chanelle Medical,
Loughrea, Co. Galway Ireland J01FF01 12545
06.06.2013
06.06.2018PoM
Ritm Farm LTD, 11/2
Totovents Street,
Apartment 34,
Yerevan, Armenia
1074 Clobetasol
clobetasol
(clobetasol
propionate)
cream for topical use0,5mg/g,
15g aluminium tube
Arpimed LLC, Kotayk
Marz, Abovyan, 2nd
Micro-District, 19
Building
Republic of
ArmeniaD07AD01 12807
05.10.2013
05.10.2018PoM
Arpimed LLC,
Kotayk Marz,
Abovyan, 2nd Micro-
District, 19 Building,
Republic of Armenia
1075 Clobetasol
clobetasol
(clobetasol
propionate)
ointment for topical
use
0,5mg/g,
15g aluminium tube
Arpimed LLC, Kotayk
Marz, Abovyan, 2nd
Micro-District, 19
Building
Republic of
ArmeniaD07AD01 12808
05.10.2013
05.10.2018PoM
Arpimed LLC,
Kotayk Marz,
Abovyan, 2nd Micro-
District, 19 Building,
Republic of Armenia
235
1076 Clogrel
clopidogrel
(clopidogrel
besilate)
tablets film-coated75mg,
in blister (28/2x14/)
Specifar SA, 1, 28
Octovriou str., Agia
Varvara, 12351
Greece B01AC04 1666011.05.2017
11.05.2022PoM
Pharmaceutical
Works Polpharma
S.A., ul. Pelplinska
19, 83-200 Starogard
Gdanski, Poland
1077 Clomentin
escitalopram
(escitalopram
oxalate)
tablets film-coated20mg,
in blister (28/2x14/)
Delorbis
Pharmaceuticals Ltd.,
17 Athinon Street,
Ergates Industrial
Area, 2643 Ergates,
P.O. Box 28629, 2081
Lefkosia
Cyprus N06AB10 13609/102.12.2014
20.06.2019PoM
Delorbis
Pharmaceuticals Ltd.,
17 Athinon Street,
Ergates Industrial
Area, 2643 Ergates,
P.O. Box 28629, 2081
Lefkosia, Cyprus
1078 Clomezole
metronidazole,
neomycin
(neomycin sulfate),
clotrimazole
suppositories vaginal500mg+200mg+ 150mg,
(10/2x5/)
Farmaprim SRL,
Crinilor str., 5,
Porumbeni, Criuleni
dis., MD-4829
Moldova G01AF20 1362427.06.2014
27.06.2019PoM
Farmaprim SRL,
Crinilor str., 5,
Porumbeni, Criuleni
dis., MD-4829,
Moldova
1079 Clonazepam clonazepam tablets2mg,
in blister (24)
Arpimed LLC, Kotayk
Marz, Abovyan, 2nd
Micro-District, 19
Building
Republic of
ArmeniaN03AE01 12723
23.07.2013
23.07.2018PoM/UC
Arpimed LLC,
Kotayk Marz,
Abovyan, 2nd Micro-
District, 19 Building,
Armenia
1080 Clonazepam clonazepam tablets2mg,
in blister (30/1x30/)
Tarchomin
Pharmaceutical
Works "Polfa" S.A.,
2,A. Fleminga str.,03-
176 Warsaw
Poland N03AE01 1581520.07.2016
20.07.2021PoM/UC
Tarchomin
Pharmaceutical
Works "Polfa" S.A.,
2,A. Fleminga str.,03-
176 Warsaw, Poland
1081 Clopacin 75mg
clopidogrel
(clopidogrel
besilate)
tablets film-coated
75mg,
in blister (28/2x14/,
84/6x14/)
Acino Pharma AG,
Birsweg 2, CH-4253
Liesberg
Switzerland B01AC04 13449/130.06.2015
06.05.2019PoM
Acino Pharma AG,
Birsweg 2, CH-4253
Liesberg, Switzerland
236
1082 Clopi-Denk 75
clopidogrel
(clopidogrel
besylate)
tablets film-coated75mg,
in blister (30/3x10/)
Artesan Pharma
GmbH & Co. KG,
Wendlandstrasse 1,
29439 Luechow
Germany B01AC04 1405319.12.2014
19.12.2019PoM
Denk Pharma GmbH
& Co. KG,
Prinzregentenstr. 79,
81675 Muenchen,
Germany
1083 Clopidogrel
clopidogrel
(clopidogrel
bisulfate)
tablets coated75mg,
in blister (10, 30/3x10/)
Belmedpreparaty
RUE, 220007, Minsk,
Fabritsius St., 30
Belarus B01AC04 1410429.12.2014
29.12.2019PoM
Belmedpreparaty
RUE, 220007, Minsk,
Fabritsius St., 30,
Belarus
1084 Clopidol
clopidogrel
(clopidogrel
bisulfate)
tablets film-coated75mg,
in blister (20/2x10/)
Tufenkji Group LLC,
Kochinyan 13/16,
Yerevan- batch
releaser, packager,
Zim Laboratories Ltd.,
B-21/22, MIDC Area,
Kalmeshwar-441 501,
Dist. Nagpur (M.S.),
India- bulk
manufacturer
Republic of
ArmeniaB01AC04 16643
25.04.2017
25.04.2022PoM
Tufenkji Group LLC,
Kochinyan 13/16,
Yerevan, Republic of
Armenia
1085Clopiton 75mg film-
coated tablets
clopidogrel
(clopidogrel
bisulfate)
tablets film-coated75mg,
in blister (28/4x7/)
Medopharm, No 34-
B,Industrial Area,
Malur-563 130,
Karnataka for Troge
Medical GmbH,
Milchstrasse 19, D-
20148 Hamburg,
Germany
India B01AC04 12335/128.09.2013
09.04.2018PoM
Troge Medical
GmbH, Milchstrasse
19, D-20148
Hamburg, Germany
237
1086 Closan-50 closantelsolution for s/c
injection
50mg/ml,
100ml glass bottle
Interchemie werken
De Adelaar Eesti AS,
Vanapere tee 14,
Viimsi, Harju county-
bulk manufacturer,
primary packager,
batch releaser,
Interchemie werken
"De Adelaar" B.V.,
Metaalweg 8, 5804
CG Venray, the
Netherlands-
secondary packager
Estonia
QP52AG09;
veterinary
drug
1606417.10.2016
17.10.2021PoM
Interchemie werken
"De Adelaar" B.V.,
Metaalweg 8, 5804
CG Venray, the
Netherlands
1087 Clostilbegytclomifene
(clomifene citrate)tablets
50mg,
in glass vial (10)
Egis Pharmaceuticals
PLC, 9900, Kormend,
Matyas Kiraly u. 65
Hungary G03GB02 1610310.11.2016
10.11.2021PoM
Egis Pharmaceuticals
PLC, 1106 Budapest,
Kereszturi ut 30-38,
Hungary
1088Clotri-Denk100
Vaginalclotrimazole tablets vaginal
100mg,
in blister (6), applicator
Artesan Pharma
GmbH & Co. KG,
Wendlandstrasse 1,
29439 Luchow
Germany G01AF02 1285917.09.2013
17.09.2018PoM
Denk Pharma GmbH
& Co. KG,
Prinzregentenstr. 79,
81675 Munchen,
Germany
1089 Clotrimazol clotrimazole spray
10mg/ml,
20g plastic container with
pump dispenser
S.C. Rompharm
Company S.R.L.,
Ilfov, 075100
Otopeni, Str. Eroilor,
Nr. 1A
Romania D01AC01 1678022.06.2017
22.06.2022OTC
S.C. Rompharm
Company S.R.L.,
Ilfov, 075100
Otopeni, Str. Eroilor,
Nr. 1A, Romania
1090 Clotrimazole clotrimazole cream for topical use10mg/g,
15g aluminium tube
Arpimed LLC, Kotayk
Marz, Abovyan, 2nd
Micro-District, 19
Building
Republic of
ArmeniaD01AC01 12462
11.08.2013
11.08.2018OTC
Arpimed LLC,
Kotayk Marz,
Abovyan, 2nd Micro-
District, 19 Building,
Republic of Armenia
238
1091 Clotrimazole clotrimazole cream vaginal20mg/g,
50g aluminium tube
Arpimed LLC, Kotayk
Marz, Abovyan, 2nd
Micro-District, 19
Building
Republic of
ArmeniaD01AC01 12463
11.08.2013
11.08.2018PoM
Arpimed LLC,
Kotayk Marz,
Abovyan, 2nd Micro-
District, 19 Building,
Republic of Armenia
1092 Clotrimazole clotrimazole solution topical10mg/ml,
30ml glass bottle
Arpimed LLC, Kotayk
Marz, Abovyan, 2nd
Micro-District, 19
Building
Republic of
ArmeniaD01AC01 12464
11.08.2013
11.08.2018OTC
Arpimed LLC,
Kotayk Marz,
Abovyan, 2nd Micro-
District, 19 Building,
Republic of Armenia
1093 Clotrimazole clotrimazole suppositories vaginal100mg
(6)
Farmaprim SRL,
Crinilor str., 5,
Porumbeni, Criuleni
dis., MD-4829
Moldova G01AF02 1316010.01.2014
10.01.2019PoM
Farmaprim SRL,
Crinilor str., 5,
Porumbeni, Criuleni
dis., MD-4829,
Moldova
1094 Clotrimazole clotrimazole cream10mg/g,
15g aluminium tube
Farmaprim SRL,
Crinilor str., 5,
Porumbeni, Criuleni
dis., MD-4829
Moldova D01AC01 1325524.02.2014
24.02.2019OTC
Farmaprim SRL,
Crinilor str., 5,
Porumbeni, Criuleni
dis., MD-4829,
Moldova
1095 Clotrimazole clotrimazolecream for external
use
10mg/g,
20g aluminium tube
GlaxoSmithKline
Pharmaceuticals
S.A.,189 Grunwaldzka
street, 60-322 Poznan
Poland D01AC01 1489924.09.2015
24.09.2020OTC
GlaxoSmithKline
Pharmaceuticals
S.A.,189
Grunwaldzka street,
60-322 Poznan,
Poland
1096 Clotrimazole clotrimazole tablets vaginal100mg,
in blister (6/1x6/)
GlaxoSmithKline
Pharmaceuticals
S.A.,189 Grunwaldzka
street, 60-322 Poznan
Poland G01AF02 1505102.12.2015
02.12.2020PoM
GlaxoSmithKline
Pharmaceuticals
S.A.,189
Grunwaldzka street,
60-322 Poznan,
Poland
239
1097 Clovate
clobetasol
(clobetasol
propionate)
ointment for
external use
0,5mg/g,
25g aluminium tube
Pharmaceutical
Company Jelfa S.A.,
ul. Wincentego Pola
21, 58-500 Jelenia
Gora
Poland D07AD01 1492720.10.2015
20.10.2020PoM
VALEANT LLC,
Shabolovka st. 31,
building 5, 115162,
Moscow, Russia
1098 Clovate
clobetasol
(clobetasol
propionate)
cream for external
use
0,5mg/g,
25g aluminium tube
Pharmaceutical
Company Jelfa S.A.,
ul. Wincentego Pola
21, 58-500 Jelenia
Gora
Poland D07AD01 1492820.10.2015
20.10.2020PoM
VALEANT LLC,
Shabolovka st. 31,
building 5, 115162,
Moscow, Russia
1099 Coal Tar coal tar shampoo20mg/ml,
100ml plastic bottle
Arpimed LLC, Kotayk
Marz, Abovyan, 2nd
Micro-District, 19
Building
Republic of
ArmeniaD11AC30 13949
29.10.2014
29.10.2019PoM
Arpimed LLC,
Kotayk Marz,
Abovyan, 2nd Micro-
District, 19 Building,
Republic of Armenia
1100 Co-Amlessa
perindopril
(perindopril tert-
butylamine),
indapamide,
amlodipine
(amlodipine
besilate)
tablets2mg+0,625mg+ 5mg,
in blister (30/3x10/)
KRKA d.d., Novo
mesto, Smarjeska
cesta 6, 8501 Novo
Mesto
Slovenia C09BX01 1585420.07.2016
20.07.2021PoM
KRKA d.d., Novo
mesto, Smarjeska
cesta 6, 8501 Novo
Mesto, Slovenia
1101 Co-Amlessa
perindopril
(perindopril tert-
butylamine),
indapamide,
amlodipine
(amlodipine
besilate)
tablets4mg+1,25mg+5mg, in
blister (30/3x10/)
KRKA d.d., Novo
mesto, Smarjeska
cesta 6, 8501 Novo
Mesto
Slovenia C09BX01 1585520.07.2016
20.07.2021PoM
KRKA d.d., Novo
mesto, Smarjeska
cesta 6, 8501 Novo
Mesto, Slovenia
1102 Co-Amlessa
perindopril
(perindopril tert-
butylamine),
indapamide,
amlodipine
(amlodipine
besilate)
tablets4mg+1,25mg+ 10mg,
in blister (30/3x10/)
KRKA d.d., Novo
mesto, Smarjeska
cesta 6, 8501 Novo
Mesto
Slovenia C09BX01 1585620.07.2016
20.07.2021PoM
KRKA d.d., Novo
mesto, Smarjeska
cesta 6, 8501 Novo
Mesto, Slovenia
240
1103 Co-Amlessa
perindopril
(perindopril tert-
butylamine),
indapamide,
amlodipine
(amlodipine
besilate)
tablets8mg+2,5mg+5mg, in
blister (30/3x10/)
KRKA d.d., Novo
mesto, Smarjeska
cesta 6, 8501 Novo
Mesto
Slovenia C09BX01 1585720.07.2016
20.07.2021PoM
KRKA d.d., Novo
mesto, Smarjeska
cesta 6, 8501 Novo
Mesto, Slovenia
1104 Co-Amlessa
perindopril
(perindopril tert-
butylamine),
indapamide,
amlodipine
(amlodipine
besilate)
tablets8mg+2,5mg+10mg, in
blister (30/3x10/)
KRKA d.d., Novo
mesto, Smarjeska
cesta 6, 8501 Novo
Mesto
Slovenia C09BX01 1585820.07.2016
20.07.2021PoM
KRKA d.d., Novo
mesto, Smarjeska
cesta 6, 8501 Novo
Mesto, Slovenia
1105 Coaxil tianeptine tablets coated12,5mg,
in blister (30/1x30/)
Les Laboratoires
Servier Industrie, 905,
route de Saran, 45520
Gidy
France N06AX14 1356710.06.2014
10.06.2019PoM/UC
Les Laboratoires
Servier, 50, rue
Carnot, 92284
Suresnes cedex,
France
1106 CocarBevit
disodium adenosine
triphosphate
trihydrate,
cocarboxylase,
cyanocobalamin,
nicotinamide
powder lyophilized
for solution for
injection
10mg+50mg+
500mcg+20mg, 2ml
ampoules (3) and 2ml
ampoules with solvent (3)
Biopharm JSC,
380060, 3 Gotua str.,
Tbilisi
Georgia C01EB 1462003.07.2015
03.07.2020PoM
GPC JSC, 6, Sanapiro
str., 0108, Tbilisi,
Georgia
1107Cocarboxylase
hydrochloride
cocarboxylase
(cocarboxylase
hydrochloride)
powder lyophilized
for solution for i/v &
i/m injection
50mg,
ampoules (5), 2ml
solvent in ampoules (5)
Pharmstandard-
UfaVITA OJSC,
450077, Ufa, str.
Khudajberdina 28
Russia A11DA 1224107.03.2013
07.03.2018PoM
Pharmstandard-
UfaVITA OJSC,
450077, Ufa, str.
Khudajberdina 28,
RUSSIA
1108Cocarboxylase
hydrochloride
cocarboxylase
(cocarboxylase
hydrochloride)
powder lyophilized
for solution for
injection
50mg,
ampoules (10) and 2ml
solvent in ampoule(10)
Biopharma PJSC,
03680, Kiev, N.
Amosova str. 9
Ukraine A11DA 1257606.06.2013
06.06.2018PoM
Biopharma PJSC,
03680, Kiev, N.
Amosova str. 9,
Ukraine
241
1109Cocarboxylase
hydrochloride
cocarboxylase
(cocarboxylase
hydrochloride)
powder lyophilized
for solution for
injection
50mg,
glass vial, in blister
(10/2x5/), glass vial
(10/1x10//(5)+ 2ml
solvent in ampoule/(5)),
in blister, glass vial
(20/2x10//(10)+ 2ml
solvent in ampoule/(10))
in blister
"BIOFARMA" "PP"
LLC, 37, Kyivska Str.,
Bila Tserkva, 09100,
Kyiv region
Ukraine A11DA 1602517.10.2016
17.10.2021PoM
"BIOFARMA" "PP"
LLC, 37, Kyivska Str.,
Bila Tserkva, 09100,
Kyiv region, Ukraine
1110 Codelac Broncho
ambroxol
(ambroxol
hydrochloride),
glycyrrhizinic acid
trisodium (sodium
glycyrrhizinate),
thermopsis extract,
sodium
hydrocarbonate
tablets
20mg+30mg+
10mg+200mg, blister
(10/1x10/, 20/2x10/)
Pharmstandard-
Leksredstva JSC,
305022, Kursk,
Agregatnaya 2nd str.,
1a/18
Russia R05CA10 14363/115.09.2016
25.03.2020OTC
OTCPharm PJSC,
123317, Moscow,
Testovskaya str., 10,
Russia
1111Codelac Broncho
with thyme
ambroxol
(ambroxol
hydrochloride),
glycyrrhizic acid
trisodium (sodium
glycyrrhizinate),
thyme extract
elixir
10mg/5ml+30mg/5ml+50
0mg/5ml; 100ml glass
bottle and measuring
spoon
Pharmstandard-
Leksredstva JSC,
305022, Kursk,
Agregatnaya 2nd str.,
1a/18
Russia R05CA10 1729026.12.2017
26.12.2021OTC
OTCPharm PJSC,
123317, Moscow,
Testovskaya str., 10,
Russia
1112 Codelac Neobutamirate
(butamirate citrate)
tablets modified-
release film-coated
50mg,
in blister (10/1x10/)
Pharmstandard-
UfaVITA OJSC,
450077, Ufa, str.
Khudaiberdina 28
Russia R05DB13 14833/129.01.2016
04.09.2020OTC
OTCPharm PJSC,
123317, Moscow,
Testovskaya str., 10,
Russia
1113 Co-Diovan
valsartan,
hydrochlorothia-
zide
tablets film-coated160mg+12,5mg,
in blister (14/1x14/)
Novartis Farma S.p.A.,
Via Provinciale Schito
131, 80058 Torre
Annunziata, (NA)
Italy C09DA03 1472615.07.2015
15.07.2020PoM
Novartis Pharma AG,
Lichtstrasse 35, 4056
Basel, Switzerland
242
1114 Co-Diovan
valsartan,
hydrochlorothia-
zide
tablets film-coated
80mg+12,5mg,
in blister (14/1x14/,
28/2x14/)
Novartis Farma S.p.A.,
Via Provinciale Schito
131, 80058 Torre
Annunziata, (NA)
Italy C09DA03 1472715.07.2015
15.07.2020PoM
Novartis Pharma AG,
Lichtstrasse 35, 4056
Basel, Switzerland
1115 Co-Diovan
valsartan,
hydrochlorothia-
zide
tablets film-coated80mg+12,5mg,
in blister (14/1x14/)
Novartis Farma S.p.A.,
Via Provinciale Schito
131, 80058 Torre
Annunziata, (NA)-
batch releaser, bulk
manufacturer,
Mipharm S.p.A., Via
Bernardo Quaranta,
12, IT-20141 Milano
(MI), Italy- packager
Italy C09DA03 1547102.04.2016
02.04.2021PoM
Novartis Pharma AG,
Lichtstrasse 35, 4056
Basel, Switzerland
1116 Co-Diovan
valsartan,
hydrochlorothia-
zide
tablets film-coated160mg+12,5mg,
in blister (14/1x14/)
Novartis Farma S.p.A.,
Via Provinciale Schito
131, 80058 Torre
Annunziata, (NA)-
batch releaser, bulk
manufacturer,
Mipharm S.p.A., Via
Bernardo Quaranta,
12, IT-20141 Milano
(MI), Italy- packager
Italy C09DA03 1547202.04.2016
02.04.2021PoM
Novartis Pharma AG,
Lichtstrasse 35, 4056
Basel, Switzerland
1117 Co-Diroton
lisinopril (lisinopril
dihydrate),
hydrochlorothia-
zide
tablets
10mg+12,5mg,
in blister (10/1x10/,
30/3x10/)
Gedeon Richter PLC,
Gyomroi ut 19-21,
1103 Budapest - batch
releaser, Gedeon
Richter Poland Sp.z
o.o., ul.Graniczna
35,Grodzisk
Mazowiecki, 05-825,
Poland - bulk
manufacturer,
packager
Hungary C09BA03 1440116.04.2015
16.04.2020PoM
Gedeon Richter PLC,
Gyomroi ut 19-21,
1103 Budapest,
Hungary
243
1118 Co-Diroton
lisinopril (lisinopril
dihydrate),
hydrochlorothia-
zide
tablets
20mg+12,5mg,
in blister (10/1x10/,
30/3x10/)
Gedeon Richter PLC,
Gyomroi ut 19-21,
1103 Budapest - batch
releaser, Gedeon
Richter Poland Sp.z
o.o., ul.Graniczna
35,Grodzisk
Mazowiecki, 05-825,
Poland - bulk
manufacturer,
packager
Hungary C09BA03 1440316.04.2015
16.04.2020PoM
Gedeon Richter PLC,
Gyomroi ut 19-21,
1103 Budapest,
Hungary
1119Coffein-natrium
benzoate
caffeine-sodium
benzoatesolution for injection
100mg/ml,
1ml ampoules (10)
Yerevan Chemical-
Pharmaceutical firm
OJSC, Yerevan,
Ajaryan street, 2 Line,
No6
Republic of
ArmeniaN06BC01 13169
10.01.2014
10.01.2019PoM
Yerevan Chemical-
Pharmaceutical firm
OJSC, Yerevan,
Ajaryan street, 2
Line, No6, Republic
of Armenia
1120Coffein-natrium
benzoate
caffeine- sodium
benzoatesolution for injection
200mg/ml,
1ml ampoules (10)
Yerevan Chemical-
Pharmaceutical firm
OJSC, Yerevan,
Ajaryan street, 2 Line,
No6
Republic of
ArmeniaN06BC01 13170
10.01.2014
10.01.2019PoM
Yerevan Chemical-
Pharmaceutical firm
OJSC, Yerevan,
Ajaryan street, 2
Line, No6, Republic
of Armenia
1121 Colchicine colchicine tablets0,5mg,
in blister (80/2x40/)
Arpimed LLC, Kotayk
Marz, Abovyan, 2nd
Micro-District, 19
Building
Republic of
ArmeniaM04AC01 14730
30.07.2015
30.07.2020PoM
Arpimed LLC,
Kotayk Marz,
Abovyan, 2nd Micro-
District, 19 Building,
Republic of Armenia
1122 Colchicine colchicine tablets1mg,
in blister (96/4x24/)
Arpimed LLC, Kotayk
Marz, Abovyan, 2nd
Micro-District, 19
Building
Republic of
ArmeniaM04AC01 16021
30.09.2016
30.09.2021PoM
Arpimed LLC,
Kotayk Marz,
Abovyan, 2nd Micro-
District, 19 Building,
Republic of Armenia
244
1123 Colchicine colchicine tablets1mg,
in blister (40/2x20/)
S.C. Biofarm S.A., str.
Logofatul Tautu No
99, sector 3,
Bucharest, 031212
Romania M04AC01 1681322.06.2017
22.06.2022PoM
S.C. Biofarm S.A., str.
Logofatul Tautu No
99, sector 3,
Bucharest, 031212,
Romania
1124Colchicine
Opocalciumcolchicine tablets
1mg,
in blister (20/1x20/)
S.C Zentiva S.A,
Theodor Pallady Blvd
nr. 50, sector 3,
Bucuresti, cod 032266
Romania M04AC01 1612910.11.2016
10.11.2021PoM
Laboratoires
MAYOLY
SPINDLER, 6 avenue
de l` Europe, 78400
Chatou, France
1125Colchicine 500
Microgram Tabletscolchicine tablets
0,5mg,
in plastic container (100)
CP Pharmaceuticals
Ltd., Ash Road North,
Wrexham LL 13 9UF -
batch releaser (dosage
form manufacturer -
Wockhardt Limited,
Survey No. 106/4-5-7,
Kadaiya, Nani Daman,
IN-396210, India)
UK M04AC01 1240518.04.2013
18.04.2018PoM
Wockhardt UK
Limited, Ash Road
North, Wrexham
Industrial Estate, LL
13 9 UF, UK
1126 Colchicum-Dispert colchicine tablets coated0,5mg,
in blister (20/1x20/)
Pharmaselect
International
Beteiligungs GmbH,
Ernst-Melchior-Gasse
20, 1020 Vienna -
batch releaser, Haupt
Pharma Wulfing
GmbH, Bethelner
Landstrasse 18,
Gronau/Leine,
Niedersachsen, 31028,
Germany- bulk
manufacturer,
packager
Austria M04AC01 1678222.06.2017
22.06.2022PoM
Pharmaselect
International
Beteiligungs GmbH,
Ernst-Melchior-Gasse
20, 1020 Vienna,
Austria
245
1127 Coldenzagelsemium
sempervirenstablets
6C,
in blister (72/3x24/)
A Nelson and Co
Limited, 5 Endeavour
Way, Wimbledon,
London SW19 8UH
UK
R05X
homeopathic
drug
1352030.05.2014
30.05.2019PoM
A Nelson and Co
Limited, 5 Endeavour
Way, Wimbledon,
London SW19 8UH,
UK
1128 Coldrex
paracetamol,
caffeine,
phenylephrine
(phenylephrine
hydrochloride),
terpin hydrate,
ascorbic acid
tablets
500mg+25mg+
5mg+20mg+30mg, in
blister (12/1x12/)
S.C. Europharm S.A.,
2 Panselelor str.,
Brasov, county of
Brasov, 500419 -
packager, batch
releaser
(GlaxoSmithKline
Dungarvan Ltd.,
Knockbrack,
Dungarvan, County
Waterford, Ireland -
bulk manufacturer)
Romania N02BE51 1384018.09.2014
18.09.2019OTC
GlaxoSmithKline
Consumer
HealthCare, 980
Great West Road,
Brentford, Middlesex,
TW8 9GS, UK
1129 Coldrex HotRem
paracetamol,
phenylephrine
(phenylephrine
hydrochloride),
ascorbic acid
powder for oral
solution with honey
and lemon flavour
750mg+10mg+ 60mg,
5g sachets (10)
SmithKline Beecham
S.A. Ctra. de Ajalvir,
KM-2500-28806,
Alcala de Henares,
Madrid
Spain N02BE51 15357/127.06.2017
26.02.2021OTC
GlaxoSmithKline
Consumer Healhtcare
(UK) Trading
Limited, 980 Great
West Road,
Brentford, Middlesex,
TW8 9GS, UK
1130 Coldrex HotRem
paracetamol,
phenylephrine
(phenylephrine
hydrochloride),
ascorbic acid
powder for oral
solution with lemon
flavour
750mg+10mg+ 60mg,
5g sachets (10)
SmithKline Beecham
S.A. Ctra. de Ajalvir,
KM-2500-28806,
Alcala de Henares,
Madrid
Spain N02BE51 15358/104.05.2017
26.02.2021OTC
GlaxoSmithKline
Consumer Healhtcare
(UK) Trading
Limited, 980 Great
West Road,
Brentford, Middlesex,
TW8 9GS, UK
246
1131 Coldrex MaxGrip
paracetamol,
phenylephrine
(phenylephrine
hydrochloride),
ascorbic acid
powder for oral
solution with lemon
flavour
1000mg+10mg+ 40mg,
6,427g sachets (10)
SmithKline Beecham
S.A. Ctra. de Ajalvir,
KM-2500-28806,
Alcala de Henares,
Madrid
Spain N02BE51 13973/125.12.2017
21.11.2019OTC
GlaxoSmithKline
Consumer Healhtcare
(UK) Trading
Limited, 980 Great
West Road,
Brentford, Middlesex,
TW8 9GS, UK
1132Coldrex Menthol
Active
paracetamol,
phenylephrine
(phenylephrine
hydrochloride)
powder for oral
solution with honey
and lemon flavour
600mg+10mg,
6g sachets (10)
SmithKline Beecham
S.A. (Carretera de
Ajalvir, km 2500,
Alcala de Henares,
Madrid, E-28806)
Spain N02BE51 12756/121.10.2013
14.08.2018OTC
GlaxoSmithKline
Consumer
HealthCare (980
Great West Road,
Brentford, Middlesex,
TW8 9GS, UK)
1133 Colexil Oral
colistin (colistin
sulfate),
enrofloxacin
solution oral
1200000IU/ml+
100mg/ml,
1000ml plastic bottle
Interchemie werken
'De Adelaar' B.V.,
Metaalweg 8, 5804
CG Venray
the Netherlands
QJ01RA95;
veterinary
drug
1497218.11.2015
18.11.2020PoM
Interchemie werken
'De Adelaar' B.V.,
Metaalweg 8, 5804
CG Venray, the
Netherlands
1134 Colokit
sodium phosphate
(sodium phosphate
monohydrate),
disodium phosphate
(disodium
phosphate
anhydrous)
tablets1102mg+398mg,
in plastic container (32)
Laboratoires
MAYOLY
SPINDLER, 6 avenue
de l'Europe-BP 51,
78400 Chatou Cedex -
batch releaser (dosage
form manufacturer,
packager - Wellspring
Pharmaceuticals
Canada Corp., 400
Iroquois Shore Road,
Oakville, ON, L6H
1M5, Canada)
France A06AD 12546/120.11.2013
06.06.2018PoM
Laboratoires
MAYOLY
SPINDLER, 6 avenue
de l,Europe-BP 51,
78400 Chatou Cedex,
France
247
1135 Colokit
sodium phosphate
(sodium phosphate
monohydrate),
disodium phosphate
(disodium
phosphate
anhydrous)
tablets1102mg+398mg,
in plastic container (32)
Laboratoires
MAYOLY
SPINDLER, 6 avenue
de l'Europe, 78400
Chatou -batch
releaser, Laboratoires
STRADIS, 29 rue
Leon Faucher 51100
Reims, France-
packager, Laboratoires
GALENIQUES
VERNIN, 20 rue
Louis-Charles Vernin,
77190 Dammarie-Les-
Lys, France -bulk
manufacurer
France A06AD 1502802.12.2015
02.12.2020PoM
Laboratoires
MAYOLY
SPINDLER, 6 avenue
de l'Europe, 78400
Chatou, France
1136 Colokit
sodium phosphate
(sodium phosphate
monohydrate),
disodium phosphate
(disodium
phosphate
anhydrous)
tablets1102mg+398mg,
in plastic container (32)
Laboratoires
GALENIQUES
VERNIN, 20 rue
Louis-Charles Vernin,
77190 Dammarie-Les-
Lys-bulk
manufacturer, batch
releaser, Laboratoires
STRADIS, 29 rue
Leon Faucher 51100
Reims, France-
packager
France A06AD 1502902.12.2015
02.12.2020PoM
Laboratoires
MAYOLY
SPINDLER, 6 avenue
de l'Europe, 78400
Chatou, France
1137CoLosar-Denk
100/12,5
losartan (losartan
potassium),
hydrochloro-
thiazide
tablets film-coated100mg+12,5mg,
in blister (28/2x14/)
Denk Pharma GmbH
& Co. KG, Goellstr. 1,
84529 Tittmoning
Germany C09DA01 1335904.04.2014
04.04.2019PoM
Denk Pharma GmbH
& Co. KG,
Prinzregentenstr. 79,
81675 Muenchen,
Germany
248
1138CoLosar-Denk
50/12,5
losartan (losartan
potassium),
hydrochloro-
thiazide
tablets film-coated50mg+12,5mg,
in blister (28/2x14/)
Denk Pharma GmbH
& Co. KG, Goellstr. 1,
84529 Tittmoning
Germany C09DA01 1607626.10.2016
26.10.2021PoM
Denk Pharma GmbH
& Co. KG,
Prinzregentenstr. 79,
81675 Munchen,
Germany
1139 Combilipen
thiamine (thiamine
hydrochloride),
pyridoxine
(pyridoxine
hydrochloride),
cyanocobalamin,
lidocaine (lidocaine
hydrochloride)
solution for i/m
injection
50mg/ml+ 50mg/ml+
0.5mg/ml+ 10mg/ml,
2ml ampoules, in blister
(5/1x5/, 10/2x5/)
Pharmstandard-
UfaVITA OJSC,
450077, Ufa, str.
Khudaiberdina 28
Russia A11DB 1465103.07.2015
03.07.2020PoM
Pharmstandard-
UfaVITA OJSC,
450077, Ufa, str.
Khudaiberdina 28,
Russia
1140 Combilipen Tabs
benfotiamine,
pyridoxine
(pyridoxine
hydrochloride),
cyanocobalamin
tablets film-coated
100mg+100mg+ 2mcg,
in blister (15/1x15/,
30/2x15/, 60/4x15/)
Pharmstandard-
UfaVITA OJSC,
450077, Ufa, str.
Khudajberdina 28
Russia A11АB 1359010.06.2014
10.06.2019PoM
Pharmstandard-
UfaVITA OJSC,
450077, Ufa, str.
Khudajberdina 28,
Russia
1141Complivit Calcium
D3
cholecalciferol,
calcium
tablets chewable
with orange flavour
0,005mg+500mg, in
plastic container (30, 100)
Pharmstandard-
UfaVITA OJSC,
450077, Ufa, str.
Khudaiberdina 28
Russia A12AX 13808/114.12.2015
05.09.2019OTC
OTCPharm PJSC,
123317, Moscow,
Testovskaya str., 10,
Russia
1142Complivit Calcium
D3 Forte
cholecalciferol,
calcium (calcium
carbonate)
tablets
chewablewith mint
flavour
500mg+0.01mg,
in plastic container (30)
and (100)
Pharmstandard-
UfaVITA OJSC,
450077, Ufa, str.
Khudaiberdina 28
Russia A12AX 14744/121.04.2016
03.08.2020OTC
OTCPharm PJSC,
123317, Moscow,
Testovskaya str., 10,
Russia
249
1143 Complivit Mamma
vitamin A, vitamin
E, vitamin B1,
vitamin B2, vitamin
B6, vitamin C,
nicotinamide, folic
acid, calcium
pantothenat,
vitamin B12,
ergocalciferol,
phosphor (calcium
hydrophosphate
dihydrate), ferrum
(ferrum fumarate),
manganese
(manganese sulfate
monohydrat
tablets film-coated
0,5675mg
(1650IU)+20mg+
2mg+2mg+5mg+
100mg+20mg+
0,4mg+10mg+ 0,005mg+
0,00625mg
(250IU)+19mg+
10mg+2,5mg+1mg+10mg
+25mg+ 25mg,
plastic container (30, 60)
Pharmstandard-
UfaVITA OJSC,
450077, Ufa, str.
Khudajberdina 28
Russia A11AA04 12310/109.02.2016
22.03.2018OTC
OTCPharm PJSC,
123317, Moscow,
Testovskaya str., 10,
Russia
1144Complivit
Ophthalmo
vitamin A, vitamin
E, vitamin B1,
vitamin B2, vitamin
B6, vitamin C, folic
acid, rutoside,
vitamin B12, lutein,
zeaxanthin, selen
(sodium selenite),
copper (copper
sulfate
pentahydrate), zinc
(zinc oxide)
tablets film-coated
1mg(2907IU)+
15mg+5mg+2mg+
5mg+50mg+
400mcg+25mg+
3mcg+2,5mg+
1mg+25mcg+ 1mg+5mg,
in plastic container (30,
60)
Pharmstandard-
UfaVITA OJSC,
450077, Ufa, str.
Khudaiberdina 28
Russia A11AA04 1539426.02.2016
26.02.2021OTC
Otcpharm PJSC,
123317, Moscow,
Testovskaya str., 10,
Russia
250
1145 Complivit-Active
vitamin A, vitamin E,
vitamin B1, vitamin B2,
vitamin B6, vitamin C,
nicotinamide, folic acid,
rutin (rutoside), calcium
pantotenat, vitamin B12,
ergocalciferol, phosphor
(calcium
hydrophosphate
dihydrate), ferrum
(ferrum fumarate),
manganese (manganese
sulfate monohydrate),
copper (copper sulfate
pentahydrate), zinc
(zinc sulfate
heptahydrate),
magnesium (magnesium
oxide), potassium
(potassium
hydrophosphate
dihydrate), selenate
(sodium selenate),
iodine(sodium iodine),
fluoride (sodium
fluoride)
tablets film-coated
0,7912mg+10mg+1mg+1
mg+1,5mg+50mg+7,5mg+
0,2mg+10mg+
5mg+0,003mg+
0,0025mg(100IU)+27mg+
10mg+1mg+1mg+5mg+22
mg+35mg+0,01mg+
0,1mg+0,5mg, plastic
container (30, 60)
Pharmstandard-
UfaVITA OJSC,
450077, Ufa, str.
Khudajberdina 28
Russia A11AA04 12219/125.07.2016
07.03.2018OTC
OTCPharm PJSC,
123317, Moscow,
Testovskaya str., 10,
Russia
1146 Concor 10mg
bisoprolol
(bisoprolol
fumarate)
tablets film-coated
10mg,
in blister (30/3x10/,
30/1x30/, 50/5x10/,
50/2x25/)
Merck KGaA
Frankfurter Strasse
250, 64 293
Darmstadt
Germany C07AB07 1339909.04.2014
09.04.2019PoM
Merck KGaA
Frankfurter Strasse
250, 64 293
Darmstadt, Germany
1147 Concor 5mg
bisoprolol
(bisoprolol
fumarate)
tablets film-coated
5mg,
in blister (30/3x10/,
30/1x30/, 50/5x10/,
50/2x25/, 90/3x30/)
Merck KGaA
Frankfurter Strasse
250, 64 293
Darmstadt
Germany C07AB07 1375225.07.2014
25.07.2019PoM
Merck KGaA
Frankfurter Strasse
250, 64 293
Darmstadt, Germany
1148 Concor COR 2,5mg
bisoprolol
(bisoprolol
fumarate)
tablets film-coated
2,5mg,
in blister (14/1x14/,
30/3x10/, 30/1x30/,
50/5x10/, 50/2x25/)
Merck KGaA
Frankfurter Strasse
250, 64 293
Darmstadt
Germany C07AB07 1375125.07.2014
25.07.2019PoM
Merck KGaA
Frankfurter Strasse
250, 64 293
Darmstadt, Germany
251
1149 Condyline podophyllotoxinsolution for external
use
5mg/ml,
3,5ml glass vial and
plastic applicators (30)
Astellas Pharma
Europe B.V.,
Hogemaat 2, 7942 JG
Meppel
the NetherlandsD06BB04;
herbal drug14042
19.12.2014
19.12.2019PoM
Astellas Pharma
Europe B.
V.,Sylviusweg 62,
2333 BE Leiden, the
Netherlands
1150 Condyline podophyllotoxinsolution for external
use
5mg/ml,
3,5ml glass vial and
plastic applicators (30)
Famar Nederland
B.V., Industrieweg 1,
5531 AD Bladel
the Netherlands D06BB04 1664811.05.2017
11.05.2022PoM
Astellas Pharma
Europe B. V.,
Sylviusweg 62, 2333
BE Leiden, the
Netherlands
1151 Contractubex
extract cepae,
heparin (heparin
sodium), allantoin
gel for external use
100mg/g+50IU/g+
10mg/g,
20g aluminium tube
Merz Pharma GmbH
& Co. KGaA,
Ludwigstrasse 22,
Reinheim, Hessen,
64354
Germany C05BA53 1656803.04.2017
03.04.2022OTC
Merz
Pharmaceuticals
GmbH, Eckenheimer
Landstrasse 100,
60318
Frankfurt/Main,
Germany
1152 Contrahist
levocetirizine
(levocetirizine
dihydrochloride)
tablets film-coated5mg,
in blister (28/4x7/)
Pharmaceutical
Works Adamed
Pharma Joint Stock
Company, 95-054
Ksawerow, Szkolna
St. 33
Poland R06AE09 1542902.04.2016
02.04.2021OTC
Adamed Limited
Liability Company,
Pienkow 149, 05-152
Czosnow, Poland
1153 Controloc
pantoprazole
(pantoprazole
sodium
sesquihydrate)
tablets gastro-
resistant
20mg,
in blister (7/1x7/,
14/1x14/)
Takeda GmbH,
Lehnitz str. 70-98,
16515 Oranienburg
Germany A02BC02 13952/120.07.2015
28.10.2019PoM
Takeda GmbH, Byk-
Gulden str. 2, D-
78467, Konstanz,
Germany
1154 Controloc
pantoprazole
(pantoprazole
sodium
sesquihydrate)
tablets gastro-
resistant
40mg,
in blister (14/1x14/,
28/2x14/)
Takeda GmbH,
Lehnitz str. 70-98,
16515 Oranienburg
Germany A02BC02 13953/120.07.2015
28.10.2019PoM
Takeda GmbH, Byk-
Gulden str. 2, D-
78467, Konstanz,
Germany
252
1155 Controloc
pantoprazole
(pantoprazole
sodium
sesquihydrate)
powder for solution
for injection
40mg,
glass vial (1)
Takeda GmbH,
Robert-Bosch-Str. 8,
78224 Singen
Germany A02BC02 13954/308.11.2017
28.10.2019PoM
Takeda GmbH, Byk-
Gulden str. 2, D-
78467, Konstanz,
Germany
1156 Convulex valproic acidtablets prolonged-
release film-coated
300mg,
in glass or plastic
container (50)
G.L. Pharma GmbH,
Schlossplatz 1, 8502
Lannach -batch
releaser, G.L. Pharma
GmbH,
Industriestrasse 1,
8502 Lannach,
Austria -bulk
manufacturer,
packager
Austria N03AG01 1434325.03.2015
25.03.2020PoM
VALEANT LLC,
Shabolovka st. 31,
building 5, 115162,
Moscow, Russia
1157 Convulex valproic acidtablets prolonged-
release film-coated
500mg,
in glass or plastic
container (50)
G.L. Pharma GmbH,
Schlossplatz 1, 8502
Lannach -batch
releaser, G.L. Pharma
GmbH,
Industriestrasse 1,
8502 Lannach,
Austria -bulk
manufacturer,
packager
Austria N03AG01 1434425.03.2015
25.03.2020PoM
VALEANT LLC,
Shabolovka st. 31,
building 5, 115162,
Moscow, Russia
1158 Convulex valproic acid solution oral
300mg/ml,
100ml glass bottle and
measuringe syringe
G.L. Pharma GmbH,
Schlossplatz 1, 8502
Lannach-batch
releaser, G.L. Pharma
GmbH, Arnethgasse
3, 1160 Vienna,
Austria -bulk
manufacturer,
packager
Austria N03AG01 1444804.05.2015
04.05.2020PoM
VALEANT LLC,
Shabolovka st. 31,
building 5, 115162,
Moscow, Russia
253
1159 Convulex valproic acid syrup
50mg/ml,
100ml glass bottle and
measuring syringe
G.L. Pharma GmbH,
Schlossplatz 1, 8502
Lannach-batch
releaser, G.L. Pharma
GmbH, Arnethgasse
3, 1160 Vienna,
Austria -bulk
manufacturer,
packager
Austria N03AG01 1444904.05.2015
04.05.2020PoM
VALEANT LLC,
Shabolovka st. 31,
building 5, 115162,
Moscow, Russia
1160 Convulsofin
calcium valproate
(calcium valproate
dihydrate)
tablets300mg,
in plastic container (100)
Merckle GmbH,
Ludwig-Merckle-
Strasse 3, 89143
Blaubeuren - batch
releaser (Klocke
Pharma-Service
GmbH, Strassburger
Str. 77, Appenweier,
77767, Germany -
bulk manufacturer,
packager)
Germany N03AG01 1399426.11.2014
26.11.2019PoM
TEVA
Pharmaceutical
Industries Ltd., 5
Basel str., P.O. Box
3190, 49131 Petach
Tikva, Israel
1161 Copegus ribavirin tablets film-coated200mg; (42), (168), in
plastic container
F. Hoffmann-La
Roche Ltd.
Wurmisweg CH-4303
Kaiseraugust-batch
releaser, secondary
packager,Patheon
Inc., 2100 Syntex
Court, Mississauga,
Ontario, L5N 7K9,
Canada-bulk
manufacturer,
primary packager
Switzerland J05AB04 1420606.02.2015
06.02.2020PoM
F. Hoffmann La
Roche Ltd.,
Grenzacherstrasse 124
Basel, CH-4070,
Switzerland
1162 CoPlavixclopidogrel,
acetylsalicylic acidtablets film-coated
75mg+100mg,
in blister (30/3x10/)
Sanofi Winthrop
Industrie, 1, rue de la
Vierge, Ambares et
Lagrave, 33565
Carbon Blanc cedex
France B01AC30 1719508.12.2017
08.12.2022PoM
Sanofi Pharma Bristol-
Myers Squibb SNC,
174 Avenue de
France-F-75013 Paris,
France
254
1163 Co-Prenessa
perindopril
(perindopril
erbumine),
indapamide
tablets8mg+2,5mg,
in blister (30/3x10/)
KRKA d.d., Novo
mesto, Smarjeska
cesta 6, 8501 Novo
Mesto
Slovenia C09BA04 1449615.05.2015
15.05.2020PoM
KRKA d.d., Novo
mesto, Smarjeska
cesta 6, 8501 Novo
Mesto, Slovenia
1164 Co-Prenessa
perindopril
(perindopril
erbumine),
indapamide
tablets4mg+1,25mg,
in blister (30/3x10/)
KRKA d.d., Novo
mesto, Smarjeska
cesta 6, 8501 Novo
Mesto
Slovenia C09BA04 1609110.11.2016
10.11.2021PoM
KRKA d.d., Novo
mesto, Smarjeska
cesta 6, 8501 Novo
Mesto, Slovenia
1165 Co-Prenessa
perindopril
(perindopril
erbumine),
indapamide
tablets2mg+0,625mg,
in blister (30/3x10/)
KRKA d.d., Novo
mesto, Smarjeska
cesta 6, 8501 Novo
Mesto
Slovenia C09BA04 1609210.11.2016
10.11.2021PoM
KRKA d.d., Novo
mesto, Smarjeska
cesta 6, 8501 Novo
Mesto, Slovenia
1166 Coraxan 5mg ivabradine tablets film-coated
5mg,
in blister 28/2x14/,
56/4x14/)
Les Laboratoires
Servier Industrie 905,
route de Saran, 45520
Gidy
France C01EB17 1641310.02.2017
10.02.2022PoM
Les Laboratoires
Servier, 50, rue
Carnot, 92284
Suresnes cedex,
France
1167 Coraxan 7,5mg ivabradine tablets film-coated
7,5mg,
in blister (28/2x14/,
56/4x14/)
Les Laboratoires
Servier Industrie 905,
route de Saran, 45520
Gidy
France C01EB17 1641410.02.2017
10.02.2022PoM
Les Laboratoires
Servier, 50, rue
Carnot, 92284
Suresnes cedex,
France
1168 Cordarone
amiodarone
(amiodarone
hydrochloride)
solution for injection50mg/ml,
3ml ampoules (6)
Sanofi Winthrop
Industrie, 1, rue de la
Vierge, Ambares et
Lagrave, 33565
Carbon Blanc cedex
France C01BD01 1251301.06.2013
01.06.2018PoM
Sanofi-Aventis
France, 1-13
boulevard Romain
Rolland, 75014 Paris,
France
255
1169 Cordarone
amiodarone
(amiodarone
hydrochloride)
tablets scored200mg,
in blister (30/2x15/)
Chinoin
Pharmaceutical and
Chemical Works
Private Co. Ltd., 2112
Veresegyhaz, Levai u.
5
Hungary C01BD01 15080/103.04.2017
07.12.2020PoM
Sanofi-Aventis
France, 1-13,
boulevard Romain
Rolland, 75014 Paris,
France
1170Cordiamin-
Darnitsanikethamide solution for injection
250mg/ml,
2ml ampoules,
in blister (10, 10/2x5/)
Darnitsa
Pharmaceutical Firm
PrJSC, 02093, Kiev,
Borisopolskaya Str.,13
Ukraine R07AB02 1234709.04.2013
09.04.2018PoM
Darnitsa
Pharmaceutical Firm
PrJSC, 02093, Kiev,
Borisopolskaya
Str.,13, Ukraine
1171 Cordipin XL nifedipinetablets modified-
release
40mg,
in blister (30/3x10/)
KRKA d.d., Novo
mesto, Smarjeska
cesta 6, 8501 Novo
Mesto
Slovenia C08CA05 1508115.12.2015
15.12.2020PoM
KRKA d.d., Novo
mesto, Smarjeska
cesta 6, 8501 Novo
Mesto, Slovenia
1172 Cordix clopidogrel tablets film-coated75mg,
in blister (28/1x28/)
Pharmaceutical
Works Polfa in
Pabianice JSC, 5
Marszalka J.
Pilsudskiego Str., 95-
200 Pabianice
Poland B01AC04 1705805.10.2017
05.10.2022PoM
Pharmaceutical
Works Adamed
Pharma Joint Stock
Company, 95-054
Ksawerow, Szkolna
St. 33, Poland
1173 Coripren
lercanidipine
(lercanidipine
hydrochloride),
enalapril (enalapril
maleate)
tablets film-coated10mg+10mg, blisters
(28/2x14/)
Recordati Industria
Chimica e
Farmaceutica S.p.A.,
Via Civitali, 1-20148
Milano
Italy C09BB02 1578020.07.2016
20.07.2021PoM
Recordati Ireland
Ltd., Raheens East,
Ringaskiddy, Co
Cork, Ireland
1174 Coripren
lercanidipine
(lercanidipine
hydrochloride),
enalapril (enalapril
maleate)
tablets film-coated10mg+20mg, blisters
(28/2x14/)
Recordati Industria
Chimica e
Farmaceutica S.p.A.,
Via Civitali, 1-20148
Milano
Italy C09BB02 1578120.07.2016
20.07.2021PoM
Recordati Ireland
Ltd., Raheens East,
Ringaskiddy, Co
Cork, Ireland
1175 Coronal 10
bisoprolol
(bisoprolol
fumarate)
tablets film-coated10mg,
in blister (30/3x10/)
Zentiva a.s.
(Nitrianska 100, 920
27 Hlohovec)
Slovakia C07AB07 1292207.10.2013
07.10.2018PoM
Zentiva a.s.
(Nitrianska 100, 920
27 Hlohovec, Slovak
Republic)
256
1176 Coronal 5
bisoprolol
(bisoprolol
fumarate)
tablets film-coated5mg,
in blister (30/3x10/)
Zentiva a.s.
(Nitrianska 100, 920
27 Hlohovec)
Slovakia C07AB07 1292107.10.2013
07.10.2018PoM
Zentiva a.s.
(Nitrianska 100, 920
27 Hlohovec, Slovak
Republic)
1177 Corsiz
alfa-bromisovaleric
acid ethyl ester,
phenobarbital,
peppermint oil
tablets8,2mg+7,5mg+ 0,58mg,
in blister (100/10x10/)
Aversi-Rational Ltd,
0198 Tbilisi,
Chirnakhuli str. 14
Georgia N05CB02 1286317.09.2013
17.09.2018OTC
Aversi-Rational Ltd,
0198 Tbilisi,
Chirnakhuli str. 14,
Georgia
1178 Cortexincattle or pig brain
cortex polypeptides
powder lyophilized
for solution for i/m
injection
10mg,
5ml glass vials (10/2x5)
"Geropharm" Ltd,
196158 Saint
Petersburg,
Moskovskoe shosse,
13, lit. VL.
Russia N06BX 12550/130.12.2016
06.06.2018PoM
"Geropharm" Ltd,
191119 Saint
Petersburg,
Zvenigorodskaya ul.
9, Russia
1179 Cortexincattle brain cortex
polypeptides
powder lyophilized
for solution for i/m
injection
10mg,
5ml glass vial, in blister
(10/2x5/)
"Geropharm" Ltd,
building 83, lit. AAN,
Obolensk, Serpukhov
district, Moscow
region, 142279
Russia N06BX 1555012.05.2016
12.05.2021PoM
"Geropharm" Ltd, 9
Zvenigorodskaya st.,
191119 Saint
Petersburg, Russia
1180 Cortexincattle brain cortex
polypeptides
powder lyophilized
for solution for i/m
injection
5mg,
3ml glass vial, in blister
(10/2x5/)
"Geropharm" Ltd,
building 83, lit. AAN,
Obolensk, Serpukhov
district, Moscow
region, 142279
Russia N06BX 1555112.05.2016
12.05.2021PoM
"Geropharm" Ltd, 9
Zvenigorodskaya st.,
191119 Saint
Petersburg, Russia
1181 Corvalol
alfa-
bromisovalerianic
acid ethyl ether ,
phenobarbital,
peppermint oil
solution
20mg/ml+ 18,26mg/ml+
1,42mg/ml,
30ml glass bottle
ESCO-PHARM LLC,
Nor-Norq V block,
Mikoyan 13, Yerevan
0079
Republic of
ArmeniaN05CM 13381
04.04.2014
04.04.2019OTC
ESCO-PHARM LLC,
Nor-Norq V block,
Mikoyan 13, Yerevan
0079, Republic of
Armenia
257
1182 Corvalol Farmak
alfa-bromisovaleric
acid ethyl ester,
phenobarbital,
peppermint oil
tablets
12.42mg+11.34mg+0.88m
g,
in blister (10/1x10/,
30/3x10/, 50/5x10/)
PJSC "Farmak", 74
Frunze str., Kiev,
04080
UkraineN05CM;
herbal drug15576/1
27.10.2016
12.05.2021OTC
PJSC "Farmak", 74
Frunze str., Kiev,
04080, Ukraine
1183 Corvalol-MFF
alfa-
bromisovalerianic
acid ethyl ether,
phenobarbital
drops oral
20mg/ml+8,26mg/ml,
15ml, 25ml and 50ml
glass vial-dropper
Moscow
Pharmaceutical
factory JSC, 125239,
Pharmaceutical
passage 1, Moscow
Russia N05CM 1354130.05.2014
30.05.2019OTC
Moscow
Pharmaceutical
factory JSC, 125239,
Pharmaceutical
passage 1, Moscow,
Russia
1184Corvalol-
Pharmstandard
alfa-bromisovaleric
acid ethyl ester,
phenobarbital,
peppermint oil
drops oral
20mg/ml+ 18,26mg/ml+
1,42mg/ml,
25ml glass bottle-dropper
Pharmstandard-
Leksredstva JSC,
305022, Kursk,
Agregatnaya 2nd str.,
1a/18
Russia N05CM 1711123.10.2017
23.10.2022OTC
Pharmstandard-
Leksredstva JSC,
305022, Kursk,
Agregatnaya 2nd str.,
1a/18, Russia
1185 Coryol carvedilol tablets12,5mg,
in blister (30/3x10/)
KRKA d.d., Novo
mesto, Smarjeska
cesta 6, 8501 Novo
Mesto
Slovenia C07AG02 1334317.03.2014
17.03.2019PoM
KRKA d.d., Novo
mesto, Smarjeska
cesta 6, 8501 Novo
Mesto, Slovenia
1186 Coryol carvedilol tablets25mg,
in blister (30/3x10/)
KRKA d.d., Novo
mesto, Smarjeska
cesta 6, 8501 Novo
Mesto
Slovenia C07AG02 1552119.04.2016
19.04.2021PoM
KRKA d.d., Novo
mesto, Smarjeska
cesta 6, 8501 Novo
Mesto, Slovenia
1187 Coryol carvedilol tablets6,25mg,
in blister (30/3x10/)
KRKA d.d., Novo
mesto, Smarjeska
cesta 6, 8501 Novo
Mesto
Slovenia C07AG02 1552219.04.2016
19.04.2021PoM
KRKA d.d., Novo
mesto, Smarjeska
cesta 6, 8501 Novo
Mesto, Slovenia
258
1188 Co-Sentor
losartan (losartan
potassium),
hydrochlorothi-
azide
tablets film-coated50mg+12,5mg,
in blister (30/3x10/)
Gedeon Richter PLC,
Gyomroi ut 19-21,
1103 Budapest - batch
releaser (Gedeon
Richter Polska Sp.z
o.o., Graniczna str.
N35 , Grodzisk
Mazowiecki 05-825,
Poland - bulk
manufacturer,
packager)
Hungary C09DA01 1392529.10.2014
29.10.2019PoM
Gedeon Richter PLC,
Gyomroi ut 19-21,
1103 Budapest,
Hungary
1189 Co-Sentor
losartan (losartan
potassium),
hydrochloro-
thiazide
tablets film-coated100mg+25mg,
in blister (30/3x10/)
Gedeon Richter PLC,
Gyomroi ut 19-21,
1103 Budapest - batch
releaser (Gedeon
Richter Polska Sp.z
o.o., Graniczna str.
N35 , Grodzisk
Mazowiecki 05-825,
Poland - bulk
manufacturer,
packager)
Hungary C09DA02 1392629.10.2014
29.10.2019PoM
Gedeon Richter PLC,
Gyomroi ut 19-21,
1103 Budapest,
Hungary
1190 Co-Sentor
losartan (losartan
potassium),
hydrochlorothia-
zide
tablets film-coated100mg+12,5mg,
in blister (30/3x10/)
Gedeon Richter
Polska Sp. z o.o., ul.
Ks. J. Poniatowskiego
5, Grodzisk
Mazowiecki, 05-825-
batch releaser,
Gedeon Richter
Polska Sp. z o.o., ul.
Graniczna 35,
Grodzisk Mazowiecki,
05-825, Poland-bulk
manufacturer,
primary and
secondary packager
Poland C09DA01 1489724.09.2015
24.09.2020PoM
Gedeon Richter PLC,
Gyomroi ut 19-21,
1103 Budapest,
Hungary
259
1191 Co-trimoxazolesulfamethoxazole,
trimethoprimtablets
400mg+80mg,
in blister (20/2x10/)
Arpimed LLC, Kotayk
Marz, Abovyan, 2nd
Micro-District, 19
Building
Republic of
ArmeniaJ01EE01 12849
17.09.2013
17.09.2018PoM
Arpimed LLC,
Kotayk Marz,
Abovyan, 2nd Micro-
District, 19 Building,
Republic of Armenia
1192 Co-trimoxazolesulfamethoxazole,
trimethoprimsuspension oral
40mg/ml+8mg/ml, 120ml
glass bottle
Arpimed LLC, Kotayk
Marz, Abovyan, 2nd
Micro-District, 19
Building
Republic of
ArmeniaJ01EE01 13295
04.03.2014
04.03.2019PoM
Arpimed LLC,
Kotayk Marz,
Abovyan, 2nd Micro-
District, 19 Building,
Republic of Armenia
1193 Co-trimoxazolesulfamethoxazole,
trimethoprimtablets
400mg+80mg,
in blister (20/2x10/)
Open joint stock
company "Borisovskiy
zavod medicinskikh
preparatov" 64,
Chapaev str., Borisov
222120, Minsk region
Belarus J01EE01 1444104.05.2015
04.05.2020PoM
Open joint stock
company "Borisovskiy
zavod medicinskikh
preparatov" 64,
Chapaev str., Borisov
222120, Minsk
region, Belarus
1194CoValsar-Denk
160/12.5
valsartan,
hydrochlorothia-
zide
tablets film-coated160mg+12,5mg,
in blister (28/4x7/)
Denk Pharma GmbH
& Co. KG, Goellstr. 1,
84529 Tittmoning
Germany C09DA03 1534026.02.2016
26.02.2021PoM
Denk Pharma GmbH
& Co. KG,
Prinzregentenstr. 79,
81675 Muenchen,
Germany
1195CoValsar-Denk
320/12.5
valsartan,
hydrochlorothia-
zide
tablets film-coated320mg+12,5mg,
in blister (28/4x7/)
Denk Pharma GmbH
& Co. KG, Goellstr. 1,
84529 Tittmoning
Germany C09DA03 1534126.02.2016
26.02.2021PoM
Denk Pharma GmbH
& Co. KG,
Prinzregentenstr. 79,
81675 Muenchen,
Germany
1196CoValsar-Denk
80/12.5
valsartan,
hydrochlorothi-
azide
tablets film-coated80mg+12,5mg,
in blister (28/4x7/)
Denk Pharma GmbH
& Co. KG, Goellstr. 1,
84529 Tittmoning
Germany C09DA03 1533926.02.2016
26.02.2021PoM
Denk Pharma GmbH
& Co. KG,
Prinzregentenstr. 79,
81675 Muenchen,
Germany
260
1197 Coverex
perindopril
(perindopril
erbumine)
tablets4mg,
in blister (30)
Egis Pharmaceuticals
PLC, 1165 Budapest,
Bokenyfoldi st. 118-
120
Hungary C09AA04 1285317.09.2013
17.09.2018PoM
Egis Pharmaceuticals
PLC, 1106 Budapest,
Kereszturi st. 30-38,
Hungary
1198 Credanil 25/250 carbidopa, levodopa tablets25mg+250mg,
in blister (50/5x10/)
Remedica Ltd,
Limassol Industrial
Estate, Aharnon
street, 3056 Limassol
Cyprus N04BA02 1459708.06.2015
08.06.2020PoM
Remedica Ltd,
Limassol Industrial
Estate, Aharnon
street, 3056 Limassol,
Cyprus
1199 Crinone progesterone gel vaginal
80mg/g,
1,125g pre-filled plastic
applicators (6) and
1,125g pre-filled plastic
applicators (15)
Central Pharma
(Contract Packing)
Limited, Caxton
Road, Bedford,
Bedfordshire, MK41
OXZ - secondary
packager, batch
releaser (Fleet
Laboratories Limited,
94 Rickmansworth
Road, Watford,
Hertfordshire, WD18
7JJ, UK - bulk
manufacturer);
(Maropack AG,
Industriestrasse
Briseck 4, CH 6144
Zell, Switzerland -
primary packager)
UK G03DA04 1344706.05.2014
06.05.2019PoM
Serono Limited,
Bedfont Cross,
Stanwell Road,
Feltham, Middlesex,
TW14 8NX, UK
1200 Crurovit cilostazol tablets
50mg,
in blister (28/2x14,
56/4x14/)
Egis Pharmaceuticals
PLC, 1165 Budapest,
Bokenyfoldi st. 118-
120
Hungary B01AC23 1449215.05.2015
15.05.2020PoM
Egis Pharmaceuticals
PLC, 1106 Budapest,
Kereszturi st. 30-38,
Hungary
1201 Crurovit cilostazol tablets
100mg,
in blister (28/2x14/,
56/4x14/)
Egis Pharmaceuticals
PLC, 1165 Budapest,
Bokenyfoldi st. 118-
121
Hungary B01AC23 1449315.05.2015
15.05.2020PoM
Egis Pharmaceuticals
PLC, 1106 Budapest,
Kereszturi st. 30-38,
Hungary
261
1202 CTC-Oblets
chlortetracycline
(chlortetracycline
hydrochloride)
tablets vaginal1000mg,
in plastic container (100)
Sogeval, Zone
Autoroutiere (53950,
Louverne)
France
QJ01AA03
veterinary
drug
1292507.10.2013
07.10.2018PoM
V.M.D. n.v. (Hoge
Mauw 900, B-2370
Arendonk, Belgium)
1203 Curiosin zinc hyaluronate gel1,027mg/g,
15g aluminium tube
Gedeon Richter OJSC,
Gyomroi ut 19-21,
1103 Budapest
Hungary D10A 1284117.09.2013
17.09.2018OTC
Gedeon Richter
OJSC, Gyomroi ut 19-
21, 1103 Budapest,
Hungary
1204 Curosurf poractant alfasuspension
endotracheal
80mg/ml,
1.5ml glass vial
Chiesi
Pharmaceuticals
GmbH, Gonzagagasse
16/16, Wien, 1010-
batch releaser, Chiesi
Farmaceutici S.p.A,
Via Palermo 26/A-
43122 Parma(PR),
Italy-bulk
manufacturer,
primary packager,
G.L. Pharma GmbH,
Arnethgasse 3, 1160
Wien, Austria-
secondary packager
Austria R07AA02 1618223.11.2016
23.11.2021PoM
Chiesi
Pharmaceuticals
GmbH, Gonzagagasse
16/16, Wien, 1010,
Austria
1205Cutiderm
Ointment
fluticasone
(fluticasone
propionate)
ointment0,05mg/g,
10g aluminum tube
Incepta
Pharmaceuticals
Limited, Dewan Idris
Road, Zirabo, Savar,
Dhaka
Bangladesh D07AC17 13580/105.09.2014
10.06.2019PoM
Incepta
Pharmaceuticals
Limited, Dewan Idris
Road, Zirabo, Savar,
Dhaka, Bangladesh
1206 Cyanocobalamin cyanocobalaminsolution for i/m or
s/c injection
0,2mg/ml,
1ml ampoules (10)
Yerevan Chemical-
Pharmaceutical firm
OJSC, Yerevan,
Ajaryan street, 2 Line,
No6
Republic of
ArmeniaB03B A01 13593
10.06.2014
10.06.2019PoM
Yerevan Chemical-
Pharmaceutical firm
OJSC, Yerevan,
Ajaryan street, 2
Line, No6, Republic
of Armenia
262
1207 Cyanocobalamin cyanocobalaminsolution for i/m or
s/c injection
0,5mg/ml,
1ml ampoules (10)
Yerevan Chemical-
Pharmaceutical firm
OJSC, Yerevan,
Ajaryan street, 2 Line,
No6
Republic of
ArmeniaB03B A01 13594
10.06.2014
10.06.2019PoM
Yerevan Chemical-
Pharmaceutical firm
OJSC, Yerevan,
Ajaryan street, 2
Line, No6, Republic
of Armenia
1208 Cyclodol
trihexyphenidyl
(trihexyphenidyl
hydrochloride)
tablets
2mg,
in blister (40/1x40/,
48/2x24/)
Arpimed LLC, Kotayk
Marz, Abovyan, 2nd
Micro-District, 19
Building
Republic of
ArmeniaN04AA01 13894
06.10.2014
06.10.2019PoM/UC
Arpimed LLC,
Kotayk Marz,
Abovyan, 2nd Micro-
District, 19 Building,
Republic of Armenia
1209 Cyclodol Grindeks
trihexyphenidyl
(trihexyphenidyl
hydrochloride)
tablets2mg,
in blister (50/2x25/)
Grindeks JSC,
Krustpils street 53, LV-
1057, Riga
Latvia N04AA01 1621808.12.2016
08.12.2021PoM/UC
Grindeks JSC,
Krustpils street 53,
LV-1057, Riga, Latvia
1210 Cyclodol-AM
trihexyphenidyl
(trihexyphenidyl
hydrochloride)
tablets2mg,
in blister (40/4x10/)
SIC Borshchahivskiy
Chemical-
Pharmaceutical Plant
PJSC, 17, Mira St,
Kiev 03134
Ukraine N04AA01 1382110.09.2014
10.09.2019PoM/UC
SIC Borshchahivskiy
Chemical-
Pharmaceutical Plant
PJSC, 17, Mira St,
Kiev 03134, Ukraine
1211 Cycloferon
acridonacetic acid,
N-methyl glucamin
(meglumin)
solution for i/m and
i/v injection
125mg/ml+ 96,3mg/ml,
2ml ampoules,
in blister (5)
Scientific
Technological
Pharmaceutical Firm
"POLISAN" Ltd,
192102, Saint
Petersburg, Salova st.
72, building 2, lit. A
Russia L03AX 1664125.04.2017
25.04.2022PoM
Scientific
Technological
Pharmaceutical Firm
"POLISAN" Ltd,
192102, Saint
Petersburg, Salova st.
72, building 2, lit. A,
Russia
1212Cyclophospha-
mide-Asteriacyclophosphamide
powder for solution
for injection
500mg,
glass vial (10)
Hankook Korus
Pharm Co., Ltd, 78
Daepungsandan-ro,
Daeso-myeon,
Eumseong-gun,
Chungcheongbuk-do
Korea Sourth L01AA01 1517417.12.2015
17.12.2020PoM
GL Corporation,
Woori Venture
Tower #201, 70,
Seonyu-ro,
Yeongdeungpo-ku,
Seoul, Korea South
263
1213 Cyclophosphan cyclophosphamidepowder for solution
for injection
200mg,
glass vial (1)
Belmedpreparaty
RUE, 220007, Minsk,
Fabritsius St., 30
Belarus L01AA01 1342514.04.2014
14.04.2019PoM
Belmedpreparaty
RUE, 220007, Minsk,
Fabritsius St., 30,
Belarus
1214 Cycloserine cycloserine capsules250mg,
in blister (30/3x10/)
Belmedpreparaty
RUE, 220007, Minsk,
Fabritsius St., 30
Belarus J04AB01 1561624.05.2016
24.05.2021PoM
Belmedpreparaty
RUE, 220007, Minsk,
Fabritsius St., 30,
Belarus
1215 Cymbalta
duloxetine
(duloxetine
hydrochloride)
capsules hard gastro-
resistant
60mg,
in blister (7, 14/1x14/,
28/2x14/)
Lilly S.A., Avda de la
Industria 30, 28108
Alcobendas-Madrid,
Spain - batch releaser,
packager (dosage form
manufacturer - Eli
Lilly and Company,
Lilly Technology
Center ,Indianapolis,
Indiana 46285, USA)
Spain N06AX21 1242729.04.2013
29.04.2018PoM
Eli Lilly Nederland
B.V., Grootslag 1-5,
NL-3991 RA Houten,
the Netherlands
1216 Cymbalta
duloxetine
(duloxetine
hydrochloride)
capsules gastro-
resistant
30mg,
in blister (7/1x7/,
14/2x7/, 14/1x14/,
28/4x7/, 28/2x14/)
Lilly S.A., Avda de la
Industria 30, 28108
Alcobendas-Madrid,
Spain - batch releaser,
packager (dosage form
manufacturer - Lilly
del Caribe Inc.,
Puerto Rico Industrial
Park, 12,6km 65th
Infantry Road,
Carolina, 00985
Puerto Rico)
Spain N06AX21 14135/129.05.2015
29.12.2019PoM
Eli Lilly Nederland
B.V., Grootslag 1-5,
NL-3991 RA Houten,
the Netherlands
264
1217 Cymbalta
duloxetine
(duloxetine
hydrochloride)
capsules gastro-
resistant
60mg,
in blister (7/1x7/,
14/2x7/, 14/1x14/,
28/4x7/, 28/2x14/)
Lilly S.A., Avda de la
Industria 30, 28108
Alcobendas-Madrid,
Spain - batch releaser,
packager (dosage form
manufacturer - Lilly
del Caribe Inc.,
Puerto Rico Industrial
Park, 12,6km 65th
Infantry Road,
Carolina, 00985
Puerto Rico)
Spain N06AX21 14136/129.05.2015
29.12.2019PoM
Eli Lilly Nederland
B.V., Grootslag 1-5,
NL-3991 RA Houten,
the Netherlands
1218 Cystone
didymocarpus
pedicellata,
saxifraga ligulata,
rubia cordifolia,
cyperus scariosus,
achyranthes aspera,
onosma bracteatum,
vernonia cinerea,
mumie purified,
lime silicate calx
tablets
65mg+49mg+
16mg+16mg+
16mg+16mg+
16mg+13mg+ 16mg,
in plastic container (100)
Himalaya Drug
Company, N11,
Makali Grama
Dasanapura Hobli,
Nelamangala Taluk,
Bangalore 562 123
India G04BX 1261921.06.2013
21.06.2018PoM
Himalaya Drug
Company, N11,
Makali Grama
Dasanapura Hobli,
Nelamangala Taluk,
Bangalore 562 123,
India
1219 Cytarabine cytarabine
powder lyophilized
for solution for
injection
100mg,
ampoules (5)
Belmedpreparaty
RUE, 220007, Minsk,
Fabritsius St., 30
Belarus L01BC01 1260221.06.2013
21.06.2018PoM
Belmedpreparaty
RUE, 220007, Minsk,
Fabritsius St., 30,
Belarus
1220 Cytarabine cytarabine
powder lyophilized
for solution for
injection
100mg,
glass vial (1)
Belmedpreparaty
RUE, 220007, Minsk,
Fabritsius St., 30
Belarus L01BC01 1529004.02.2016
04.02.2021PoM
Belmedpreparaty
RUE, 220007, Minsk,
Fabritsius St., 30,
Belarus
265
1221 Cyteal
hexamidine
(hexamidine
diisetionate),
chlorhexidine
(chlorhexidine
digluconate),
chlorocresol
solution for external
use
100mg/100ml+
0.5ml/100ml+
300mg/100ml, 250ml
plastic container
Pierre Fabre
Medicament
Production, site
Progipharm, Rue du
Lycee, 45500 Gien
France D08AC52 1566108.06.2016
08.06.2021OTC
Pierre Fabre
Medicament
Production, 45, place
Abel Gance, 92100
Boulogne, France
1222 Cytosar cytarabine
powder lyophilized
for solution for
injection
500mg,
glass vial and 10ml
solvent in ampoule
Actavis Italy S.p.A.,
Viale Pasteur, 10,
20014 Nerviano,
Milan
Italy L01BC01 1460118.06.2015
18.06.2020PoM
Pfizer H.C.P.
Corporation, 235,
East 42nd street, New
York 10017, USA
1223 Cytosar cytarabine
powder lyophilized
for solution for
injection
100mg,
glass vial and 5ml solvent
in ampoule
Actavis Italy S.p.A.,
Viale Pasteur, 10,
20014 Nerviano,
Milan
Italy L01BC01 1460218.06.2015
18.06.2020PoM
Pfizer H.C.P.
Corporation, 235,
East 42nd street, New
York 10017, USA
1224 Cytotec misoprostol tablets
200mcg,
in blister (28/2x14/,
60/6x10/)
Piramal Healthcare
UK Limited, Whalton
Road Morpeth,
Northumberland,
NE61 3YA
UK A02BB01 1391629.10.2014
29.10.2019PoM
Pfizer H.C.P.
Corporation, 235,
East 42nd str. New
York 10017, USA
1225 Dacarbazine medac dacarbazine
powder lyophilized
for solution for
injection
100mg,
glass vial (10)
Medac GmbH,
Theaterstrasse 6,
22880 Wedel -
secondary packager,
batch releaser
(Oncotec Pharma
Production GmbH,
Am Pharmapark,
06861 Dessau-
Rosslau, Germany -
bulk manufacturer,
primary packager)
Germany L01AX04 13770/106.12.2016
05.09.2019PoM
Medac GmbH,
Theaterstrasse 6,
22880 Wedel,
Germany
266
1226 Dacarbazine medac dacarbazine
powder for solution
for injection or
infusion
200mg,
glass vial (10)
Medac GmbH,
Theaterstrasse 6,
22880 Wedel -
secondary packager,
batch releaser
(Oncotec Pharma
Production GmbH,
Am Pharmapark,
06861 Dessau-
Rosslau, Germany -
bulk manufacturer,
primary packager)
Germany L01AX04 13771/231.03.2017
05.09.2019PoM
Medac GmbH,
Theaterstrasse 6,
22880 Wedel,
Germany
1227 Dafneginciclopirox
(ciclopirox olamine)cream vaginal
10mg/g,
78g aluminium tube and
(14) applicator
Doppel Farmaceutici
S.R.L., Via Martiri
delle Foibe, 1, 29016
Cortemaggiore (PC)
Italy G01AX12 1613010.11.2016
10.11.2021PoM
Polichem S.r.l., Via G.
Marcora, 11, 20121
Milan (MI), Italy
1228 Dafneginciclopirox
(ciclopirox olamine)suppositories vaginal
100mg,
(6/1x6/) and applicator (6)
Doppel Farmaceutici
S.R.L., Via Martiri
delle Foibe, 1, 29016
Cortemaggiore (PC)
Italy G01AX12 1613110.11.2016
10.11.2021PoM
Polichem S.r.l., Via G.
Marcora, 11, 20121
Milan (MI), Italy
1229 Daivobet
betamethasone
(betamethasone
dipropionate),
calcipotriol
(calcipotriol
monohydrate)
ointment for
external use
0,5mg/g+ 0,05mg/g,
15g, 30galuminium or
plastic tube
LEO Laboratories
Limited, 285 Cashel
Road, Dublin 12
Ireland D05AX52 12750/122.11.2016
06.08.2018PoM
LEO Pharmaceutical
Products Ltd A/S
(LEO Pharma
A/S),Industriparken
55, DK-2750
Ballerup, Denmark
267
1230 D-AL prick-test
I-pollen - 1000JSK/1000PNU (1-
grass pollen mixture
I(1000JSK/ml) -
Arrhenatherum elatius,
Dactylis glomerata, Festuca sp.,
Lolium sp., Phleum pratense,
Secale cereale, 2-Spring trees
(1000 JSK /ml) - Alnus
glutinosa, Betula pendula,
Carpinus betulus, Corylus
avellana, 3-Autumn pollen
mixture (1000PNU/ml) -
Artemisia absinthium,
Artemisia vulgaris, Solidago
canadensis, 4-ambrosia
(1000JSK/ml) - Ambrosia
artemisiifolia, 5-ambrosia
(1000PNU/ml) - Ambrosia
artemisiifolia), II-mites -
1000PNU (mixture of mites
(1000PNU/ml) - Acarus siro,
Dermatophagoides farinae,
Dermatophagoides
pteronyssinus), III-moulds -
1000PNU(1-outdoor mould
mixture (1000PNU/ml) -
Alternaria sp.. Botrytis cinerea,
Cladosporium sp., Fusarium
sp., Chrysonilia sitophila, 2-
indoor mould mixture
(1000PNU/ml) - Aspergillus
fumigatus, Aspergillus niger,
Penicillium sp., Mucor sp.,
Rhizopus sp)
solution for skin-
prick test
I-pollen - 1000JSK/ml,
1000PNU/ml+II-mites -
1000PNU/ml+III-moulds -
1000PNU/ml, (1) glass vial
3ml and control solution
in I or III glass vial 3ml
Sevapharma a.s.,
Vitavska 53, 252 63
Roztoky, building 101
and 102
Czech Republic V04CL 1398326.11.2014
26.11.2019PoM
Sevapharma a.s.,
Prumyslova 1472/11,
102 19 Praha 10,
Czech Republic
1231 Dalacin
clindamycin
(clindamycin
hydrochloride)
capsules150mg,
blisters (16/2x8/)
Fareva Amboise, Zone
Industrielle, 29 route
des Industries, 37530
Poce-sur-Cisse
France G01AA10 13411/109.09.2016
14.04.2019PoM
Pfizer H.C.P.
Corporation, 235,
East 42nd Street, New
York 10017, USA
1232 Dalacin
clindamycin
(clindamycin
hydrochloride)
capsules300mg,
blisters (16/2x8/)
Fareva Amboise, Zone
Industrielle, 29 route
des Industries, 37530
Poce-sur-Cisse
France J01FF01 13412/109.09.2016
14.04.2019PoM
Pfizer H.C.P.
Corporation, 235,
East 42nd street New
York 10017, USA
1233 Dalacin
clindamycin
(clindamycin
phosphate)
cream vaginal
20mg/g,
20g plastic or aluminium
tube and applicators (3)
Pharmacia and
Upjohn Company,
7000 Portage road,
Kalamazoo MI 49001
USA J01FF01 1450915.05.2015
15.05.2020PoM
Pfizer H.C.P.
Corporation, 235,
East 42nd street, New
York 10017, USA
268
1234 Dapsone dapsone tablets100mg,
in blister (50/5x10/)
Arpimed LLC, Kotayk
Marz, Abovyan, 2nd
Micro-District, 19
Building
Republic of
ArmeniaJ04BA02 16759
31.05.2017
31.05.2022PoM
Arpimed LLC,
Kotayk Marz,
Abovyan, 2nd Micro-
District, 19 Building,
Republic of Armenia
1235 Dareq desloratadine tablets film-coated5mg,
in blister (30/3x10/)
Delorbis
Pharmaceuticals Ltd.,
17 Athinon Street,
Ergates Industrial
Area, 2643 Ergates,
P.O. Box 28629, 2081
Lefkosia - packager,
batch releaser (Iberfar-
Industria
Farmaceutica, S.A.,
Rua Consiglieri
Pedroso, No 121-123-
Queluz de Baixo,
Barcarena- 2745-557,
Portugal - bulk
manufacturer)
Cyprus R06AX27 13445/118.12.2014
16.04.2019PoM
Delorbis
Pharmaceuticals
Ltd.,17 Athinon
str.,Ergates Industrial
Area, 2643 Ergates,
P.O. Box 28629, 2081
Lefkosia, Cyprus
1236 Decapeptiltriptorelin
(triptorelin acetate)solution for injection
0,1mg/ml,
1ml pre-filled syringes (7)
Ferring GmbH,
Wittland 11, Postfach
21 45, D-24109 Kiel -
dosage form
manufacturer,
primary packager,
batch releaser
(secondary packager -
Ferring International
Center SA, Chemin
de la Vergognausaz
50, 1162 Saint-Prex,
Switzerland)
Germany L02AE04 1263425.06.2013
25.06.2018PoM
Ferring International
Center SA, Chemin
de la Vergognausaz
50, 1162 Saint-Prex,
Switzerland
269
1237 Decapeptil Depotriptorelin
(triptorelin acetate)
microcapsules for
suspension for
injection
3,75mg,
pre-filled syringe, 1ml
solvent in pre-filled
syringe, needle
Ferring GmbH,
Wittland 11, Postfach
21 45, D-24109 Kiel -
dosage form
manufacturer,
primary packager,
batch releaser
(secondary packager -
Ferring International
Center SA, Chemin
de la Vergognausaz
50, 1162 Saint-Prex,
Switzerland)
Germany L02AE04 1263525.06.2013
25.06.2018PoM
Ferring International
Center SA, Chemin
de la Vergognausaz
50, 1162 Saint-Prex,
Switzerland
1238 Decaris
levamisole
(levamisole
hydrochloride)
tablets50mg,
in blister (2/1x2/)
Gedeon Richter PLC,
Gyomroi ut 19-21,
1103 Budapest - batch
releaser (S.C. Gedeon
Richter Romania S.A.,
99-105 Guza Voda
str., 540306, Targu-
Mures, Romania -
bulk manufacturer,
packager)
Hungary P02CE01 1401426.11.2014
26.11.2019PoM
Gedeon Richter PLC,
Gyomroi ut 19-21,
1103 Budapest,
Hungary
1239 Decaris
levamisole
(levamisole
hydrochloride)
tablets150mg,
in blister (1)
Gedeon Richter PLC,
Gyomroi ut 19-21,
1103 Budapest - batch
releaser (S.C. Gedeon
Richter Romania S.A.,
99-105 Guza Voda
str., 540306, Targu-
Mures, Romania -
bulk manufacturer,
packager)
Hungary P02CE01 1401526.11.2014
26.11.2019PoM
Gedeon Richter PLC,
Gyomroi ut 19-21,
1103 Budapest,
Hungary
270
1240 Deep Heat
methyl salicylate,
menthol (racemic),
eucalyptus oil,
terpentine oil
cream for external
use
128mg/g+ 59,1mg/g+
19,7mg/g+ 14,7mg/g,
15g, 67g aluminium tube
The Mentholatum
Company Limited, 1
Redwood Avenue,
Peel Park Campus,
East Kilbride, G74
5PE, Scotland
UK M02AC 1478614.08.2015
14.08.2020OTC
The Mentholatum
Company Limited, 1
Redwood Avenue,
Peel Park Campus,
East Kilbride, G74
5PE, Scotland, UK
1241 Deep Relief
ibuprofen,
levomenthol
(menthol)
gel for external use50mg/g+30mg/g, 15g, 50g,
100g aluminium tube
The Mentholatum
Company Limited, 1
Redwood Avenue,
Peel Park Campus,
East Kilbride, G74
5PE, Scotland
UK M02AX10 1478714.08.2015
14.08.2020OTC
The Mentholatum
Company Limited, 1
Redwood Avenue,
Peel Park Campus,
East Kilbride, G74
5PE, Scotland, UK
1242 Delufen
sinapis nigra D2,
euphorbium D6,
pulsatilla pratensis
D6, luffa operculata
D12, hydrargyrum
biiodatum D12
spray nasal
0,01ml+0,1ml+
0,1ml+0,1ml+ 0,1ml,
20ml plastic bottle
Richard Bittner AG,
Ossiacherstrasse 7, A-
9560 Feldkirchen
Austria
R01AX
homeopathic
drug
1259221.06.2013
21.06.2018OTC
Richard Bittner AG,
Reisnerstrasse 55-57,
A-1030 Wien, Austria
1243 Denk-Air 10mg
montelukast
(montelukast
sodium)
tablets film-coated10mg,
in blister (28/2x14/)
Denk Pharma GmbH
& Co. KG, Goellstr. 1,
84529 Tittmoning
Germany R03DC03 1680022.06.2017
22.06.2022PoM
Denk Pharma GmbH
& Co. KG,
Prinzregentenstr. 79,
81675 Muenchen,
Germany
1244Denk-Air Junior
4mg
montelukast
(montelukast
sodium)
tablets chewable4mg,
in blister (28/2x14/)
Denk Pharma GmbH
& Co. KG, Goellstr. 1,
84529 Tittmoning
Germany R03DC03 1679922.06.2017
22.06.2022PoM
Denk Pharma GmbH
& Co. KG,
Prinzregentenstr. 79,
81675 Muenchen,
Germany
1245Denk-Air Junior
5mg
montelukast
(montelukast
sodium)
tablets chewable5mg,
in blister (28/2x14/)
Denk Pharma GmbH
& Co. KG, Goellstr. 1,
84529 Tittmoning
Germany R03DC03 1679822.06.2017
22.06.2022PoM
Denk Pharma GmbH
& Co. KG,
Prinzregentenstr. 79,
81675 Muenchen,
Germany
271
1246 De-Nol
bismuth
tripotassium
dicitrate
tablets coated
120mg,
in blister (56/7x8/,
112/14x8/)
Astellas Pharma
Europe B.V.,
Hogemaat 2, 7942 JG
Meppel
the Netherlands A02BX05 1436125.03.2015
25.03.2020PoM
Astellas Pharma
Europe B. V.,
Sylviusweg 62, 2333
BE Leiden, the
Netherlands
1247 De-Nol
bismuth
tripotassium
dicitrate
tablets film-coated
120mg,
in blister (32/8x4/,
56/8x7/, 112/8x14/)
"ORTAT" JSC,
Kostromskaya distr.,
Susaninsky region, vil.
Severnoe, microdistr.
Kharitonovo, 157092-
batch releaser,
packager, "R-Pharm"
JSC, Gromova str.,15,
150061, Yaroslavl,
Russia - bulk
manufacturer
Russia A02BX05 17007/108.11.2017
05.09.2022PoM
Astellas Pharma
Europe B. V.,
Sylviusweg 62, 2333
BE Leiden, the
Netherlands
1248 Dentinox-Gel N
tincture
chamomille,
lidocaine (lidocaine
hydrochloride),
polidocanol 600
gel
150mg/g+
3,4mg/g+3,2mg/g, 10g
aluminium tube
Dentinox Company Germany G03GA07 1253901.06.2013
01.06.2018OTC
Pharmaceutical
Products Lenk &
Schuppan KG,
Nunsdorfer Ring
1912277, Berlin,
Germany
1249 Dentokind
belladonna D6,
chamomilla D6,
ferrum
phosphoricum D6,
hepar sulfuris D12,
pulsatilla D6
tablets
15mg+15mg+
15mg+15mg+ 15mg,
in glass container (150)
Deutsche
Homoopathie-Union
DHU-Arzneimittel
GmbH & Co. KG,
Ottostrasse 24, 76227
Karlsruhe
Germany
A01A;
homeopathic
drug
1678722.06.2017
22.06.2022OTC
Deutsche
Homoopathie-Union
DHU-Arzneimittel
GmbH & Co. KG,
Ottostrasse 24, 76227
Karlsruhe, Germany
1250 DepaChronvalproic acid
(valproate sodium)
tablets controlled-
release coated
300mg,
in blister (50/5x10/)
Incepta
Pharmaceuticals
Limited, Dewan Idris
Road, Zirabo, Savar,
Dhaka
Bangladesh N03AG01 1309109.12.2013
09.12.2018PoM
Incepta
Pharmaceuticals
Limited, 40, Shahid
Taijuddin Ahmed
Sarani,Tejgaon I/A,
Dhaka -1208,
Bangladesh
272
1251 Depakinevalproate sodium
(valproic acid)syrup
57,64mg/ml,
150ml glass vial and
measuring syringe
Unither Liquid
Manufacturing, 1-3
Allee de la Neste Z.I.
d'En Sigal, 31770,
Colomiers
France N03AG01 1539709.03.2016
09.03.2021PoM
Sanofi-Aventis
France, 1-13,
boulevard Romain
Rolland, 75014 Paris,
France
1252 Depakine Chronovalproic acid
(valproate sodium)
tablets prolonged-
release film-coated
300mg,
in plastic container
(100/2x50/)
Sanofi Winthrop
Industrie 1, rue de la
Vierge 33565 Carbon
Blanc cedex
France N03AG01 1273323.07.2013
23.07.2018PoM
Sanofi-Aventis
(Suisse) SA, 11, rue de
Veyrot 1217 Meyrin,
Switzerland
1253 Depakine Chronovalproic acid
(valproate sodium)
tablets prolonged-
release film-coated
500mg,
in plastic container (30)
Sanofi Winthrop
Industrie, 1, rue de la
Vierge, Ambares et
Lagrave, 33565
Carbon Blanc cedex
France N03AG01 1273423.07.2013
23.07.2018PoM
Sanofi-Aventis
France, 1-13
boulevard Romain
Rolland, 75014 Paris,
France
1254Depakine enteric
300
valproate sodium
(valproic acid)
tablets gastro-
resistant
300mg,
in blister (100/10x10/)
Sanofi-Aventis S.A.,
Ctra. C35 La Batlloria
a Hostalric, km
63.09,17404 Riells I
Viabrea (Girona)
Spain N03AG01 1591023.08.2016
23.08.2021PoM
Sanofi Winthrop
Industrie, 1, rue de la
Vierge-Ambares et
Lagreve, 33565
Carbon Blanc-Cedex,
France
1255 Depanthol
dexpanthenol,
chlorhexidine
(chlorhexidine
bigluconate)
suppositories vaginal 100mg+16mg, (10/2x5/)
Nizhpharm JSC,
603950, Nizhny
Novgorod, GSP-459,
Salganskaya st., 7
Russia G01AX 13544/103.02.2016
30.05.2019OTC
Nizhpharm JSC,
603950, Nizhny
Novgorod, GSP-459,
Salganskaya st., 7,
Russia
1256 Depanthol
dexpanthenol,
chlorhexidine
(chlorhexidine
bigluconate)
cream for external
use
52,5mg/g+8mg/g, 30g
aluminium tube
Nizhpharm JSC,
603950, Nizhny
Novgorod, GSP-459,
Salganskaya st., 7
Russia D08AC52 13860/122.01.2016
18.09.2019OTC
Nizhpharm JSC,
603950, Nizhny
Novgorod, GSP-459,
Salganskaya st., 7,
Russia
273
1257 Deprexor
venlafaxine
(venlafaxine
hydrochloride)
tablets
37,5mg,
in blister (30/3x10/,
60/6x10/)
Sopharma JSC, str.
Iliensko shosse 16,
1220 Sofia - batch
releaser (Unipharm
JSC, 3 Traiko Stanoev
Str., Sofia 1797,
Bulgaria - bulk
manufacturer,
packager)
Bulgaria N06AX16 1346706.05.2014
06.05.2019PoM
Sopharma JSC, str.
Iliensko shosse 16,
1220 Sofia, Bulgaria
1258 Deprexor
venlafaxine
(venlafaxine
hydrochloride)
tablets
75mg,
in blister (30/3x10/,
60/6x10/)
Sopharma JSC, str.
Iliensko shosse 16,
1220 Sofia - batch
releaser (Unipharm
JSC, 3 Traiko Stanoev
Str., Sofia 1797,
Bulgaria - bulk
manufacturer,
packager)
Bulgaria N06AX16 1346806.05.2014
06.05.2019PoM
Sopharma JSC, str.
Iliensko shosse 16,
1220 Sofia, Bulgaria
1259 Deprimsulfamethoxazole,
trimethoprimtablets
400mg+80mg,
in bliater (20/2x10/)
Remedica Ltd.,
Limassol Industrial
Estate, Aharnon
street, 3056 Limassol
Cyprus J01EE01 1249017.05.2013
17.05.2018PoM
Remedica Ltd.,
Limassol Industrial
Estate, Aharnon
street, P.O. Box
51706, 3508 Limassol,
Cyprus
1260 Dercin
gemcitabine
(gemcitabine
hydrochloride)
powder lyophilized
for solution for
infusion
1000mg,
glass vial (1)
Egis Pharmaceuticals
PLC, 1165 Budapest,
Bokenyfoldi st. 118-
120 -batch releaser,
SUN Pharmaceutical
Industries Ltd.,Baroda
Highway, Halol,
Gujarat, 389350, India-
bulk manufacturer,
packager
Hungary L01BC05 1424620.02.2015
20.02.2020PoM
Egis Pharmaceuticals
PLC, 1106 Budapest,
Kereszturi st. 30-38,
Hungary
274
1261 Dercin
gemcitabine
(gemcitabine
hydrochloride)
powder lyophilized
for solution for
infusion
200mg,
glass vial (1)
Egis Pharmaceuticals
PLC, 1165 Budapest,
Bokenyfoldi st. 118-
120 -batch releaser,
SUN Pharmaceutical
Industries Ltd.,Baroda
Highway, Halol,
Gujarat, 389350, India-
bulk manufacturer,
packager
Hungary L01BC05 1424720.02.2015
20.02.2020PoM
Egis Pharmaceuticals
PLC, 1106 Budapest,
Kereszturi st. 30-38,
Hungary
1262 Dermamed Cream
clobetasol
(clobetasol
propionate)
cream0,5mg/g,
30g aluminium tube
Medpharma Pharm .
& Chem. Inds LLC,
Sharjah, Industrial
Area 13, P.O. Box:
25235
United Arab
EmiratesD07A D01 13471
06.05.2014
06.05.2019PoM
Medpharma Pharm .
& Chem. Inds LLC,
Sharjah, Industrial
Area 13, P.O. Box:
25235, United Arab
Emirates
1263Dermamed
Ointment
clobetasol
(clobetasol
propionate)
ointment0,5mg/g,
30g aluminium tube
Medpharma Pharm .
& Chem. Inds LLC,
Sharjah, Industrial
Area 13, P.O. Box:
25235
United Arab
EmiratesD07A D01 13470
06.05.2014
06.05.2019PoM
Medpharma Pharm .
& Chem. Inds LLC,
Sharjah, Industrial
Area 13, P.O. Box:
25235, United Arab
Emirates
1264 Dermatril
betamethasone
(betamethasone
dipropionate),
clotrimazole,
gentamicin
(gentamicin sulfate)
cream0,5mg/g+10mg/g+ 1mg/g,
15g aluminium tube
Arpimed LLC, Kotayk
Marz (Abovyan, 2nd
Micro-District, 19
Building)
Republic of
ArmeniaD07CC01 12902
07.10.2013
07.10.2018PoM
Arpimed LLC,
Kotayk Marz
(Abovyan, 2nd Micro-
District, 19 Building,
Republic of Armenia)
1265 Dermazin silver sulfadiazine cream10mg/g,
50g aluminium tube
Salutas Pharma
GmbH, Lange
Goehren 3, 39171
Osterweddingen
Germany D06BA01 1495015.10.2015
15.10.2020OTC
Lek Pharmaceuticals
d.d., Verovskova Str.
57, 1526 Ljubljana,
Slovenia
275
1266 Dermobacter
benzalkonium
chloride,
chlorhexidine
(chlorhexidine
digluconate)
solution for external
application
500mg/100ml+
200mg/100ml, 125ml,
300ml plastic bottle
Innothera Chouzy,
Rue Rene Chantereau
"Lisle Vert", 41150
Chouzy-Sur-Cisse
France D08AX 1409418.12.2014
18.12.2019OTC
Laboratoire Innotech
International, 22,
Avenue Aristide
Briand, 94110
Arcueil, France
1267 Dermovate
clobetasol
(clobetasol
propionate)
cream0,5mg/g,
25g in aluminium tube
GlaxoSmithKline
Pharmaceuticals S.A.
(189 Grunwaldzka
street, 60-322
Poznan)
Poland D07AD01 1294421.10.2013
21.10.2018PoM
GlaxoSmithKline
Export Ltd (980 Great
West Road,
Brentford, Middlesex,
TW8 9GS, UK)
1268 Dermovate
clobetasol
(clobetasol
propionate)
ointment0,5mg/g,
25g aluminium tube
GlaxoSmithKline
Pharmaceuticals S.A.
(189 Grunwaldzka
street, 60-322
Poznan)
Poland D07AD01 1294521.10.2013
21.10.2018PoM
GlaxoSmithKline
Export Ltd (980 Great
West Road,
Brentford, Middlesex,
TW8 9GS, UK)
1269Desa 5mg F.C
tabletsdesloratadine tablets film-coated
5mg,
in strip (20/2x10/)
Delta Pharma,
Industrial Zone
B4,10th of Ramadan
city
Egypt R06AX27 1424820.02.2015
20.02.2020PoM
Delta Pharma,
Industrial Zone
B4,10th of Ramadan
city, Egypt
1270 Deslora-Denk 5 desloratadine tablets film-coated5mg,
in blister (10/1x10/)
Denk Pharma GmbH
& Co. KG, Goellstr. 1,
84529 Tittmoning
Germany R06AX27 1450315.05.2015
15.05.2020PoM
Denk Pharma GmbH
& Co. KG,
Prinzregentenstr. 79,
81675 Muenchen,
Germany
1271 Desmopressin
desmopressin
(desmopressin
acetate)
drops nasal0,1mg/ml,
5ml glass vial-dropper
Biopharm JSC, 0160,
Gotua str. 3, TbilisiGeorgia H01BA02 14105
29.12.2014
29.12.2019PoM
Biopharm JSC, 0160,
Gotua str. 3, Tbilisi,
Georgia
276
1272 Detralex diosmin, hesperidin tablets film-coated
450mg+50mg,
in blisters (30/2x15/,
36/3x12/, 60/4x15/)
Les Laboratoires
Servier Industrie 905,
route de Saran, 45520
Gidy
France C05CA53 12745/202.05.2016
23.07.2018OTC
Les Laboratoires
Servier, 50,rue
Carnot, 92284
Suresnes cedex,
France
1273 Detralex diosmin, hesperidin tablets film-coated
450mg+50mg,
in blister (30/2x15/,
36/3x12/, 60/4x15/)
Les Laboratoires
Servier Industrie 905,
route de Saran, 45520
Gidy
France C05CA53 1719408.12.2017
08.12.2022OTC
Les Laboratoires
Servier, 50, rue
Carnot, 92284
Suresnes cedex,
France
1274 Detrimed cholecalciferol drops oral
15000IU/ml,
10ml and 15ml glass
bottle and dropper
Medical Horizon Ltd,
Ararat province,
Masis city, Masis
station, Gortsaranain
22
Republic of
ArmeniaA11CC05 14901
24.09.2015
24.09.2020PoM
Medical Horizon Ltd,
Ararat province,
Masis city, Masis
station, Gortsaranain
22, Republic of
Armenia
1275 Devit 50000 cholecalciferol tablets film-coated
1,25mg (50 000IU),
in blister (15/1x15/,
8/1x8/)
Quest Vitamins
Middle East Fze,Jebel-
Ali Free Zone, P.O.
Box 17836, Dubai
United Arab
EmiratesA11CC05 16794
22.06.2017
22.06.2022PoM
Lamyra LLP, 3rd
floor, 49 Farringdon
Road, London
EC1M3JP, UK
1276 Dexalfen
dexketoprofen
(dexketoprofen
trometamol)
solution for i/m and
i/v injection
25mg/ml,
2ml ampoules,
in blister (5/1x5/)
"Sotex"PharmFirm"
CJSC, Bld. 10, 11, 12,
village Belikovo, rural
settlement
Bereznjakovskoe,
Sergiev-Posad
municipal district,
Moscow Region,
141345
Russia M01AE17 1660010.04.2017
10.04.2022PoM
"Sotex"PharmFirm"
CJSC, Bld. 11, village
Belikovo, rural
settlement
Bereznjakovskoe,
Sergiev-Posad
municipal district,
Moscow Region,
141345, Russia
277
1277 Dexalgin
dexketoprofen
(dexketoprofen
trometamol)
tablets film-coated
25mg,
in blister (10/1x10/,
30/3x10/, 50/5x10/)
Laboratorios Menarini
S.A., str. Alfonso XII,
587 08918 Badalona
(Barcelona)
Spain M01AE17 1635830.12.2016
30.12.2021OTC
Menarini
International
Operations
Luxembourg S.A.,1,
avenue de la Gare,
1611, Luxembourg
1278 Dexalgin
dexketoprofen
(dexketoprofen
trometamol)
tablets film-coated
25mg,
in blister (10/1x10/,
30/3x10/, 50/5x10/)
A.Menarini
Manufacturing
Logistics and Services
S.r.l.,Via Campo Di
Pile, 67100 L` Aquila
Italy M01AE17 1706005.10.2017
05.10.2022OTC
Menarini
International
Operations
Luxembourg S.A.,1,
avenue de la Gare,
1611, Luxembourg
1279 Dexalgin inject
dexketoprofen
(dexketoprofen
trometamol)
solution for i/v and
i/m injection
25mg/ml,
2ml ampoules
(1, 5)
A. Menarini
Manufacturing
Logistic and Services
Srl Via Sette Santi 3,
50131 Firenze
Italy M01AE17 1392129.10.2014
29.10.2019PoM
Menarini
International O. L.
S.A., Luxembourg 1,
Avenue de la Gare, L-
1611 Luxembourg
1280 Dexalgin sachet
dexketoprofen
(dexketoprofen
trometamol)
granules for oral
solution
25mg,
sachets (10, 20, 30)
Laboratorios Menarini
S.A., str. Alfonso XII,
587 08918 Badalona
(Barcelona)
Spain M01AE17 1676302.06.2017
02.06.2022OTC
Menarini
International
Operations
Luxembourg S.A.,1,
avenue de la Gare,
1611, Luxembourg
1281 Dexamethason
dexamethasone
(dexamethasone
sodium phosphate)
solution for injection4mg/ml,
1ml ampoules (25/5x5/)
KRKA d.d., Novo
mesto, Smarjeska
cesta 6, 8501 Novo
Mesto
Slovenia H02AB02 1671323.05.2017
23.05.2022PoM
KRKA d.d., Novo
mesto, Smarjeska
cesta 6, 8501 Novo
Mesto, Slovenia
1282 Dexamethason dexamethasone tablets0,5mg,
in blister (10/1x10/)
KRKA d.d., Novo
mesto, Smarjeska
cesta 6, 8501 Novo
Mesto
Slovenia H02AB02 1672020.05.2017
20.05.2022PoM
KRKA d.d., Novo
mesto, Smarjeska
cesta 6, 8501 Novo
Mesto, Slovenia
278
1283Dexamethason
0,1%dexamethasone
drops eye
(suspension)
1mg/ml,
5ml plastic vial
Warsaw
Pharmaceutical
Works "Polfa" S.A.,
Karolkowa 22/24 str.,
01-207 Warsaw
Poland S01BA01 1307309.12.2013
09.12.2018PoM
Warsaw
Pharmaceutical
Works "Polfa" S.A.,
Karolkowa 22/24 str.,
01-207 Warsaw,
Poland
1284 Dexamethasone
dexamethasone
(dexamethasone
sodium phosphate)
solution for injection
4mg/ml,
1ml ampoules (5), 1ml
ampoules, in blister
(5/1x5/)
Lekhim-Kharkiv JSC,
36, 17-go Partsyezda
str., 61115 Kharkov
Ukraine H02AB02 1301425.11.2013
25.11.2018PoM
Lekhim-Kharkiv JSC,
36, 17-go Partsyezda
str., 61115 Kharkov,
Ukraine
1285 Dexamethasone
dexamethasone
(dexamethasone
sodium phosphate)
solution for injection
4mg/ml,
2ml ampoules, in blister
(10/2x5/)
Arpimed LLC, Kotayk
Marz, Abovyan, 2nd
Micro-District, 19
Building
Republic of
ArmeniaH02AB02 13313
04.03.2014
04.03.2019PoM
Arpimed LLC,
Kotayk Marz,
Abovyan, 2nd Micro-
District, 19 Building,
Republic of Armenia
1286 Dexamethasone
dexamethasone
(dexamethasone
sodium phosphate)
solution for injection
4mg/ml,
1ml ampoules (10, 25,
100)
S.C. Rompharm
Company S.R.L.,
Ilfov, 75100 Otopeni,
Str. Eroilor, Nr. 1A
Romania H02AB02 1426820.02.2015
20.02.2020PoM
S.C. Rompharm
Company S.R.L.,
Ilfov, 75100 Otopeni,
Str. Eroilor, Nr. 1A,
Romania
1287 Dexamethasone
dexamethasone
(dexamethasone
sodium phosphate)
solution for i/m and
i/v injection
4mg/ml,
1ml ampoules, in blister
(10/2x5/)
Arpimed LLC, Kotayk
Marz, Abovyan, 2nd
Micro-District, 19
Building
Republic of
ArmeniaH02AB02 15304
04.02.2016
04.02.2021PoM
Arpimed LLC,
Kotayk Marz,
Abovyan, 2nd Micro-
District, 19 Building,
Republic of Armenia
1288 Dexamethasone dexamethasonedrops eye,
suspension
1mg/ml,
10ml plastic vial-dropper
S.C. Rompharm
Company S.R.L.,
Ilfov, 075100
Otopeni, Str. Eroilor,
Nr. 1A
Romania S01BA01 1603817.10.2016
17.10.2021PoM
S.C. Rompharm
Company S.R.L.,
Ilfov, 075100
Otopeni, Str. Eroilor,
Nr. 1A, Romania
279
1289
Dexamethasone
sodium phosphate
4mg/ml injection
dexamethasone
(dexamethasone
sodium phosphate)
solution for injection 4mg/ml,
1ml ampoules (10)
Cisen Pharmaceutical
Co., Ltd, Tongji Tech
Industry garden,
Jining High & New
Technology Industries
Development Zone,
Haichuan Road,
Jining,Shandong
Province
China H02AB02 1689108.08.2017
08.08.2022PoM
Troge Medical
GmbH, Milchstrasse
19, 20148 Hamburg,
Germany
1290Dexamethasone-
Asteria Inj. 5mg/ml
dexamethasone
(dexamethasone
disodium
phosphate)
solution for injection
5mg/ml,
1ml ampoules, in blister
(50/5x10/)
Hankook Korus
Pharm Co., Ltd, 78
Daepungsandan-ro,
Daeso-myeon,
Eumseong-gun,
Chungcheongbuk-do
Korea Sourth H02AB02 13728/116.07.2015
24.07.2019PoM
GL Corporation,
Woori Venture
Tower #201, 70,
Seonyu-ro,
Yeongdeungpo-ku,
Seoul, Korea South
1291 Dexarom
dexketoprofen
(dexketoprofen
trometamol)
solution for i/v and
i/m injection
25mg/ml,
2ml ampoules (5/1x5/)
and 2ml ampoules, in
blister (10/2x5/)
S.C. Rompharm
Company S.R.L.,
Ilfov, 075100
Otopeni, Str. Eroilor,
Nr. 1A
Romania M01AE17 1462203.07.2015
03.07.2020PoM
S.C. Rompharm
Company S.R.L.,
Ilfov, 075100
Otopeni, Str. Eroilor,
Nr. 1A, Romania
1292 Dexatobromtobramycin,
dexamethasone
drops eye
(suspension)
3mg/ml+1mg/ml,
5ml plastic vial
S.C. Rompharm
Company S.R.L.,
Ilfov, 075100
Otopeni, Str. Eroilor,
Nr. 1A
Romania S01CA01 1663325.04.2017
25.04.2022PoM
S.C. Rompharm
Company S.R.L.,
Ilfov, 075100
Otopeni, Str. Eroilor,
Nr. 1A, Romania
1293 Dexdor
dexmedetomidine
(dexmedetomidine
hydrochloride)
concentrate for
solution for infusion
100mcg/ml,
2ml ampoules (5, 25)
Orion Corporation,
Orionintie 1, 02200
Espoo
Finland N05CM18 1479404.09.2015
04.09.2020PoM
Orion Corporation,
Orionintie 1, 02200
Espoo, Finland
280
1294Deximune 100mg
soft capsulesciclosporin capsules soft
100mg,
in blister (30/1x30/)
Dexcel-Pharma Ltd.,
7 Sopwith Way,
Drayton Fields
Industrial Estate,
Daventry,
Northamptonshire,
NN11 8PB (Swiss
Caps AG,
Husenstrasse 35,
Kirchberg, CH-9533,
Switzerland - bulk
manufacturer)
(Klocke Verpackungs-
Service GmbH, Max-
Becker-Strasse 6,
Weingarten, D-76356,
Germany - packager)
UK L04AD01 1339804.04.2014
04.04.2019PoM
Dexcel-Pharma Ltd.,
7 Sopwith Way,
Drayton Fields
Industrial Estate,
Daventry,
Northamptonshire,
NN11 8PB, UK
1295Dexpanthenol-
Hemofarmdexpanthenol
ointment for
external use
50mg/g,
30g aluminium tube
Hemofarm A.D.,
26300 Vrsac,
Beogradskii put bb-
batch releaser,
Hemofarm A.D.
Vrsac, branch plant
Sabac, 15000, Sabac,
Hajduk Veljkova str.
No: bb, Serbia-bulk
manufacturer,
packager
Serbia D03AX03 1621208.12.2016
08.12.2021OTC
Hemofarm A.D.,
26300 Vrsac,
Beogradskii put bb,
Serbia
1296 Diabeton MR gliclazidetablets modified-
release
60mg,
in blister (30/2x15/)
Les Laboratoires
Servier Industrie, 905,
route de Saran, 45520
Gidy
France A10BB09 1495115.10.2015
15.10.2020PoM
Les Laboratoires
Servier, 50, rue
Carnot, 92284
Suresnes cedex,
France
1297 Diabeton MR gliclazidetablets modified-
release
60mg,
in blister (30/2x15/)
Servier (Ireland)
Industries Ltd, Gorey
Road, Arklow-Co
Wicklow
Ireland A10BB09 1495215.10.2015
15.10.2020PoM
Les Laboratoires
Servier, 50, rue
Carnot, 92284
Suresnes cedex,
France
281
1298 Diacarb acetazolamide tablets250mg,
in blister (30/3x10/)
Pharmaceutical
Works Polpharma
S.A., ul. Pelplinska 19,
83-200 Starogard
Gdanski
Poland S01EC01 1587823.08.2016
23.08.2021PoM
Pharmaceutical
Works Polpharma
S.A., ul. Pelplinska
19, 83-200 Starogard
Gdanski, Poland
1299 Dialipon thioctic acid capsules
300mg,
in blister (30/3x10/,
60/6x10/)
PJSC "Farmak", 74
Frunze str., Kiev,
04080
Ukraine A16AX01 1597815.09.2016
15.09.2021PoM
PJSC "Farmak", 74
Frunze str., Kiev,
04080, Ukraine
1300 Dialipon thioctic acid solution for infusion
30mg/ml,
20ml ampoules
(5, 10),
20ml ampoules,
in blister (5/1x5/, 10/2x5/)
PJSC "Farmak", 74
Frunze str., Kiev,
04080
Ukraine A16AX01 1634530.12.2016
30.12.2021PoM
PJSC "Farmak", 63
Frunze str., Kiev,
04080, Ukraine
1301 DiaMar-M
metformin
(metformin
hydrochloride),
glimepiride
tablets500mg+2mg,
in blister (100/10x10/)
Perdaman
Pharmaceuticals Pvt.
Ltd., G/5 & G/6
Gorwa B.I.D.C., City
Vadodara-390 016,
dist. Vadodara
India A10BD02 1725412.12.2017
12.12.2022PoM
Perdaman
Pharmaceuticals Pvt.
Ltd., Level-11, A-111,
Himalaya House, KG
Marg, Cannaught
Place, New Delhi-
110001, India
1302 DiaMet F
metformin
(metformin
hydrochloride)
tablets film-coated500mg,
in blister (100/10x10/)
Perdaman
Pharmaceuticals Pvt.
Ltd. (G/5 & G/6
Gorwa B.I.D.C., City
Vadodara-390 016,
dist. Vadodara)
India A10BA02 1292807.10.2013
07.10.2018PoM
Perdaman
Pharmaceuticals Pvt.
Ltd. (Level-11, A-111,
Himalaya House, KG
Marg, Cannaught
Place, New Delhi-
110001, India)
282
1303 DiaMet F
metformin
(metformin
hydrochloride)
tablets film-coated850mg,
in blister (100/10x10/)
Perdaman
Pharmaceuticals Pvt.
Ltd., G/5 & G/6
Gorwa B.I.D.C., City
Vadodara-390 016,
dist. Vadodara
India A10BA02 1374424.07.2014
24.07.2019PoM
Perdaman
Pharmaceuticals Pvt.
Ltd., Level-11, A-111,
Himalaya House, KG
Marg, Cannaught
Place, New Delhi-
110001, India
1304 DiaMet F
metformin
(metformin
hydrochloride)
tablets film-coated
1000mg,
in blister (100/10x10/,
150/15x10/)
Perdaman
Pharmaceuticals Pvt.
Ltd., G/5 & G/6
Gorwa B.I.D.C., City
Vadodara-390 016,
dist. Vadodara
India A10BA02 1725512.12.2017
12.12.2022PoM
Perdaman
Pharmaceuticals Pvt.
Ltd., Level-11, A-111,
Himalaya House, KG
Marg, Cannaught
Place, New Delhi-
110001, India
1305 Diane 35
cyproterone
(cyproterone
acetate),
ethinylestradiol
dragee2mg+0,035mg,
in blister (21/1x21/)
Bayer Pharma AG,
Mullerstrasse 178,
13353 Berlin -
packager, batch
releaser (Bayer
Weimar GmbH & Co.
KG,
Doebereinerstrasse
20, 99427 Weimar,
Germany - bulk
manufacturer)
Germany G03HB01 1377705.09.2014
05.09.2019PoM
Bayer Pharma AG,
Mullerstrasse 178,
13353 Berlin,
Germany
283
1306 Diaxelmet 1000mg
metformin
(metformin
hydrochloride)
tablets film-coated1000mg,
in blister (30/2x15/)
Centre Specialites
Pharmaceutiques,
Z.A.C. des Suzots, 35
rue de la Chapelle,
63450, Saint Amant
Tallende- batch
releaser, Micro Labs
Limited, Plot No.
S155- S159, Verna
Industrial Estate,
Phase III, Verna
Salcette, 403722 Goa,
India - bulk
manufacturer,
packager
France A10BA02 1650917.03.2017
17.03.2022PoM
Les Laboratoires
Servier, 50, rue
Carnot, 92284
Suresnes cedex,
France
1307 Diaxelmet 500mg
metformin
(metformin
hydrochloride)
tablets film-coated500mg,
in blister (30/2x15/)
Centre Specialites
Pharmaceutiques,
Z.A.C. des Suzots, 35
rue de la Chapelle,
63450, Saint Amant
Tallende- batch
releaser, Micro Labs
Limited, Plot No.
S155- S159, Verna
Industrial Estate,
Phase III, Verna
Salcette, 403722 Goa,
India - bulk
manufacturer,
packager
France A10BA02 1651017.03.2017
17.03.2022PoM
Les Laboratoires
Servier, 50, rue
Carnot, 92284
Suresnes cedex,
France
284
1308 Diaxelmet 850mg
metformin
(metformin
hydrochloride)
tablets film-coated850mg,
in blister (30/2x15/)
Centre Specialites
Pharmaceutiques,
Z.A.C. des Suzots, 35
rue de la Chapelle,
63450, Saint Amant
Tallende- batch
releaser, Micro Labs
Limited, Plot No.
S155- S159, Verna
Industrial Estate,
Phase III, Verna
Salcette, 403722 Goa,
India - bulk
manufacturer,
packager
France A10BA02 1650817.03.2017
17.03.2022PoM
Les Laboratoires
Servier, 50, rue
Carnot, 92284
Suresnes cedex,
France
1309 Diazepam 10mg diazepam tablets10mg,
in blister (24/1x24/)
Arpimed LLC, Kotayk
Marz, Abovyan, 2nd
Micro-District, 19
Building
Republic of
ArmeniaN05BA01 13486
30.04.2014
30.04.2019PoM/UC
Arpimed LLC,
Kotayk Marz,
Abovyan, 2nd Micro-
District, 19 Building,
Republic of Armenia
1310 Diazepam 5mg diazepam tablets5mg,
in blister (24/1x24/)
Arpimed LLC, Kotayk
Marz, Abovyan, 2nd
Micro-District, 19
Building
Republic of
ArmeniaN05BA01 13485
30.04.2014
30.04.2019PoM/UC
Arpimed LLC,
Kotayk Marz,
Abovyan, 2nd Micro-
District, 19 Building,
Republic of Armenia
285
1311 Diazepam Alkaloid diazepam solution for injection10mg/2ml,
2ml ampoules (10)
Alkaloid AD Skopje,
Blvd. Aleksandar
Makedonski 12, 1000
Skopje-batch releaser,
secondary packager,
Mefar Ilac Sanayii
A.S., Ramazanoglu,
Mah. Ensar-Cad.
No:20, 34906 Kurtkoy-
Pendik, Istanbul,
Turkey- bulk
manufacturer,
primary packager
Macedonia N05BA01 1637430.12.2016
30.12.2021PoM/UC
Alkaloid AD Skopje,
Blvd. Aleksandar
Makedonski 12, 1000
Skopje, Macedonia
1312 Diazepam Alkaloid diazepam tablets coated5mg,
in blister (30/2x15/)
Alkaloid AD Skopje,
Blvd. Aleksandar
Makedonski 12, 1000
Skopje
Macedonia N05BA01 1637530.12.2016
30.12.2021PoM/UC
Alkaloid AD Skopje,
Blvd. Aleksandar
Makedonski 12, 1000
Skopje, Macedonia
1313 Diazolin
mebhydrolin
(mebhydrolin
napadisylate)
dragee100mg,
in blister (20/2x10/)
Marbiopharm JSC,
424006, the Republic
of Mari El,Yoshkar-
Ola, st. Karl Marx 121
Russia R06AX15 1439616.04.2015
16.04.2020OTC
Marbiopharm JSC,
424006, the Republic
of Mari El,Yoshkar-
Ola, st. Karl Marx
121, Russia
1314 Diazoline-Farmak mebhydrolin tablets coated50mg,
in blister (10, 20/2x10/)
PJSC "Farmak", 74
Frunze str., Kiev,
04080
Ukraine R06AX15 1577204.07.2016
04.07.2021OTC
PJSC "Farmak", 63
Frunze str., Kiev,
04080, Ukraine
1315 DiaZone-MR 60mg gliclazidetablets modified-
release
60mg,
in blister (100/10x10/)
Perdaman
Pharmaceuticals Pvt.
Ltd., G/5 & G/6
Gorwa B.I.D.C., City
Vadodara-390 016,
dist. Vadodara
India A10BB09 1725612.12.2017
12.12.2022PoM
Perdaman
Pharmaceuticals Pvt.
Ltd., Level-11, A-111,
Himalaya House, KG
Marg, Cannaught
Place, New Delhi-
110001, India
286
1316 Dibazol bendazolsolution for i/m
injection
10mg/ml,
1ml ampoules (10)
Yerevan Chemical-
Pharmaceutical firm
OJSC, Yerevan,
Ajaryan street, 2 Line,
No6
Republic of
ArmeniaC04AX 15674
08.06.2016
08.06.2021PoM
Yerevan Chemical-
Pharmaceutical firm
OJSC, Yerevan,
Ajaryan street, 2
Line, No6, Republic
of Armenia
1317 Dibazol bendazolsolution for i/m
injection
10mg/ml,
5ml ampoules (10)
Yerevan Chemical-
Pharmaceutical firm
OJSC, Yerevan,
Ajaryan street, 2 Line,
No6
Republic of
ArmeniaC04AX 15675
08.06.2016
08.06.2021PoM
Yerevan Chemical-
Pharmaceutical firm
OJSC, Yerevan,
Ajaryan street, 2
Line, No6, Republic
of Armenia
1318 Dicetel
pinaverium
(pinaverium
bromide)
tablets film-coated100mg,
in blister (30/2x15/)
Abbott Healthcare
SAS, Route de
Belleville, Lieu dit
Maillard, 01400
Chatillon sur
Chalaronne
France A03AX04 1501202.12.2015
02.12.2020PoM
Abbott Products SAS,
42 rue Rouget de
Lisle, 92150 Suresnes,
France
1319 Dicetel
pinaverium
(pinaverium
bromide)
tablets film-coated50mg,
in blister (20/1x20/)
Abbott Healthcare
SAS, Route de
Belleville, Lieu dit
Maillard, 01400
Chatillon sur
Chalaronne
France A03AX04 1501302.12.2015
02.12.2020PoM
Abbott Products SAS,
42 rue Rouget de
Lisle, 92150 Suresnes,
France
1320 Diclac 75mg/3mldiclofenac
(diclofenac sodium)solution for injection
75mg/3ml,
3ml ampoules (5, 10)
Lek Pharmaceuticals
d.d., Verovskova Str.
57, 1526 Ljubljana
Slovenia M01AB05 1583420.07.2016
20.07.2021PoM
Sandoz
Pharmaceuticals d.d.,
Verovskova Str. 57,
1000 Ljubljana,
Slovenia
287
1321 Diclac gel 5%diclofenac
(diclofenac sodium)gel for external use
50mg/g,
50g aluminium tube
Salutas Pharma
GmbH,
Betriebsstaette
Osterweddingen,
Lange Goehren
3,Suelzetal, OT
Osterweddingen,Sach
sen-Anhalt, 39171
Germany M02AA15 1618323.11.2016
23.11.2021OTC
Sandoz
Pharmaceuticals d.d.,
Verovskova Str. 57,
1000 Ljubljana,
Slovenia
1322 Diclac ID 150diclofenac
(diclofenac sodium)
tablets modified-
release
150mg,
in blister (100/10x10/)
Salutas Pharma
GmbH, Otto-von-
Guericke-Alle-1,
39179 Barleben
Germany M01AB05 1446822.04.2015
22.04.2020PoM
Sandoz
Pharmaceuticals d.d.,
Verovskova Str. 57,
1000 Ljubljana,
Slovenia
1323 Diclac ID 75diclofenac
(diclofenac sodium)
tablets modified-
release
75mg,
in blister (20/2x10/)
Salutas Pharma
GmbH, Otto-von-
Guericke-Alle-1,
39179 Barleben
Germany M01AB05 1446722.04.2015
22.04.2020PoM
Sandoz
Pharmaceuticals d.d.,
Verovskova Str. 57,
1000 Ljubljana,
Slovenia
1324 Diclarendiclofenac
(diclofenac sodium)gel for external use
10mg/g,
100g aluminium tube
Laboratorios Basi-
Industria
Farmaceutica, S.A.,
Parque Industrial
Manuel Lourenco
Ferreira, lote 15, 3450-
232 Mortagua
Portugal M02AA15 1653617.03.2017
17.03.2022OTC
GM Pharmaceuticals
Ltd, 65,Phonichala
str., Tbilisi, Georgia
1325 Dicloberl N 75diclofenac
(diclofenac sodium)solution for injection
25mg/ml,
3ml ampoules (5)
A. Menarini
Manufacturing
Logistics and Services
S.r.l. (Via Sette Santi,
3-50131 Florence)
Italy M01AB05 1297828.10.2013
28.10.2018PoM
Berlin-Chemie AG
(Glienicker Weg 125,
12489 Berlin,
Germany)
288
1326 Dicloberl N 75diclofenac
(diclofenac sodium)solution for injection
25mg/ml,
3ml ampoules (5)
Berlin-Chemie AG
(Glienicker Weg 125,
12489 Berlin) - batch
releaser (dosage form
manufacturer,
packager - A.
Menarini
Manufacturing
Logistics and Services
S.r.l. /Via Sette Santi,
3-50131 Firenze,
Italy/)
Germany M01AB05 1297928.10.2013
28.10.2018PoM
Berlin-Chemie AG
(Glienicker Weg 125,
12489 Berlin,
Germany)
1327 Dicloberl retarddiclofenac
(diclofenac sodium)
capsules prolonged-
release
100mg,
in blister (20/2x10/)
Berlin-Chemie AG,
Glienicker Weg 125,
12489 Berlin -
packager, batch
releaser (bulk
manufacturer -
Riemser Speciality
Production GmbH,
Gartenstrasse 6,
88471, Laupheim,
Baden-Wurttemberg,
Germany)
Germany M01AB05 1302025.11.2013
25.11.2018PoM
Berlin-Chemie AG,
Glienicker Weg 125,
12489 Berlin,
Germany
1328 Dicloberl retarddiclofenac
(diclofenac sodium)
capsules prolonged-
release
100mg,
in blister (20/2x10/)
Menarini-Von
Heyden GmbH,
Germany Leipziger
Strasse 7-13, 01097
Dresden- packager,
Riemser Speciality
Production GmbH,
88471 Laupheim,
Mittelstrasee 18,
Germany-bulk
manufacturer, Berlin-
Chemie AG,
Glienicker Weg 125,
12489 Berlin-batch
releaser
Germany M01AB05 1416224.12.2014
24.12.2019PoM
Berlin-Chemie AG
(Menarini Group),
Glienicker Weg 125,
12489 Berlin,
Germany
289
1329 Dicloberl retarddiclofenac
(diclofenac sodium)
capsules prolonged-
release
100mg,
in blister (20/2x10/)
Berlin-Chemie AG,
Glienicker Weg 125,
12489 Berlin-batch
releaser (Hennig
Arzneimittel GmbH
& Co. KG,
Liebigstrasse 1 - 2,
65439 Floersheim-am-
Main, Hessen,
Germany-bulk
manufacturer,
Menarini-Von
Heyden
GmbH,Leipziger
Strasse 7-13, 01097
Dresden, Germany-
packager)
Germany M01AB05 1450815.05.2015
15.05.2020PoM
Berlin-Chemie AG,
Glienicker Weg 125,
12489 Berlin,
Germany
1330 Diclobrudiclofenac
(diclofenac sodium)
solution for i/m and
i/v injection
25mg/ml,
3ml ampoules in blister
(5)
Brupharmexport
SPRL, Rue de la
Grotte, 14, Bruxelles,
1020 - batch releaser
(dosage form
manufacturer,
packager -
Laboratoires Sterop
NV, Scheutlaan 46-
50, Anderlecht, B-
1070, Belgium)
Belgium M01AB05 1277814.08.2013
14.08.2018PoM
Brupharmexport
SPRL, Rue de la
Grotte, 14, Bruxelles,
1020, Belgium
1331Diclo-Denk 100
Rectal
diclofenac
(diclofenac sodium)suppositories rectal
100mg,
in blister (10)
Haupt Pharma
Wulfing GmbH
Bethelner Landstr. 18,
31028 Gronau
Germany M01AB05 12146/125.02.2013
01.02.2018PoM
Denk Pharma GmbH
& Co. KG :
Prinzregentenstr. 79,
81675 Munchen,
Germany
1332Diclo-Denk 100
Retard
diclofenac
(diclofenac sodium)
tablets delayed-
release
100mg,
in blister (10/1x10/) and
(100/10x10/)
Denk Pharma GmbH
& Co. KG, Goellstr. 1,
84529 Tittmoning
Germany M01AB05 1607828.10.2016
28.10.2021PoM
Denk Pharma GmbH
& Co. KG,
Prinzregentenstr. 79,
81675 Munchen,
Germany
290
1333 Diclo-Denk 50diclofenac
(diclofenac sodium)
tablets enteric-
coated
50mg,
in blister (20/2x10/,
100/10x10/)
Denk Pharma GmbH
& Co. KG, Goellstr. 1,
84529 Tittmoning
Germany M01AB05 1607928.10.2016
28.10.2021PoM
Denk Pharma GmbH
& Co. KG,
Prinzregentenstr. 79,
81675 Munchen,
Germany
1334Diclo-Denk 75
injection
diclofenac
(diclofenac sodium)solution for injection
25mg/ml,
3ml ampoules (10)
Haupt Pharma
Wulfing GmbH
Bethelner Landstr. 18,
31028 Gronau
Germany M01AB0 1214501.02.2013
01.02.2018PoM
Denk Pharma GmbH
& Co. KG :
Prinzregentenstr. 79,
81675 Munchen,
Germany
1335 Diclofenacdiclofenac
(diclofenac sodium)
tablets film-coated
prolonged-release
100mg,
blisters (20/2x10/)
Hemofarm Ltd,
249030, Obninsk,
Kaluga Region, 62
Kievskoye shosse St.
Russia M01AB05 12205/115.06.2016
07.03.2018PoM
Nizhpharm JSC,
603950, Nizhny
Novgorod, GSP-459,
Salganskaya st., 7,
Russia
1336 Diclofenacdiclofenac
(diclofenac sodium)suppositories rectal
50mg,
(6)
Farmaprim SRL,
Crinilor str., 5,
Porumbeni, Criuleni
dis.,MD-4829
Moldova M01AB05 1245607.05.2013
07.05.2018PoM
Farmaprim SRL,
Crinilor str., 5,
Porumbeni, Criuleni
dis.,MD-4829,
Moldova
1337 Diclofenacdiclofenac
(diclofenac sodium)suppositories rectal
100mg,
(6, 10/2x5/)
Farmaprim SRL,
Crinilor str., 5,
Porumbeni, Criuleni
dis.,MD-4829
Moldova M01AB05 1245707.05.2013
07.05.2018PoM
Farmaprim SRL,
Crinilor str., 5,
Porumbeni, Criuleni
dis.,MD-4829,
Moldova
1338 Diclofenacdiclofenac
(diclofenac sodium)
tablets enteric film-
coated
50mg,
blisters (20/2x10/)
Hemofarm Ltd,
249030, Obninsk,
Kaluga Region, 62
Kievskoye shosse St.
Russia M01AB05 12584/106.04.2016
06.06.2018PoM
Nizhpharm JSC,
603950, Nizhny
Novgorod, GSP-459,
Salganskaya st., 7,
Russia
1339 Diclofenacdiclofenac
(diclofenac sodium)gel for external use
10mg/g,
40g aluminium tube
Hemofarm D.O.O.
Sabac, 15000, Sabac,
Hajduk Veljkova str.
No: bb
Serbia M02AA15 1287719.09.2013
19.09.2018OTC
Hemofarm A.D.,
26300 Vrsac,
Beogradskii put bb,
Serbia
291
1340 Diclofenacdiclofenac
(diclofenac sodium)
tablets gastro-
resistant film-coated
50mg,
in blister (20/2x10/)
Hemofarm A.D.
26300, Vrsac,
Beogradskii put bb-
batch releaser,
Hemofarm D.O.O.,
Bosnia and
Herzegovina-bulk
manufacturer,
packager
Serbia M01AB05 1360420.06.2014
20.06.2019PoM
Hemofarm A.D.,
26300, Vrsac,
Beogradskii put bb,
Serbia
1341 Diclofenacdiclofenac
(diclofenac sodium)
tablets prolonged-
release film-coated
100mg,
in blister (20/2x10/)
Hemofarm A.D.,
26300, Vrsac,
Beogradskii put bb
Serbia M01AB05 1360520.06.2014
20.06.2019PoM
Hemofarm A.D.,
26300, Vrsac,
Beogradskii put bb,
Serbia
1342 Diclofenacdiclofenac
(diclofenac sodium)
solution for i/m
injection
25mg/ml,
3ml ampoules (5)
Hemofarm A.D.,
26300, Vrsac,
Beogradskii put bb
Serbia M01AB05 1411629.12.2014
29.12.2019PoM
Hemofarm A.D.,
26300, Vrsac,
Beogradskii put bb,
Serbia
1343 Diclofenacdiclofenac
(diclofenac sodium)gel for external use
10mg/g,
40g aluminium tube
Hemofarm A.D.,
26300 Vrsac,
Beogradskii put bb-
batch releaser,
Hemofarm A.D.
Vrsac, branch plant
Sabac, 15000, Sabac,
Hajduk Veljkova str.
No: bb, Serbia-bulk
manufacturer,
packager
Serbia M02AA15 1627819.12.2016
19.12.2021OTC
Hemofarm A.D.,
26300 Vrsac,
Beogradskii put bb,
Serbia
1344Diclofenac
Ophthalmic
diclofenac
(diclofenac sodium)drops eye
1mg/ml,
10ml vial-dropper
Liqvor CJSC, 0089,
Yerevan, str.
Kochinyan, 7/9
Republic of
ArmeniaS01BC03 15796
20.07.2016
20.07.2021PoM
Liqvor CJSC, 0089,
Yerevan, str.
Kochinyan, 7/9,
Republic of Armenia
292
1345 Diclofenac sodiumdiclofenac
(diclofenac sodium)
ointment for
external use
10mg/g,
30g aluminium tube
Open joint stock
company "Borisovskiy
zavod medicinskikh
preparatov" 64,
Chapaev str., Borisov
222518, Minsk region
Belarus M01AB05 13853/122.01.2015
18.09.2019OTC
Open joint stock
company "Borisovskiy
zavod medicinskikh
preparatov" 64,
Chapaev str., Borisov
222518, Minsk
region, Belarus
1346 Diclofenac sodiumdiclofenac
(diclofenac sodium)
solution for i/m and
i/v injection
25mg/ml,
3ml ampoules, in blister
(5, 5/1x5/)
Lekhim-Kharkiv JSC,
36, 17-go Partsyezda
str., 61115 Kharkov
Ukraine M01AB05 1602417.10.2016
17.10.2021PoM
Lekhim-Kharkiv JSC,
36, 17-go Partsyezda
str., 61115 Kharkov,
Ukraine
1347 Diclofenac-Asteriadiclofenac
(diclofenac sodium)tablets
100mg,
in blister (20/2x10/,
100/10x10/)
Hankook Korus
Pharm Co., Ltd, 30,
Gangjeo-ro, Jecheon-
si, Chungcheongbuk-
do
Korea Sourth M01AB05 1517117.12.2015
17.12.2020PoM
GL Corporation,
Woori Venture
Tower #201, 70,
Seonyu-ro,
Yeongdeungpo-ku,
Seoul, South Korea
1348 Diclofenac-Asteriadiclofenac
(diclofenac sodium)tablets
50mg,
in blister (20/2x10/,
100/10x10/)
Hankook Korus
Pharm Co., Ltd, 30,
Gangjeo-ro, Jecheon-
si, Chungcheongbuk-
do
Korea Sourth M01AB05 1517217.12.2015
17.12.2020PoM
GL Corporation,
Woori Venture
Tower #201, 70,
Seonyu-ro,
Yeongdeungpo-ku,
Seoul, South Korea
1349 Diclofenac-Asteriadiclofenac
(diclofenac sodium)solution for injection
75mg/3ml,
3ml ampoules (5)
Hankook Korus
Pharm Co., Ltd, 78
Daepungsandan-ro,
Daeso-myeon,
Eumseong-gun,
Chungcheongbuk-do
Korea South M01AB05 1647706.03.2017
06.03.2022PoM
GL Corporation,
Woori Venture
Tower 201, 70,
Seonyu-ro,
Yeongdeungpo-ku,
Seoul, Korea South
1350Diclofenac-
Zdorovye
diclofenac
(diclofenac sodium)gel for external use
10mg/g,
30g, 50g aluminium tube
Pharmaceutical
Company "Zdorovye"
LLC, 61013, Kharkov,
Shevchenko str., 22
Ukraine M01AB55 1631530.12.2016
30.12.2021OTC
Pharmaceutical
Company "Zdorovye"
LLC, 61013, Kharkov,
Shevchenko str., 22,
Ukraine
293
1351 Dicloflex 75mg SRdiclofenac
(diclofenac sodium)
tablets prolonged-
release
75mg,
in blister (28/2x14/,
56/4x14/)
Dexcel-Pharma Ltd.,
7 Sopwith Way,
Drayton Fields
Industrial Estate,
Daventry,
Northamptonshire,
NN11 8PB - batch
releaser (dosage form
manufacturer,
packager - Dexcel
Ltd., 1 Dexcel St., Or-
Akiva 30600, Israel)
UK M01AB05 1269017.07.2013
17.07.2018PoM
Dexcel-Pharma Ltd.,
7 Sopwith Way,
Drayton Fields
Industrial Estate,
Daventry,
Northamptonshire,
NN11 8PB, UK
1352Dicloflex Retard
100mg
diclofenac
(diclofenac sodium)
tablets prolonged-
release
100mg,
in blister (28/2x14/)
Dexcel-Pharma Ltd.,
7 Sopwith Way,
Drayton Fields
Industrial Estate,
Daventry,
Northamptonshire,
NN11 8PB - batch
releaser (dosage form
manufacturer,
packager - Dexcel
Ltd., 1 Dexcel St., Or-
Akiva 30600, Israel)
UK M01AB05 1269117.07.2013
17.07.2018PoM
Dexcel-Pharma Ltd.,
7 Sopwith Way,
Drayton Fields
Industrial Estate,
Daventry,
Northamptonshire,
NN11 8PB, UK
1353 Diclondiclofenac
(diclofenac sodium)suppositories rectal
12,5mg
(10/2x5/)
Medical Horizon Ltd,
Ararat province,
Masis city, Masis
station, Gortsaranain
22
Republic of
ArmeniaM01AB05 13595
10.06.2014
10.06.2019PoM
Medical Horizon Ltd,
Ararat province,
Masis city, Masis
station, Gortsaranain
22, Republic of
Armenia
1354 Diclondiclofenac
(diclofenac sodium)suppositories rectal
25mg
(10/2x5/)
Medical Horizon Ltd,
Ararat province,
Masis city, Masis
station, Gortsaranain
22
Republic of
ArmeniaM01AB05 13596
10.06.2014
10.06.2019PoM
Medical Horizon Ltd,
Ararat province,
Masis city, Masis
station, Gortsaranain
22, Republic of
Armenia
294
1355 Diclondiclofenac
(diclofenac sodium)suppositories rectal
50mg
(10/2x5/)
Medical Horizon Ltd,
Ararat province,
Masis city, Masis
station, Gortsaranain
22
Republic of
ArmeniaM01AB05 13597
10.06.2014
10.06.2019PoM
Medical Horizon Ltd,
Ararat province,
Masis city, Masis
station, Gortsaranain
22, Republic of
Armenia
1356 Diclondiclofenac
(diclofenac sodium)suppositories rectal
100mg
(10/2x5/)
Medical Horizon Ltd,
Ararat province,
Masis city, Masis
station, Gortsaranain
22
Republic of
ArmeniaM01AB05 13598
10.06.2014
10.06.2019PoM
Medical Horizon Ltd,
Ararat province,
Masis city, Masis
station, Gortsaranain
22, Republic of
Armenia
1357 Dicloton 75mg/3mldiclofenac
(diclofenac sodium)
solution for
injection/infusion
25mg/ml,
3ml ampoules (5)
Medochemie Ltd., 48
Iapetou street, Agios
Athanassios Industrial
Area, 4101 Agios
Athanassios, Limassol
Cyprus M01AB05 1462103.07.2015
03.07.2020PoM
Medochemie Ltd., 1-
10 Constantinoupo-
leos street, 3011
Limassol, Cyprus
1358 Dicynone etamsylate solution for injection250mg/2ml,
2ml ampoules (50)
Lek Pharmaceuticals
d.d. Verovskova Str.
57, 1526 Ljubljana
Slovenia B02BX01 1409018.12.2014
18.12.2019PoM
Lek Pharmaceuticals
d.d. Verovskova Str.
57, 1526 Ljubljana,
Slovenia
1359 Dicynone etamsylate tablets250mg,
in blister (100/10x10/)
Lek Pharmaceuticals
d.d. Verovskova Str.
57, 1526 Ljubljana
Slovenia B02BX01 1409118.12.2014
18.12.2019PoM
Lek Pharmaceuticals
d.d. Verovskova Str.
57, 1526 Ljubljana,
Slovenia
1360 Dicynone etamsylate tablets250mg,
in blister (100/10x10/)
Lek Pharmaceuticals
d.d.,Trimlini 2D,
Lendava, 9220 -batch
releaser, packager,
Lek Pharmaceuticals
d.d., Verovskova Str.
57, 1526 Ljubljana,
Slovenia-bulk
manufacturer
Slovenia B02BX01 1727513.12.2017
13.12.2022PoM
Lek Pharmaceuticals
d.d., Verovskova Str.
57, 1526 Ljubljana,
Slovenia
295
1361 Dicynone 250 etamsylatesolution for i/v and
i/m injection
125mg/ml,
2ml ampoules (4)
OM Pharma SA, 22,
rue du Bois-du-Lan,
1217 Meyrin
2/Geneva - secondary
packager, batch
releaser (Sanofi
Winthrop Industrie, 6
boulevard de l-
Europe-21800
Quetigny, France -
bulk manufacturer,
primary packager)
Switzerland B02BX01 1398226.11.2014
26.11.2019PoM
OM Pharma SA, 22,
rue du Bois-du-Lan,
1217 Meyrin
2/Geneva,
Switzerland
1362 Dieverm 600 albendazole bolus600mg,
blisters (50/5x10/)
Zagros Pharmed Pars
Pharma. Co., Malayer
Ring Way, Borujerd
Iran
QP52AC11;
veterinary
drug
14710/224.10.2016
16.07.2020PoM
Zagros Pharmed Pars
Pharma. Co., No 26,
Nader Alley, Parvin
st., West Dr. Fatemi
ave., Tehran, Iran
1363 Dificlir fidaxomicin tablets film-coated
200mg,
in blister (20/2x10/,
100/10x10/)
Astellas Pharma
Europe B.V.,
Hogemaat 2, 7942 JG
Meppel, (packager,
batch releaser),
Patheon Inc., 2100
Syntex Court,
Mississauga, Ontario,
L5N 7K9, Canada
(dosage form
manufacturer)
the Netherlands A07AA12 1412429.12.2014
29.12.2019PoM
Astellas Pharma
Europe B.V.,
Sylviusweg 62, 2333
BE Leiden, the
Netherlands
1364 Diflazon fluconazole capsules150mg,
in blister (1)
KRKA d.d., Novo
mesto, Smarjeska
cesta 6, 8501 Novo
Mesto
Slovenia J02AC01 1337304.04.2014
04.04.2019PoM
KRKA d.d., Novo
mesto, Smarjeska
cesta 6, 8501 Novo
Mesto, Slovenia
1365 Diflucan fluconazolesolution for i/v
infusion
2mg/ml,
50ml glass vial
Fareva Amboise, Zone
Industrielle, 29 route
des Industries, 37530
Poce-sur-Cisse
France J02AC01 13112/124.07.2017
24.12.2018PoM
Pfizer H.C.P.
Corporation, 235,
East 42nd street New
York 10017, USA
296
1366 Diflucan fluconazole capsules50mg,
in blister (7)
Fareva Amboise, Zone
Industrielle, 29 route
des Industries, 37530
Poce-sur-Cisse
France J02AC01 13113/124.07.2017
24.12.2018PoM
Pfizer H.C.P.
Corporation, 235,
East 42nd street New
York 10017, USA
1367 Diflucan fluconazole capsules150mg,
in blister (1)
Fareva Amboise, Zone
Industrielle, 29 route
des Industries, 37530
Poce-sur-Cisse
France J02AC01 13114/124.07.2017
24.12.2018PoM
Pfizer H.C.P.
Corporation, 235,
East 42nd street New
York 10017, USA
1368 Diflukonazol fluconazole capsules150mg,
in blister (1)
Replek Farm Ltd,
Skopje, 188 str. Kozle,
1000 Skopje
Macedonia J02AC01 1357610.06.2014
10.06.2019PoM
Esculap Ltd., 17/2, 1
block, Davidashen,
0054, Yerevan,
Republic of Armenia
1369 Difluzol fluconazole capsules150mg,
in blister (1)
Kievmedpreparat
PJSC, 01032, Kiev,
Saksaganskogo street,
139
Ukraine J02AC01 1358610.06.2014
10.06.2019PoM
Kievmedpreparat
PJSC, 01032, Kiev,
Saksaganskogo street,
139, Ukraine
1370 Digoxin digoxin tablets250mcg,
in blister (30/3x10/)
Pharmstandard-
Tomskchimpharm
OJSC, 634009, Tomsk,
avenue Lenina, 211
Russia C01AA05 1221807.03.2013
07.03.2018PoM
Pharmstandard-
Tomskchimpharm
OJSC, 634009, Tomsk,
avenue Lenina, 211,
Russia
1371 Digoxin digoxin tablets0,25mg,
in blister (30/2x15/)
Warsaw
Pharmaceutical
Works "Polfa" S.A.,
Karolkowa 22/24 str.,
01-207 Warsaw
Poland C01AA05 1464503.07.2015
03.07.2020PoM
Warsaw
Pharmaceutical
Works "Polfa" S.A.,
Karolkowa 22/24 str.,
01-207 Warsaw,
Poland
1372 Digoxin digoxin tablets0,25mg,
in blister (40/1x40/)
Arpimed LLC, Kotayk
Marz, Abovyan, 2nd
Micro-District, 19
Building
Republic of
ArmeniaC01AA05 14884
24.09.2015
24.09.2020PoM
Arpimed LLC,
Kotayk Marz,
Abovyan, 2nd Micro-
District, 19 Building,
Republic of Armenia
297
1373 Digoxin digoxin solution for injection
0,25mg/ml,
1ml ampoules,
in blister
(10/1x10/, 10/2x5/)
Pharmaceutical
Company "Zdorovye"
LLC, 61013, Kharkov,
Shevchenko str., 22
Ukraine C01AA05 1701626.09.2017
26.09.2022PoM
Experimental Plant
"GNCLS" LLC, 61057,
Kharkov, Vorobyova
str., 8, Ukraine
1374 Digoxin Grindeks digoxin tablets0,25mg,
in blister (50/2x25/)
Grindeks JSC,
Krustpils street 53, LV-
1057, Riga
Latvia C01AA05 1624919.12.2016
19.12.2021PoM
Grindeks JSC,
Krustpils street 53,
LV-1057, Riga, Latvia
1375 Digoxin-Zdorovye digoxin tablets
0,25mg,
in blister (50/5x10,
50/1x50, 50)
Pharmaceutical
Company "Zdorovye"
LLC, 61013, Kharkov,
Shevchenko str., 22
Ukraine C01AA05 1636230.12.2016
30.12.2021PoM
Pharmaceutical
Company "Zdorovye"
LLC, 61013, Kharkov,
Shevchenko str., 22,
Ukraine
1376 Diklofendiclofenac
(diclofenac sodium)
solution for i/v and
i/m injection
25mg/ml,
3ml ampoules (5)
Galenika a.d.
Batajnicki drum bb,
11080 Belgrade-batch
releaser, secondary
packager, Mefar Ilac
Sanayii A.S.,
Ramazanoglu Mah.
Ensar Cad. No. 20,
Kurtkoy-Pendik, TR-
34906 Istanbul,
Turkey-bulk
manufacturer,
primary packager
Serbia M01AB05 1418806.02.2015
06.02.2020PoM
Galenika a.d., 11080
Belgrade, Batajnicki
drum b.b.,Serbia
298
1377 Dilatrend carvedilol tablets6,25mg,
in blister (30/3x10/)
F. Hoffmann-La
Roche Ltd.,
Grenzacherstrasse
124, 4070 Basel -
batch releaser (Roche
S.p.A, Via Morelli 2,
20090, Segrate, Italy -
bulk manufacturer)
(F.Hoffmann-La
Roche Ltd.,
Wurmisweg, 4303
Kaiseraugust,
Switzerland -
packager)
Switzerland C07AG02 1382218.09.2014
18.09.2019PoM
F. Hoffmann-La
Roche Ltd.,
Grenzacherstrasse
124, 4070 Basel,
Switzerland
1378 Dilatrend carvedilol tablets12,5mg,
in blister (30/3x10/)
F. Hoffmann-La
Roche Ltd.,
Grenzacherstrasse
124, 4070 Basel -
batch releaser (Roche
S.p.A, Via Morelli 2,
20090, Segrate, Italy -
bulk manufacturer)
(F.Hoffmann-La
Roche Ltd.,
Wurmisweg, 4303
Kaiseraugust,
Switzerland -
packager)
Switzerland C07AG02 1382318.09.2014
18.09.2019PoM
F. Hoffmann-La
Roche Ltd.,
Grenzacherstrasse
124, 4070 Basel,
Switzerland
1379 Dilatrend carvedilol tablets25mg,
in blister (30/3x10/)
F. Hoffmann-La
Roche Ltd.,
Grenzacherstrasse
124, 4070 Basel -
batch releaser (Roche
S.p.A, Via Morelli 2,
20090, Segrate, Italy -
bulk manufacturer)
(F.Hoffmann-La
Roche Ltd.,
Wurmisweg, 4303
Kaiseraugust,
Switzerland -
packager)
Switzerland C07AG02 1382418.09.2014
18.09.2019PoM
F. Hoffmann-La
Roche Ltd.,
Grenzacherstrasse
124, 4070 Basel,
Switzerland
299
1380 Diltiazemdiltiazem (diltiazem
hydrochloride)tablets
60mg,
in blister (10/1x10/,
30/3x10/)
'Lubnypharm' PJSC,
37500, Poltava region,
Lubny, Petrovskogo
str. 16
Ukraine C08DB01 1551519.04.2016
19.04.2021PoM
Lubnypharm' PJSC,
37500, Poltava region,
Lubny, Petrovskogo
str. 16, Ukraine
1381Diltiazem
Lannacher 180mg
diltiazem (diltiazem
hydrochloride)
tablets film-coated
prolonged-release
180mg,
in blister (30/3x10/)
G.L. Pharma GmbH,
Schlossplatz 1, 8502
Lannach -batch
releaser, G.L. Pharma
GmbH,
Industriestrasse 1,
8502 Lannach,
Austria -bulk
manufacturer,
packager
Austria C08DB01 1432825.03.2015
25.03.2020PoM
VALEANT LLC,
Shabolovka st. 31,
building 5, 115162,
Moscow, Russia
1382Diltiazem
Lannacher 90mg
diltiazem (diltiazem
hydrochloride)
tablets film-coated
prolonged-release
90mg,
in blister (20/2x10/)
G.L. Pharma GmbH,
Schlossplatz 1, 8502
Lannach -batch
releaser, G.L. Pharma
GmbH,
Industriestrasse 1,
8502 Lannach,
Austria -bulk
manufacturer,
packager
Austria C08DB01 1432725.03.2015
25.03.2020PoM
VALEANT LLC,
Shabolovka st. 31,
building 5, 115162,
Moscow, Russia
1383 Diltiazem Retarddiltiazem (diltiazem
hydrochloride)
capsules prolonged-
release
90mg,
in blister (21/3x7/)
S.C. Rompharm
Company S.R.L.,
Ilfov, 75100 Otopeni,
Str. Eroilor, Nr. 1A
Romania C08DB01 1317110.01.2014
10.01.2019PoM
S.C. Rompharm
Company S.R.L.,
Ilfov, 75100 Otopeni,
Str. Eroilor, Nr. 1A,
Romania
1384 Diltiazem Retarddiltiazem (diltiazem
hydrochloride)
capsules prolonged-
release
180mg,
in blister (30/3x10/)
S.C. Rompharm
Company S.R.L.,
Ilfov, 75100 Otopeni,
Str. Eroilor, Nr. 1A
Romania C08DB01 1317210.01.2014
10.01.2019PoM
S.C. Rompharm
Company S.R.L.,
Ilfov, 75100 Otopeni,
Str. Eroilor, Nr. 1A,
Romania
300
1385 Dilvecor 25mg carvedilol tablets25mg,
in blister (30/3x10/)
Antibiotice S.A., 1,
Valea Lupului,
707410 lasi
Romania C07AG02 1402026.11.2014
26.11.2019PoM
Antibiotice S.A., 1,
Valea Lupului,
707410 lasi, Romania
1386 Dilvecor 6,25mg carvedilol tablets6,25mg,
in blister (30/3x10/)
Antibiotice S.A., 1,
Valea Lupului,
707410 lasi
Romania C07AG02 1401926.11.2014
26.11.2019PoM
Antibiotice S.A., 1,
Valea Lupului,
707410 lasi, Romania
1387 Dimedrol
diphenhydramine
(diphenhydramine
hydrochloride)
solution for injection
10mg/ml; (10) ampoules
1ml, (10) ampoules 1ml
label banderol, (10)
ampoules 1ml dividella
Open Joint Stock
Company
<Borisovskiy zavod
Medicinckikh
Preparatov>, 64/27,
Chapayev str., Borisov
222120, Minsk oblast
Belarus R06AA02 1249201.06.2013
01.06.2018PoM
Open Joint Stock
Company
<Borisovskiy zavod
Medicinckikh
Preparatov>, 64/27,
Chapayev str.,
Borisov 222120,
Minsk oblast, Belarus
1388 Dimedrol
diphenhydramine
(diphenhydramine
hydrochloride)
solution for injection10mg/ml,
1ml ampoules (10)
Yerevan Chemical-
Pharmaceutical firm
OJSC, Yerevan,
Ajaryan street, 2 Line,
No6
Republic of
ArmeniaR06AA02 16762
02.06.2017
02.06.2022PoM
Yerevan Chemical-
Pharmaceutical firm
OJSC, Yerevan,
Ajaryan street, 2
Line, No6, Republic
of Armenia
1389 Dimedrol
diphenhydramine
(diphenhydramine
hydrochloride)
solution for i/m
injection
10mg/ml,
1ml ampoules (10), 1ml
ampoules label banderol
(10), 1ml ampoules, in
blister (10/1x10/)
Open joint stock
company "Borisovskiy
zavod medicinskikh
preparatov" 64, ul.
Chapaeva, Borisov
222518, Minsk region
Belarus R06AA02 1720508.12.2017
08.12.2022PoM
Open joint stock
company "Borisovskiy
zavod medicinskikh
preparatov" 64, ul.
Chapaeva, Borisov
222518, Minsk
region, Belarus
1390 Dimedrol-Belmed
diphenhydramine
(diphenhydramine
hydrochloride)
tablets
50mg,
in blister (10/1x10/,
20/2x10/, 30/3x10/)
Belmedpreparaty
RUE, Grodninsky
region, Skidzyel,
Kizevich str., 50
Belarus R06AA02 1638810.02.2017
10.02.2022PoM
Belmedpreparaty
RUE, 220007, Minsk,
Fabritsius St., 30,
Belarus
301
1391 Dimedrol-Darnitsa
diphenhydramine
(diphenhydramine
hydrochloride)
tablets50mg,
in blister (10)
Darnitsa
Pharmaceutical Firm
PrJSC, 02093, Kiev,
Borisopolskaya Str.,13
Ukraine R06AA02 1235009.04.2013
09.04.2018PoM
Darnitsa
Pharmaceutical Firm
PrJSC, 02093, Kiev,
Borisopolskaya
Str.,13, Ukraine
1392 Dimedrol-Darnitsa
diphenhydramine
(diphenhydramine
hydrochloride)
solution for injection
10mg/ml,
1ml ampoules,
in blister (10/2x5), 1ml
ampoules (10)
Darnitsa
Pharmaceutical Firm
PrJSC, 02093, Kiev,
Borispolskaya Str.,13
Ukraine R06AA02 1259121.06.2013
21.06.2018PoM
Darnitsa
Pharmaceutical Firm
PrJSC, 02093, Kiev,
Borispolskaya Str.,13,
Ukraine
1393 Dimex
diphenhydramine
(diphenhydramine
hydrochloride),
ammonium
chloride
syrup
1.992mg/ml+
19.92mg/ml,
125ml glass or plastic
bottle and measuring cup
Sopharma JSC, str.
Iliensko shosse 16,
1220 Sofia - batch
releaser, Sopharma
JSC, Vrabevo vlg.
5660, district of
Lovetch, Bulgaria-
bulk manufacturer,
primary and
secondary packager
Bulgaria R06AA52 1488324.09.2015
24.09.2020OTC
Sopharma JSC, str.
Iliensko shosse 16,
1220 Sofia, Bulgaria
1394 Dimexid dimethylsulfoxide
concentrate for
solution for external
use
100ml,
glass bottle
Marbiopharm JSC,
424006,The Republic
of Mari El,Yoshkar-
Ola, st. Karl Marx 121
Russia M02AX03 1222007.03.2013
07.03.2018OTC
Marbiopharm JSC,
424006,The Republic
of Mari El,Yoshkar-
Ola, st. Karl Marx
121, RUSSIA
1395 Dimexid dimethylsulfoxide
concentrate for
solution for external
use
100ml,
100ml glass bottle
ESCO-PHARM LLC,
Nor-Norq V block,
Mikoyan 13, Yerevan
0079
Republic of
ArmeniaM02AX03 13131
10.01.2014
10.01.2019OTC
ESCO-PHARM LLC,
Nor-Norq V block,
Mikoyan 13, Yerevan
0079, Republic of
Armenia
1396 Dimiadrospirenone,
ethinylestradioltablets film-coated
3mg+0,02mg,
in blister (28/1x28/,
84/3x28/)
Gedeon Richter PLC,
Gyomroi ut 19-21,
1103 Budapest
Hungary G03AA12 1720208.12.2017
08.12.2022PoM
Gedeon Richter PLC,
Gyomroi ut 19-21,
1103 Budapest,
Hungary
302
1397 Diminaveto
diminazene
(diminazene
diaceturate),
antipyrine
(phenazone)
granules
445mg/g+ 555mg/g,
2.36g sachets (10) 23.6g
sachets (10)
Laboratoria Smeets
NV, Fotografielaan
42, 2610 Wilrijk
Belgium
QP51AX07;
veterinary
drug
1479304.09.2015
04.09.2020PoM
V.M.D. NV, Hoge
Mauw 900,B- 2370
Arendonk, Belgium
1398 Dinga
glimepiride,
metformin
(metformin
hydrochloride)
tablets2mg+500mg,
in blister (30/3x10/)
Arpimed LLC, Kotayk
Marz, Abovyan, 2nd
Micro-District, 19
Building
Republic of
ArmeniaA10BD02 13103
09.12.2013
09.12.2018PoM
Arpimed LLC,
Kotayk Marz,
Abovyan, 2nd Micro-
District, 19 Building,
Republic of Armenia
1399 Diovan valsartan tablets film-coated
80mg,
in blister (14/1x14/,
28/2x14/)
Novartis Farmaceutica
S.A., Ronda de Santa
Maria 158, 08210
Barbera del Valles,
Barcelona
Spain C09CA03 1459508.06.2015
08.06.2020PoM
Novartis Pharma AG,
Lichtstrasse 35, 4056
Basel, Switzerland
1400 Diovan valsartan tablets film-coated
160mg,
in blister (14/1x14/,
28/2x14/)
Novartis Farmaceutica
S.A., Ronda de Santa
Maria 158, 08210
Barbera del Valles,
Barcelona
Spain C09CA03 1459608.06.2015
08.06.2020PoM
Novartis Pharma AG,
Lichtstrasse 35, 4056
Basel, Switzerland
1401 Dipal Conc. 1+4 iodinesolution for external
use
7,5mg/ml,
1l, 5l, 10l, 20l, 60l and
200l in plastic container
DeLaval N.V.,
Industriepark-
Drongen 10, B-9031,
Gent
Belgium
QD08AG
veterinary
drug
1388006.10.2014
06.10.2019OTC
DeLaval N.V.,
Industriepark-
Drongen 10, B-9031,
Gent, Belgium
1402 Diphenin phenytoin tablets117mg,
in blister (10)
Arpimed LLC, Kotayk
Marz, Abovyan, 2nd
Micro-District, 19
Building
Republic of
ArmeniaN03AB02 16874
31.07.2017
31.07.2022PoM
Arpimed LLC,
Kotayk Marz,
Abovyan, 2nd Micro-
District, 19 Building,
Republic of Armenia
303
1403 Diphereline 0,1mgtriptorelin
(triptorelin acetate)
powder lyophilized
for solution for s/c
injection
0,1mg,
0,1mg glass vial (7) and
1ml solvent in ampoules
(7)
Ipsen Pharma
Biotech, Parc
d'Activites du Plateau
de Signes, Chemin
departemental No
402, SIGNES, 83870
France L02AE04 1672405.06.2017
05.06.2022PoM
Ipsen Pharma, 65
quai Georges
Gorse,92100
Boulogne-Billancourt,
France
1404Diphereline
3,75mg
triptorelin
(triptorelin acetate)
powder lyophilized
for prolonged-release
suspension for i/m
injection
3,75mg,
3,75mg glass vial, 2ml
solvent in ampoule, 3ml
syringe and needles (2)
Ipsen Pharma
Biotech, Parc
d'Activites du Plateau
de Signes, Chemin
departemental No
402, SIGNES, 83870
France L02AE04 1672505.06.2017
05.06.2022PoM
Ipsen Pharma, 65
quai Georges
Gorse,92100
Boulogne-Billancourt,
France
1405 Diprosalic
betamethasone
(betamethasone
dipropionate),
salicylic acid
ointment0,5mg/g+30mg/g, 30g
aluminium tube
Schering-Plough Labo
N.V., Industriepark
30 B-2220, Heist-op-
den-Berg
Belgium D07XC01 1356510.06.2014
10.06.2019PoM
Schering-Plough
Central East AG,
Weystrasse 20, CH-
6000 Lucerne 6,
Switzerland
1406 Diprosalic
betamethasone
(betamethasone
dipropionate),
salicylic acid
lotion0,5mg/g+20mg/g, 30ml
plastic container-dropper
Cenexi HSC, 2 Rue
Louis Pasteur, 14200
Herouville Saint-
Clair
France D07XC 14740/111.12.2017
03.08.2020PoM
Schering-Plough
Central East AG,
Weystrasse 20, P.O.
Box CH-6000
Lucerne 6,
Switzerland
1407 Diprospan
betamethasone
(betamethasone
dipropionate),
betamethasone
(betamethasone
sodium phosphate)
suspension for
injection
5mg/ml+2mg/ml, 1ml
ampoules (5)
Schering-Plough Labo
N.V., Industriepark
30 B-2220, Heist-op-
den-Berg
Belgium H02AB01 1457109.06.2015
09.06.2020PoM
Schering-Plough
Central East AG,
Weystrasse 20, P.O.
Box CH-6000
Lucerne 6,
Switzerland
1408 Dirotonlisinopril (lisinopril
dihydrate)tablets
5mg,
in blister (14/1x14/,
28/2x14/, 56/4x14/)
Gedeon Richter PLC,
Gyomroi ut 19-21,
1103 Budapest
Hungary C09AA03 1693905.09.2017
05.09.2022PoM
Gedeon Richter PLC,
Gyomroi ut 19-21,
1103 Budapest,
Hungary
304
1409 Dirotonlisinopril (lisinopril
dihydrate)tablets
10mg,
in blister (14/1x14/,
28/2x14/, 56/4x14/)
Gedeon Richter PLC,
Gyomroi ut 19-21,
1103 Budapest
Hungary C09AA03 1694005.09.2017
05.09.2022PoM
Gedeon Richter PLC,
Gyomroi ut 19-21,
1103 Budapest,
Hungary
1410 Dirotonlisinopril (lisinopril
dihydrate)tablets
20mg,
in blister (14/1x14/,
28/2x14/, 56/4x14/)
Gedeon Richter PLC,
Gyomroi ut 19-21,
1103 Budapest
Hungary C09AA03 1694105.09.2017
05.09.2022PoM
Gedeon Richter PLC,
Gyomroi ut 19-21,
1103 Budapest,
Hungary
1411 Disflatyl simethicone drops oral40mg/ml,
30ml glass bottle
Legacy
Pharmaceuticals
Switzerland GmbH,
Ruhrbergstrasse 21,
4127 Birsfelden
Switzerland A03AX13 1442108.04.2015
08.04.2020OTC
MEDA
Pharmaceuticals
Switzerland GmbH,
Hegnaustrasse 60,
8602 Wangen-
Bruttisellen,
Switzerland
1412 Disgren triflusal capsules hard300mg,
in blister (30/3x10/)
J. Uriach & Cia., S.A.
Av. Cami Reial, 51-
57, 08184 Palau-Solita
i Plegamans,
Barcelona
Spain B01AC18 1526722.01.2016
22.01.2021PoM
J. Uriach & Cia., S.A.
Av. Cami Reial, 51-
57, 08184 Palau-Solita
i Plegamans,
Barcelona, Spain
1413 DISTREPTAZAstreptokinase,
streptodornasesuppositories rectal
15000IU+1250IU; (6/1x6/)
in blister
"BIOMED-LUBLIN"
Wytwornia Surowic i
Szczepionek Spolka
Akcyjna, ul.
Uniwersytecka 10, 20-
029, Lublin
Poland B06AA55 1713807.11.2017
07.11.2022PoM
"BIOMED-LUBLIN"
Wytwornia Surowic i
Szczepionek Spolka
Akcyjna, ul.
Uniwersytecka 10, 20-
029, Lublin, Poland
1414 Dithylin
suxamethonium
(suxamethonium
iodide)
solution for i/v
injection
20mg/ml,
5ml ampoules (10) and
divider, ampoules 5ml in
blister (5/1x5/, 10/2x5/)
and divider
Belmedpreparaty
RUE, 220007, Minsk,
Fabritsius St., 30
Belarus M03AB01 1379905.09.2014
05.09.2019PoM
Belmedpreparaty
RUE, 220007, Minsk,
Fabritsius St., 30,
Belarus
305
1415 Dithylin-Darnitsa
suxamethonium
(suxamethonium
iodide)
solution for injection
20mg/ml,
5ml ampoules, in blister,
(5/1x5/, 10/2x5/)
Darnitsa
Pharmaceutical Firm
PrJSC, 02093, Kiev,
Boryspilska Str.,13
Ukraine M03AB01 15787/103.10.2016
20.07.2021PoM
Darnitsa
Pharmaceutical Firm
PrJSC, 02093, Kiev,
Boryspilska Str.,13,
Ukraine
1416 Divigelestradiol (estradiol
hemihydrate)gel
1mg/g,
1g sachets (28)
Orion Corporation,
Orionintie 1, 02200
Espoo-batch releaser,
Orion Corporation,
Tengstrominkatu 8,
20360 Turku, Finland-
bulk manufacturer,
packager
Finland G03CA03 1506602.12.2015
02.12.2020PoM
Orion Corporation,
Orionintie 1, 02200
Espoo, Finland
1417 Divigelestradiol (estradiol
hemihydrate)gel
1mg/g,
0,5g sachets (28)
Orion Corporation,
Orionintie 1, 02200
Espoo-batch releaser,
Orion Corporation,
Tengstrominkatu 8,
20360 Turku, Finland-
bulk manufacturer,
packager
Finland G03CA03 1541209.03.2016
09.03.2021PoM
Orion Corporation,
Orionintie 1, 02200
Espoo, Finland
1418 Dlianos
xylometazoline
(xylometazoline
hydrochloride)
spray nasal
1mg/ml,
10ml plastic container
with nebulizer
Sandoz Private
Limited, Plot No.
801/P, G.I.D.C.,
Ankleshwar 393 002,
Bharuch
India R01AA07 1324024.02.2014
24.02.2019OTC
Novartis Consumer
Health S.A., Route de
I`Etraz, 1260 Nyon,
Switzerland
1419 Dlianos
xylometazoline
(xylometazoline
hydrochloride)
drops nasal
0,5mg/ml,
10ml glass bottle and
dropper
Sandoz Private
Limited, Plot No.
801/P, G.I.D.C.,
Ankleshwar 393 002,
Bharuch
India R01AA07 1324124.02.2014
24.02.2019OTC
Novartis Consumer
Health S.A., Route de
I`Etraz, 1260 Nyon,
Switzerland
306
1420 Dobutamin Hexal
dobutamine
(dobutamine
hydrochloride)
lyophilisate for
solution for infusion
250mg,
glass vial (1)
Salutas Pharma
GmbH, Otto-von-
Guericke-Alle-1,
39179 Barleben-
batch releaser,
Wasserburger
Arzneimittelwerk
GmbH, Herderstrasse
1,2 und Molkerei-
Bauer-Strasse 18-
83512 Wasserburg,
Germany- bulk
manufacturer,
packager
Germany C01CA07 1667611.05.2017
11.05.2022PoM
Hexal AG,
Industriestrasse 25,
83607 Holzkirchen,
Germany
1421 Docetaxel docetaxelconcentrate for
solution for infusion
20mg/ml,
glass vial 1ml (1)
Belmedpreparaty
RUE, 220007, Minsk,
Fabritsius St., 30
Belarus L01CD02 1579120.07.2016
20.07.2021PoM
Belmedpreparaty
RUE, 220007, Minsk,
Fabritsius St., 30,
Belarus
1422
Docetaxel Accord
160mg/8ml
concentrate for
solution for
infusion
docetaxelconcentrate for
solution for infusion
20mg/ml,
8ml concentrate in 10ml
glass vial (1)
Accord Healthcare
Limited, Sage House,319
Pinner Road, North
Harrow, Middlesex, HA1
4HF -batch releaser, Intas
Pharmaceuticals Limited,
Plot No 5/6/7, Pharmez,
Near Village Matoda,
Sarkhej-Bavla Highway,
NH-8A, Matoda, District-
Ahmedabad, 382 210,
Gujarat, India-bulk
manufacturer, primary
packager, Accord
Healthcare Limited, Unit C
& D, Homefield Business
Park, Homefield Road,
Haverhill, CB9 8QP, UK-
secondary packager
UK L01CD02 1453204.06.2015
04.06.2020PoM
Accord Healthcare
Limited, Sage
House,319 Pinner
Road, North Harrow,
Middlesex, HA1 4HF,
UK
307
1423
Docetaxel Accord
160mg/8ml
concentrate for
solution for
infusion
docetaxelconcentrate for
solution for infusion
20mg/ml,
8ml concentrate in 10ml
glass vial (1)
Accord Healthcare
Limited, Sage House,319
Pinner Road, North
Harrow, Middlesex, HA1
4HF-batch releaser, Intas
Pharmaceuticals Limited,
Plot No 457 & 458 &
191/218 P, Sarkhej-Bavla
Highway, Matoda Village,
Sanand, District-
Ahmedabad, 382 210,
Gujarat, India-bulk
manufacturer, primary
packager, Accord
Healthcare Limited, Unit C
& D, Homefield Business
Park, Homefield Road,
Haverhill, CB9 8QP, UK-
secondary packager
UK L01CD02 1453404.06.2015
04.06.2020PoM
Accord Healthcare
Limited, Sage
House,319 Pinner
Road, North Harrow,
Middlesex, HA1 4HF,
UK
1424
Docetaxel Accord
20mg/ml
concentrate for
solution for
infusion
docetaxelconcentrate for
solution for infusion
20mg/ml,
1ml concentrate in 5ml
glass vial (1)
Accord Healthcare
Limited, Sage House,319
Pinner Road, North
Harrow, Middlesex, HA1
4HF -batch releaser, Intas
Pharmaceuticals Limited,
Plot No 5/6/7, Pharmez,
Near Village Matoda,
Sarkhej-Bavla Highway,
NH-8A, Matoda, District-
Ahmedabad, 382 210,
Gujarat, India-bulk
manufacturer, primary
packager, Accord
Healthcare Limited, Unit C
& D, Homefield Business
Park, Homefield Road,
Haverhill, CB9 8QP, UK-
secondary packager
UK L01CD02 1453604.06.2015
04.06.2020PoM
Accord Healthcare
Limited, Sage
House,319 Pinner
Road, North Harrow,
Middlesex, HA1 4HF,
UK
308
1425
Docetaxel Accord
20mg/ml
concentrate for
solution for
infusion
docetaxelconcentrate for
solution for infusion
20mg/ml,
1ml concentrate in 5ml
glass vial (1)
Accord Healthcare
Limited, Sage House,319
Pinner Road, North
Harrow, Middlesex, HA1
4HF-batch releaser, Intas
Pharmaceuticals Limited,
Plot No 457 & 458 &
191/218 P, Sarkhej-Bavla
Highway, Matoda Village,
Sanand, District-
Ahmedabad, 382 210,
Gujarat, India-bulk
manufacturer, primary
packager, Accord
Healthcare Limited, Unit C
& D, Homefield Business
Park, Homefield Road,
Haverhill, CB9 8QP, UK-
secondary packager
UK L01CD02 1453704.06.2015
04.06.2020PoM
Accord Healthcare
Limited, Sage
House,319 Pinner
Road, North Harrow,
Middlesex, HA1 4HF,
UK
1426
Docetaxel Accord
80mg/4ml
concentrate for
solution for
infusion
docetaxelconcentrate for
solution for infusion
20mg/ml,
4ml concentrate in 5ml
glass vial (1)
Accord Healthcare
Limited, Sage House,319
Pinner Road, North
Harrow, Middlesex, HA1
4HF-batch releaser, Intas
Pharmaceuticals Limited,
Plot No 457 & 458 &
191/218 P, Sarkhej-Bavla
Highway, Matoda Village,
Sanand, District-
Ahmedabad, 382 210,
Gujarat, India-bulk
manufacturer, primary
packager, Accord
Healthcare Limited, Unit C
& D, Homefield Business
Park, Homefield Road,
Haverhill, CB9 8QP, UK-
secondary packager
UK L01CD02 1453304.06.2015
04.06.2020PoM
Accord Healthcare
Limited, Sage
House,319 Pinner
Road, North Harrow,
Middlesex, HA1 4HF,
UK
309
1427
Docetaxel Accord
80mg/4ml
concentrate for
solution for
infusion
docetaxelconcentrate for
solution for infusion
20mg/ml,
4ml concentrate in 5ml
glass vial (1)
Accord Healthcare
Limited, Sage House,319
Pinner Road, North
Harrow, Middlesex, HA1
4HF -batch releaser, Intas
Pharmaceuticals Limited,
Plot No 5/6/7, Pharmez,
Near Village Matoda,
Sarkhej-Bavla Highway,
NH-8A, Matoda, District-
Ahmedabad, 382 210,
Gujarat, India-bulk
manufacturer, primary
packager, Accord
Healthcare Limited, Unit C
& D, Homefield Business
Park, Homefield Road,
Haverhill, CB9 8QP, UK-
secondary packager
UK L01CD02 1453504.06.2015
04.06.2020PoM
Accord Healthcare
Limited, Sage
House,319 Pinner
Road, North Harrow,
Middlesex, HA1 4HF,
UK
1428 Docetaxel Ebewe docetaxelconcentrate for
solution for infusion
10mg/ml,
2ml glass vial
EBEWE Pharma Ges.
m.b.H. Nfg. KG,
Mondseestrasse 11, A-
4866 Unterach am
Attersee
Austria L01CD02 1626719.12.2016
19.12.2021PoM
EBEWE Pharma Ges.
m.b.H. Nfg. KG,
Mondseestrasse 11, A-
4866 Unterach am
Attersee, Austria
1429 Docetaxel Ebewe docetaxelconcentrate for
solution for infusion
10mg/ml,
8ml glass vial
EBEWE Pharma Ges.
m.b.H. Nfg. KG,
Mondseestrasse 11, A-
4866 Unterach am
Attersee
Austria L01CD02 1626819.12.2016
19.12.2021PoM
EBEWE Pharma Ges.
m.b.H. Nfg. KG,
Mondseestrasse 11, A-
4866 Unterach am
Attersee, Austria
1430 Doktor Mom
adhatoda vasika,
aloe barbadensis,
ocimum sanctum,
inula racemosa,
zingiber officinale,
curcuma longa,
solanum indicum,
piper cubeba,
glycyrrhiza glabra,
terminalia belerica,
levomenthol
syrup
6mg/ml+5mg/ml+
10mg/ml+2mg/ml+
1mg/ml+5mg/ml+
2mg/ml+1mg/ml+
6mg/ml+2mg/ml+
0,6mg/ml,
100ml, 150ml plastic
bottle and measuring cup
Unique
Pharmaceutical
Laboratories, Plot N0
215, 216, G.I.D.C
Industrial Area,
Panoli: 394 116,
Gujarat State
IndiaR05CA10;
herbal drug13257/1
18.04.2017
24.02.2019OTC
Johnson & Johnson
LLC, 121614,
Moscow, Krylatskaya
str., 17, building 2,
Russia
310
1431 Doktor MOM Fito
camphor,
levomenthol,
nutmeg oil,
turpentine oil,
thymol, eucalyptus
oil
ointmentc for
external use
1.05g/20g+ 0.61g/20g+
0,11ml/20g+ 1,11ml/20g+
0,02g/20g+ 0,3ml/20g,
20g plastic container
Unique
Pharmaceutical
Laboratories (a
division of J. B.
Chemicals &
Pharmaceuticals Ltd.),
Plot N 304-308,
G.I.D.C. Industrial
Area, Panoli: 394 116,
Gujarat State
IndiaR05X;
herbal drug15370/1
27.09.2016
26.02.2021OTC
Johnson & Johnson
LLC, 121614,
Moscow, Krylatskaya
str., 17, building 2,
Russia
1432
Doktor MOM
herbal cough
lozenges
glycyrrhiza glabra,
zingiber officinale,
emblica officinalis,
levomenthol
lozenges with orange
flavour
15mg+10mg+10mg+7mg,
in strip (20/4x5/)
Unique
Pharmaceutical
Laboratories, Survey
No. 101/2 and 102/1,
Daman Industrial
Estate, Kadaiya,
Daman-396 210
IndiaR05CA10;
herbal drug 14442
04.05.2015
04.05.2020OTC
Johnson & Johnson
LLC, 121614,
Moscow, Krylatskaya
str., 17, building 2,
Russia
1433
Doktor MOM
herbal cough
lozenges
glycyrrhiza glabra,
zingiber officinale,
emblica officinalis,
levomenthol
lozenges with lemon
flavour
15mg+10mg+10mg+7mg,
in strip (20/4x5/)
Unique
Pharmaceutical
Laboratories, Survey
No. 101/2 and 102/1,
Daman Industrial
Estate, Kadaiya,
Daman-396 210
IndiaR05CA10;
herbal drug 14443
04.05.2015
04.05.2020OTC
Johnson & Johnson
LLC, 121614,
Moscow, Krylatskaya
str., 17, building 2,
Russia
1434
Doktor MOM
herbal cough
lozenges
glycyrrhiza glabra,
zingiber officinale,
emblica officinalis,
levomenthol
lozenges with berries
flavour
15mg+10mg+ 10mg+7mg,
in strip (20/4x5/)
Unique
Pharmaceutical
Laboratories, Survey
No. 101/2 and 102/1,
Daman Industrial
Estate, Kadaiya,
Daman-396 210
IndiaR05CA10;
herbal drug 14444
04.05.2015
04.05.2020OTC
Johnson & Johnson
LLC, 121614,
Moscow, Krylatskaya
str., 17, building 2,
Russia
1435 DolEx
diclofenac
(diclofenac sodium),
lidocaine (lidocaine
hydrochloride)
solution for i/m
injection
37,5mg/ml+ 10mg/ml,
2ml glass vials (5)
Liqvor CJSC, 0089,
Yerevan, str.
Kochinyan, 7/9
Republic of
ArmeniaM01AB55 13280
04.03.2014
04.03.2019PoM
Liqvor CJSC, 0089,
Yerevan, str.
Kochinyan, 7/9,
Republic of Armenia
311
1436 Doloforte Denk
tramadol (tramadol
hydrochloride),
paracetamol
tablets film-coated37,5mg+325mg,
in blister (20/2x10/)
Denk Pharma GmbH
& Co. KG, Goellstr. 1,
84529 Tittmoning
Germany N02AJ13 1669423.05.2017
23.05.2022PoM
Denk Pharma GmbH
& Co. KG,
Prinzregentenstr. 79,
81675 Munchen,
Germany
1437 Dolpassketorolac (ketorolac
tromethamine)
solution for i/v and
i/m injection
30mg/ml,
1ml glass vial (5)
Liqvor CJSC, 0089,
Yerevan, str.
Kochinyan, 7/9
Republic of
ArmeniaM01AB15 13287
04.03.2014
04.03.2019PoM
Liqvor CJSC, 0089,
Yerevan, str.
Kochinyan, 7/9,
Republic of Armenia
1438 Domosedan gel
detomidine
(detomidine
hydrochloride)
gel oromucosal7,6mg/ml,
3ml pre-filled syringe (1)
Orion Corporation,
Orionintie 1, 02200
Espoo
Finland
QN05CM90;
veterinary
drug
1589223.08.2016
23.08.2021OTC
Orion Corporation,
Orionintie 1, 02200
Espoo, Finland
1439 DONA
glucosamine
(glucosamine
sulfate)
powder for oral
solution
1500mg,
sachets (20, 30)
Rottapharm Ltd.,
Damastown Industrial
Park, Mulhuddart,
Dublin 15
Ireland M01AX05 1547302.04.2016
02.04.2021PoM
Rottapharm S.p.A.,
Galleria Unione 5,
20122, Milan, Italy
1440 DONA
ampoule A-
glucosamine
(glucosamine
sulfate), ampoule B-
solvent
solution for i/m
injection
200mg/ml; (6) ampoule A
2ml, (6) ampoule B 1ml
Biologici Italia
Laboratories S.r.l., via
Filippo Serpero, 2 -
20060 Masate (MI)
Italy M01AX05 15474/108.06.2017
02.04.2021PoM
MEDA Pharma
GmbH & Co. KG,
Benzstrasse 1, 61352
Bad Homburg,
Germany
1441 Donormyl
doxylamine
(doxylamine
succinate)
tablets coated
15mg,
in plastic container, (10,
30)
UPSA SAS, 304,
avenue du Docteur
Jean Bru, 47000
AGEN
France R06AA09 13653/107.07.2017
08.07.2019PoM
UPSA SAS, 3, rue
Joseph Monier- 92500
Rueil- Malmaison,
France
1442 Dopegyt
methyldopa
(methyldopa
sesquihydrate)
tablets250mg,
in glass container (50)
Egis Pharmaceuticals
PLC, 9900, Kormend,
Matyas Kiraly u. 65
Hungary C02AB01 1540309.03.2016
09.03.2021PoM
Egis Pharmaceuticals
PLC, 1106 Budapest,
Kereszturi ut 30-38,
Hungary
1443 Dopmin
dopamine
(dopamine
hydrochloride)
concentrate for
solution for infusion
40mg/ml,
5ml ampoules (5)
Orion Corporation,
Orionintie 1, 02200
Espoo
Finland C01CA04 1490024.09.2015
24.09.2020PoM
Orion Corporation,
Orionintie 1, 02200
Espoo, Finland
312
1444 Dorzopt
dorzolamide
(dorzolamide
hydrochloride)
drops eye20mg/ml,
5ml plastic vial-dropper
S.C. Rompharm
Company S.R.L.,
Ilfov, 075100
Otopeni, Str. Eroilor,
Nr. 1A
Romania S01EC03 1611910.11.2016
10.11.2021PoM
S.C. Rompharm
Company S.R.L.,
Ilfov, 075100
Otopeni, Str. Eroilor,
Nr. 1A, Romania
1445 Dostinex cabergoline tablets
0,5mg,
in glass container (2) and
(8)
Pfizer Italia S.r.L.,
Localita Marino del
Tronto, 63100 Ascoli
Piceno
Italy G02CB03 1722708.12.2017
08.12.2022PoM
Pfizer H.C.P.
Corporation, 235,
East 42nd Street, New
York 10017, USA
1446 Doxiproct
calcium dobesilate
(calcium dobesilate
monohydrate),
lidocaine (lidocaine
hydrochloride)
ointment
40mg/g+20mg/g, 30g
aluminium tube and
cannula
OM Pharma S.A., Rua
da Industria, 2 Quinta
Grande, 2610-088
Amadora, Lisbon
Portugal C05AX 1438316.04.2015
16.04.2020OTC
OM Pharma S.A., Rua
da Industria, 2 Quinta
Grande, 2610-088
Amadora, Lisbon,
Portugal
1447 Doxiproct Plus
calcium dobesilate
(calcium dobesilate
monohydrate),
lidocaine (lidocaine
hydrochloride),
dexamethasone
(dexamethasone
acetate)
ointment
40mg/g+20mg/g+
0,25mg/g,
20g aluminium tube
OM Pharma S.A., Rua
da Industria, 2 Quinta
Grande, 2610-088
Amadora, Lisbon
Portugal C05AX03 1429819.03.2015
19.03.2020PoM
OM Pharma S.A., Rua
da Industria, 2 Quinta
Grande, 2610-088
Amadora, Lisbon,
Portugal
313
1448
Doxorubicin
2mg/ml
Concentrate for
Solution for
Infusion
doxorubicin
(doxorubicin
hydrochloride)
concentrate for
solution for infusion
2mg/ml,
100ml glass vial (1)
Accord Healthcare
Limited, Sage House,319
Pinner Road, North
Harrow, Middlesex, HA1
4HF - batch releaser (bulk
manufacturer, primary
packager- Intas
Pharmaceuticals Limited,
Plot No 457 & 458 &
191/218 P, Sarkhej-Bavla
Highway, Matoda Village,
Sanand, District-
Ahmedabad, 382 210,
Gujarat, India) (secondary
packager- Accord
Healthcare Limited, Unit C
& D, Homefield Business
Park, Homefield Road,
Haverhill, CB9 8QP, UK)
UK L01DB01 14672/109.07.2015
29.06.2020PoM
Accord Healthcare
Limited, Sage
House,319 Pinner
Road, North Harrow,
Middlesex, HA1 4HF,
UK
1449
Doxorubicin
2mg/ml
Concentrate for
Solution for
Infusion
doxorubicin
(doxorubicin
hydrochloride)
concentrate for
solution for infusion
2mg/ml,
5ml glass vial (1)
Accord Healthcare
Limited, Sage House,319
Pinner Road, North
Harrow, Middlesex, HA1
4HF - batch releaser (bulk
manufacturer, primary
packager- Intas
Pharmaceuticals Limited,
Plot No 5/6/7, Pharmez,
Near Village Matoda,
Sarkhej-Bavla Highway,
NH-8A, Matoda, District-
Ahmedabad, 382 210,
Gujarat, India) (secondary
packager- Accord
Healthcare Limited, Unit C
& D, Homefield Business
Park, Homefield Road,
Haverhill, CB9 8QP, UK)
UK L01DB01 14673/109.07.2015
29.06.2020PoM
Accord Healthcare
Limited, Sage
House,319 Pinner
Road, North Harrow,
Middlesex, HA1 4HF,
UK
314
1450
Doxorubicin
2mg/ml
Concentrate for
Solution for
Infusion
doxorubicin
(doxorubicin
hydrochloride)
concentrate solution
for infusion
2mg/ml,
100ml glass vial (1)
Accord Healthcare
Limited, Sage House,319
Pinner Road, North
Harrow, Middlesex, HA1
4HF - batch releaser (bulk
manufacturer, primary
packager- Intas
Pharmaceuticals Limited,
Plot No 5/6/7, Pharmez,
Near Village Matoda,
Sarkhej-Bavla Highway,
NH-8A, Matoda, District-
Ahmedabad, 382 210,
Gujarat, India) (secondary
packager- Accord
Healthcare Limited, Unit C
& D, Homefield Business
Park, Homefield Road,
Haverhill, CB9 8QP, UK)
UK L01DB01 14674/109.07.2015
29.06.2020PoM
Accord Healthcare
Limited, Sage
House,319 Pinner
Road, North Harrow,
Middlesex, HA1 4HF,
UK
1451
Doxorubicin
2mg/ml
Concentrate for
Solution for
Infusion
doxorubicin
(doxorubicin
hydrochloride)
concentrate for
solution for infusion
2mg/ml,
50ml glass vial (1)
Accord Healthcare
Limited, Sage House,319
Pinner Road, North
Harrow, Middlesex, HA1
4HF - batch releaser (bulk
manufacturer, primary
packager- Intas
Pharmaceuticals Limited,
Plot No 457 & 458 &
191/218 P, Sarkhej-Bavla
Highway, Matoda Village,
Sanand, District-
Ahmedabad, 382 210,
Gujarat, India) (secondary
packager- Accord
Healthcare Limited, Unit C
& D, Homefield Business
Park, Homefield Road,
Haverhill, CB9 8QP, UK)
UK L01DB01 14675/109.07.2015
29.06.2020PoM
Accord Healthcare
Limited, Sage
House,319 Pinner
Road, North Harrow,
Middlesex, HA1 4HF,
UK
315
1452
Doxorubicin
2mg/ml
Concentrate for
Solution for
Infusion
doxorubicin
(doxorubicin
hydrochloride)
concentrate for
solution for infusion
2mg/ml,
50ml glass vial (1)
Accord Healthcare
Limited, Sage House,319
Pinner Road, North
Harrow, Middlesex, HA1
4HF - batch releaser (bulk
manufacturer, primary
packager- Intas
Pharmaceuticals Limited,
Plot No 5/6/7, Pharmez,
Near Village Matoda,
Sarkhej-Bavla Highway,
NH-8A, Matoda, District-
Ahmedabad, 382 210,
Gujarat, India) (secondary
packager- Accord
Healthcare Limited, Unit C
& D, Homefield Business
Park, Homefield Road,
Haverhill, CB9 8QP, UK)
UK L01DB01 14676/109.07.2015
29.06.2020PoM
Accord Healthcare
Limited, Sage
House,319 Pinner
Road, North Harrow,
Middlesex, HA1 4HF,
UK
1453
Doxorubicin
2mg/ml
Concentrate for
Solution for
Infusion
doxorubicin
(doxorubicin
hydrochloride)
concentrate for
solution for infusion
2mg/ml,
25ml glass vial (1)
Accord Healthcare
Limited, Sage House,319
Pinner Road, North
Harrow, Middlesex, HA1
4HF - batch releaser (bulk
manufacturer, primary
packager- Intas
Pharmaceuticals Limited,
Plot No 457 & 458 &
191/218 P, Sarkhej-Bavla
Highway, Matoda Village,
Sanand, District-
Ahmedabad, 382 210,
Gujarat, India) (secondary
packager- Accord
Healthcare Limited, Unit C
& D, Homefield Business
Park, Homefield Road,
Haverhill, CB9 8QP, UK)
UK L01DB01 14677/109.07.2015
29.06.2020PoM
Accord Healthcare
Limited, Sage
House,319 Pinner
Road, North Harrow,
Middlesex, HA1 4HF,
UK
316
1454
Doxorubicin
2mg/ml
Concentrate for
Solution for
Infusion
doxorubicin
(doxorubicin
hydrochloride)
concentrate for
solution for infusion
2mg/ml,
25ml glass vial (1)
Accord Healthcare
Limited, Sage House,319
Pinner Road, North
Harrow, Middlesex, HA1
4HF - batch releaser (bulk
manufacturer, primary
packager- Intas
Pharmaceuticals Limited,
Plot No 5/6/7, Pharmez,
Near Village Matoda,
Sarkhej-Bavla Highway,
NH-8A, Matoda, District-
Ahmedabad, 382 210,
Gujarat, India) (secondary
packager- Accord
Healthcare Limited, Unit C
& D, Homefield Business
Park, Homefield Road,
Haverhill, CB9 8QP, UK)
UK L01DB01 14678/109.07.2015
29.06.2020PoM
Accord Healthcare
Limited, Sage
House,319 Pinner
Road, North Harrow,
Middlesex, HA1 4HF,
UK
1455
Doxorubicin
2mg/ml
Concentrate for
Solution for
Infusion
doxorubicin
(doxorubicin
hydrochloride)
concentrate for
solution for infusion
2mg/ml,
10ml glass vial (1)
Accord Healthcare
Limited, Sage House,319
Pinner Road, North
Harrow, Middlesex, HA1
4HF - batch releaser (bulk
manufacturer, primary
packager- Intas
Pharmaceuticals Limited,
Plot No 457 & 458 &
191/218 P, Sarkhej-Bavla
Highway, Matoda Village,
Sanand, District-
Ahmedabad, 382 210,
Gujarat, India) (secondary
packager- Accord
Healthcare Limited, Unit C
& D, Homefield Business
Park, Homefield Road,
Haverhill, CB9 8QP, UK)
UK L01DB01 14679/109.07.2015
29.06.2020PoM
Accord Healthcare
Limited, Sage
House,319 Pinner
Road, North Harrow,
Middlesex, HA1 4HF,
UK
317
1456
Doxorubicin
2mg/ml
Concentrate for
Solution for
Infusion
doxorubicin
(doxorubicin
hydrochloride)
concentrate for
solution for infusion
2mg/ml,
10ml glass vial (1)
Accord Healthcare
Limited, Sage House,319
Pinner Road, North
Harrow, Middlesex, HA1
4HF - batch releaser (bulk
manufacturer, primary
packager- Intas
Pharmaceuticals Limited,
Plot No 5/6/7, Pharmez,
Near Village Matoda,
Sarkhej-Bavla Highway,
NH-8A, Matoda, District-
Ahmedabad, 382 210,
Gujarat, India) (secondary
packager- Accord
Healthcare Limited, Unit C
& D, Homefield Business
Park, Homefield Road,
Haverhill, CB9 8QP, UK)
UK L01DB01 14680/109.07.2015
29.06.2020PoM
Accord Healthcare
Limited, Sage
House,319 Pinner
Road, North Harrow,
Middlesex, HA1 4HF,
UK
1457
Doxorubicin
2mg/ml
Concentrate for
Solution for
Infusion
doxorubicin
(doxorubicin
hydrochloride)
concentrate for
solution for infusion
2mg/ml,
5ml glass vial (1)
Accord Healthcare
Limited, Sage House,319
Pinner Road, North
Harrow, Middlesex, HA1
4HF - batch releaser (bulk
manufacturer, primary
packager- Intas
Pharmaceuticals Limited,
Plot No 457 & 458 &
191/218 P, Sarkhej-Bavla
Highway, Matoda Village,
Sanand, District-
Ahmedabad, 382 210,
Gujarat, India) (secondary
packager- Accord
Healthcare Limited, Unit C
& D, Homefield Business
Park, Homefield Road,
Haverhill, CB9 8QP, UK)
UK L01DB01 14681/109.07.2015
29.06.2020PoM
Accord Healthcare
Limited, Sage
House,319 Pinner
Road, North Harrow,
Middlesex, HA1 4HF,
UK
1458Doxorubicin
EBEWE
doxorubicin
(doxorubicin
hydrochloride)
concentrate for
solution for infusion
2mg/ml,
5ml glass vial
EBEWE Pharma Ges.
m.b.H. Nfg. KG,
Mondseestrasse 11, A-
4866 Unterach am
Attersee
Austria L01DB01 1404319.12.2014
19.12.2019PoM
EBEWE Pharma Ges.
m.b.H. Nfg. KG,
Mondseestrasse 11, A-
4866 Unterach am
Attersee, Austria
318
1459Doxorubicin
EBEWE
doxorubicin
(doxorubicin
hydrochloride)
concentrate for
solution for infusion
2mg/ml,
25ml glass vial
EBEWE Pharma Ges.
m.b.H. Nfg. KG,
Mondseestrasse 11, A-
4866 Unterach am
Attersee
Austria L01DB01 1404419.12.2014
19.12.2019PoM
EBEWE Pharma Ges.
m.b.H. Nfg. KG,
Mondseestrasse 11, A-
4866 Unterach am
Attersee, Austria
1460Doxorubicin
hydrochloride
doxorubicin
(doxorubicin
hydrochloride)
powder lyophilized
for solution for
injection
10mg,
10ml glass vial
Belmedpreparaty
RUE, 220007, Minsk,
Fabritsius St., 30
Belarus L01DB01 1284217.09.2013
17.09.2018PoM
Belmedpreparaty
RUE, 220007, Minsk,
Fabritsius St., 30,
Belarus
1461Doxorubicin
hydrochloride
doxorubicin
(doxorubicin
hydrochloride)
powder lyophilized
for solution for i/v
injection
10mg,
10ml glass vial (10, 40)
Belmedpreparaty
RUE, 220007, Minsk,
Fabritsius St., 30
Belarus L01DB01 1708412.10.2017
12.10.2022PoM
Belmedpreparaty
RUE, 220007, Minsk,
Fabritsius St., 30,
Belarus
1462 Doxotil
doxorubicin
(doxorubicin
hydrochloride)
solution for injection2mg/ml,
5ml glass vial
Genepharm S.A., 18th
km Marathonos
Avenue, 153 51
Pallini Attiki
Greece L01DB01 1372324.07.2014
24.07.2019PoM
Genepharm S.A.,
18th km Marathonos
Avenue, 153 51
Pallini Attiki, Greece
1463 Doxotil
doxorubicin
(doxorubicin
hydrochloride)
solution for injection2mg/ml,
25ml glass vial
Genepharm S.A., 18th
km Marathonos
Avenue, 153 51
Pallini Attiki
Greece L01DB01 1372424.07.2014
24.07.2019PoM
Genepharm S.A.,
18th km Marathonos
Avenue, 153 51
Pallini Attiki, Greece
1464 Doxy-500 WS
doxycycline
(doxycycline
hyclate)
powder oral500mg/g,
1000g plastic container
Interchemie werken
'De Adelaar' B.V.,
Metaalweg 8, 5804
CG Venray
the Netherlands
QJ01AA02;
veterinary
drug
1414229.12.2014
29.12.2019PoM
Interchemie werken
'De Adelaar' B.V.,
Metaalweg 8, 5804
CG Venray
1465 Doxycycline
doxycycline
(doxycycline
hyclate)
capsules100mg,
in blister (100/10x10/)
Medicamen Biotech
Ltd, SP-1192 A&B,
Phase IV,Industrial
Area,Bhiwadi,Dist.
Alwar (Rajasthan)
India J01AA02 1217101.02.2013
01.02.2018PoM
Troge Medical
GmbH, Milchstrasse
19, D-20148
Hamburg, Germany
319
1466 Doxycycline
doxycycline
(doxycycline
hyclate)
capsules100mg,
in blister (10/1x10/)
Belmedpreparaty
RUP, 220007, Minsk,
Fabritsius St., 30
Belarus J01AA02 1244507.05.2013
07.05.2018PoM
Belmedpreparaty
RUP, 220007, Minsk,
Fabritsius St., 30,
Belarus
1467 Doxycycline
doxycycline
(doxycycline
hyclate)
capsules100mg,
in blister (8)
Chanelle Medical,
Loughrea, Co. Galway Ireland J01AA02 12543
06.06.2013
06.06.2018PoM
Ritm Farm LTD, 11/2
Totovents Street,
Apartment 34,
Yerevan, Armenia
1468 Doxycycline
doxycycline
(doxycycline
hyclate)
capsules
100mg,
in blister (10/1x10/,
20/2x10/)
Open joint stock
company "Borisovskiy
zavod medicinskikh
preparatov" 64,
Chapaev str., Borisov
222518, Minsk region
Belarus J01AA02 1410729.12.2014
29.12.2019PoM
Open joint stock
company "Borisovskiy
zavod medicinskikh
preparatov" 64,
Chapaev str., Borisov
222518, Minsk
region, Belarus
1469Doxycycline-
Asteria
doxycycline
(doxycycline
hyclate)
capsules
100mg,
in blister (20/2x10/,
100/10x10/)
Hankook Korus
Pharm Co., Ltd, 30,
Gangjeo-ro, Jecheon-
si, Chungcheongbuk-
do
Korea Sourth J01AA02 1517317.12.2015
17.12.2020PoM
GL Corporation,
Woori Venture
Tower #201, 70,
Seonyu-ro,
Yeongdeungpo-ku,
Seoul, South Korea
1470 Doxy-Denk 100
doxycycline
(doxycycline
hyclate)
tablets100mg,
in blister (20/2x10/)
Artesan Pharma
GmbH & Co. KG,
Wendlandstrasse 1,
29439 Luchow
Germany J01AA02 1273023.07.2013
23.07.2018PoM
Denk Pharma GmbH
& Co. KG,
Prinzregentenstr. 79,
81675 Munchen,
Germany
1471Dr. Theiss
Bronchosept
thyme liquid
extract, star anise
oil
drops oral250mg/g+50mg/g, 30ml
bottle-dropper
Dr.Theiss Naturwaren
GmbH,
Michelinstrasse 10, D-
66424 Homburg
Saarland
GermanyR05CA;
herbal drug 14604
03.07.2015
03.07.2020OTC
Dr.Theiss Naturwaren
GmbH,
Michelinstrasse 10, D-
66424 Homburg
Saarland, Germany
320
1472Dr. Theiss ribwort
plantain syrupribwort plantain syrup
50mg/g,
100ml and 250ml glass
bottle
Dr.Theiss Naturwaren
GmbH,
Michelinstrasse 10, D-
66424 Homburg
Saarland
GermanyR05CA
herbal drug13652
08.07.2014
08.07.2019OTC
Dr.Theiss Naturwaren
GmbH,
Michelinstrasse 10, D-
66424 Homburg
Saarland, Germany
1473 Dramina dimenhydrinate tablets
50mg,
in blister (5/1x5/,
10/1x10/)
JADRAN-GALENSKI
LABORATORIJ d.d.,
Svilno 20, 51000
Rijeka
Croatia R06AX 1710123.10.2017
23.10.2022OTC
JADRAN-GALENSKI
LABORATORIJ d.d.,
Svilno 20, 51000
Rijeka, Croatia
1474 Drapolene
cetrimide,
benzalkonium
chloride
cream0,2%+0,01%,
55g in plastic tube
GlaxoSmithKline
Pharmaceuticals S.A.,
189 Grunwaldzka
street, 60-322 Poznan
Poland D08AJ 1258705.06.2013
05.06.2018OTC
Glaxo Wellcome UK
Limited, Stockley
Park, Middlesex, UB
11 1BT, UK
1475 Driptane
oxybutynin
(oxybutynin
hydrochloride)
tablets5mg,
in blister (30)
Recipharm Fontaine,
Rue des Pres Potets,
21121 Fontaine les
Dijon
France G04BD04 12266/213.05.2015
07.03.2018PoM
Laboratoires Fournier
SAS, 42 Rue Rouget
de Lisle, 92150
Suresnes, France
1476 Drotaverine
drotaverine
(drotaverine
hydrochloride)
solution for injection20mg/ml,
2ml ampoules (10)
Open Joint Stock
Company
"Borisovskiy zavod
Medicinskikh
Preparatov" (64/27,
Chapayev str., Borisov
222120, Minsk oblast)
Belarus A03AD02 1289107.10.2013
07.10.2018PoM
Open Joint Stock
Company
"Borisovskiy zavod
medicinskikh
preparatov" (64/27,
Chapayev str.,
Borisov 222120,
Minsk oblast, Belarus)
321
1477Drotaverine
hydrochloride
drotaverine
(drotaverine
hydrochloride)
tablets40mg,
in blister (20/2x10/)
Open joint stock
company "Borisovskiy
zavod medicinskikh
preparatov" 64, ul.
Chapaeva, Borisov
222518, Minsk region
Belarus A03AD02 1685210.07.2017
10.07.2022OTC
Open joint stock
company "Borisovskiy
zavod medicinskikh
preparatov" 64, ul.
Chapaeva, Borisov
222518, Minsk
region, Belarus
1478 Duac
clindamycin
(clindamycin
phosphate), benzoyl
peroxide
gel for external use10mg/g+50mg/g, 15g
aluminium tube
Glaxo Operations UK
Limited, Harmire
Road, Barnard Castle,
Co Durham DL12
8DT
UK D10AF51 1492920.10.2015
20.10.2020PoM
GlaxoSmithKline UK
Limited, 980 Great
West Road,
Brentford, Middlesex,
TW8 9GS, UK
1479 Duodart
dutasteride,
tamsulosin
(tamsulosin
hydrochloride)
capsules0,5mg+0,4mg,
plastic container (30)
Catalent Germany
Schorndorf GmbH,
Steinbeisstrasse 1und
2, 73614, Schorndorf -
packager, batch
releaser (Catalent
France Beinheim SA,
74 rue Principale,
67930 Beinheim,
France - dutasteride
soft capsules
manufacturer
(intermediate)),
(Rottendorf Pharma
GmbH, Ostenfelder
Strasse 51-61, 59320
Ennigerloh, Germany -
tamsulosin pellets
manufacturer
(intermediate))
Germany G04CA52 13559/126.10.2017
10.06.2019PoM
GlaxoSmithKline
GmbH & Co. KG,
Prinzregentenplatz 9,
81675 Munich,
Germany
1480 Duotravtravoprost, timolol
(timolol maleate)drops eye (solution)
40mcg/ml+ 5mg/ml,
2,5ml plastic vial
S.A. Alcon-Couvreur
N.V., Rijksweg 14
2870 Puurs
Belgium S01ED51 1368625.07.2014
25.07.2019PoM
S.A. Alcon-Couvreur
N.V., Rijksweg 14
2870 Puurs, Belgium
322
1481 Duovit
vitamin A, vitamin
D3, vitamin C,
vitamin B1, vitamin
B2, vitamin B6,
vitamin B12,
vitamin PP, folic
acid, vitamin B5,
vitamin E, calcium
hydrophosphate
dihydrate, ferrous
fumarate, copper
sulfate
pentahydrate, zinc
sulfate
heptahydrate,
magnesium lactate
dihydrate,
manganese sulfate
monohydrate,
sodium molybdate
dihydrate
tablets coated
2,94mg+0,2mg+
60mg+1mg+ 1,2mg+2mg+
3mcg+13mg+
0,4mg+5mg+
10mg+64,5mg+
30,3mg+4mg+
13,3mg+200mg+
3,1mg+0,22mg,
in blister (40/4x5+5/5
red+5 blue/)
KRKA d.d., Novo
mesto, Smarjeska
cesta 6, 8501 Novo
Mesto - batch
releaser, KRKA d.d.,
Novo mesto, Ulica
Rada Pusenjaka 10,
Ljutomer, 9240,
Slovenia-bulk
manufacturer,
packager
Slovenia A11AA03 1652717.03.2017
17.03.2022OTC
KRKA d.d., Novo
mesto, Smarjeska
cesta 6, 8501 Novo
Mesto, Slovenia
1482 Duphalac lactulose syrup
667mg/ml,
200ml, 500ml, 1000ml,
15ml sachets (10)
ABBOTT Biologicals
B.V., Veerweg 12,
8121 AA Olst
the Netherlands A06AD11 1548230.03.2016
30.03.2021OTC
ABBOTT Healthcare
Products B.V., C.J.
van Houtenlaan 36,
NL-1381 CP Weesp,
the Netherlands
1483 Duphaston dydrogesterone tablets film-coated10mg,
blister (20/1x20/)
ABBOTT Biologicals
B.V., Veerweg 12,
8121 AA Olst
the Netherlands G03DB01 1548905.04.2016
05.04.2021PoM
ABBOTT Healthcare
Products B.V., C.J.
van Houtenlaan 36,
NL-1381 CP Weesp,
the Netherlands
323
1484 Duplecor
atorvastatin
(atorvastatin L-
lysine), amlodipine
(amlodipine
besilate)
tablets film-coated10mg+5mg,
in blister (30/3x10/)
Gedeon Richter OJSC
(Gyomroi ut 19-21,
1103 Budapest) -
batch releaser (dosage
form manufacturer,
packager - S.C.
Gedeon Richter
Romania S.A. /99-105
Guza Voda street,
540306, Targu-Mures,
Romania/)
Hungary C10BX03 1297028.10.2013
28.10.2018PoM
Gedeon Richter OJSC
(Gyomroi ut 19-21,
1103 Budapest,
Hungary)
1485 Duplecor
atorvastatin
(atorvastatin L-
lysine), amlodipine
(amlodipine
besilate)
tablets film-coated10mg+10mg,
in blister (30/3x10/)
Gedeon Richter OJSC
(Gyomroi ut 19-21,
1103 Budapest) -
batch releaser (dosage
form manufacturer,
packager - S.C.
Gedeon Richter
Romania S.A. /99-105
Guza Voda street,
540306, Targu-Mures,
Romania/)
Hungary C10BX03 1297128.10.2013
28.10.2018PoM
Gedeon Richter OJSC
(Gyomroi ut 19-21,
1103 Budapest,
Hungary)
1486 Duplecor
atorvastatin
(atorvastatin
calcium),
amlodipine
(amlodipine
besilate)
tablets film-coated20mg+10mg,
in blister (30/3x10/)
Gedeon Richter OJSC
(Gyomroi ut 19-21,
1103 Budapest) -
batch releaser (dosage
form manufacturer,
packager - S.C.
Gedeon Richter
Romania S.A. /99-105
Guza Voda street,
540306, Targu-Mures,
Romania/)
Hungary C10BX03 1297228.10.2013
28.10.2018PoM
Gedeon Richter OJSC
(Gyomroi ut 19-21,
1103 Budapest,
Hungary)
324
1487 Duplecor
atorvastatin
(atorvastatin L-
lysine), amlodipine
(amlodipine
besilate)
tablets film-coated20mg+5mg,
in blister (30/3x10/)
Gedeon Richter OJSC
(Gyomroi ut 19-21,
1103 Budapest) -
batch releaser (dosage
form manufacturer,
packager - S.C.
Gedeon Richter
Romania S.A. /99-105
Guza Voda street,
540306, Targu-Mures,
Romania/)
Hungary C10BX03 1297328.10.2013
28.10.2018PoM
Gedeon Richter OJSC
(Gyomroi ut 19-21,
1103 Budapest,
Hungary)
1488 Duspatalin
mebeverine
(mebeverine
hydrochloride)
capsules hard
prolonged-release
200mg,
in blister (30/2x15/)
Abbott Healthcare
SAS, Route de
Belleville, Lieu dit
Maillard, 01400
Chatillon sur
Chalaronne
France A03AA04 1541409.03.2016
09.03.2021PoM
ABBOTT Healthcare
Products B.V., C.J.
van Houtenlaan 36,
NL-1381 CP Weesp,
the Netherlands
1489 Dymista
azelastine(azelastine
hydrochloride),
fluticasone
(fluticasone
propionate)
spray nasal
(suspension)
137mcg/dose+
50mcg/dose,
23g (17ml suspension/not
less than 120 doses) glass
bottle with dispenser
MEDA Pharma
GmbH & Co. KG,
Benzstrasse 1, 61352
Bad Homburg - batch
releaser; Cipla Ltd,
Plot NO. 9, 10, Indore
Special Economic
Zone, Phase II,
Pithampur, district
Dhar, Madhya
Pradesh 454 775,
India - bulk
manufacturer,
packager
Germany R01AD58 1697105.09.2017
05.09.2022PoM
MEDA Pharma
GmbH & Co. KG,
Benzstrasse 1, 61352
Bad Homburg,
Germany
1490 Dysmenorm
agnus castus,
pulsatilla trit.D3,
rosmarinus
officinalis trit.D2,
apis mellifica
trit.D3
tablets
125mg+25mg+
25mg+25mg,
in glass container (80)
Deutsche
Homoopathie-Union
DHU-Arzneimittel
GmbH & Co. KG,
Ottostrasse 24, 76227
Karlsruhe
Germany
G02C;
homeopathic
drug
1427519.03.2015
19.03.2020OTC
Deutsche
Homoopathie-Union
DHU-Arzneimittel
GmbH & Co. KG,
Ottostrasse 24, 76227
Karlsruhe, Germany
325
1491 Dysport
clostridium
botulinum type A
toxin-
haemagglutinin
complex
powder lyophilized
for solution for
injection
500U,
glass vial (1)
Ipsen Biopharm
Limited, Ash Road,
Wrexham Industrial
Estate, Wrexham,
LL13 9UF for Ipsen
Pharma, 65 quai
Georges Gorse,92100
Boulogne-Billancourt,
France
UK M03AX01 1568608.06.2016
08.06.2021PoM
1492 Ecobol
amoxicillin
(amoxicillin
trihydrate)
tablets
250mg,
in blister (10/2x5/,
10/1x10/, 20/4x5/,
20/2x10/)
"AVVA RUS" JSC,
53a, Luganskaya Str.,
Kirov, 610044
Russia J01CA04 1604717.10.2016
17.10.2021PoM
"AVVA RUS" JSC,
30/9, Krylatskie
Holmy, Moscow,
121614, Russia
1493 Ecobol
amoxicillin
(amoxicillin
trihydrate)
tablets
500mg,
in blister (10/2x5/,
10/1x10/, 20/4x5/,
20/2x10/)
"AVVA RUS" JSC,
53a, Luganskaya Str.,
Kirov, 610044
Russia J01CA04 1604817.10.2016
17.10.2021PoM
"AVVA RUS" JSC,
30/9, Krylatskie
Holmy, Moscow,
121614, Russia
1494 Edarbiazilsartan
medoxomiltablets
40mg,
in blister (28/2x14/)
Takeda Ireland Ltd.,
Bray Business Park
Kilruddery Co.
Wicklow-batch
releaser, packager,
Takeda
Pharmaceutical
Company Limited,
Osaka Plant, 17-85,
Jusohonmachi 2-
chome, Yodogawa-
ku, Osaka, 532-8686,
Japan-bulk
manufacturer
Ireland C09CA09 1566508.06.2016
08.06.2021PoM
Takeda Pharma A/S,
Dybendal Alle 10,
2630 Taastrup,
Denmark
326
1495 Edarbiazilsartan
medoxomiltablets
80mg,
in blister (28/2x14/)
Takeda Ireland Ltd.,
Bray Business Park
Kilruddery Co.
Wicklow-batch
releaser, packager,
Takeda
Pharmaceutical
Company Limited,
Osaka Plant, 17-85,
Jusohonmachi 2-
chome, Yodogawa-
ku, Osaka, 532-8686,
Japan-bulk
manufacturer
Ireland C09CA09 1566608.06.2016
08.06.2021PoM
Takeda Pharma A/S,
Dybendal Alle 10,
2630 Taastrup,
Denmark
1496 Edarbi Clo
azilsartan
medoxomil,
chlortalidone
tablets film-coated40mg +25mg,
in blister (28/2x14/)
Takeda Ireland Ltd.,
Bray Business Park
Kilruddery Co.
Wicklow-batch
releaser, packager,
Takeda
Pharmaceutical
Company Limited,
Osaka Plant, 17-85,
Jusohonmachi 2-
chome, Yodogawa-
ku, Osaka, 532-8686,
Japan -bulk
manufacturer
Ireland C09DA09 1714407.11.2017
07.11.2022PoM
Takeda
Pharmaceuticals USA,
Inc, One Takeda
Parkway,
Deerfield,Illinois
60015, USA
1497 Edarbi Clo
azilsartan
medoxomil,
chlortalidone
tablets film-coated40mg+12,5mg,
in blister (28/2x14/)
Takeda Ireland Ltd.,
Bray Business Park
Kilruddery Co.
Wicklow-batch
releaser, packager,
Takeda
Pharmaceutical
Company Limited,
Osaka Plant, 17-85,
Jusohonmachi 2-
chome, Yodogawa-
ku, Osaka, 532-8686,
Japan -bulk
manufacturer
Ireland C09DA09; 1714507.11.2017
07.11.2022PoM
Takeda
Pharmaceuticals USA,
Inc, One Takeda
Parkway,
Deerfield,Illinois
60015, USA
327
1498 Edicin
vancomycin
(vancomycin
hydrochloride)
powder for solution
for i/v injection
1000mg,
glass vial
Lek Pharmaceuticals
d.d., Verovskova Str.
57, 1526 Ljubljana
Slovenia J01XA01 1592123.08.2016
23.08.2021PoM
Lek Pharmaceuticals
d.d., Verovskova Str.
57, 1526 Ljubljana,
Slovenia
1499 Ednytenalapril (enalapril
maleate)tablets
5mg,
in blister (20/2x10/)
Gedeon Richter PLC,
Gyomroi ut 19-21,
1103 Budapest
Hungary C09AA02 1401026.11.2014
26.11.2019PoM
Gedeon Richter PLC,
Gyomroi ut 19-21,
1103 Budapest,
Hungary
1500 Ednytenalapril (enalapril
maleate)tablets
10mg,
in blister (20/2x10/)
Gedeon Richter PLC,
Gyomroi ut 19-21,
1103 Budapest
Hungary C09AA02 1401126.11.2014
26.11.2019PoM
Gedeon Richter PLC,
Gyomroi ut 19-21,
1103 Budapest,
Hungary
1501 Ednytenalapril (enalapril
maleate)tablets
20mg,
in blister (20/2x10/)
Gedeon Richter PLC,
Gyomroi ut 19-21,
1103 Budapest
Hungary C09AA02 1401226.11.2014
26.11.2019PoM
Gedeon Richter PLC,
Gyomroi ut 19-21,
1103 Budapest,
Hungary
1502 Edurant rilpivirine tablets film-coated25mg,
in plastic container (30)
Janssen-Cilag S.p.A.,
Via C. Janssen, 04100
Borgo San Michele,
Latina
Italy J05AG05 1564024.05.2016
24.05.2021PoM
Johnson & Johnson
LLC, 121614,
Moscow, Krylatskaya
str., 17, building 2,
Russia
1503 Efferalgan paracetamol suppositories rectal80mg
(10/2x5/)
UPSA SAS, 304,
avenue du Docteur
Jean Bru, 47000
AGEN, France
France N02BE01 13408/107.07.2017
14.04.2019OTC
UPSA SAS, 3, rue
Joseph Monier- 92500
Rueil- Malmaison,
France
1504 Efferalgan paracetamol suppositories rectal150mg
(10/2x5/)
UPSA SAS, 304,
avenue du Docteur
Jean Bru, 47000
AGEN, France
France N02BE01 13409/107.07.2017
14.04.2019OTC
UPSA SAS, 3, rue
Joseph Monier- 92500
Rueil- Malmaison,
France
328
1505 Efferalgan paracetamol suppositories rectal300mg
(10/2x5/)
UPSA SAS, 304,
avenue du Docteur
Jean Bru, 47000
AGEN, France
France N02BE01 13410/107.07.2017
14.04.2019OTC
UPSA SAS, 3, rue
Joseph Monier- 92500
Rueil- Malmaison,
France
1506 Efferalgan paracetamol solution oral
30mg/ml,
90ml plastic bottle and
measuring spoon
UPSA SAS, 304,
avenue du Docteur
Jean Bru, 47000
AGEN, France
France N02BE01 14687/110.10.2017
29.06.2020OTC
UPSA SAS, 3, rue
Joseph Monier- 92500
Rueil- Malmaison,
France
1507 Efferalgan paracetamol tablets effervescent500mg,
in strip (16/4x4/)
UPSA SAS, 979,
Avenue des Pyrenees,
47520 Le Passage
France N02BE01 1703226.09.2017
26.09.2022OTC
UPSA SAS, 3, rue
Joseph Monier- 92500
Rueil- Malmaison,
France
1508 Efisol
dequalinium
(dequalinium
chloride), ascorbic
acid
lozenges
0,25mg+30mg,
in blister (20/1x20/,
40/2x20/)
Balkanpharma-
Razgrad AD, 68,
Aprilsko vastanie
Blvd, 7200 Razgrad
Bulgaria R02AA 1603717.10.2016
17.10.2021OTC
Balkanpharma-
Dupnitsa AD, 3,
Samokovsko shosse
str., 2600 Dupnitsa,
Bulgaria
1509 Efloran metronidazole solution for infusion5mg/ml,
100ml glass bottle
KRKA d.d., Novo
mesto, Smarjeska
cesta 6, 8501 Novo
Mesto
Slovenia J01XD01 1609010.11.2016
10.11.2021PoM
KRKA d.d., Novo
mesto, Smarjeska
cesta 6, 8501 Novo
Mesto, Slovenia
1510 Egilok
metoprolol
(metoprolol
tartrate)
tablets25mg,
in glass container (60)
Egis Pharmaceuticals
PLC 9900, Kormend,
Matyas kiraly u. 65 -
batch releaser,
packager (Egis
Pharmaceuticals PLC,
1165 Budapest,
Bokenyfoldi st. 118-
120, Hungary -bulk
manufacturer)
Hungary C07AB02 13526/122.04.2015
30.05.2019PoM
Egis Pharmaceuticals
PLC, Hungary 1106
Budapest, Kereszturi
ut 30-38
329
1511 Egilok
metoprolol
(metoprolol
tartrate)
tablets50mg,
in glass container (60)
Egis Pharmaceuticals
PLC 9900, Kormend,
Matyas kiraly u. 65 -
batch releaser,
packager (Egis
Pharmaceuticals PLC,
1165 Budapest,
Bokenyfoldi st. 118-
120, Hungary -bulk
manufacturer)
Hungary C07AB02 13527/122.04.2015
30.05.2019PoM
Egis Pharmaceuticals
PLC, Hungary 1106
Budapest, Kereszturi
ut 30-38
1512 Egilok
metoprolol
(metoprolol
tartrate)
tablets100mg,
in glass container (30, 60)
Egis Pharmaceuticals
PLC 9900, Kormend,
Matyas kiraly u. 65 -
batch releaser,
packager (Egis
Pharmaceuticals PLC,
1165 Budapest,
Bokenyfoldi st. 118-
120, Hungary -bulk
manufacturer)
Hungary C07AB02 13528/122.04.2015
30.05.2019PoM
Egis Pharmaceuticals
PLC, Hungary 1106
Budapest, Kereszturi
ut 30-38
1513 Egistrozol anastrozole tablets coated
1mg,
in blister (28/2x14/,
30/3x10/, 90/9x10/)
Egis Pharmaceuticals
PLC, 1165 Budapest,
Bokenyfoldi st. 118-
120 - batch releaser
(Synthon Hispaina,
S.L., Castello,
1,Poligono Las
Salines, 08830 Sant
Boi De Llobregat,
Spain - bulk
manufacturer) (
Rottendorf Pharma
GmbH, Ostenfelder
Strasse 51-61, 59320
Ennigerloh, Germany -
packager)
Hungary L02BG03 1392829.10.2014
29.10.2019PoM
Egis Pharmaceuticals
PLC, 1106 Budapest,
Kereszturi st. 30-38,
Hungary
330
1514 Egistrozol anastrozole tablets coated
1mg,
in blister (28/2x14/,
30/3x10/, 90/9x10/)
Egis Pharmaceuticals
PLC, 1165 Budapest,
Bokenyfoldi st. 118-
120 - batch releaser
(Synthon Hispaina,
S.L., Castello,
1,Poligono Las
Salines, 08830 Sant
Boi De Llobregat,
Spain - bulk
manufacturer,
packager)
Hungary L02BG03 1392929.10.2014
29.10.2019PoM
Egis Pharmaceuticals
PLC, 1106 Budapest,
Kereszturi st. 30-38,
Hungary
1515 Eglonyl sulpiride tablets200mg,
in blister (12/1x12/)
Delpharm Dijon, 6,
Boulevard de l`
Europe 21800,
Quetigny
France N05AL01 1697405.09.2017
05.09.2022PoM
Sanofi-Aventis
France, 1-13,
boulevard Romain
Rolland, 75014 Paris,
France
1516 Eglonyl sulpiride capsules50mg,
in blister (30/1x30/)
Delpharm Dijon, 6,
Boulevard de l`
Europe 21800,
Quetigny
France N05AL01 1707905.10.2017
05.10.2022PoM
Sanofi-Aventis
France, 1-13,
boulevard Romain
Rolland, 75014 Paris,
France
1517 Eglonyl sulpiridesolution for i/m
injection
50mg/ml,
2ml ampoules,
in blister (6/1x6/)
Delpharm Dijon, 6,
Boulevard de l`
Europe 21800,
Quetigny
France N05AL01 1712907.11.2017
07.11.2022PoM
Sanofi-Aventis
France, 1-13,
boulevard Romain
Rolland, 75014 Paris,
France
1518 Egolanza
olanzapine
(olanzapine
dihydrochloride
trihydrate)
tablets film-coated
5mg,
in blisters (28/4x7/,
56/8x7/)
Egis Pharmaceuticals
PLC, 1165 Budapest,
Bokenyfoldi st. 118-
124
Hungary N05AH03 14285/116.11.2017
19.03.2020PoM
Egis Pharmaceuticals
PLC, 1106 Budapest,
Kereszturi st. 30-38,
Hungary
1519 Egolanza
olanzapine
(olanzapine
dihydrochloride
trihydrate)
tablets film-coated
15mg,
in blisters (28/4x7/,
56/8x7/)
Egis Pharmaceuticals
PLC, 1165 Budapest,
Bokenyfoldi st. 118-
121
Hungary N05AH03 14286/116.11.2017
19.03.2020PoM
Egis Pharmaceuticals
PLC, 1106 Budapest,
Kereszturi st. 30-38,
Hungary
331
1520 Egolanza
olanzapine
(olanzapine
dihydrochloride
trihydrate)
tablets film-coated
20mg,
in blisters (28/4x7/,
56/8x7/)
Egis Pharmaceuticals
PLC, 1165 Budapest,
Bokenyfoldi st. 118-
123
Hungary N05AH03 14287/116.11.2017
19.03.2020PoM
Egis Pharmaceuticals
PLC, 1106 Budapest,
Kereszturi st. 30-38,
Hungary
1521 Egolanza
olanzapine
(olanzapine
dihydrochloride
trihydrate)
tablets film-coated
7,5mg,
in blisters (28/4x7/,
56/8x7/)
Egis Pharmaceuticals
PLC, 1165 Budapest,
Bokenyfoldi st. 118-
122
Hungary N05AH03 14288/116.11.2017
19.03.2020PoM
Egis Pharmaceuticals
PLC, 1106 Budapest,
Kereszturi st. 30-38,
Hungary
1522 Egolanza
olanzapine
(olanzapine
dihydrochloride
trihydrate)
tablets film-coated
10mg,
in blisters (28/4x7/,
56/8x7/)
Egis Pharmaceuticals
PLC, 1165 Budapest,
Bokenyfoldi st. 118-
120
Hungary N05AH03 14289/116.11.2017
19.03.2020PoM
Egis Pharmaceuticals
PLC, 1106 Budapest,
Kereszturi st. 30-38,
Hungary
1523 Ekvator
amlodipine
(amlodipine
besilate), lisinopril
(lisinopril
dihydrate)
tablets
5mg+20mg,
in blister (10/1x10/,
30/3x10/, 60/6x10/)
Gedeon Richter OJSC,
Gyomroi ut 19-21,
1103 Budapest
Hungary C09BB03 1328304.03.2014
04.03.2019PoM
Gedeon Richter
OJSC, Gyomroi ut 19-
21, 1103 Budapest,
Hungary
1524 Ekvator
lisinopril (lisinopril
dihydrate),
amlodipine
(amlodipine
besilate)
tablets
20mg+10mg,
in blister (10, 30/3x10/,
60/6x10/)
Gedeon Richter PLC,
Gyomroi ut 19-21,
1103 Budapest
Hungary C09BB03 1488724.09.2015
24.09.2020PoM
Gedeon Richter PLC,
Gyomroi ut 19-21,
1103 Budapest,
Hungary
1525 Ekvator
lisinopril (lisinopril
dihydrate),
amlodipine
(amlodipine
besilate)
tablets
10mg+5mg,
in blister (10, 30/3x10/,
60/6x10/)
Gedeon Richter PLC,
Gyomroi ut 19-21,
1103 Budapest
Hungary C09BB03 1488824.09.2015
24.09.2020PoM
Gedeon Richter PLC,
Gyomroi ut 19-21,
1103 Budapest,
Hungary
332
1526 Elafra leflunomide tablets film-coated10mg,
in plastic container (30)
S.C. Rompharm
Company S.R.L.,
Ilfov, 075100
Otopeni, Str. Eroilor,
Nr. 1A - secondary
packager, batch
releaser (dosage form
manufacturer,
primary packager -
Haupt Pharma
Muenster GmbH,
Schleebruggenkamp
15, 48159 Muenster,
Germany)
Romania L04AA13 12640/130.08.2013
04.07.2018PoM
S.C. Rompharm
Company S.R.L.,
Ilfov, 075100
Otopeni, Str. Eroilor,
Nr. 1A, Romania
1527 Elafra leflunomide tablets film-coated20mg,
in plastic container (30)
S.C. Rompharm
Company S.R.L.,
Ilfov, 075100
Otopeni, Str. Eroilor,
Nr. 1A - secondary
packager, batch
releaser (dosage form
manufacturer,
primary packager -
Haupt Pharma
Muenster GmbH,
Schleebruggenkamp
15, 48159 Muenster,
Germany)
Romania L04AA13 12641/130.08.2013
04.07.2018PoM
S.C. Rompharm
Company S.R.L.,
Ilfov, 075100
Otopeni, Str. Eroilor,
Nr. 1A, Romania
1528 Elenium chlordiazepoxide tablets coated10mg,
in blister (50/2x25/)
Tarchomin
Pharmaceutical
Works "Polfa" S.A.,
2,A. Fleminga str.,03-
176 Warsaw
Poland N05BA02 1581420.07.2016
20.07.2021PoM/UC
Tarchomin
Pharmaceutical
Works "Polfa" S.A.,
2,A. Fleminga str.,03-
176 Warsaw, Poland
1529Eleutherococcus
extract liquid
eleutherococcus
senticosus rhizomes
with roots
extract for oral
administration
(liquid)
1mg/ml,
50ml glass bottle
Tatchempharmprepar
aty JSC, 420091
Kazan, str.
Belomorskaya 260
RussiaA13A
herbal drug 13735/2
30.12.2016
24.07.2019OTC
Tatchempharmprepar
aty JSC, 420091
Kazan, str.
Belomorskaya 260,
Russia
333
1530 Elevit Pronatal
vitamin A, vitamin
D3, vitamin E,
vitamin C, folic
acid, vitamin
B1,vitamin B2,
vitamin B6, vitamin
B12, nicotinamide,
biotin, calcium
pantothenate,
calcium,
magnesium,
phosphor, ferrum,
zinc, copper,
manganese
tablets film-coated
3600IU+500IU+
15mg+100mg+
0,8mg+1,6mg+
1,8mg+2,6mg+
4mcg+19mg+
0,2mg+10mg+
125mg+100mg+
125mg+60mg+
7,5mg+1mg+1mg, in
blister (30/3x10/,
100/10x10/)
Rottendorf Pharma
GmbH, Ostenfelder
Strasse 51-61, 59320
Ennigerloh
Germany A11AA 1486318.09.2015
18.09.2020OTC
Bayer Consumer Care
AG, Peter Merian-
Strasse 84, 4052 Basel,
Switzerland
1531 Elidel pimecrolimus cream10mg/g,
15g aluminium tube
MEDA Pharma
GmbH & Co. KG,
Benzstrasse 1, 61352
Bad Homburg - batch
releaser (dosage form
manufacturer,
packager - Novartis
Pharma Produktions
GmbH, Oeflinger
Strasse 44, 79664
Wehr ,Baden
Wurttemberg,
Germany)
Germany D11AH02 1313910.01.2014
10.01.2019PoM
MEDA Pharma
GmbH & Co. KG,
Benzstrasse 1, 61352
Bad Homburg,
Germany
1532 Elidel pimecrolimus cream10mg/g,
15g aluminium tube
MEDA
Manufacturing,
Avenue JF Kennedy,
33700 Merignac
France D11AH02 1474503.08.2015
03.08.2020PoM
MEDA Pharma
GmbH & Co. KG,
Benzstrasse 1, 61352
Bad Homburg,
Germany
334
1533 Eligard
leuprorelin
(leuprorelin
acetate)
powder lyophilized
for solution for s/c
injection
7,5mg,
syringe A tray contains
pre-filled syringe A with
343mg solvent, plunger
rod for syringe B, syringe
B tray contains pre-filled
syringe B with 7,5mg
lyophilized powder and
needle
Astellas Pharma
Europe B.V.,
Hogemaat 2, NL-7942
JG Meppel - batch
releaser (dosage form
manufacturer,
packager - Tolmar
Inc., 701 Centre
Avenue, Ft. Collins,
CO 80526, USA)
the Netherlands L02AE02 1286617.09.2013
17.09.2018PoM
Astellas Pharma
Europe B.V.
Elisabethhof 19, 2353
EW Leiderdorp, the
Netherlands
1534 Eligard
leuprorelin
(leuprorelin
acetate)
powder lyophilized
for solution for s/c
injection
22,5mg,
syringe A tray contains
pre-filled syringe A with
457mg solvent and
plunger rod for syringe B,
syringe B tray contains
pre-filled syringe B with
29,2mg lyophilized
powder and needle
Astellas Pharma
Europe B.V.,
Hogemaat 2, NL-7942
JG Meppel - batch
releaser (dosage form
manufacturer,
packager - Tolmar
Inc., 701 Centre
Avenue, Ft. Collins,
CO 80526, USA)
the Netherlands L02AE02 1286717.09.2013
17.09.2018PoM
Astellas Pharma
Europe B.V.
Elisabethhof 19, 2353
EW Leiderdorp, the
Netherlands
1535 Eligard
leuprorelin
(leuprorelin
acetate)
powder lyophilized
for solution for s/c
injection
45mg,
syringe A tray contains
pre-filled syringe A with
434mg solvent and
plunger rod for syringe B,
syringe B tray contains
pre-filled syringe B with
59,2mg lyophilized
powder and needle
Astellas Pharma
Europe B.V.,
Hogemaat 2, NL-7942
JG Meppel - batch
releaser (dosage form
manufacturer,
packager - Tolmar
Inc., 701 Centre
Avenue, Ft. Collins,
CO 80526, USA)
the Netherlands L02AE02 1286817.09.2013
17.09.2018PoM
Astellas Pharma
Europe B.V.
Elisabethhof 19, 2353
EW Leiderdorp, the
Netherlands
335
1536 Eligard
leuprorelin
(leuprorelin
acetate)
powder lyophilized
for solution for s/c
injection
7,5mg,
syringe A-343mg solvent
and B syringe plunger in
plastic container, syringe
B-10,6mg lyophilized
powder and needle in
plastic container
MediGene AG,
Lochhamerstrasse
11/15, 82152
Planegg/Martinsried -
batch releaser;
(Tolmar Inc., 701
Centre Avenue, Ft.
Collins, CO 80526,
USA- syringe A &
syringe B bulk
manufacturer,
packager)
Germany L02AE02 1336804.04.2014
04.04.2019PoM
Astellas Pharma
Europe B.V., the
Netherlands
Elisabethhof 19, 2353
EW Liederdorp the
Netherlands
1537 Eligard
leuprorelin
(leuprorelin
acetate)
powder lyophilized
for solution for s/c
injection
22,5mg; syringe A-457mg
solvent and B syringe
plunger in plastic
container, syringe B-
29,2mg lyophilized
powder and needle in
plastic container
MediGene AG,
Lochhamerstrasse
11/15, 82152
Planegg/Martinsried -
batch releaser;
(Tolmar Inc., 701
Centre Avenue, Ft.
Collins, CO 80526,
USA- syringe A &
syringe B bulk
manufacturer,
packager)
Germany L02AE02 1336904.04.2014
04.04.2019PoM
Astellas Pharma
Europe B.V., the
Netherlands
Elisabethhof 19, 2353
EW Liederdorp the
Netherlands
1538 Eligard
leuprorelin
(leuprorelin
acetate)
powder lyophilized
for solution for s/c
injection
45mg,
syringe A-434mg solvent
and B syringe plunger in
plastic container; syringe
B-59,2mg lyophilized
powder and needle in
plastic container
MediGene AG,
Lochhamerstrasse
11/15, 82152
Planegg/Martinsried -
batch releaser;
(Tolmar Inc., 701
Centre Avenue, Ft.
Collins, CO 80526,
USA- syringe A &
syringe B bulk
manufacturer,
packager)
Germany L02AE02 1337004.04.2014
04.04.2019PoM
Astellas Pharma
Europe B.V., the
Netherlands
Elisabethhof 19, 2353
EW Liederdorp the
Netherlands
336
1539 Eligard
leuprorelin
(leuprorelin
acetate)
powder lyophilized
and solvent for
solution for s/c
injection
7,5mg,
(I) syringe A- 343mg
solvent and plunger for
syringe B, in plastic pack,
(II)- syringe B- 10.6mg
lyophilized powder and
needle, in plastic pack
Astellas Pharma
Europe B.V.,
Hogemaat 2, 7942 JG
Meppel-batch
releaser, secondary
packager, Tolmar Inc.,
701 Centre Avenue,
Ft. Collins, CO 80526,
USA-bulk
manufacturer,
primary packager
(syringe A and
syringe B)
the Netherlands L02AE02 1575004.07.2016
04.07.2021PoM
Astellas Pharma
Europe B.V.,
Sylviusweg 62, 2333
BE Leiden, the
Netherlands
1540 Eligard
leuprorelin
(leuprorelin
acetate)
powder lyophilized
and solvent for
solution for s/c
injection
45mg,
(I) syringe A- 434mg
solvent and plunger for
syringe B, in plastic pack,
(II) syringe B- 59.2mg
lyophilized powder and
needle, in plastic pack
Astellas Pharma
Europe B.V.,
Hogemaat 2, 7942 JG
Meppel-batch
releaser, secondary
packager, Tolmar Inc.,
701 Centre Avenue,
Ft. Collins, CO 80526,
USA-bulk
manufacturer,
primary packager
(syringe A and
syringe B)
the Netherlands L02AE02 1575104.07.2016
04.07.2021PoM
Astellas Pharma
Europe B.V.,
Sylviusweg 62, 2333
BE Leiden, the
Netherlands
1541 Eligard
leuprorelin
(leuprorelin
acetate)
powder lyophilized
and solvent for
solution for s/c
injection
22,5mg,
(I) syringe A- 457mg
solvent and plunger for
syringe B, in plastic pack,
(II) syringe B- 29.2mg
lyophilized powder and
needle, in plastic pack
Astellas Pharma
Europe B.V.,
Hogemaat 2, 7942 JG
Meppel-batch
releaser, secondary
packager, Tolmar Inc.,
701 Centre Avenue,
Ft. Collins, CO 80526,
USA-bulk
manufacturer,
primary packager
(syringe A and
syringe B)
the Netherlands L02AE02 1575204.07.2016
04.07.2021PoM
Astellas Pharma
Europe B.V.,
Sylviusweg 62, 2333
BE Leiden, the
Netherlands
337
1542 Eliquis apixaban tablets film-coated
2,5mg,
in blister (20/2x10/,
60/6x10/)
Bristol-Myers Squibb
S.R.L., Loc. Fontana
del Ceraso 03012
Anagni (FR)-batch
releaser, packager,
Bristol-Myers Squibb
Manufacturing
Company, Puerto
Rico, State Road #3,
Km 77.5, Humacao,
00791, USA-bulk
manufacturer
Italy B01AF02 1461003.07.2015
03.07.2020PoM
Pfizer H.C.P.
Corporation, 235,
East 42nd street, New
York 10017, USA
1543 Eliquis apixaban tablets film-coated
5mg,
in blister (20/2x10/,
60/6x10/)
Bristol-Myers Squibb
S.R.L., Loc. Fontana
del Ceraso 03012
Anagni (FR)-batch
releaser, packager,
Bristol-Myers Squibb
Manufacturing
Company, Puerto
Rico, State Road #3,
Km 77.5, Humacao,
00791, USA-bulk
manufacturer
Italy B01AF02 1469516.07.2015
16.07.2020PoM
Pfizer H.C.P.
Corporation, 235,
East 42nd street, New
York 10017, USA
1544 Elocom
mometasone
(mometasone
furoate)
lotion1mg/g,
30ml plastic bottle
Schering-Plough
S.p.A., Via F.lli
Kennedy 5, 26833
Comazzo
Italy D07AC13 1229822.03.2013
22.03.2018PoM
Merck Sharp &
Dohme Idea AG,
Weystrasse 20, P.O.
Box CH-6000
Lucerne 6,
Switzerland
1545 Elocom
mometasone
(mometasone
furoate)
lotion
1mg/g,
30ml plastic bottle with
dropper
Famar Montreal Inc.,
3535 Trans Canada
Highway, Pointe-
Claire, Quebec, H9R
1B4
Canada D07AC13 13406/211.12.2017
14.04.2019PoM
Schering-Plough
Central East AG,
Weystrasse 20, 6000
Lucerne 6,
Switzerland
338
1546 Elocom
mometasone
(mometasone
furoate)
ointment1mg/g,
15g aluminum tube
Schering-Plough Labo
N.V., Industriepark
30 B-2220, Heist-op-
den-Berg
Belgium D07AC13 1425920.02.2015
20.02.2020PoM
Schering-Plough
Central East AG,
Weystrasse 20, P.O.
Box CH-6000
Lucerne 6,
Switzerland
1547 Elocom
mometasone
(mometasone
furoate)
cream1mg/g,
15g aluminium tube
Schering-Plough Labo
N.V., Industriepark
30 B-2220, Heist-op-
den-Berg
Belgium D07AC13 1633030.12.2016
30.12.2021PoM
Schering-Plough
Central East AG,
Weystrasse 20, CH-
6000 Lucerne 6,
Switzerland
1548 Elonva corifollitropin alfa solution for injection
150mcg/0,5ml, 0,5ml pre-
filled syringe and needle
(1)
Organon (Ireland)
Ltd., Drynam Road,
Swords, Co. Dublin -
batch releaser,
secondary packager,
Vetter Pharma-
Fertigung GmbH &
Co. KG,
Schutzenstrasse 87
and 99/101, D-88212
Ravensburg, Germany-
bulk manufacturer,
primary packager
Ireland
G03GA09;
new
indication
14120/129.12.2014
29.12.2019PoM
Schering-Plough
Central East AG,
Weystrasse 20, CH-
6000 Lucerne 6,
Switzerland
1549 Elonva corifollitropin alfa solution for injection100mcg/0,5ml, 0,5ml pre-
filled syringeand needle
Organon (Ireland)
Ltd., Drynam Road,
Swords, Co. Dublin -
secondary packager,
batch releaser (bulk
manufacturer,
primary packager -
Vetter Pharma-
Fertigung GmbH &
Co. KG,
Schutzenstrasse 87
and 99/101, D-88212
Ravensburg,
Germany)
Ireland
G03GA09;
new
indication
14121/129.12.2014
29.12.2019PoM
Central East AG,
Weystrasse 20, P.O.
Box CH-6000
Lucerne 6,
Switzerland
339
1550 Elonva corifollitropin alfa solution for injection
150mcg/0,5ml,
0,5ml pre-filled syringe
(1) and needle
N.V. Organon,
Kloosterstraat 6, 5349
AB Oss- batch
releaser, secondary
packager, Vetter
Pharma-Fertigung
GmbH & Co. KG,
Schutzenstrasse 87
and 99/101, D-88212
Ravensburg, Germany-
bulk manufacturer,
primary packager
the Netherlands G03GA09 1696205.09.2017
05.09.2022PoM
Schering-Plough
Central East AG,
Weystrasse 20, CH-
6000 Lucerne 6,
Switzerland
1551 Elonva corifollitropin alfa solution for injection
100mcg/0,5ml,
0,5ml pre-filled syringe
(1) and needle
N.V. Organon,
Kloosterstraat 6, 5349
AB Oss- batch
releaser, secondary
packager, Vetter
Pharma-Fertigung
GmbH & Co. KG,
Schutzenstrasse 87
and 99/101, D-88212
Ravensburg, Germany-
bulk manufacturer,
primary packager
the Netherlands G03GA09 1696305.09.2017
05.09.2022PoM
Schering-Plough
Central East AG,
Weystrasse 20, CH-
6000 Lucerne 6,
Switzerland
1552 Eludril PRO
chlorhexidine
(chlorhexidine
digluconate),
chlorobutanol
(chlorobutanol
hemihydrate)
solution for
mouthwash
1mg/ml+5mg/ml, plastic
bottle 90ml and
measuring cup
Pierre Fabre
Medicament
Production, site
Progipharm, Rue du
Lycee, 45500 Gien
France A01AB03 1581720.07.2016
20.07.2021OTC
Pierre Fabre
Medicament
Production, 45, place
Abel Gance, 92100
Boulogne, France
1553 Emanera
esomeprazole
(esomeprazole
magnesium)
capsules gastro-
resistant
20mg,
in blister (7/1x7/, 14/2x7/,
15/3x5/, 28/4x7/,
30/3x10/, 56/8x7/,
60/6x10/)
KRKA d.d., Novo
mesto, Smarjeska
cesta 6, 8501 Novo
Mesto
Slovenia A02BC05 1418406.02.2015
06.02.2020PoM
KRKA d.d., Novo
mesto, Smarjeska
cesta 6, 8501 Novo
Mesto, Slovenia
340