2019 مﺎﻌﻟ ﻒﯿﻨﺼﺘﻠﻟ تاﺮﻀﺤﺘﺴﻤﻟا و …...krka d.d. novo mesto...

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1 Pharmacy TWFS nb. Import/ Export nb. Import/Ex port Date Tradename Strength Form Presentation Agent Manufacturer Ingredient Country TYPE 201811248255 1 2.1.2019 elpida 20mg film coated tablets 60 Hikma-Liban S.A.R.L. the arab pharmaceutical manufacturing PSC-JORDAN MAH: hikma pharmaceuticals - jordan dasatinib monohydrate Jordan DRUG 201811248256 2 2.1.2019 elpida 50mg film coated tablets 60 Hikma-Liban S.A.R.L. the arab pharmaceutical manufacturing PSC-JORDAN MAH: hikma pharmaceuticals - jordan dasatinib monohydrate Jordan DRUG 201811248258 3 2.1.2019 elpida 70mg film coated tablets 60 Hikma-Liban S.A.R.L. the arab pharmaceutical manufacturing PSC-JORDAN MAH: hikma pharmaceuticals - jordan dasatinib monohydrate Jordan DRUG 201811228608 4 2.1.2019 elpida 140mg film coated tablets 30 Hikma-Liban S.A.R.L. the arab pharmaceutical manufacturing PSC-JORDAN MAH: hikma pharmaceuticals - jordan dasatinib monohydrate Jordan DRUG 201811242983 5 2.1.2019 heparin sodium rovi 5000 IU/ML solution for injection 100 vials x5ml katena lab rovi contract manufacturing SL- SPAIN MAH: laboratorios farmaceuticos rovi SA- spain heparin sodium spain DRUG 201811232306 6 2.1.2019 aleract vaginal capsules x6 medispharm nutrilinea S.R.L. - italy MAH: lo.li.pharma srl-italy italy CLASSIFICATION 201811239709 7 2.1.2019 desensitizer 7.5% climax control gel of 28 grams medispharm natureplex - USA MAH: natureplex - USA USA CLASSIFICATION 2019 طﻠﺒﺎت ﺗﺴﺠﯿﻞ اﻻدوﯾﺔ و اﻟﻤﺴﺘﺤﻀﺮات ﻟﻠﺘﺼﻨﯿﻒ ﻟﻌﺎم ﺟﺪول ﺗﻘﺪﯾﻢ

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Page 1: 2019 مﺎﻌﻟ ﻒﯿﻨﺼﺘﻠﻟ تاﺮﻀﺤﺘﺴﻤﻟا و …...krka d.d. novo mesto MAH: krka d.d. novo mesto - slovenia telmisartan + HCT slovenia DRUG 201711212219 62

1

Pharmacy TWFS nb.

Import/Export

nb.

Import/Export Date Tradename Strength Form Presentation Agent Manufacturer Ingredient Country TYPE

201811248255 1 2.1.2019 elpida 20mg film coated tablets 60Hikma-Liban

S.A.R.L.

the arab pharmaceutical manufacturing PSC-JORDAN

MAH: hikma pharmaceuticals - jordan

dasatinib monohydrate Jordan DRUG

201811248256 2 2.1.2019 elpida 50mg film coated tablets 60Hikma-Liban

S.A.R.L.

the arab pharmaceutical manufacturing PSC-JORDAN

MAH: hikma pharmaceuticals - jordan

dasatinib monohydrate Jordan DRUG

201811248258 3 2.1.2019 elpida 70mg film coated tablets 60Hikma-Liban

S.A.R.L.

the arab pharmaceutical manufacturing PSC-JORDAN

MAH: hikma pharmaceuticals - jordan

dasatinib monohydrate Jordan DRUG

201811228608 4 2.1.2019 elpida 140mg film coated tablets 30Hikma-Liban

S.A.R.L.

the arab pharmaceutical manufacturing PSC-JORDAN

MAH: hikma pharmaceuticals - jordan

dasatinib monohydrate Jordan DRUG

201811242983 5 2.1.2019heparin sodium

rovi 5000 IU/MLsolution for

injection 100 vials x5ml katena lab

rovi contract manufacturing SL- SPAIN MAH:

laboratorios farmaceuticos rovi SA- spain heparin sodium spain DRUG

201811232306 6 2.1.2019aleract vaginal

capsules x6 medispharmnutrilinea S.R.L. - italy

MAH: lo.li.pharma srl-italy italy CLASSIFICATION

201811239709 7 2.1.2019

desensitizer 7.5% climax control gel

of 28 grams medispharmnatureplex - USA

MAH: natureplex - USA USA CLASSIFICATION

جدول تقدیم طلبات تسجیل االدویة و المستحضرات للتصنیف لعام 2019

Page 2: 2019 مﺎﻌﻟ ﻒﯿﻨﺼﺘﻠﻟ تاﺮﻀﺤﺘﺴﻤﻟا و …...krka d.d. novo mesto MAH: krka d.d. novo mesto - slovenia telmisartan + HCT slovenia DRUG 201711212219 62

2

Pharmacy TWFS nb.

Import/Export

nb.

Import/Export Date Tradename Strength Form Presentation Agent Manufacturer Ingredient Country TYPE

جدول تقدیم طلبات تسجیل االدویة و المستحضرات للتصنیف لعام 2019

201811239709 7 2.1.2019

burn x lidocaine HCL 2.5% topical

analgesic(29 grams) medispharm

natureplex - USA MAH: natureplex - USA USA CLASSIFICATION

20181122678 8 3.1.2019

iprasal vem single dose inhalation

solution for nebulization 20vialsx2.5ml new europharm

vem ilac san ve tic as -turkeyMAH: vem ilac san ve tic as -

turkey

ipratropium bromide /

salbutamol sulfate Turkey DRUG

201811222042 9 3.1.2019 yodafar 200mcg tablets 50Levant Alie

Houses S.A.L.

fine foods & pharmaceuticals N.T.M, SPA -italy MAH:

bial - portela & ca SA - Portogal potassium iodide italy DRUG

201811243300 18 8.1.2019 efferalgan 3% 3%pediatric oral

solution 90mlpacific pharma

S.A.L.

upsa (agen)sas -france MAH: upsa (malmason )sas -

france paracetamol France DRUG

201811243302 19 8.1.2019 efferalgan 80mgpediatric

suppository 10pacific pharma

S.A.L.

upsa (agen)sas -france MAH: upsa (malmason )sas -

france paracetamol France DRUG

201811243967 20 8.1.2019 efferalgan 150mgpediatric

suppository 10pacific pharma

S.A.L.

upsa (agen)sas -france MAH: upsa (malmason )sas -

france paracetamol France DRUG

201811243965 21 8.1.2019 efferalgan 300mgpediatric

suppository 10pacific pharma

S.A.L.

upsa (agen)sas -france MAH: upsa (malmason )sas -

france paracetamol France DRUG

Page 3: 2019 مﺎﻌﻟ ﻒﯿﻨﺼﺘﻠﻟ تاﺮﻀﺤﺘﺴﻤﻟا و …...krka d.d. novo mesto MAH: krka d.d. novo mesto - slovenia telmisartan + HCT slovenia DRUG 201711212219 62

3

Pharmacy TWFS nb.

Import/Export

nb.

Import/Export Date Tradename Strength Form Presentation Agent Manufacturer Ingredient Country TYPE

جدول تقدیم طلبات تسجیل االدویة و المستحضرات للتصنیف لعام 2019

201811239951 23 10.1.2019conjyclear

ophthalmic solution 5mlMacromed

S.A.R.L.

orchidia pharmaceutical industries

MAH: orchidia pharmaceutical industries-

egypt olopatadine 0.1% Egypt DRUG

2019112552 31 10.1.2019

mycells autologous platelet preparation

kit kalium S.A.L.

pro-tech design & manufacturing, inc. -usa

MAH: kaylight corporation - usa USA CLASSIFICATION

20191121067 33 10.1.2019

memory gel smooth moderate plus profile xtra

(all sizes)Khalil Fattal &

Fils S.A.L. mentor medical systems b.v. Netherlands CLASSIFICATION

20191121067 33 10.1.2019

memory gel smooth high

profile xtra (all sizes)

Khalil Fattal & Fils S.A.L. mentor medical systems b.v. Netherlands CLASSIFICATION

20191121067 33 10.1.2019

memory gel siltex moderate plus profile xtra (all

sizes)Khalil Fattal &

Fils S.A.L. mentor medical systems b.v. Netherlands CLASSIFICATION

20191121067 33 10.1.2019

memory gel siltex high profile xtra

(all sizes)Khalil Fattal &

Fils S.A.L. mentor medical systems b.v. Netherlands CLASSIFICATION

20191121068 34 10.1.2019damad - prep pad

100 swabs Alfamed S.A.L.the national medical products

co. Ltd Saudi Arabia CLASSIFICATION

Page 4: 2019 مﺎﻌﻟ ﻒﯿﻨﺼﺘﻠﻟ تاﺮﻀﺤﺘﺴﻤﻟا و …...krka d.d. novo mesto MAH: krka d.d. novo mesto - slovenia telmisartan + HCT slovenia DRUG 201711212219 62

4

Pharmacy TWFS nb.

Import/Export

nb.

Import/Export Date Tradename Strength Form Presentation Agent Manufacturer Ingredient Country TYPE

جدول تقدیم طلبات تسجیل االدویة و المستحضرات للتصنیف لعام 2019

201711242622 38 14.1.2019

neutricid suspension

buvable en sachets 18Cesar Chalhoub

et Fils

grimberg SA-france MAH: grimberg sa - france

oxyde d'aluminium

hydrate, phosphate

d'aluminium hydrate,

hydroxyde de Mg France DRUG

201811242125 39 14.1.2019 vapreza100 100mg

powder for suspension for

injection 1vialPharmaline

S.A.L.

secondary packed by pharmaline under license

from natco pharma limited -india

azacitidine 100 mg Lebanon DRUG

201811251774 40 14.1.2019 bonafor 150 150mg film coated tablets 1Pharmaline

S.A.L. Pharmaline S.A.L.

ibandronic acid 150mg as sodium

monohydrate Lebanon DRUG

20191121334 45 14.1.2019

alfalyte travel pack WHO formula

strawberry flavor No colorant 50 packs of 4.3g powder each

alfa laboratories S.A.L alfa laboratories S.A.L Lebanon CLASSIFICATION

201811212716 51 15.1.2019 briviact 25mg film coated tablets 56 sadco

UCB pharma SA -belgium MAH: UCB pharma SA -

belgium brivaracetam Belgium DRUG

201811212717 52 15.1.2019 briviact 50mg film coated tablets 56 sadco

UCB pharma SA -belgium MAH: UCB pharma SA -

belgium brivaracetam Belgium DRUG

Page 5: 2019 مﺎﻌﻟ ﻒﯿﻨﺼﺘﻠﻟ تاﺮﻀﺤﺘﺴﻤﻟا و …...krka d.d. novo mesto MAH: krka d.d. novo mesto - slovenia telmisartan + HCT slovenia DRUG 201711212219 62

5

Pharmacy TWFS nb.

Import/Export

nb.

Import/Export Date Tradename Strength Form Presentation Agent Manufacturer Ingredient Country TYPE

جدول تقدیم طلبات تسجیل االدویة و المستحضرات للتصنیف لعام 2019

201811212718 53 15.1.2019 briviact 10mg film coated tablets 14 sadco

UCB pharma SA -belgium MAH: UCB pharma SA -

belgium brivaracetam Belgium DRUG

20181121528 61 17.1.2019 tolucombi 80mg/12.5mg tablets 28Medicapharm

S.A.L.

krka d.d. novo mesto MAH: krka d.d. novo mesto -

sloveniatelmisartan +

HCT slovenia DRUG

201711212219 62 17.1.2019 isocaine 3%

injection USP without

vasoconstrictor 50cartridges of

1.8ml denta pharm

novocol pharmaceutical of canada inc

MAH: novocol pharmaceutical of canada inc

- canadamepivacaine

HCL Canada DRUG

201811252234 63 21.1.2019

labetalol hydrochloride

injection 100mg/20ml box of 1 x20mlvial 1Medi drug

S.A.L.

omega laboratories ltd MAH: omega laboratories ltd

- canadalabetalol

hydrochloride Canada DRUG

201811222056 64 21.1.2019

tenofovir disoproxil fumarate/ efavirenz/

emtricitabine/300mg/600mg/

200mg tablets 30

Mediterranean Pharmaceutical

Company

mylan laboratories limited MAH: mylan laboratories

limited - india

tenofovir disoproxil

fumarate IH 300mg/

efavirenz USP 600mg/

emtricitabine IH 200mg India DRUG

20191122014 66 21.1.2019prontosan wound

gel (20x30ml)Droguerie de

l'Union

B.Braun medical AG, seesatz17

Switzerland CLASSIFICATION

20191122014 66 21.1.2019prontosan wound gel X (20x250gr)

Droguerie de l'Union

B.Braun medical AG, seesatz17

Switzerland CLASSIFICATION

Page 6: 2019 مﺎﻌﻟ ﻒﯿﻨﺼﺘﻠﻟ تاﺮﻀﺤﺘﺴﻤﻟا و …...krka d.d. novo mesto MAH: krka d.d. novo mesto - slovenia telmisartan + HCT slovenia DRUG 201711212219 62

6

Pharmacy TWFS nb.

Import/Export

nb.

Import/Export Date Tradename Strength Form Presentation Agent Manufacturer Ingredient Country TYPE

جدول تقدیم طلبات تسجیل االدویة و المستحضرات للتصنیف لعام 2019

20191122014 66 21.1.2019prontosan wound

gel X (20x50gr)Droguerie de

l'Union

B.Braun medical AG, seesatz17

Switzerland CLASSIFICATION

20191122014 66 21.1.2019

prontosan wound irrigation solution

(10x1000ml)Droguerie de

l'Union

B.Braun medical AG, seesatz17

Switzerland CLASSIFICATION

20191122014 66 21.1.2019

prontosan wound irrigation solution

(10x350ml)Droguerie de

l'Union

B.Braun medical AG, seesatz17

Switzerland CLASSIFICATION

20191122014 66 21.1.2019prontosan wound spray (20x75ml)

Droguerie de l'Union

B.Braun medical AG, seesatz17

Switzerland CLASSIFICATION

20191122284 77 21.1.2019 sanilax 20 tabnew pharma

health

amazonia fito preparati s.r.l.-SAN MARINO

MAH: advanced biomedical s.r.l Italy CLASSIFICATION

20191122284 77 21.1.2019 pyloril 30 capnew pharma

health

amazonia fito preparati s.r.l.-SAN MARINO

MAH: advanced biomedical s.r.l Italy CLASSIFICATION

20191122284 77 21.1.2019 appeti 150ml syrupnew pharma

health

amazonia fito preparati s.r.l.-SAN MARINO

MAH: advanced biomedical s.r.l Italy CLASSIFICATION

Page 7: 2019 مﺎﻌﻟ ﻒﯿﻨﺼﺘﻠﻟ تاﺮﻀﺤﺘﺴﻤﻟا و …...krka d.d. novo mesto MAH: krka d.d. novo mesto - slovenia telmisartan + HCT slovenia DRUG 201711212219 62

7

Pharmacy TWFS nb.

Import/Export

nb.

Import/Export Date Tradename Strength Form Presentation Agent Manufacturer Ingredient Country TYPE

جدول تقدیم طلبات تسجیل االدویة و المستحضرات للتصنیف لعام 2019

20191122284 77 21.1.2019 trio gastro30capnew pharma

health

amazonia fito preparati s.r.l.-SAN MARINO

MAH: advanced biomedical s.r.l Italy CLASSIFICATION

20191122284 77 21.1.2019bunga -M and

bunga-W 60 tabnew pharma

health

amazonia fito preparati s.r.l.-SAN MARINO

MAH: advanced biomedical s.r.l Italy CLASSIFICATION

20191122543 91 21.1.2019

gynoferrin, 30 vegetable hard

capsulesAbela Frères

S.A.L.laphal industries, rousset MAH: gynov SAS - france France CLASSIFICATION

201811249358 101 22.1.2019 ozempic 0.25mgsolution for

injection

prefilled pen 1.5ml, 1pen and 4 disposable needles Mersaco S.A.L.

novo nordisk A/S MAH: novo nordisk A/S -

denmark semaglutide Danemark DRUG

201811249242 102 22.1.2019 ozempic 0.5mgsolution for

injection

prefilled pen 1.5ml, 1pen and 4 disposable needles Mersaco S.A.L.

novo nordisk A/S MAH: novo nordisk A/S -

denmark semaglutide Danemark DRUG

201811249338 103 22.1.2019 ozempic 1mgsolution for

injection

prefilled pen 3ml, 1pen and 4

disposable needles Mersaco S.A.L.

novo nordisk A/S MAH: novo nordisk A/S -

denmark semaglutide Danemark DRUG

20191122921 104 22.1.2019novagola throat

spray strong 30mlMacromed

S.A.R.L.

industria farmaceutica nova argentia SPA MAH: industria

farmaceutica nova argentia SPA - Italy Italy CLASSIFICATION

Page 8: 2019 مﺎﻌﻟ ﻒﯿﻨﺼﺘﻠﻟ تاﺮﻀﺤﺘﺴﻤﻟا و …...krka d.d. novo mesto MAH: krka d.d. novo mesto - slovenia telmisartan + HCT slovenia DRUG 201711212219 62

8

Pharmacy TWFS nb.

Import/Export

nb.

Import/Export Date Tradename Strength Form Presentation Agent Manufacturer Ingredient Country TYPE

جدول تقدیم طلبات تسجیل االدویة و المستحضرات للتصنیف لعام 2019

201811215348 115 30/01/2019 keflam MS 100mg/2mlsolution for

injection x 5 vial of 2ml

Pharmanet Drugstore S.A.R.L.

MS pharma MAH: MS pharma - jordan ketoprofen Jordan DRUG

201811227422 117 31/01/2019 tractan 62.5mg film coated tablets 56 broadmed SAL

pharmactive ilac san.ve.tic A.S

MAH: pharmactive ilac san.ve.tic A.S - turkey bosentan turkey DRUG

201811222070 118 31/01/2019 tractan 125mg film coated tablets 56 broadmed SAL

pharmactive ilac san.ve.tic A.S

MAH: pharmactive ilac san.ve.tic A.S - turkey bosentan turkey DRUG

201811234895 120 04/02/2019

frezyderm lice free set shampoo + lotion 2x125ml Alfamed S.A.L. frezyderm sa Greece CLASSIFICATION

201811234895 120 04/02/2019baby gums gel

25ml Alfamed S.A.L. frezyderm sa Greece CLASSIFICATION

201811234895 120 04/02/2019

frezyderm colic relief massage gel

100ml Alfamed S.A.L. frezyderm sa Greece CLASSIFICATION

201811234895 120 04/02/2019 first aid butter 50ml Alfamed S.A.L. frezyderm sa Greece CLASSIFICATION

Page 9: 2019 مﺎﻌﻟ ﻒﯿﻨﺼﺘﻠﻟ تاﺮﻀﺤﺘﺴﻤﻟا و …...krka d.d. novo mesto MAH: krka d.d. novo mesto - slovenia telmisartan + HCT slovenia DRUG 201711212219 62

9

Pharmacy TWFS nb.

Import/Export

nb.

Import/Export Date Tradename Strength Form Presentation Agent Manufacturer Ingredient Country TYPE

جدول تقدیم طلبات تسجیل االدویة و المستحضرات للتصنیف لعام 2019

201811234891 121 04/02/2019

intim vaginal douche pH 3.5

150ml Alfamed S.A.L. frezyderm sa Greece CLASSIFICATION

201811234891 121 04/02/2019

intim vaginal douche pH 9.0

150ml Alfamed S.A.L. frezyderm sa Greece CLASSIFICATION

201811234891 121 04/02/2019

intim vaginal douche pH 4.5

150ml Alfamed S.A.L. frezyderm sa Greece CLASSIFICATION

201811234891 121 04/02/2019anticort cream

50ml Alfamed S.A.L. frezyderm sa Greece CLASSIFICATION

201811238100 124 07/02/2019revanesse contour,

2 syringes x1ml omni medicalprollenium medical

technologies inc Canada CLASSIFICATION

201811238100 124 07/02/2019revanesse contour +, 2 syringes x1ml omni medical

prollenium medical technologies inc Canada CLASSIFICATION

201811238100 124 07/02/2019revanesse +, 2 syringes x1ml omni medical

prollenium medical technologies inc Canada CLASSIFICATION

Page 10: 2019 مﺎﻌﻟ ﻒﯿﻨﺼﺘﻠﻟ تاﺮﻀﺤﺘﺴﻤﻟا و …...krka d.d. novo mesto MAH: krka d.d. novo mesto - slovenia telmisartan + HCT slovenia DRUG 201711212219 62

10

Pharmacy TWFS nb.

Import/Export

nb.

Import/Export Date Tradename Strength Form Presentation Agent Manufacturer Ingredient Country TYPE

جدول تقدیم طلبات تسجیل االدویة و المستحضرات للتصنیف لعام 2019

201811238100 124 07/02/2019revanesse kiss +, 2

syringes x1ml omni medicalprollenium medical

technologies inc Canada CLASSIFICATION

201811231477 126 08/02/2019 after bite, 14ml pen broadmed SAL tender corporation USA CLASSIFICATION

201811242118 128 11/02/2019 lidamid 10 10mg capsules 21Pharmaline

S.A.L. pharmaline under license from natco pharma limited

lenalidomide 10mg Lebanon DRUG

201811242119 129 11/02/2019 lidamid 15 15mg capsules 21Pharmaline

S.A.L. pharmaline under license from natco pharma limited

lenalidomide 15mg Lebanon DRUG

201811242121 130 11/02/2019 lidamid 25 25mg capsules 21Pharmaline

S.A.L. pharmaline under license from natco pharma limited

lenalidomide 25mg Lebanon DRUG

20181126047 131 11/02/2019lamivudine

zidovudine arrow 150mg/300mgcomprimes

pellicules secable 60 karout pharmacy

apl swift services MAH: arrow generiques -

francelamivudine / zidovudine Malta DRUG

201811239833 132 11/02/2019 phosome 50mg x 1vial Unipharm S.A.L.cipla ltd

MAH: cipla ltd - india

amphotericin b liposome for

injection India DRUG

Page 11: 2019 مﺎﻌﻟ ﻒﯿﻨﺼﺘﻠﻟ تاﺮﻀﺤﺘﺴﻤﻟا و …...krka d.d. novo mesto MAH: krka d.d. novo mesto - slovenia telmisartan + HCT slovenia DRUG 201711212219 62

11

Pharmacy TWFS nb.

Import/Export

nb.

Import/Export Date Tradename Strength Form Presentation Agent Manufacturer Ingredient Country TYPE

جدول تقدیم طلبات تسجیل االدویة و المستحضرات للتصنیف لعام 2019

20191122402 133 11/02/2019 imilastin

powder for solution for

infusion box of 10 vials pharmadex

PACKED BY PHARMADEX UNDER LICENSE FROM facta

farmaceutici s.p.a

imipenem monohydrate500

mg cilastatin sodium 500mg Lebanon DRUG

20191121161 134 11/02/2019 emgality 120mg/mlinjection x1 single dose prefilled pen

Droguerie de l'Union

eli lilly and company MAH: eli lilly and company -

USA galcanezumab USA DRUG

20191123581 147 11/02/2019

magnesium diasporal 1box of

20sachets Unipharm S.A.L.

protina pharmaseutische GmbH -germany

MAH:protina pharmaseutische GmbH -

germany Germany CLASSIFICATION

20191123585 149 11/02/2019

magnesium diasporal

direct1box of 20sachets Unipharm S.A.L.

protina pharmaseutische GmbH -germany

MAH:protina pharmaseutische GmbH -

germany Germany CLASSIFICATION

201811233913 151 12/02/2019

gaviscon advance aniseed flavour oral suspension 300ml

Droguerie Columbus

reckitt benckiser healthcare (UK) limited

MAH: reckitt benckiser healthcare (UK) limited - UK

sodium alginate 100mg/ml potassium hydrogen carbonate 20mg/ml UK DRUG

201711250694 152 12/02/2019 briviact 10mg/ml oral solution 300ml Sadco

unither manufacturing LLCMAH: UCB pharma SA -

belgium brivaracetam USA DRUG

201811250484 153 12/02/2019 anodyne 500x10 rectal suppAvicenna pharm

S.A.L.

abu raihan pharmaceutical company

MAH: abu raihan pharmaceutical company -

iran naproxen Iran DRUG

Page 12: 2019 مﺎﻌﻟ ﻒﯿﻨﺼﺘﻠﻟ تاﺮﻀﺤﺘﺴﻤﻟا و …...krka d.d. novo mesto MAH: krka d.d. novo mesto - slovenia telmisartan + HCT slovenia DRUG 201711212219 62

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Pharmacy TWFS nb.

Import/Export

nb.

Import/Export Date Tradename Strength Form Presentation Agent Manufacturer Ingredient Country TYPE

جدول تقدیم طلبات تسجیل االدویة و المستحضرات للتصنیف لعام 2019

201811215495 154 12/02/2019

marie rose lotion extra forte poux et

lentes

Raymond Georges Abou

Adal & Co

laboratoires juva production MAH: laboratoires juva sante

- France France DRUG

201811243337 156 12/02/2019 sedatin 50mg/mlsolution for

injection 10 vialsBellapharma

S.A.R.L.MS pharma

MAH: MS pharma - jordanpethidine HCL

50mg Jordan DRUG

201811243336 157 12/02/2019 sedatin 100mg/2mlsolution for

injection 10 vialsBellapharma

S.A.R.L.MS pharma

MAH: MS pharma - jordanpethidine HCL

100mg Jordan DRUG

201811222178 190 13/02/2019

yukon chrome PC - sirolimus eluting

coronary stent system

promedz drugstoreS.A.L. translumina GmbH - germany Germany DRUG

20191124393 192 13/02/2019

alsavisc ( sodium hyaluronate) all concentrations

alpha - tech pharma

vsy biotechnology MAH : alsanza

medizintechnik und pharma GmbH - germany turkey DRUG

201811218842 200 15/02/2019 dolonil 75mg/3ml

solution for intramuscular

injection 5 ampoules Arwan Arwan diclofenac

sodium lebanon DRUG

201811252754 219 18/02/2019

vaxigriptetra, vaccin grippal quadrivalent 0.5ml

suspension injectable en 1

seringue preremplie avec aiguille attachee UPO S.A.L.

sanofi pasteur MAH: sanofi pasteur - france

inactive a virion fragmente France DRUG

Page 13: 2019 مﺎﻌﻟ ﻒﯿﻨﺼﺘﻠﻟ تاﺮﻀﺤﺘﺴﻤﻟا و …...krka d.d. novo mesto MAH: krka d.d. novo mesto - slovenia telmisartan + HCT slovenia DRUG 201711212219 62

13

Pharmacy TWFS nb.

Import/Export

nb.

Import/Export Date Tradename Strength Form Presentation Agent Manufacturer Ingredient Country TYPE

جدول تقدیم طلبات تسجیل االدویة و المستحضرات للتصنیف لعام 2019

201811226365 221 18/02/2019

hyatears uno ophtalmic solution 0.2% 20reclosable

vials of 0.5ml Benta S.A.L.

incos cosmeceutica industiale S.R.L.-italy

secondary packaged by Benta S.A.L. - lebanon

MAH:NTC-ITALY Lebanon CLASSIFICATION

201811226387 222 18/02/2019

hyatears preservative free

10ml bottle Benta S.A.L.

coc farmaceutici srl-italysecondary packaged by Benta S.A.L. - lebanon

MAH:NTC-ITALY Lebanon CLASSIFICATION

201811226387 222 18/02/2019

hyatears forte preservative free

10ml bottle Benta S.A.L.

coc farmaceutici srl-italysecondary packaged by Benta S.A.L. - lebanon

MAH:NTC-ITALY Lebanon CLASSIFICATION

201811226387 222 18/02/2019hydradrops 10ml bottle Benta S.A.L.

coc farmaceutici srl-italysecondary packaged by Benta S.A.L. - lebanon

MAH:NTC-ITALY Lebanon CLASSIFICATION

20191124975 229 18/02/2019

tray life activator med 2X2ML

VIALS medipro group

promoitalia groupMAH: promoitalia group -

italy Italy CLASSIFICATION

20191124975 229 18/02/2019tray life tube gel H

2x90ml tubes medipro group

promoitalia groupMAH: promoitalia group -

italy Italy CLASSIFICATION

20191124975 229 18/02/2019tray life tube gel

2x90ml tubes medipro group

promoitalia groupMAH: promoitalia group -

italy Italy CLASSIFICATION

Page 14: 2019 مﺎﻌﻟ ﻒﯿﻨﺼﺘﻠﻟ تاﺮﻀﺤﺘﺴﻤﻟا و …...krka d.d. novo mesto MAH: krka d.d. novo mesto - slovenia telmisartan + HCT slovenia DRUG 201711212219 62

14

Pharmacy TWFS nb.

Import/Export

nb.

Import/Export Date Tradename Strength Form Presentation Agent Manufacturer Ingredient Country TYPE

جدول تقدیم طلبات تسجیل االدویة و المستحضرات للتصنیف لعام 2019

20191124975 229 18/02/2019 tray life kit x2 medipro group

promoitalia groupMAH: promoitalia group -

italy Italy CLASSIFICATION

20191124976 230 18/02/2019 skin fill silver plus medipro group

istituto ricerche applicate s.r.lMAH: promoitalia group -

italy Italy CLASSIFICATION

20191124976 230 18/02/2019 skin fill gold plus medipro group

istituto ricerche applicate s.r.lMAH: promoitalia group -

italy Italy CLASSIFICATION

20191124976 230 18/02/2019skin fill diamond

plus medipro group

istituto ricerche applicate s.r.lMAH: promoitalia group -

italy Italy CLASSIFICATION

20191125089 239 19/02/2019

enflog 360 28 gastro - resistant

capsulesnew europharm

s.a.r.l

truffini & regge farmaceutici s.r.l.

MAH: future live s.r.l a.c.r. unip - italy Italy CLASSIFICATION

20191125585 248 20/02/2019

artelac ectoin SDU 20X 0.5ml eye

drops Spephal S.A.L.

dr gerhard mann chem.- pharm fabrik Gmbh

MAH: dr gerhard mann chem.- pharm fabrik Gmbh -

germany Germany CLASSIFICATION

201811227429 274 21/02/2019lopinavir/ ritonavir

tablets USP 200mg/50mg film coated tablets 120

Mediterranean Pharmaceutical

Company

mylan laboratories limited MAH: mylan laboratories

limited - india

lopinavir USP 200mg ; ritonavir

USP 50mg India DRUG

Page 15: 2019 مﺎﻌﻟ ﻒﯿﻨﺼﺘﻠﻟ تاﺮﻀﺤﺘﺴﻤﻟا و …...krka d.d. novo mesto MAH: krka d.d. novo mesto - slovenia telmisartan + HCT slovenia DRUG 201711212219 62

15

Pharmacy TWFS nb.

Import/Export

nb.

Import/Export Date Tradename Strength Form Presentation Agent Manufacturer Ingredient Country TYPE

جدول تقدیم طلبات تسجیل االدویة و المستحضرات للتصنیف لعام 2019

DRUG

20191122351 293 22/02/2019 merolin 1G IV

powder for solution for injection / infusion box of 10 vials pharmadex

p y p lebanon

under license facta farmaceutici S.P.A. - italy

manufactured by facta farmaceutici S.P.A. - italy

meropenem trihydrate Lebanon DRUG

20191127500 300 22/02/2019

p 32mg (H-

HA)+32mg (L-HA) /2ml

hyaluronic acid sodium salt

e-pharma middle east

IBSA Farmaceutici Italia Srl

mah: IBSA Farmaceutici Italia Srl - italy Italy CLASSIFICATION

20191127503 301 22/02/2019

aliaxin FL 2prefilled syringes

e-pharma middle east

regenyal laboratories SRL mah: rose pharma s.a. Italy DRUG

20191127503 301 22/02/2019

- aliaxin-GP2prefilled

syringese-pharma

middle eastregenyal laboratories SRL

mah: rose pharma s.a. Italy DRUG

20191127503 301 22/02/2019

- aliaxin-EV2prefilled

syringese-pharma

middle eastregenyal laboratories SRL

mah: rose pharma s.a. Italy DRUG

20191127503 301 22/02/2019

aliaxin SR2prefilled

syringese-pharma

middle eastregenyal laboratories SRL

mah: rose pharma s.a. Italy DRUG

Page 16: 2019 مﺎﻌﻟ ﻒﯿﻨﺼﺘﻠﻟ تاﺮﻀﺤﺘﺴﻤﻟا و …...krka d.d. novo mesto MAH: krka d.d. novo mesto - slovenia telmisartan + HCT slovenia DRUG 201711212219 62

16

Pharmacy TWFS nb.

Import/Export

nb.

Import/Export Date Tradename Strength Form Presentation Agent Manufacturer Ingredient Country TYPE

جدول تقدیم طلبات تسجیل االدویة و المستحضرات للتصنیف لعام 2019

201811230473 305 26/02/2019lamiderm emulsin

x 60ml Pharmalap

laboratoria qualipher n.v./sa

mah: gifrer barbezat - france Belgium DRUG

201711242695 306 26/02/2019 histergan cream 25GTaba Chemipharm

fleet laboratories limited mah: norma chemicals limited - uk

diphenhydramine hcl UK DRUG

20191128323 330 27/02/2019

ribocrosste 1 sterile single

prefilleed syringe 1.5 ml

kettaneh pharma

iros r.c.srlmah: servimed industrial

spa - italy Italy DRUG

201811218901 336 28/02/2019 tracimol 75mg/650mg tablets 10Mectapharm

S.A.L.ferrer internacional sa

mah: acino ag - germanytramadol/paraceta

mol Spain DRUG

201811218900 337 28/02/2019 tracimol37.5mg/325m

g tablets 10Mectapharm

S.A.L.ferrer internacional sa

mah: acino ag - germanytramadol/parace

tamol Spain DRUG

201811234105 345 01/03/2019 zolicin 5mgfilm coated

tablets 20 Mersaco S.A.L.

Manufacturing Company

mah: Tabuk Pharmaceutical

Manufacturing Company - saudi arabia

levocetirizine dihydrochloride Saudi Arabia DRUG

201811252771 346 01/03/2019 thymoglobuline 5mg/ml

powder for solution for

infusion 1 vial, 25mg/5ml Mersaco S.A.L.

genzyme polyclonals s.a.smah: genzyme europe b.v. -

netherlands

rabbit anti - human

thymocyte immunoglobulin

e France DRUG

Page 17: 2019 مﺎﻌﻟ ﻒﯿﻨﺼﺘﻠﻟ تاﺮﻀﺤﺘﺴﻤﻟا و …...krka d.d. novo mesto MAH: krka d.d. novo mesto - slovenia telmisartan + HCT slovenia DRUG 201711212219 62

17

Pharmacy TWFS nb.

Import/Export

nb.

Import/Export Date Tradename Strength Form Presentation Agent Manufacturer Ingredient Country TYPE

جدول تقدیم طلبات تسجیل االدویة و المستحضرات للتصنیف لعام 2019

201711219175 347 01/03/2019 etoxib 30mgfilm coated

tablets 28Medicapharm

S.A.L.

karka d.d novo mestomah: tad phrama GmbH -

germany etoricoxib Slovenia DRUG

201711219172 348 01/03/2019 etoxib 60mgfilm coated

tablets 28Medicapharm

S.A.L.

karka d.d novo mestomah: tad phrama GmbH -

germany etoricoxib Slovenia DRUG

201711219174 349 01/03/2019 etoxib 90mgfilm coated

tablets 28Medicapharm

S.A.L.

karka d.d novo mestomah: tad phrama GmbH -

germany etoricoxib Slovenia DRUG

201711219173 350 01/03/2019 etoxib 120mgfilm coated

tablets 7Medicapharm

S.A.L.

karka d.d novo mestomah: tad phrama GmbH -

germany etoricoxib Slovenia DRUG

20191122334 357 04/03/2019 zebinix 800mg tablets 30Levant Alie

Houses S.A.L.

bilal - portela&ca s.a.mah: bilal - portela&ca s.a.

- Portugaleslicarbazepine

acetate Portugal DRUG

20191121198 358 04/03/2019 edolfene eye drop solution 5mlkettaneh pharma

laboratories edol - produtos farmaceuticos.amah:laboratories edol -

produtos farmaceuticos.a- Portugal flurbiprofen Portugal DRUG

20191129632 384 04/03/2019

deep freeze pain relief glide-on

gel 50g Sadco the mentholatum co. ltd UK DRUG

Page 18: 2019 مﺎﻌﻟ ﻒﯿﻨﺼﺘﻠﻟ تاﺮﻀﺤﺘﺴﻤﻟا و …...krka d.d. novo mesto MAH: krka d.d. novo mesto - slovenia telmisartan + HCT slovenia DRUG 201711212219 62

18

Pharmacy TWFS nb.

Import/Export

nb.

Import/Export Date Tradename Strength Form Presentation Agent Manufacturer Ingredient Country TYPE

جدول تقدیم طلبات تسجیل االدویة و المستحضرات للتصنیف لعام 2019

20191129635 386 04/03/2019apisal spark ling nasal spray 50ml

Germanous healthcare

supplies SARL aurena laboratories ab Sweden DRUG

20191129640 389 04/03/2019 cyclolux-unilux droguerie tamer sanochemia austria CLASSIFICATION

201811237978 395 05/03/2019 kenacare -A 40mg/1ml injection BP 3vials of 1ml swiss pharm

swiss parenterals ltdmah: swiss parenterals ltd -

Indiatriamcinolone

acetonide India DRUG

201811236050 409 07/03/2019 benzaflex 10mgfilm coated

tablets 30Khalil Fattal &

Fils S.A.L.

spimacomah: spimaco - saudi

arabiacyclobenzaprine

hcl Saudi Arabia DRUG

201811236052 410 07/03/2019 benzaflex 5mgfilm coated

tablets 30Khalil Fattal &

Fils S.A.L.

spimacomah: spimaco - saudi

arabiacyclobenzaprine

hcl Saudi Arabia DRUG

201811252923 411 07/03/2019 hyrimoz 40mgsolution for

injection 2 pre-filled penKhalil Fattal &

Fils S.A.L.

sandoz gmbh, schaftenaumah: sandoz gmbh, kundl -

austria adalimumab Austria DRUG

201811252919 412 07/03/2019 hyrimoz 40mgsolution for

injection 2 pre-filled

syringeKhalil Fattal &

Fils S.A.L.

sandoz gmbh, schaftenaumah: sandoz gmbh, kundl -

austria adalimumab Austria DRUG

Page 19: 2019 مﺎﻌﻟ ﻒﯿﻨﺼﺘﻠﻟ تاﺮﻀﺤﺘﺴﻤﻟا و …...krka d.d. novo mesto MAH: krka d.d. novo mesto - slovenia telmisartan + HCT slovenia DRUG 201711212219 62

19

Pharmacy TWFS nb.

Import/Export

nb.

Import/Export Date Tradename Strength Form Presentation Agent Manufacturer Ingredient Country TYPE

جدول تقدیم طلبات تسجیل االدویة و المستحضرات للتصنیف لعام 2019

201811249378 413 07/03/2019 ocaliva 5mgfilm coated

tablets 30 mercury

almac pharma services limited

mah: intercept pharma ltd. - uk obeticholic acid UK DRUG

201811249374 414 07/03/2019 ocaliva 10mgfilm coated

tablets 30 mercury

almac pharma services limited

mah: intercept pharma ltd. - uk obeticholic acid UK DRUG

201711214295 416 08/03/2019 etozox -E60 60mgfilm coated

tablets 30Unipharm

S.A.L.cipla ltd

mah: cipla ltd - india etocoxib India DRUG

201711214297 417 08/03/2019 etozox -E90 90mgfilm coated

tablets 30Unipharm

S.A.L.cipla ltd

mah: cipla ltd - india etocoxib India DRUG

201711214293 418 08/03/2019 etozox -E120 120mgfilm coated

tablets 10Unipharm

S.A.L.cipla ltd

mah: cipla ltd - india etocoxib India DRUG

20171127055 419 11/03/2019d-mannose with cranberry extract

Cesar Chalhoub et

Filssiit.s.r.l.

mah: lagap sa - Switzerland Italy CLASSIFICATION

20171127182 420 11/03/2019

altrazeal transforming

powder dressing 0.75g * 5 blisters Catafago

anteco pharma llcmah: uluru inc - usa USA CLASSIFICATION

Page 20: 2019 مﺎﻌﻟ ﻒﯿﻨﺼﺘﻠﻟ تاﺮﻀﺤﺘﺴﻤﻟا و …...krka d.d. novo mesto MAH: krka d.d. novo mesto - slovenia telmisartan + HCT slovenia DRUG 201711212219 62

20

Pharmacy TWFS nb.

Import/Export

nb.

Import/Export Date Tradename Strength Form Presentation Agent Manufacturer Ingredient Country TYPE

جدول تقدیم طلبات تسجیل االدویة و المستحضرات للتصنیف لعام 2019

201811226140 427 11/03/2019for dal drops

30mlnew pharmahealth

erobozeta s.p.a.mah: advanced biomedical

srl ab.m - italy san - marino CLASSIFICATION

201811226140 427 11/03/2019for dal f drops

30mlnew pharmahealth

erobozeta s.p.a.mah: advanced biomedical

srl ab.m - italy san - marino CLASSIFICATION

201811232511 428 11/03/2019

meteogaz 10 sticks de poudre

orodispersible Spephal S.A.L.s.i.i.t.s.r.l.

mah: s.i.i.t.s.r.l. - italy Italy CLASSIFICATION

201811134063 430 11/03/2019Glyco-A 12%

TUBE OF 30ml MEDEXalpol cosmetique -france

MAH:ISIS pharma -france France CLASSIFICATION

201811234679 431 11/03/2019hyalo4 skin cream

* 25g Catafago fidia farmaceutici s.p.a. Italy CLASSIFICATION

201811234679 431 11/03/2019hyalo4 start

ointment * 30g Catafago fidia farmaceutici s.p.a. Italy CLASSIFICATION

201811234679 431 11/03/2019hyalo4 control spray * 50ml

recalled from agent this only Catafago fidia farmaceutici s.p.a. Italy CLASSIFICATION

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21

Pharmacy TWFS nb.

Import/Export

nb.

Import/Export Date Tradename Strength Form Presentation Agent Manufacturer Ingredient Country TYPE

جدول تقدیم طلبات تسجیل االدویة و المستحضرات للتصنیف لعام 2019

201811236690 435 11/03/2019venaseal tm

closure systempromedz drugstore

medtronic irelandmah: medtronic, inc. - usa Ireland CLASSIFICATION

201811236956 436 11/03/2019xilaplus af 8

capsules Spephal S.A.L.labomar s.r.l.

mah: noventure s.l - spain Italy CLASSIFICATION

201811239035 438 11/03/2019radian ice gel

150ml Mersaco S.A.L.galena pharma oy

stada nordic aps, - finland finland CLASSIFICATION

201811239035 438 11/03/2019radian ice gel roll-

on 75ml Mersaco S.A.L.galena pharma oy

stada nordic aps, - finland finland CLASSIFICATION

201911210240 444 13/03/2019 magro 14 sachetsnew pharmahealth

amazzonia fito preparati s.r.l

mah: advanced biomedical s.r.l. (abm) - italy Italy CLASSIFICATION

201911210240 444 13/03/2019 armonia 30 capnew pharmahealth

amazzonia fito preparati s.r.l

mah: advanced biomedical s.r.l. (abm) - italy Italy CLASSIFICATION

201911210240 444 13/03/2019 actibrain 30 capnew pharmahealth

amazzonia fito preparati s.r.l

mah: advanced biomedical s.r.l. (abm) - italy Italy CLASSIFICATION

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22

Pharmacy TWFS nb.

Import/Export

nb.

Import/Export Date Tradename Strength Form Presentation Agent Manufacturer Ingredient Country TYPE

جدول تقدیم طلبات تسجیل االدویة و المستحضرات للتصنیف لعام 2019

201911210257 445 13/03/2019medis fer drops

60mlMedis Pharm

Drugstore

kinezika do.omah: pharmalinea ltd -

slovenia Slovenia CLASSIFICATION

201911210257 445 13/03/2019medis Dk2 drops

10mlMedis Pharm

Drugstore

kinezika do.omah: pharmalinea ltd -

slovenia Slovenia CLASSIFICATION

201811221724 466 14/03/2019

nuraid II MLC 901 x180 capsules new europharm

POLI MEDICAL COMPANY PTE LTD

mah: moleac belgium sprl - belgium Singapore CLASSIFICATION

201811220715 476 15/03/2019methylprednisolone orbucell inj. 40mg

powder for solution for

injection box of 10 vials pharmadex

packed by pharmadex - lebanon

under license from orbucell pharma canadamanufactured by esseti

farmaceutici S.P.A. - italy

methylprednisolone sodium

succinate Lebanon DRUG

201811220716 477 15/03/2019methylprednisolone orbucell inj. 125mg

powder for solution for

injection box of 10 vials pharmadex

packed by pharmadex - lebanon

under license from orbucell pharma canadamanufactured by esseti

farmaceutici S.P.A. - italy

methylprednisolone sodium

succinate Lebanon DRUG

20191125767 478 15/03/2019 inflacam 20mg/mlampoule for im

injection 3ampoulesMacromed

S.A.R.L.

arab company for pharmaceuticals medicinal plants -mepaco-medifood

piroxicam Egypt DRUG

201811233790 494 18/03/2019 aviravir 1mgfilm coated

tablets 30 broadmed SAL

pharmactive ilac san.ve tic a.s

mah: pharmactive ilac san.ve tic a.s - turky

entecavir monohydrate turky DRUG

Page 23: 2019 مﺎﻌﻟ ﻒﯿﻨﺼﺘﻠﻟ تاﺮﻀﺤﺘﺴﻤﻟا و …...krka d.d. novo mesto MAH: krka d.d. novo mesto - slovenia telmisartan + HCT slovenia DRUG 201711212219 62

23

Pharmacy TWFS nb.

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nb.

Import/Export Date Tradename Strength Form Presentation Agent Manufacturer Ingredient Country TYPE

جدول تقدیم طلبات تسجیل االدویة و المستحضرات للتصنیف لعام 2019

201811233792 495 18/03/2019 aviravir 0.5mgfilm coated

tablets 30 broadmed SAL

pharmactive ilac san.ve tic a.s

mah: pharmactive ilac san.ve tic a.s - turky

entecavir monohydrate turky DRUG

201911211779 509 18/03/2019hemo plus 30ml

dropsph mustakbal-

akkar

amazzonia fito preparati s.r.lmah: advanced biomedical -

italy san - marino cLASSIFICATION

201911211779 509 18/03/2019 coliflor 10ml dropsph mustakbal-

akkar

amazzonia fito preparati s.r.lmah: advanced biomedical -

italy san - marino cLASSIFICATION

201911211779 509 18/03/2019

fantasia 24 cheweble tablets &32 chewable

tabletsph mustakbal-

akkar

amazzonia fito preparati s.r.lmah: advanced biomedical -

italy san - marino cLASSIFICATION

201911211779 509 18/03/2019immunifull 150ml

syrupph mustakbal-

akkar

amazzonia fito preparati s.r.lmah: advanced biomedical -

italy san - marino cLASSIFICATION

201911211779 509 18/03/2019florasan 30 enteric

coated capsph mustakbal-

akkar

amazzonia fito preparati s.r.lmah: advanced biomedical -

italy san - marino cLASSIFICATION

201911212443 528 20/03/2019rahamin topical

ointment 30g ibn sina pharm

raha pharmaceutical co.mah: raha pharmaceutical

co. - iran iran CLASSIFICATION

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24

Pharmacy TWFS nb.

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nb.

Import/Export Date Tradename Strength Form Presentation Agent Manufacturer Ingredient Country TYPE

جدول تقدیم طلبات تسجیل االدویة و المستحضرات للتصنیف لعام 2019

2019112323 529 21/03/2019 abremia 250mg tablets 120 century pharma

The Arab Pharmaceutical Manufacturing psc

mah: hikma Pharmaceuticals - jordan

abiraterone acetate Jordan DRUG

201911211517 530 21/03/2019 erelzi 50mgsolution for

injection 4 pre-filled pen Codipha

sandoz gmbh schaftenau langkampfen

mah: sandoz gmbh kundl - austria etanercept austria DRUG

201911211513 531 21/03/2019 erelzi 50mgsolution for

injection4 pre-filled

syringe Codipha

sandoz gmbh schaftenau langkampfen

mah: sandoz gmbh kundl - austria etanercept austria DRUG

201911211515 532 21/03/2019 erelzi 25mgsolution for

injection4 pre-filled

syringe Codipha

sandoz gmbh schaftenau langkampfen

mah: sandoz gmbh kundl - austria etanercept austria DRUG

20191125924 533 21/03/2019 cubicin RF 500mg/vial

lyophilized injection

powder for solution x 1vial

Droguerie de l'Union

patheon italia s.p.a.mah: merck sharp &

dohme corp - usa

daptomycin reformulated 500mg/vial Italy DRUG

201811226181 534 22/03/2019idrata 250ml 4

sachet of 62.5ml pentamed

biomega natural nutrienissl mah: aragonesa de

exportaion international - Spain Spain CLASSIFICATION

20191128435 541 28/03/2019 fosfolag 3ggranules for oral

solution1sachet of granules

Cesar Chalhoub et

Filslabiana pharmaceuticals slumah: lagap sa - switzerland

fosfomycin trometamol 3g Spain DRUG

Page 25: 2019 مﺎﻌﻟ ﻒﯿﻨﺼﺘﻠﻟ تاﺮﻀﺤﺘﺴﻤﻟا و …...krka d.d. novo mesto MAH: krka d.d. novo mesto - slovenia telmisartan + HCT slovenia DRUG 201711212219 62

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Pharmacy TWFS nb.

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nb.

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جدول تقدیم طلبات تسجیل االدویة و المستحضرات للتصنیف لعام 2019

201811232333 542 28/03/2019 miovisin 20mg/2ml

powder and solvent for solution for injection for

intraocular use

6 ampoules powder+6 ampoules

solvent 2mlnew larys

pharmfarmigea s.p.a

mah: farmigea s.p.a - italyacetylcholine

chloride Italy DRUG

201811250528 543 29/03/2019 lamivudine arrow 300mg comprime

pellicule 30karout

pharmacy

apl swift services )malta)limited-malta

mah: arrow generiques - france

lamivudine 300mg malta DRUG

201811250531 544 29/03/2019 lamivudine arrow 150mg comprime

pellicule secable 60karout

pharmacy

services limited mah: arrow generiques -

francelamivudine

150mg malta DRUG

201811233911 545 29/03/2019

tenofovir disoproxil fumarate 300mg tablets 30

Mediterranean Pharmaceutical

Company

mylan laboratories limited mah: mylan laboratories

limited - india

tenofovir disoproxil

fumarate 300mg India DRUG

20191122763 549 29/03/2019algeness prefilled

syringe medica

ghimas s.p.amah: algeness - europe ltd -

ireland Italy CLASSIFICATION

201911212852 554 29/03/2019

cetaphil ultra - gentle soothing

body wash

Raymond Georges Abou

Adal & Co CLASSIFICATION

201911212905 561 29/03/2019

proeye eyedrops single dose

container drops 20ml med mix pharm

optoflex s.r.lmah: optoflex s.r.l exclusive distributor worldwide valida

health care - italy Italy CLASSIFICATION

Page 26: 2019 مﺎﻌﻟ ﻒﯿﻨﺼﺘﻠﻟ تاﺮﻀﺤﺘﺴﻤﻟا و …...krka d.d. novo mesto MAH: krka d.d. novo mesto - slovenia telmisartan + HCT slovenia DRUG 201711212219 62

26

Pharmacy TWFS nb.

Import/Export

nb.

Import/Export Date Tradename Strength Form Presentation Agent Manufacturer Ingredient Country TYPE

جدول تقدیم طلبات تسجیل االدویة و المستحضرات للتصنیف لعام 2019

201811233826 563 01/04/2019 zevtera 500mg

powder for concentrate solution for

infusion 10 vialsHikma-Liban

S.A.R.L.

patheon uk limited under license from basila

pharmaceutica international ltd-switzerland

mah: jazeera pharmaceuticals industries - saudi arabia

ceftobiprole medocaril sodium uk DRUG

201811244671 580 01/04/2019 orthocam 20mg/ml solution for

injection 5vials

new nouvellepharm

drug storems pharma

mah: ms pharma - jordan

piroxicam 20mg/ml

solution for injection jordan DRUG

201911213813 582 01/04/2019

apisal single unidose

ampoules 30x5ml

germanous healthcare

supplies SARL unolab manufactury s.l espania CLASSIFICATION

201911213817 583 01/04/2019

licemafi (dimethicone dual formula

spray)

germanous healthcare

supplies SARLamman pharmaceutical

industries Jordan CLASSIFICATION

201911213692 599 01/04/2019

asterane gentle cleansing care

box of 20 liquid sachets-dose

Mapico S.A.R.L.

manufactured by opalia pharma s.a tunisia

recordati group tunisia CLASSIFICATION

201911213692 599 01/04/2019lalugyn vaginal

pessary box of 10Mapico S.A.R.L.

manufactured by opalia pharma s.a tunisia

recordati group tunisia CLASSIFICATION

201911213692 599 01/04/2019

lalulens lenses maiintenance

solution bottle of 250ml

Mapico S.A.R.L.

manufactured by opalia pharma s.a tunisia

recordati group tunisia CLASSIFICATION

Page 27: 2019 مﺎﻌﻟ ﻒﯿﻨﺼﺘﻠﻟ تاﺮﻀﺤﺘﺴﻤﻟا و …...krka d.d. novo mesto MAH: krka d.d. novo mesto - slovenia telmisartan + HCT slovenia DRUG 201711212219 62

27

Pharmacy TWFS nb.

Import/Export

nb.

Import/Export Date Tradename Strength Form Presentation Agent Manufacturer Ingredient Country TYPE

جدول تقدیم طلبات تسجیل االدویة و المستحضرات للتصنیف لعام 2019

201911213692 599 01/04/2019lalufresh buccal gel bottle of 20 g

Mapico S.A.R.L.

manufactured by opalia pharma s.a tunisia

recordati group tunisia CLASSIFICATION

201911213734 605 05/04/2019 bosulif 100mgfilm coated

tablets 28Mectapharm

S.A.L.

pfizer manufactury deutschland gmbh

mah: pfizer europe maeeig - belgium bosutinib Germany DRUG

201911213737 606 05/04/2019 bosulif 400mgfilm coated

tablets 28Mectapharm

S.A.L.

pfizer manufactury deutschland gmbh

mah: pfizer europe maeeig - belgium bosutinib Germany DRUG

201911213733 607 05/04/2019 bosulif 500mgfilm coated

tablets 28Mectapharm

S.A.L.

pfizer manufactury deutschland gmbh

mah: pfizer europe maeeig - belgium bosutinib Germany DRUG

20191121213 608 05/04/2019 zoxta 80mgfilm coated

tablets 30 new europharmsavvy pharm

mah: savvy pharm - jordan febuxostat 80mg Jordan DRUG

201911211625 609 08/04/2019 fervex

adults granules for oral solution sachets 8

pacific pharma s.a.l

upsa sas le passage mah: upsa sas - france

paracetamol 0.5g + ascorbic

acid 0.2g pheniramine

maleate 0.025g France DRUG

201911211609 610 08/04/2019 fervex

children sugar free, granules

for oral solution sachets 8

pacific pharma s.a.l

upsa sas le passage mah: upsa sas - france

paracetamol 0.28g +

ascorbic acid 0.10g

pheniramine maleate 0.01g France DRUG

Page 28: 2019 مﺎﻌﻟ ﻒﯿﻨﺼﺘﻠﻟ تاﺮﻀﺤﺘﺴﻤﻟا و …...krka d.d. novo mesto MAH: krka d.d. novo mesto - slovenia telmisartan + HCT slovenia DRUG 201711212219 62

28

Pharmacy TWFS nb.

Import/Export

nb.

Import/Export Date Tradename Strength Form Presentation Agent Manufacturer Ingredient Country TYPE

جدول تقدیم طلبات تسجیل االدویة و المستحضرات للتصنیف لعام 2019

201911211622 611 08/04/2019 fervex

adults raspberry,

granules for oral solution sachets 8

pacific pharma s.a.l

upsa sas le passage mah: upsa sas - france

paracetamol 0.5g + ascorbic

acid 0.2g pheniramine maleate 0.25g France DRUG

201911211623 612 08/04/2019 fervex

sugar free, granules for oral solution sachets 8

pacific pharma s.a.l

upsa sas le passage mah: upsa sas - france

paracetamol 0.5g + ascorbic

acid 0.2g pheniramine maleate 0.25g France DRUG

201911214232 617 08/04/2019 aptamil LF 400g

Food & Drug Corporation

FDC nutricia cuijk B.V. Netherlands CLASSIFICATION

201911214943 622 08/04/2019vitafos vanilla x

400g

pharma marketing &

services Laboratorios ordesa,s.l. Spain CLASSIFICATION

201811239939 627 09/04/2019cicloviral -

medinfar creme 5% 10g Medex

farmalabor produtos farmaceuticos s.a.

mah: medinfar consumer health produtos

farmaceuticos l.d - Portugalaciclovir 50mg/g Portugal DRUG

201811221707 628 09/04/2019B-good heat

patches x 2pcs ecopharm s.a.r.l.honnes saglik veerdustriyel

urunleri anonin sirketi turkey CLASSIFICATION

201811223123 629 09/04/2019 sleep inn syrup 100mlalfayha almina

pharmacy

radiant parenterals ltd mah: pranada biopharne prt

ltd - india india DRUG

Page 29: 2019 مﺎﻌﻟ ﻒﯿﻨﺼﺘﻠﻟ تاﺮﻀﺤﺘﺴﻤﻟا و …...krka d.d. novo mesto MAH: krka d.d. novo mesto - slovenia telmisartan + HCT slovenia DRUG 201711212219 62

29

Pharmacy TWFS nb.

Import/Export

nb.

Import/Export Date Tradename Strength Form Presentation Agent Manufacturer Ingredient Country TYPE

جدول تقدیم طلبات تسجیل االدویة و المستحضرات للتصنیف لعام 2019

201811222243 634 11/04/2019 arivir-800 film coated tablets 30Unipharm

S.A.L.cipla ltd

mah: cipla ltd - india darunavir india DRUG

201811222246 635 11/04/2019 arivir-600 film coated tablets 60Unipharm

S.A.L.cipla ltd

mah: cipla ltd - india darunavir india DRUG

201911215182 643 11/04/2019

mesoestetic mesofiller global

20mg/m 2steriledisposable

needles +1ml syringe ha

alrahbany pharmacy

mesoestetic pharmagroupmah: mesoestetic - spain spain CLASSIFICATION

201911215189 644 11/04/2019

mesoestetic mesofiller intese

25mg/ml2steriledisposable

needles +1ml syringe ha

alrahbany pharmacy

mesoestetic pharmagroupmah: mesoestetic - spain spain CLASSIFICATION

201811237333 655 12/04/2019 osinyle 0.5mg capsule box of 30 pharmadex s.a.l

packed by pharmadex lebanon

under license windlas healthcare pvt.limited -

indiamanufactured by windlas healthcare pvt.limited -

india fingolimod Lebanon DRUG

201811243338 656 15/04/2019 orabloc 1.100000solution for

injection

with adrenaline 5x10 carfridges

of 1.8mla.m.g. medical

s.a.l.

pierrel s.p.a.mah: pierrel pharma s.r.l. -

italyarticaine+epine

phrine italy DRUG

Page 30: 2019 مﺎﻌﻟ ﻒﯿﻨﺼﺘﻠﻟ تاﺮﻀﺤﺘﺴﻤﻟا و …...krka d.d. novo mesto MAH: krka d.d. novo mesto - slovenia telmisartan + HCT slovenia DRUG 201711212219 62

30

Pharmacy TWFS nb.

Import/Export

nb.

Import/Export Date Tradename Strength Form Presentation Agent Manufacturer Ingredient Country TYPE

جدول تقدیم طلبات تسجیل االدویة و المستحضرات للتصنیف لعام 2019

201811246612 671 16/04/2019dexmedetomidine

ever pharma 100mcg/ml

concentrate for solution for

infusion pack of 5x4ml

vials Codipha

ever pharma jena, gmbhmah: ever valinject, gmbh -

austria dexmedetomidin Germany DRUG

201811246614 672 16/04/2019dexmedetomidine

ever pharma 100mcg/ml

concentrate for solution for

infusion pack of 5x2ml

vials Codipha

ever pharma jena, gmbhmah: ever valinject, gmbh -

austria dexmedetomidin Germany DRUG

201811246616 673 16/04/2019dexmedetomidine

ever pharma 100mcg/ml

concentrate for solution for

infusion pack of 5x10ml

vials Codipha

ever pharma jena, gmbhmah: ever valinject, gmbh -

austria dexmedetomidin Germany DRUG

20191128246 674 16/04/2019 alerjoneye drops solution 10ml kettane pharma

laboratoris edol-prodotos farmaceuticos -sa

mah: laboratoris edol-prodotos farmaceuticos -sa

- portugal

chlorhydrate doxymetazoline

0.25mg/ml Portugal DRUG

201911212507 677 16/04/2019 anesic 5%dermal cream

tube of 30 grMapico S.A.R.L.

opalia pharma s.a.mah: opalia pharma s.a. -

tunisia

2.5% lidocaine + 2.5%

prilocaine tunisia DRUG

201711250911 701 18/04/2019 pecfent 100mcgnasal spray

solution1.55ml x1

bottlesdroguery mercury

l. molteni & c dei f. lli alitti societa di esercizio

s.p.a.mah: kyowa kirin holdings

b.v. - netherlands fentanyl as citrate Italy DRUG

201711250908 702 18/04/2019 pecfent 100mcgnasal spray

solution1.55ml x 4

bottlesdroguery mercury

l. molteni & c dei f. lli alitti societa di esercizio

s.p.a.mah: kyowa kirin holdings

b.v. - netherlands fentanyl as citrate Italy DRUG

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31

Pharmacy TWFS nb.

Import/Export

nb.

Import/Export Date Tradename Strength Form Presentation Agent Manufacturer Ingredient Country TYPE

جدول تقدیم طلبات تسجیل االدویة و المستحضرات للتصنیف لعام 2019

201711250907 703 18/04/2019 pecfent 400mcgnasal spray

solution1.55ml x 1

bottlesdroguery mercury

l. molteni & c dei f. lli alitti societa di esercizio

s.p.a.mah: kyowa kirin holdings

b.v. - netherlands fentanyl as citrate Italy DRUG

201711250915 704 18/04/2019 pecfent 400mcgnasal spray

solution1.55ml x 4

bottlesdroguery mercury

l. molteni & c dei f. lli alitti societa di esercizio

s.p.a.mah: kyowa kirin holdings

b.v. - netherlands fentanyl as citrate Italy DRUG

201911211629 705 18/04/2019 efferalgan 80mg paediatic

effervescent powder for oral

solution 12 sachets Pacific pharmaupsa sas le passage

mah: upsa sas - france paracetamol

80mg France DRUG

201911211630 706 18/04/2019 efferalgan 150mg paediatic

effervescent powder for oral

solution 12 sachets Pacific pharmaupsa sas le passage

mah: upsa sas - france paracetamol

150mg France DRUG

201911211633 707 18/04/2019 efferalgan 250mg paediatic

effervescent powder for oral

solution 12 sachets Pacific pharmaupsa sas le passage

mah: upsa sas - france paracetamol

250mg France DRUG

201811239849 709 23/04/2019 atosiban genfarna 37.5mg/5ml

concentrate for solution for

infusion 1vial alfamed

genfema laboratorio s.lmah: genfema laboratorio s.l -

spain atosiban Spain DRUG

201911211891 721 23/04/2019 trillerg

eye drops sterile ophthalmic

solution 10mlMacromed

S.A.R.L.

orchidia pharmaceutical industries

mah: orchidia pharmaceutical industries - egypt

antazoline hydrochloride

0.5mgtetryzoline

hydrochloride 0.4mg egypt DRUG

Page 32: 2019 مﺎﻌﻟ ﻒﯿﻨﺼﺘﻠﻟ تاﺮﻀﺤﺘﺴﻤﻟا و …...krka d.d. novo mesto MAH: krka d.d. novo mesto - slovenia telmisartan + HCT slovenia DRUG 201711212219 62

32

Pharmacy TWFS nb.

Import/Export

nb.

Import/Export Date Tradename Strength Form Presentation Agent Manufacturer Ingredient Country TYPE

جدول تقدیم طلبات تسجیل االدویة و المستحضرات للتصنیف لعام 2019

201811233719 722 23/04/2019sevoflurane halocarbon bottle 250ml

medi Drug S.A.R.L.

halocarbon products corporation

mah: halocarbon products corporation - usa sevoflurane USA DRUG

201911216572 728 24/04/2019cedallym zinc

30tabletsdroguerie solupharm

phyteo laboratoire -franceMAH: cedem healthcare ltd-

uk France CLASSIFICATION

201911217107 734 24/04/2019 dormy drops 50mlnew

pharmahealth

erbozeta spa-san marinoMAH:advanced biomdical srl-

italy Italy CLASSIFICATION

201911213105 736 25/04/2019 carivalan 6.25mg/5mg film coated tablets 56Khalil Fattal &

Fils S.A.L.

les laboratoires servier industrie

mah: les laboratoires servier - france

carvedilol/ ivabradine France DRUG

201911213077 737 25/04/2019 carivalan 6.25mg/7.5mg film coated tablets 56Khalil Fattal &

Fils S.A.L.

les laboratoires servier industrie

mah: les laboratoires servier - france

carvedilol/ ivabradine France DRUG

201911213079 738 25/04/2019 carivalan 12.5mg/5mg film coated tablets 56Khalil Fattal &

Fils S.A.L.

les laboratoires servier industrie

mah: les laboratoires servier - france

carvedilol/ ivabradine France DRUG

201911213119 739 25/04/2019 carivalan 12.5mg/7.5mgfilm coated

tablets 56Khalil Fattal &

Fils S.A.L.

les laboratoires servier industrie

mah: les laboratoires servier - france

carvedilol/ ivabradine France DRUG

Page 33: 2019 مﺎﻌﻟ ﻒﯿﻨﺼﺘﻠﻟ تاﺮﻀﺤﺘﺴﻤﻟا و …...krka d.d. novo mesto MAH: krka d.d. novo mesto - slovenia telmisartan + HCT slovenia DRUG 201711212219 62

33

Pharmacy TWFS nb.

Import/Export

nb.

Import/Export Date Tradename Strength Form Presentation Agent Manufacturer Ingredient Country TYPE

جدول تقدیم طلبات تسجیل االدویة و المستحضرات للتصنیف لعام 2019

201911213111 740 25/04/2019 carivalan 25mg/5mgfilm coated

tablets 56Khalil Fattal &

Fils S.A.L.

les laboratoires servier industrie

mah: les laboratoires servier - france

carvedilol/ ivabradine France DRUG

201911213115 741 25/04/2019 carivalan 25mg/7.5mgfilm coated

tablets 56Khalil Fattal &

Fils S.A.L.

les laboratoires servier industrie

mah: les laboratoires servier - france

carvedilol/ ivabradine France DRUG

201811246619 742 25/04/2019 travoprost BGR 40mg/ml

collyre en solution 1 flacon

de 2.5ml ctr

Pharmathen SAmah: laboratoires biogaran

- france travoprost Greece DRUG

201911211604 743 25/04/2019 imfinzi120mg/2.4ml-

50mg/ml injection 1vial OmnipharmaCatalent indiana llc

mah: astrazeneca uk ltd - uk durvalumab USA DRUG

201911211601 744 25/04/2019 imfinzi500mg/10ml-

50mg/ml injection 1vial OmnipharmaCatalent indiana llc

mah: astrazen eco uk ltd - uk durvalumab USA DRUG

201911217192 762 02/05/2019 omevita drops 30mlph mustakbal-

akkar

amazzonia fito preparati s.r.lmah: advanced biomedical -

italy san marino CLASSIFICATION

201911217192 762 02/05/2019quatre B12

30coated tabletsph mustakbal-

akkar

amazzonia fito preparati s.r.lmah: advanced biomedical -

italy san marino

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34

Pharmacy TWFS nb.

Import/Export

nb.

Import/Export Date Tradename Strength Form Presentation Agent Manufacturer Ingredient Country TYPE

جدول تقدیم طلبات تسجیل االدویة و المستحضرات للتصنیف لعام 2019

201911213628 763 02/05/2019 lenizak 75mg/25mg film coated tablets 20 sadco

menarini von heyden gmbh mah: laboratoires menarini

s.a. - spain

tramadol hydrochloride/dex

ketoprofen Germany DRUG

201911217284 766 02/05/2019neural plactive 20

tablets new europharmopko health spain

MAH: opko health spain Spain CLASSIFICATION

201811239904 790 08/05/2019 marovarex 120mggastro-resistant hard capsules 14 century pharma

Hikma pharmaceuticalsmah: Hikma pharmaceuticals

- jordan dimethyl

fumarate 120mg jordan DRUG

201811239901 791 08/05/2019 marovarex 240mggastro-resistant hard capsules 56 century pharma

Hikma pharmaceuticalsmah: Hikma pharmaceuticals

- jordan dimethyl

fumarate 240mg jordan DRUG

201911215991 805 09/05/2019 talzenna 0.25 mg capsules 30Droguerie Fattal

S.A.L.pfizer pharmaceuticals LLC

MAH: Pfizer Inc - USA Talazoparib USA DRUG

201911215989 806 09/05/2019 talzenna 1 mg capsules 30Droguerie Fattal

S.A.L.pfizer pharmaceuticals LLC

MAH: Pfizer Inc - USA Talazoparib USA DRUG

201811246565 834 13/05/2019 carglumic acid 200mg dispersible tablets 60 pharmamed waymade plc-uk carglumic acid uk DRUG

Page 35: 2019 مﺎﻌﻟ ﻒﯿﻨﺼﺘﻠﻟ تاﺮﻀﺤﺘﺴﻤﻟا و …...krka d.d. novo mesto MAH: krka d.d. novo mesto - slovenia telmisartan + HCT slovenia DRUG 201711212219 62

35

Pharmacy TWFS nb.

Import/Export

nb.

Import/Export Date Tradename Strength Form Presentation Agent Manufacturer Ingredient Country TYPE

جدول تقدیم طلبات تسجیل االدویة و المستحضرات للتصنیف لعام 2019

201911216001 843 20/05/2019 elmetacin solution 50ml pharmamedic

mobilat produktions GmbH-germany

MAH :daiichi sankyo europe GmbH-GERMANY indometacine Germany DRUG

20191121182 844 20/05/2019 baclocalm 10mg tablets 50 pharmalab labatec pharma sa baclofen Switzerland DRUG

20191121185 845 20/05/2019 baclocalm 25mg tablets 50 pharmalab labatec pharma sa baclofen Switzerland DRUG

201811237956 846 20/05/2019 cresemba 200mg

powder for concentrate solution for

infusion 1vialHikma-Liban

S.A.R.L.

baxter pharmaceutical solutions llc-usa

under license from basilea pharmaceutica international

ltd -switzerland MAH: hikma

pharmaceuticals -jordanisavuconazonium

sulfate usa DRUG

201811250494 847 20/05/2019 energ MR 35mg film coated tablets 60Bellapharma

S.A.R.L. pharma international co trimetazidine Jordan DRUG

201911212740 849 21/05/2019 ibufen -L suppositories 10 biopharm amino agibuprofen+lidocai

ne Switzerland DRUG

201811210310 850 21/05/2019 tournes 50mg tablets 4 pharmalinepharmaline under license from sandoz kundl-ausria sildenafil Lebanon DRUG

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36

Pharmacy TWFS nb.

Import/Export

nb.

Import/Export Date Tradename Strength Form Presentation Agent Manufacturer Ingredient Country TYPE

جدول تقدیم طلبات تسجیل االدویة و المستحضرات للتصنیف لعام 2019

201811210313 851 21/05/2019 tournes 100mg tablets 4 pharmalinepharmaline under license from sandoz kundl-ausria sildenafil Lebanon DRUG

201911217866 903 27/05/2019 trio-2000depigmentant

ointment 40g pharmadex pharmadex

hydroquinone+tretinoin+hydrocorti

sone acetate Lebanon DRUG

201911219714 904 28/05/2019 lorbrena 25mg tablets 30 fattalpfizer pharmaceuticals LLC

MAH: Pfizer Inc - USA lorlatinib USA DRUG

201911219707 905 28/05/2019 lorbrena 100mg tablets 30 fattalpfizer pharmaceuticals LLC

MAH: Pfizer Inc - USA lorlatinib USA DRUG

201811252778 906 29/05/2019 ebastine arrow 10mg comprime pellicule 30 tamipharm

centre specialites pharmaceutiques-franceMAH: arrow generiques-

france ebastine France DRUG

201811250558 907 31/05/2019 azicure 500mg

powder for solution for iv

injection 1vial fouad pharmacyms pharma

mah: ms pharma - jordan azithromycin Jordan DRUG

201911219719 908 31/05/2019 glunorm M 50mg/850mg film coated tablets 60 sadco dar aldawavidagliptin+metfo

rmin Jordan DRUG

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37

Pharmacy TWFS nb.

Import/Export

nb.

Import/Export Date Tradename Strength Form Presentation Agent Manufacturer Ingredient Country TYPE

جدول تقدیم طلبات تسجیل االدویة و المستحضرات للتصنیف لعام 2019

201911219711 909 31/05/2019 glunorm M 50mg/1000mg film coated tablets 60 sadco dar aldawavidagliptin+metfo

rmin Jordan DRUG

201911219655 926 07/06/2019 Nixoran film coated tablets 6droguerie phinicia roemmers S.A.I.C.F nitazoxanide Argentine DRUG

201911216022 927 07/06/2019 Nixoran powder for oral

suspension 60mldroguerie phinicia

mah roemmers S.A.I.C.Fdicofar srl argentine

(manufacturer )nitazoxanide Argentine DRUG

201811217778 928 07/06/2019dermagiq intima

250mlmaximed

pharma b factory health product bv Netherlands CLASSIFICATION

201811251876 956 11/06/2019 liloprost 0.05mg/0.5mlsolution for

infusion 5vials milia pharmms pharma

mah: ms pharma - jordan iloprost Jordan DRUG

201911213988 957 11/06/2019 illusof 300mg I/ml injection 1vial x100ml Mersaco S.A.L.

Tabuk Pharmaceutical Manufacturing Company

mah: Tabuk Pharmaceutical Manufacturing Company -

saudi arabia

iohexol equivalent to

300mg organic iodine Saudi Arabia DRUG

201911224121 989 12/06/2019TRUEVITAL1

400GIBN SINA PAHRMA

behdasht kar companyMAH:niksan salamat

behdood iran DRUG

Page 38: 2019 مﺎﻌﻟ ﻒﯿﻨﺼﺘﻠﻟ تاﺮﻀﺤﺘﺴﻤﻟا و …...krka d.d. novo mesto MAH: krka d.d. novo mesto - slovenia telmisartan + HCT slovenia DRUG 201711212219 62

38

Pharmacy TWFS nb.

Import/Export

nb.

Import/Export Date Tradename Strength Form Presentation Agent Manufacturer Ingredient Country TYPE

جدول تقدیم طلبات تسجیل االدویة و المستحضرات للتصنیف لعام 2019

20191126271 991 17/06/2019noradrenaline

hikma 4mg/4ml

concentrate for solution for

infusion 10ampoules century pharma

hikma italy spaMAH: HIKMA

pharmaceuticals-jordannoradrenaline

bitartrate Italy DRUG

201911224004 992 17/06/2019 azacitidine neapolis 100mg

lyophilizat for injection

1vial medispharm neapolis pharma azacitidine tunisia DRUG

201811244485 1005 24/06/2019 uralyt-u granules 280g Omnipharma

madaus GmbH-GERMANYMAH:meda pharma GmbH-

GERMANY

potassium sodium hydrogen

citrate Germany DRUG

201911218634 1031 25/06/2019 binosto 70mg effervescent tablets 4 pharmalab

swiss co services AG-switzerland

MAH; labatec pharma sa -switzerland

alendronate sodium Switzerland DRUG

201711245785 1043 28/06/2019 budena 50mcg

actuation pressurized inhalation suspension 200puffs 10ml

Power Pharm S.A.R.L. laboratorio aldo union sl budesonide spain DRUG

201911221642 1088 04/07/2019 pifeltro 100mg film coated tablets 30Droguerie de

l'Union

MSD international GmbH-IRELAND

mah:merck sharp&dohme BV-netherlands doravirine Ireland DRUG

201911221639 1089 04/07/2019 delstrigo film coated tablets 30Droguerie de

l'Union

MSD international GmbH-IRELAND

mah:merck sharp&dohme BV-netherlands

doravirine+lamivudine+tenofovir

disoproxil Ireland DRUG

Page 39: 2019 مﺎﻌﻟ ﻒﯿﻨﺼﺘﻠﻟ تاﺮﻀﺤﺘﺴﻤﻟا و …...krka d.d. novo mesto MAH: krka d.d. novo mesto - slovenia telmisartan + HCT slovenia DRUG 201711212219 62

39

Pharmacy TWFS nb.

Import/Export

nb.

Import/Export Date Tradename Strength Form Presentation Agent Manufacturer Ingredient Country TYPE

جدول تقدیم طلبات تسجیل االدویة و المستحضرات للتصنیف لعام 2019

201911225285 1090 04/07/2019 inuver nexthaler 100mcg/6mcgpowder for inhalation 120doses Sadco chiese farmaceutici spa

beclamethasone +formoterol Italy DRUG

201911228900 1127 12/07/2019

juvederm volux 2x1ml injectable

gel UPO S.A.L. allergan france CLASSIFICATION

201911212825 1130 15/07/2019ramipril/amlodipin

e genericon 2.5mg/5mg hard capsules 30 algenericon med

adamed pharma sa-polandMAH : genericon pharma

gmb-austriaamlodipine+

ramipril poland DRUG

201911212823 1131 15/07/2019ramipril/amlodipine

genericon 5mg/5mg hard capsules 30 algenericon med

adamed pharma sa-polandMAH : genericon pharma

gmb-austriaamlodipine+

ramipril poland DRUG

201911212822 1132 15/07/2019ramipril/amlodipine

genericon 10mg/5mg hard capsules 30 algenericon med

adamed pharma sa-polandMAH : genericon pharma

gmb-austriaamlodipine+

ramipril poland DRUG

201911212827 1133 15/07/2019ramipril/amlodipine

genericon 10mg/10mg hard capsules 30 algenericon med

adamed pharma sa-polandMAH : genericon pharma

gmb-austriaamlodipine+

ramipril poland DRUG

201911211578 1134 16/07/2019 arabitro 250mg tablets 120 medispharmglenmark pharmaceuticals

ltd abiraterone india DRUG

Page 40: 2019 مﺎﻌﻟ ﻒﯿﻨﺼﺘﻠﻟ تاﺮﻀﺤﺘﺴﻤﻟا و …...krka d.d. novo mesto MAH: krka d.d. novo mesto - slovenia telmisartan + HCT slovenia DRUG 201711212219 62

40

Pharmacy TWFS nb.

Import/Export

nb.

Import/Export Date Tradename Strength Form Presentation Agent Manufacturer Ingredient Country TYPE

جدول تقدیم طلبات تسجیل االدویة و المستحضرات للتصنیف لعام 2019

201811246536 1147 18/07/2019colistimethate sodium GES 2MIU

powder for solution for injection by

nebulizer 10vials alfamed

genfema laboratorio s.lmah: GES generico

espanoles laboratorio sa-spain colistimethate Spain DRUG

201911123341 1151 18/07/2019 renastart 400g can omnipharma

glambia nutritionals deutschland GmbH -germanyvitaflo international limited -

uk germany CLASSIFICATION

201911219651 1153 23/07/2019 sagifor 100mg film coated tablets 30 pharmaline pharmaline sitagliprin Lebanon DRUG

201911226471 1154 23/07/2019 sagimet 50mg/500mg film coated tablets 60 pharmaline pharmalinesitagliprin+metfor

min Lebanon DRUG

201911226472 1155 23/07/2019 sagimet 50mg/850mg film coated tablets 60 pharmaline pharmalinesitagliprin+metfor

min Lebanon DRUG

201911226470 1156 23/07/2019 sagimet 50mg/1000mg film coated tablets 60 pharmaline pharmalinesitagliprin+metfor

min Lebanon DRUG

201911225415 1157 23/07/2019 fasenra 30mgsolution for

injection 1prefilled syringe omnipharma

catalent indiana llc-usaMAH: Astrazeneca AB -

SWEDEN benralizumab USA dRUG

Page 41: 2019 مﺎﻌﻟ ﻒﯿﻨﺼﺘﻠﻟ تاﺮﻀﺤﺘﺴﻤﻟا و …...krka d.d. novo mesto MAH: krka d.d. novo mesto - slovenia telmisartan + HCT slovenia DRUG 201711212219 62

41

Pharmacy TWFS nb.

Import/Export

nb.

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جدول تقدیم طلبات تسجیل االدویة و المستحضرات للتصنیف لعام 2019

201911229739 1164 24/07/2019

primavera vulvo vaginal revamp

3vials of 5ml medispharm renaissance srl Italy classification

201911229343 1181 25/07/2019isosorbide dinitrate

0.1%10MG IN

10ML

concentrate for solution for injection or

infusion 10x10ml ampoules medidrug

torbay and south devon NHS Foundation trust

MAH:torbay and south devon NHS Foundation trust

isosorbide dinitrate UK DRUG

20191124945 1182 25/07/2019 complavin 75mg/100mg film coated tablets 30 mersaco

sanofi winthrop industrie-france

MAH:sanofi kk-japanclopidogrel+acety

lsalicylic acid france dRUG

201911226497 1183 25/07/2019 fabrazyme 35mg

powder for solution for

infusion 1vial mersaco

genzyme ireland ltd-irelandMAH: GENZYME EUROPE

BV-NETHERLANDS agalsidase beta Ireland dRUG

201911219669 1220 01/08/2019 vominore tablets 20 catafagothe jordanian pharmaceutical

manufacturing co (jpm)meclozine+pyrido

xine jordan dRUG

201911214390 1218 01/08/2019 detridine XR 2 2mgextended release

capsules 30 benta benta tolterodine tatrate lebanon dRUG

201911214388 1219 01/08/2019 detridine XR 4 4mgextended release

capsules 30 benta benta tolterodine tatrate lebanon DRUG

Page 42: 2019 مﺎﻌﻟ ﻒﯿﻨﺼﺘﻠﻟ تاﺮﻀﺤﺘﺴﻤﻟا و …...krka d.d. novo mesto MAH: krka d.d. novo mesto - slovenia telmisartan + HCT slovenia DRUG 201711212219 62

42

Pharmacy TWFS nb.

Import/Export

nb.

Import/Export Date Tradename Strength Form Presentation Agent Manufacturer Ingredient Country TYPE

جدول تقدیم طلبات تسجیل االدویة و المستحضرات للتصنیف لعام 2019

20191126078 1227 02/08/2019 clariscan 0.5mmmol/mlsolution for

injection 1x10mlDroguerie de

l'Union GE healthcare AS gadoteric acid Norway DRUG

20191126079 1228 02/08/2019 clariscan 0.5mmmol/mlsolution for

injection 1x15mlDroguerie de

l'Union GE healthcare AS gadoteric acid Norway DRUG

20191126082 1229 02/08/2019 clariscan 0.5mmmol/mlsolution for

injection 1x20mlDroguerie de

l'Union GE healthcare AS gadoteric acid Norway DRUG

201911225311 1253 08/08/2019 Sitamet 50mg/1000mg film coated tablets 56 evix sarl

sunshine lake pahrma co ltd -china

MAH:hec pharm gmbh-germany

sitagliptin +metformin china DRUG

201911225314 1254 08/08/2019 Sitamet 50mg/850mg film coated tablets 56 evix sarl

sunshine lake pahrma co ltd -china

MAH:hec pharm gmbh-germany

sitagliptin +metformin china DRUG

201911231900 1255 14/08/2019 Cinnora 40mg/0.8mlprefilled syringes

for sc injection x2 lebiran sarl cinnagen co adalimumab iran DRUG

201911231904 1256 14/08/2019 zytux 100mg/10ml

concentrate for solution for

infusion 2vials of 10ml lebiran sarl aryogen pharmed rituximab iran DRUG

Page 43: 2019 مﺎﻌﻟ ﻒﯿﻨﺼﺘﻠﻟ تاﺮﻀﺤﺘﺴﻤﻟا و …...krka d.d. novo mesto MAH: krka d.d. novo mesto - slovenia telmisartan + HCT slovenia DRUG 201711212219 62

43

Pharmacy TWFS nb.

Import/Export

nb.

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جدول تقدیم طلبات تسجیل االدویة و المستحضرات للتصنیف لعام 2019

201911231905 1257 14/08/2019 zytux 500mg/50ml

concentrate for solution for

infusion 1vial lebiran sarl aryogen pharmed rituximab iran DRUG

201811243313 1261 19/08/2019 cresemba 100mg hard capsules 14Hikma-Liban

S.A.R.L.

swissco services AG-switzerland under license

from basilea pharmaceutica international -switzerland

MAH:hikma pharmaceuticals-jordan

isavuconazonium sulfate Switzerland DRUG

20181126737 1293 22/08/2019extra stength

headache relief tablets 24 PMD allegiant healthacetaminophen+a

spirin+caffeine usa DRUG

201911213728 1294 22/08/2019 stiffano 150mg tablets 30 eva pharm plus joswe medicaltolperisone

hydrochloride jordan DRUG

201911234225 1298 22/08/2019

NMCLA diabet 200ml vanilla

flavor

Mediterranean Pharmaceutical

Company

corporacion alimentaria penasanta SA- (CAPSA

FOOD )spainMAH:cantabria labs

nutricion medica SL-spain Spain CLASSIFICATION

201911234225 1298 22/08/2019

NMCLA IBD 200ml vanilla

flavor

Mediterranean Pharmaceutical

Company

corporacion alimentaria penasanta SA- (CAPSA

FOOD )spainMAH:cantabria labs

nutricion medica SL-spain Spain CLASSIFICATION

201811238291 1316 26/08/2019 depadium 20mg film coated tablets 30 mapicothe united pharmaceuical

manufacturing coltdlercanidipine hydrochloride jordan DRUG

Page 44: 2019 مﺎﻌﻟ ﻒﯿﻨﺼﺘﻠﻟ تاﺮﻀﺤﺘﺴﻤﻟا و …...krka d.d. novo mesto MAH: krka d.d. novo mesto - slovenia telmisartan + HCT slovenia DRUG 201711212219 62

44

Pharmacy TWFS nb.

Import/Export

nb.

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جدول تقدیم طلبات تسجیل االدویة و المستحضرات للتصنیف لعام 2019

201811238292 1317 26/08/2019 depadium 10mg film coated tablets 30 mapicothe united pharmaceuical

manufacturing coltdlercanidipine hydrochloride jordan DRUG

20191121456 1318 26/08/2019 tebeta 4mg/mlsolution for

injection 3vials fouad pharmacy ms pharmabetamethasone

sodium phosphate jordan DRUG

201811251661 1343 30/08/2019 rotavac 0.5ml single dose vial1vial for oral administration

Mediterranean Pharmaceutical

Companybharat biotech international

ltdrotavirus live

attenuated India DRUG

201911229736 1347 03/09/2019 G-warts 5%w/w cream 12sachets medispharmglenmark pharmaceuticals

ltd imiquimod india DRUG

201911219750 1349 05/09/2019 candam 16mg/5mg hard capsules 30 algenericon med

adamed pharma sa-polandMAH : genericon pharma

gmb-austriaamlodipine+cand

esartan Poland DRUG

201911219744 1350 05/09/2019 candam 8mg/5mg hard capsules 30 algenericon med

adamed pharma sa-polandMAH : genericon pharma

gmb-austriaamlodipine+cand

esartan Poland DRUG

201911219751 1351 05/09/2019 candam 16mg/10mg hard capsules 30 algenericon med

adamed pharma sa-polandMAH : genericon pharma

gmb-austriaamlodipine+cand

esartan Poland DRUG

Page 45: 2019 مﺎﻌﻟ ﻒﯿﻨﺼﺘﻠﻟ تاﺮﻀﺤﺘﺴﻤﻟا و …...krka d.d. novo mesto MAH: krka d.d. novo mesto - slovenia telmisartan + HCT slovenia DRUG 201711212219 62

45

Pharmacy TWFS nb.

Import/Export

nb.

Import/Export Date Tradename Strength Form Presentation Agent Manufacturer Ingredient Country TYPE

جدول تقدیم طلبات تسجیل االدویة و المستحضرات للتصنیف لعام 2019

201911225343 1352 05/09/2019 cefproz 500 500mg film coated tablets 10C. Catafago &

Comedpharma pharma & chem

ind llc cefprozilUnited Arab

Emirates DRUG

20191128272 1353 05/09/2019 glufix 50mg tablets 90 ph ain mreisse laboratoires teriak sa acarbose tunisia DRUG

201911233884 1354 05/09/2019 goutyless tablets 30Macromed

S.A.R.L. october pharma SAEprobenecid+colch

icine Egypt DRUG

201911120573 1356 06/09/2019aphtofix mouth ulcer cream 10g PH RAMADAN bonyf AG Switzerland CLASSIFICATION

201911232667 1384 12/09/2019 altebrel 50mg/mlsolution for

injection 4PFS LEBIRAN aryogen pharmed etanercept IRAN DRUG

201911236600 1385 12/09/2019 altebrel 25mg/0.5mlsolution for

injection 4PFS LEBIRAN aryogen pharmed etanercept IRAN DRUG

201911232666 1386 12/09/2019 alvocade 3.5mgpowder for

injection 1vial LEBIRANnano fanavaran darouei

alvand co bortezomib iran DRUG

Page 46: 2019 مﺎﻌﻟ ﻒﯿﻨﺼﺘﻠﻟ تاﺮﻀﺤﺘﺴﻤﻟا و …...krka d.d. novo mesto MAH: krka d.d. novo mesto - slovenia telmisartan + HCT slovenia DRUG 201711212219 62

46

Pharmacy TWFS nb.

Import/Export

nb.

Import/Export Date Tradename Strength Form Presentation Agent Manufacturer Ingredient Country TYPE

جدول تقدیم طلبات تسجیل االدویة و المستحضرات للتصنیف لعام 2019

201911134537 1388 13/09/2019Modulen IBD

400G omnipharma

nestle nederland bvmag: PRODUITS NESTLE

sa-switzerland netherlands cLASSIFICATION

201911229687 1389 13/09/2019remifentanil B

braun 2mg

powder for concentrate for

soluion for injection or

infusion 5vialsDroguerie de

l'Union

hemofarm AD-SERBIAmah:Bbraun melsungen AG-

germany remifentanyl serbia DRUG

201911237121 1390 13/09/2019sculptra (poly-l

lactic acid ) 1 vialmedica

pharmaceuticals

Legal manufacturer:qmed AB-sweden

manufacturing site : sanofi spa -ITALY

Italy CLASSIFICATION

201911237815 1391 18/09/2019 Cinnal-f 450IU/0.75mlsolution for

injection 1prefilled pen lebiran sarl cinnagen co follitropin alfa iran DRUG

201911237813 1392 18/09/2019 Cinnal-f 900IU/1.5mlsolution for

injection 1prefilled pen lebiran sarl cinnagen co follitropin alfa iran DRUG

201911237812 1393 18/09/2019 cinnovex 30mcgsolution for

injection 4 prefilled syringe lebiran sarl cinnagen co interferon beta-1a iran DRUG

201911237811 1394 18/09/2019 recigen 44 44 mcg/0.5mlsolution for

injection 12 prefilled

syringe lebiran sarl cinnagen co interferon beta-1a iran DRUG

Page 47: 2019 مﺎﻌﻟ ﻒﯿﻨﺼﺘﻠﻟ تاﺮﻀﺤﺘﺴﻤﻟا و …...krka d.d. novo mesto MAH: krka d.d. novo mesto - slovenia telmisartan + HCT slovenia DRUG 201711212219 62

47

Pharmacy TWFS nb.

Import/Export

nb.

Import/Export Date Tradename Strength Form Presentation Agent Manufacturer Ingredient Country TYPE

جدول تقدیم طلبات تسجیل االدویة و المستحضرات للتصنیف لعام 2019

201911237809 1395 19/09/2019 aryoseven RT 1mg 50KIU

1vialof powder for solution +1 vial of solvent lebiran sarl aryogen pharmed eptacog alfa iran DRUG

201911238353 1396 25/09/2019 prenan 1 RTF 70ml

societe pour exportation des produits nestle

SA wyeth nutritionals ireland ireland CLASSIFICATION

201911238353 1396 25/09/2019NAN optipro 1RTF 70ml

societe pour exportation des produits nestle

SA wyeth nutritionals ireland ireland CLASSIFICATION

201911120053 1397 25/09/2019

I vascular luminor 14M

paclitaxel eluting PTA balloon

dilataion catheter (all sizes) pharmaworld

life vascular devices biotech SL SPAIN CLASSIFICATION

201911120053 1397 25/09/2019

I vascular luminor 18

paclitaxel eluting PTA balloon

dilataion catheter (all sizes) pharmaworld

life vascular devices biotech SL SPAIN CLASSIFICATION

201911120053 1397 25/09/2019

I vascular luminor35

paclitaxel eluting PTA balloon

dilataion catheter (all sizes) pharmaworld

life vascular devices biotech SL SPAIN CLASSIFICATION

Page 48: 2019 مﺎﻌﻟ ﻒﯿﻨﺼﺘﻠﻟ تاﺮﻀﺤﺘﺴﻤﻟا و …...krka d.d. novo mesto MAH: krka d.d. novo mesto - slovenia telmisartan + HCT slovenia DRUG 201711212219 62

48

Pharmacy TWFS nb.

Import/Export

nb.

Import/Export Date Tradename Strength Form Presentation Agent Manufacturer Ingredient Country TYPE

جدول تقدیم طلبات تسجیل االدویة و المستحضرات للتصنیف لعام 2019

201911120053 1397 25/09/2019

I vascular angiolite sirolimus eluting

coronary stent system pharmaworld

life vascular devices biotech SL SPAIN

201911120053 1397 25/09/2019

I vascular angiolite BTK sirolimus

eluting peripheral stent system pharmaworld

life vascular devices biotech SL SPAIN

201911120053 1397 25/09/2019

I vascular essential paclitaxel eluting coronary balloon dilatation catheter pharmaworld

life vascular devices biotech SL SPAIN

201911235396 1398 26/09/2019baclofen

intrathecal sintetica 0.05mg/1ml solution injectable 10ampoules mersaco sintetica sa baclofen Switzerland DRUG

201911235397 1399 26/09/2019baclofen

intrathecal sintetica 10mg/20ml solution injectable 5ampoules mersaco sintetica sa baclofen Switzerland DRUG

201911235398 1400 26/09/2019baclofen

intrathecal sintetica 40mg/20ml solution injectable 1ampoules mersaco sintetica sa baclofen Switzerland DRUG

201911235399 1401 26/09/2019baclofen

intrathecal sintetica 10mg/5ml solution injectable 10ampoules mersaco sintetica sa baclofen Switzerland DRUG

Page 49: 2019 مﺎﻌﻟ ﻒﯿﻨﺼﺘﻠﻟ تاﺮﻀﺤﺘﺴﻤﻟا و …...krka d.d. novo mesto MAH: krka d.d. novo mesto - slovenia telmisartan + HCT slovenia DRUG 201711212219 62

49

Pharmacy TWFS nb.

Import/Export

nb.

Import/Export Date Tradename Strength Form Presentation Agent Manufacturer Ingredient Country TYPE

جدول تقدیم طلبات تسجیل االدویة و المستحضرات للتصنیف لعام 2019

201911230830 1402 26/09/2019 kanjinti 150mg

powder for concentrate for

soluion for injection or

infusion 1vial mersaco amgen europe bv trastuzumab Netherlands DRUG

201911230833 1403 26/09/2019 kanjinti 420mg

powder for concentrate for

soluion for injection or

infusion 1vial mersaco amgen europe bv trastuzumab Netherlands DRUG

201911219728 1434 27/09/2019 sotalol biogaran 160mgcomprimes

secables 30 ctr

laboratoires BTT -franceMAH; laboratoires biogaran-

france sotalol france DRUG

201911219730 1435 27/09/2019 sotalol biogaran 80mgcomprimes

secables 30 ctr

laboratoires BTT -franceMAH; laboratoires biogaran-

france sotalol france DRUG

201911239154 1436 27/09/2019silgen AG spray all

sizes medispharm genadyne biotechnologies inc USA DRUG

201911239154 1436 27/09/2019silgen AG sterile

spray all sizes medispharm genadyne biotechnologies inc USA DRUG

201911230794 1437 01/10/2019 Skyrizi 75mg2prefilled syringe +2 alcohol pads

solution for injection interpharma

boehringer ingelheim pharma gmbh & co kg-germany

MAH:Abbvie deutschland gmbh &co kg -germay risankizumab germany DRUG

Page 50: 2019 مﺎﻌﻟ ﻒﯿﻨﺼﺘﻠﻟ تاﺮﻀﺤﺘﺴﻤﻟا و …...krka d.d. novo mesto MAH: krka d.d. novo mesto - slovenia telmisartan + HCT slovenia DRUG 201711212219 62

50

Pharmacy TWFS nb.

Import/Export

nb.

Import/Export Date Tradename Strength Form Presentation Agent Manufacturer Ingredient Country TYPE

جدول تقدیم طلبات تسجیل االدویة و المستحضرات للتصنیف لعام 2019

201811223143 1438 02/10/2019 mucus relief DM 10 tablets pmd allegiant healthdextromethorphan+ guaifenesin usa DRUG

20191126140 1448 03/10/2019 crusia 2000IU

(20mg/0.2ml) 2 prefilled syringes

solution for injection in

prefilled syringesHikma-Liban

S.A.R.L.

rovi contract manufacturing SL- SPAIN MAH:

laboratorios farmaceuticos rovi SA- spain enoxaparin Spain DRUG

20191126139 1449 03/10/2019 crusia 2000IU

(20mg/0.2ml)10prefilled

syringes

solution for injection in

prefilled syringesHikma-Liban

S.A.R.L.

rovi contract manufacturing SL- SPAIN MAH:

laboratorios farmaceuticos rovi SA- spain enoxaparin Spain DRUG

20191126135 1450 03/10/2019 crusia 4000IU

(40mg/0.4ml) 2 prefilled syringes

solution for injection in

prefilled syringesHikma-Liban

S.A.R.L.

rovi contract manufacturing SL- SPAIN MAH:

laboratorios farmaceuticos rovi SA- spain enoxaparin Spain DRUG

20191126134 1451 03/10/2019 crusia 4000IU

(40mg/0.4ml)10 prefilled

syringes

solution for injection in

prefilled syringesHikma-Liban

S.A.R.L.

rovi contract manufacturing SL- SPAIN MAH:

laboratorios farmaceuticos rovi SA- spain enoxaparin Spain DRUG

20191126138 1452 03/10/2019 crusia 6000IU

(60mg/0.6ml) 2 prefilled syringes

solution for injection in

prefilled syringesHikma-Liban

S.A.R.L.

rovi contract manufacturing SL- SPAIN MAH:

laboratorios farmaceuticos rovi SA- spain enoxaparin Spain DRUG

20191126137 1453 03/10/2019 crusia 6000IU

(60mg/0.6ml)10 prefilled

syringes

solution for injection in

prefilled syringesHikma-Liban

S.A.R.L.

rovi contract manufacturing SL- SPAIN MAH:

laboratorios farmaceuticos rovi SA- spain enoxaparin Spain DRUG

Page 51: 2019 مﺎﻌﻟ ﻒﯿﻨﺼﺘﻠﻟ تاﺮﻀﺤﺘﺴﻤﻟا و …...krka d.d. novo mesto MAH: krka d.d. novo mesto - slovenia telmisartan + HCT slovenia DRUG 201711212219 62

51

Pharmacy TWFS nb.

Import/Export

nb.

Import/Export Date Tradename Strength Form Presentation Agent Manufacturer Ingredient Country TYPE

جدول تقدیم طلبات تسجیل االدویة و المستحضرات للتصنیف لعام 2019

20191126129 1454 03/10/2019 crusia 8000IU

(80mg/0.8ml) 2 prefilled syringes

solution for injection in

prefilled syringesHikma-Liban

S.A.R.L.

rovi contract manufacturing SL- SPAIN MAH:

laboratorios farmaceuticos rovi SA- spain enoxaparin Spain DRUG

20191126128 1455 03/10/2019 crusia 8000IU

(80mg/0.8ml)10 prefilled

syringes

solution for injection in

prefilled syringesHikma-Liban

S.A.R.L.

rovi contract manufacturing SL- SPAIN MAH:

laboratorios farmaceuticos rovi SA- spain enoxaparin Spain DRUG

20191126133 1456 03/10/2019 crusia 10000IU

(100mg/1ml) 2 prefilled syringes

solution for injection in

prefilled syringesHikma-Liban

S.A.R.L.

rovi contract manufacturing SL- SPAIN MAH:

laboratorios farmaceuticos rovi SA- spain enoxaparin Spain DRUG

20191126132 1457 03/10/2019 crusia 10000IU

(100mg/1ml)10 prefilled

syringes

solution for injection in

prefilled syringesHikma-Liban

S.A.R.L.

rovi contract manufacturing SL- SPAIN MAH:

laboratorios farmaceuticos rovi SA- spain enoxaparin Spain DRUG

20191126124 1458 03/10/2019 crusia 12000IU

(120mg/0.8ml)10 prefilled

syringes

solution for injection in

prefilled syringesHikma-Liban

S.A.R.L.

rovi contract manufacturing SL- SPAIN MAH:

laboratorios farmaceuticos rovi SA- spain enoxaparin Spain DRUG

20191126126 1459 03/10/2019 crusia 15000IU

(150mg/1ml)10 prefilled

syringes

solution for injection in

prefilled syringesHikma-Liban

S.A.R.L.

rovi contract manufacturing SL- SPAIN MAH:

laboratorios farmaceuticos rovi SA- spain enoxaparin Spain DRUG

201911212719 1460 03/10/2019 cortinase 64mcg/dosenasal suspension

spray botle of 120doses Mapico S.A.R.L. opalia pharma sa budesonide tunisia DRUG

Page 52: 2019 مﺎﻌﻟ ﻒﯿﻨﺼﺘﻠﻟ تاﺮﻀﺤﺘﺴﻤﻟا و …...krka d.d. novo mesto MAH: krka d.d. novo mesto - slovenia telmisartan + HCT slovenia DRUG 201711212219 62

52

Pharmacy TWFS nb.

Import/Export

nb.

Import/Export Date Tradename Strength Form Presentation Agent Manufacturer Ingredient Country TYPE

جدول تقدیم طلبات تسجیل االدویة و المستحضرات للتصنیف لعام 2019

201911239153 1502 04/10/2019Nutrepidia NM 400g and 800g

Mediterranean Pharmaceutical

Company

soluciones tecnicas en alimentacion (soteal) sl-spain

MAH:nutricion medica sl-spain Spain CLASSIFICATION

201911239153 1502 04/10/2019

NMCLA high pro 200ml vanilla

flavor

Mediterranean Pharmaceutical

Company

corporacion alimentaria penasanta SA- (CAPSA

FOOD )spainMAH:nutricion medica sl-

spain Spain CLASSIFICATION

201911231919 1518 07/10/2019vitamine B12

amino 1000mcg solution injectable10ampoules of

1ml Evix SARL aminoAG vitamin B12 Switzerland DRUG

201811228643 1519 07/10/2019 entecavir arow 0.5mgcomprimes

pellicule 30karout

pharmacy

apl swift services )malta)limited-malta

mah: arrow generiques - france entecavir malta DRUG

2018112233892 1520 07/10/2019 entecavir arow 1mgcomprimes

pellicule 30karout

pharmacy

apl swift services )malta)limited-malta

mah: arrow generiques - france entecavir malta DRUG

201911213722 1521 07/10/2019 gefitinib arrow 250mgcomprimes

pellicule 30 darapharma

remedica ltd -cyprusmah: arrow generiques -

france gefitinib Cyprus DRUG

201911237230 1522 07/10/2019 prevymis 240mg film coated tablets 28Droguerie de

l'Union

MSD international GmbH-IRELAND

mah:merck sharp&dohme BV-netherlands letermovir Ireland DRUG

Page 53: 2019 مﺎﻌﻟ ﻒﯿﻨﺼﺘﻠﻟ تاﺮﻀﺤﺘﺴﻤﻟا و …...krka d.d. novo mesto MAH: krka d.d. novo mesto - slovenia telmisartan + HCT slovenia DRUG 201711212219 62

53

Pharmacy TWFS nb.

Import/Export

nb.

Import/Export Date Tradename Strength Form Presentation Agent Manufacturer Ingredient Country TYPE

جدول تقدیم طلبات تسجیل االدویة و المستحضرات للتصنیف لعام 2019

201911237233 1523 07/10/2019 prevymis 480mg film coated tablets 28Droguerie de

l'Union

MSD international GmbH-IRELAND

mah:merck sharp&dohme BV-netherlands letermovir Ireland DRUG

201911212930 1524 08/10/2019 sinaheal-H rectal suppositories 10 ibn sina pharm aburaihan pharmaceutical co

aluminium subacetae+hydrocortisone acetate+lidocaine+zinc oxide iran DRUG

201911235431 1525 08/10/2019 lebacef 1g

sterile powder and solvent for IM

injectable solution

1vial of sterile powder

+1ampoule of 3.5ml lidocaine

solvent arwanmitim srl -italy packed by

arwan -lebanon ceftriaxone Lebanon DRUG

201911222772 1526 08/10/2019 ferricure 100mg/5ml oral solution 200ml biopharmsa laboratoires

pharmaceutiques trenkeriron

polysaccharide Belgium DRUG

201911222774 1527 08/10/2019 ferricure 100mg/5ml oral solution 60ml biopharmsa laboratoires

pharmaceutiques trenkeriron

polysaccharide Belgium DRUG

201811233836 1528 09/10/2019 flopadex 8mghard gelatin

capsules 30 catafago

eva pharma for pharmaceuticals and medical

appliances silodosin Egypt DRUG

201911228800 1560 10/10/2019lacosamide/geneph

arm 50mg film coated tablets 14 nobelpharm genepharm SA lacosamide Greece DRUG

Page 54: 2019 مﺎﻌﻟ ﻒﯿﻨﺼﺘﻠﻟ تاﺮﻀﺤﺘﺴﻤﻟا و …...krka d.d. novo mesto MAH: krka d.d. novo mesto - slovenia telmisartan + HCT slovenia DRUG 201711212219 62

54

Pharmacy TWFS nb.

Import/Export

nb.

Import/Export Date Tradename Strength Form Presentation Agent Manufacturer Ingredient Country TYPE

جدول تقدیم طلبات تسجیل االدویة و المستحضرات للتصنیف لعام 2019

201911228803 1561 10/10/2019lacosamide/geneph

arm 100mg film coated tablets 56 nobelpharm genepharm SA lacosamide Greece DRUG

201911228804 1562 10/10/2019lacosamide/geneph

arm 200mg film coated tablets 56 nobelpharm genepharm SA lacosamide Greece DRUG

201911235414 1563 14/10/2019 vigor -50 film coated tablets 4 Pharmadex

pharmadex under license from macleods pharmaceuticals sildenafil citrate Lebanon DRUG

201911238117 1564 14/10/2019 verda 10mg

orally disintegrating

tablets 4 Pharmadex

pharmadex under license from macleods pharmaceuticals

vardenafil hydrochloride Lebanon DRUG

201911240876 1565 14/10/2019 sinadoxosome 20mg/10ml concentrate for

infusion 1vial lebiran sarl exirnanosina company

pegylated liposomal

doxorubicin iran DRUG

201911240870 1566 14/10/2019 lenoma 5mghard gelatin

capsules 21 lebiran sarl

nano fanavaran darouei alvand co

NANOALVAND lenalidomide iran DRUG

201911240872 1567 14/10/2019 lenoma 10mghard gelatin

capsules 21 lebiran sarl

nano fanavaran darouei alvand co

NANOALVAND lenalidomide iran DRUG

Page 55: 2019 مﺎﻌﻟ ﻒﯿﻨﺼﺘﻠﻟ تاﺮﻀﺤﺘﺴﻤﻟا و …...krka d.d. novo mesto MAH: krka d.d. novo mesto - slovenia telmisartan + HCT slovenia DRUG 201711212219 62

55

Pharmacy TWFS nb.

Import/Export

nb.

Import/Export Date Tradename Strength Form Presentation Agent Manufacturer Ingredient Country TYPE

جدول تقدیم طلبات تسجیل االدویة و المستحضرات للتصنیف لعام 2019

201911240873 1568 14/10/2019 lenoma 15mghard gelatin

capsules 21 lebiran sarl

nano fanavaran darouei alvand co

NANOALVAND lenalidomide iran DRUG

201911240875 1569 14/10/2019 lenoma 25mghard gelatin

capsules 21 lebiran sarl

nano fanavaran darouei alvand co

NANOALVAND lenalidomide iran DRUG

201911241644 1585 15/10/2019 aropem 1g

sterile powder for solution for IV

injection 1vial arwansavior lifetc corporation

taiwain for arwan -lebanon meropenem lebanon DRUG

201911241645 1586 15/10/2019 aropem 0.5g

sterile powder for solution for IV

injection 1vial arwansavior lifetc corporation

taiwain for arwan -lebanon meropenem lebanon DRUG

201911241521 1596 17/10/2019ropivacaine B

Braun 7.5mg/ml

(75mg/10ml)solution for

injection20x10ml plastic ampoules

Droguerie de l'Union B Braun melsungen AG ropivacaine Germany DRUG

201911216065 1597 17/10/2019 anabact 1g IM/IV 1vial miliapharm pahrma international ceftizoxime Jordan DRUG

201911242882 1613 25/10/2019ketonutri NM

vanilla flavor 300g

Mediterranean Pharmaceutical

Company

soluciones tecnicas en alimentacion (soteal) sl-spain

MAH:nutricion medica sl-spain Spain classification

Page 56: 2019 مﺎﻌﻟ ﻒﯿﻨﺼﺘﻠﻟ تاﺮﻀﺤﺘﺴﻤﻟا و …...krka d.d. novo mesto MAH: krka d.d. novo mesto - slovenia telmisartan + HCT slovenia DRUG 201711212219 62

56

Pharmacy TWFS nb.

Import/Export

nb.

Import/Export Date Tradename Strength Form Presentation Agent Manufacturer Ingredient Country TYPE

جدول تقدیم طلبات تسجیل االدویة و المستحضرات للتصنیف لعام 2019

201911242882 1613 25/10/2019colief infant drops

15ml

Mediterranean Pharmaceutical

Companycrosscare ltd -ireland

MAH: crosscare ltd -uk Ireland classification

201911242739 1614 28/10/2019 febuxostat biogaran 80mgcomprimes pellicules 28 ctr

bluepharma industria farmaceutica sa-portugal

MAH:biogran -france febuxostat Portugal DRUG

201911242735 1615 28/10/2019 febuxostat biogaran 120mgcomprimes pellicules 28 ctr

bluepharma industria farmaceutica sa-portugal

MAH:biogran -france febuxostat Portugal DRUG

201911242730 1616 28/10/2019tenofovir

disoproxil biogaran 245mgcomprimes pellicules 30 ctr

remedical ltd -cyprusMAH:BIOGARAN-FRANCE tenofovir Cyprus DRUG

201911242732 1617 28/10/2019 gefitinib biogaran 250mgcomprimes pellicules 30 ctr

remedical ltd -cyprusMAH:BIOGARAN-FRANCE gefitinib Cyprus DRUG

201911242727 1618 28/10/2019 entecavir biogaran 0.5mgcomprimes pellicules 30 ctr

remedical ltd -cyprusMAH:BIOGARAN-FRANCE entecavir Cyprus DRUG

201911242729 1619 28/10/2019 entecavir biogaran 1mgcomprimes pellicules 30 ctr

remedical ltd -cyprusMAH:BIOGARAN-FRANCE entecavir Cyprus DRUG

Page 57: 2019 مﺎﻌﻟ ﻒﯿﻨﺼﺘﻠﻟ تاﺮﻀﺤﺘﺴﻤﻟا و …...krka d.d. novo mesto MAH: krka d.d. novo mesto - slovenia telmisartan + HCT slovenia DRUG 201711212219 62

57

Pharmacy TWFS nb.

Import/Export

nb.

Import/Export Date Tradename Strength Form Presentation Agent Manufacturer Ingredient Country TYPE

جدول تقدیم طلبات تسجیل االدویة و المستحضرات للتصنیف لعام 2019

201911235401 1620 29/10/2019 presoryl 10mg film coated tablets 30 mersacotabuk pharmaceutical

manufacturing companyperindopril

arginine Saudi Arabia DRUG

201911235400 1621 29/10/2019 presoryl 5mg film coated tablets 30 mersacotabuk pharmaceutical

manufacturing companyperindopril

arginine Saudi Arabia DRUG

201911242925 1622 29/10/2019 refixa 500IU

powder and solvent for solution for

injection 1vial+1prefilled

syringe mersaco novo nordisknonacog beta

pegol (factorIX) Danemark DRUG

201911242927 1623 29/10/2019 refixa 1000IU

powder and solvent for solution for

injection 1vial+1prefilled

syringe mersaco novo nordisknonacog beta

pegol (factorIX) Danemark DRUG

201911242928 1624 29/10/2019 refixa 2000IU

powder and solvent for solution for

injection 1vial+1prefilled

syringe mersaco novo nordisknonacog beta

pegol (factorIX) Danemark DRUG

201911241984 1625 29/10/2019 monomak 20mg tablets 20 ph ain mreisse october pharma SAisosorbide

dinitrate Egypt DRUG

201911241986 1626 29/10/2019 monomak 40mg tablets 20 ph ain mreisse october pharma SAisosorbide

dinitrate Egypt DRUG

Page 58: 2019 مﺎﻌﻟ ﻒﯿﻨﺼﺘﻠﻟ تاﺮﻀﺤﺘﺴﻤﻟا و …...krka d.d. novo mesto MAH: krka d.d. novo mesto - slovenia telmisartan + HCT slovenia DRUG 201711212219 62

58

Pharmacy TWFS nb.

Import/Export

nb.

Import/Export Date Tradename Strength Form Presentation Agent Manufacturer Ingredient Country TYPE

جدول تقدیم طلبات تسجیل االدویة و المستحضرات للتصنیف لعام 2019

201911242731 1627 29/10/209 acticare 1.2% (0.025%) gel 45gMacromed

S.A.R.L.hayat pharmaceutical

industries co plc

clindamycin phosphate

1.2%+tretinoin 0.025% Jordan DRUG

20191126085 1628 29/10/209 combiwave SF 250 metered doses 120 medispharm glenmark pharmaceuticals ltd

salmeterol ximafoate 25

mcg +fluticasone propionate

250mg India DRUG

20191126086 1629 29/10/209 combiwave SF 50 metered doses 120 medispharm glenmark pharmaceuticals ltd

salmeterol ximafoate 25

mcg +fluticasone propionate 50mg India DRUG

20191126087 1630 29/10/209 combiwave SF 125 metered doses 120 medispharm glenmark pharmaceuticals ltd

salmeterol ximafoate 25

mcg +fluticasone propionate

125mg India DRUG

201911241598 1631 01/11/2019 galtiplex 40mg/mlsolution for

injection12 prefilled

syringes abela

synthon hispania sl-spainMAH:ASPEN

HEALTHCARE MALTA LIMITED -MALTA glatiramer acetate Spain DRUG

201911225310 1632 04/11/2019 dupixent 300mgsolution for

injection2 prefilled

syringessanofi aventis

liban

sanofi winthrop industrie-france

MAH:sanofi aventis groupe -france dupilumab France DRUG

Page 59: 2019 مﺎﻌﻟ ﻒﯿﻨﺼﺘﻠﻟ تاﺮﻀﺤﺘﺴﻤﻟا و …...krka d.d. novo mesto MAH: krka d.d. novo mesto - slovenia telmisartan + HCT slovenia DRUG 201711212219 62

59

Pharmacy TWFS nb.

Import/Export

nb.

Import/Export Date Tradename Strength Form Presentation Agent Manufacturer Ingredient Country TYPE

جدول تقدیم طلبات تسجیل االدویة و المستحضرات للتصنیف لعام 2019

201911241500 1633 05/11/2019 caffeine citrate 10mg/mlinjectable solution

USP 100 ampoules

x1ml alfa alfa caffeine citrate Lebanon DRUG

201911219786 1659 06/11/2019 arotan 10mg film coated tablets 30 broadmed

haupt pharma munster GmbH-GERMANY

MAH:delorbis pharmaceuticals ltd -cyprus leflunomide Germany DRUG

201911219784 1660 06/11/2019 arotan 20mg film coated tablets 30 broadmed

haupt pharma munster GmbH-GERMANY

MAH:delorbis pharmaceuticals ltd -cyprus leflunomide Germany DRUG

201911228765 1661 07/11/2019 piqray 200mg+50mg film coated tablets28 (50mg )+28

(200mg)Khalil Fattal &

Fils S.A.L.

novartis pharma stein AG -switzerland

MAH:novartis pharmaceuticals coporation -

usa alpelisib Switzerland DRUG

2019112228762 1662 07/11/2019 piqray 150mg+150mg film coated tablets 56Khalil Fattal &

Fils S.A.L.

novartis pharma stein AG-switzerland

MAH:novartis pharmaceuticals coporation -

usa alpelisib Switzerland DRUG

201911228760 1663 07/11/2019 piqray 200mg film coated tablets 28Khalil Fattal &

Fils S.A.L.

novartis pharma stein AG -switzerland

MAH:novartis pharmaceuticals coporation -

usa alpelisib Switzerland DRUG

201911230782 1664 07/11/2019 tafinlar 50mg hard capsules 28Khalil Fattal &

Fils S.A.L.

glaxo opertions uk limited-ukMAH:novartis pharma AG-

switzerland dabrafenib UK DRUG

Page 60: 2019 مﺎﻌﻟ ﻒﯿﻨﺼﺘﻠﻟ تاﺮﻀﺤﺘﺴﻤﻟا و …...krka d.d. novo mesto MAH: krka d.d. novo mesto - slovenia telmisartan + HCT slovenia DRUG 201711212219 62

60

Pharmacy TWFS nb.

Import/Export

nb.

Import/Export Date Tradename Strength Form Presentation Agent Manufacturer Ingredient Country TYPE

جدول تقدیم طلبات تسجیل االدویة و المستحضرات للتصنیف لعام 2019

2019112330784 1665 07/11/2019 tafinlar 75mg hard capsules 28Khalil Fattal &

Fils S.A.L.

glaxo opertions uk limited-ukMAH:novartis pharma AG-

switzerland dabrafenib UK DRUG

201911244302 1721 14/11/2019

PROPOFOL 1% MCT/LCT fresenius

emulsion for injetion or infusion

50x20ml ampoules benta trading

fresenius kabi austria gmh austria

MAH: fresenius kabi deutschland gmbh-germany propofol Austria DRUG

201911245162 1722 15/11/2019 sinaheal-H Rectal ointment 15g ibn sin pharm aburaihan pharmaceutical co

aluminium subacetae+hydroc

ortisone acetate+lidocaine

+zinc oxide iran DRUG

20191129331 1723 15/11/2019 zolicin 0.5mg/ml oral solution 200ml Mersaco S.A.L.tabuk pharmaceutical

manufacturing companylevocetrirzine hydrochloride Saudi Arabia DRUG

201911230837 1724 18/11/2019 nictur 360mcg/ml oral solution 15ml MPC

laboratorio reig jofre sa-spainMAH: GP-PHARM sa-

SPAINdesmopressin

acetate spain DRUG

201811220004 1725 18/11/2019

perfect vaginal gel 4*6ml single dose

syringes +applicators pharmacrew

klosterfraw berlin gmbh MAH: kessel medintim

gmbh-germany Germany classification

201911253141 1726 18/11/2019neuralgin extra ibu-

lysinate 684mg film coated tablets 20 Evix SARL

dr Pfleger chemishe fabrik gmbh-germany

ibuprofen Germany DRUG

Page 61: 2019 مﺎﻌﻟ ﻒﯿﻨﺼﺘﻠﻟ تاﺮﻀﺤﺘﺴﻤﻟا و …...krka d.d. novo mesto MAH: krka d.d. novo mesto - slovenia telmisartan + HCT slovenia DRUG 201711212219 62

61

Pharmacy TWFS nb.

Import/Export

nb.

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جدول تقدیم طلبات تسجیل االدویة و المستحضرات للتصنیف لعام 2019

201911245226 1728 18/11/2019

mevalia PKU complete 0-1 balance 500g MPC

dr Schar deutschland GmbH -germany

MAH: dr Shar AG/SPA-italy Germany classification

201911245226 1728 18/11/2019

mevalia PKU complete 1+ balance 500g MPC

dr Schar deutschland GmbH -germany

MAH: dr Shar AG/SPA-italy Germany classification

201911245226 1728 18/11/2019mevalia PKU 1+

balance 500g MPC

dr Schar deutschland GmbH -germany

MAH: dr Shar AG/SPA-italy Germany classification

201911245226 1728 18/11/2019mevalia PKU 6+

balance 500g MPC

dr Schar deutschland GmbH -germany

MAH: dr Shar AG/SPA-italy Germany classification

201911245226 1728 18/11/2019

mevalia PKU 6+ balance orange 30

x15 g sachets MPC

dr Schar deutschland GmbH -germany

MAH: dr Shar AG/SPA-italy Germany classification

201911245226 1728 18/11/2019mevalia PKU 14+

balance 500g MPC

dr Schar deutschland GmbH -germany

MAH: dr Shar AG/SPA-italy Germany classification

201911245226 1728 18/11/2019

mevalia PKU 14+ balance orange 20x 29 sachets MPC

dr Schar deutschland GmbH -germany

MAH: dr Shar AG/SPA-italy Germany classification

Page 62: 2019 مﺎﻌﻟ ﻒﯿﻨﺼﺘﻠﻟ تاﺮﻀﺤﺘﺴﻤﻟا و …...krka d.d. novo mesto MAH: krka d.d. novo mesto - slovenia telmisartan + HCT slovenia DRUG 201711212219 62

62

Pharmacy TWFS nb.

Import/Export

nb.

Import/Export Date Tradename Strength Form Presentation Agent Manufacturer Ingredient Country TYPE

جدول تقدیم طلبات تسجیل االدویة و المستحضرات للتصنیف لعام 2019

201911245226 1728 18/11/2019

mevalia PKU motion yellow

fruits 10g 30x70ml pouches MPC dr Shar AG/SPA-italy Italy classification

201911245226 1728 18/11/2019

mevalia PKU motion yellow

fruits 20g 30x140ml pouches MPC dr Shar AG/SPA-italy Italy classification

201911245226 1728 18/11/2019

mevalia PKU motion red fruits

10g 30x70ml pouches MPC dr Shar AG/SPA-italy Italy classification

201911245226 1728 18/11/2019

mevalia PKU motion red fruits

20g 30x140ml pouches MPC dr Shar AG/SPA-italy Italy classification

201911245226 1728 18/11/2019

mevalia PKU motion tropical

fruits 10g 30x70ml pouches MPC dr Shar AG/SPA-italy Italy classification

201911245226 1728 18/11/2019

mevalia PKU motion tropical

fruits 20g 30x140ml pouches MPC dr Shar AG/SPA-italy Italy classification

201911241546 1729 19/11/2019 davlex 50mgextended release

tablets 30 mapicothe united pharmaceuical

manufacturing co ltd desvenlafaxine Jordan DRUG

Page 63: 2019 مﺎﻌﻟ ﻒﯿﻨﺼﺘﻠﻟ تاﺮﻀﺤﺘﺴﻤﻟا و …...krka d.d. novo mesto MAH: krka d.d. novo mesto - slovenia telmisartan + HCT slovenia DRUG 201711212219 62

63

Pharmacy TWFS nb.

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nb.

Import/Export Date Tradename Strength Form Presentation Agent Manufacturer Ingredient Country TYPE

جدول تقدیم طلبات تسجیل االدویة و المستحضرات للتصنیف لعام 2019

201911241547 1730 19/11/2019 davlex 100mgextended release

tablets 30 mapicothe united pharmaceuical

manufacturing co ltd desvenlafaxine Jordan DRUG

201911244433 1750 20/11/2019 tobracin 0.30% eye ointment 5g

germanos healthcare supplies

amman pharmaceutical industries co tobramycin Jordan DRUG

201911244631 1751 20/11/2019 cinnopar 250mcg/ml 1prefilled pen 2.4ml lebiran cinnagen co teriparatide iran DRUG

201911244635 1752 20/11/2019 stivant 100mg/4ml

concentrate for solution for

infusion 1vial lebiran aryogen pharmed bevacizumab iran DRUG

201911244633 1753 20/11/2019 stivant 400mg/16ml

concentrate for solution for

infusion 1vial lebiran aryogen pharmed bevacizumab iran DRUG

201911244520 1769 20/11/2019 herzuma 150mg

concentrate for solution for

infusion 1 vialHikma-Liban S.A.R.L.

celtrion inc-koreaMAH:hikma pharmaceuticals-

jordan trastuzumab korea DRUG

201911244521 1770 20/11/2019 herzuma 440mg

concentrate for solution for

infusion 1 vial+1BWFI vialHikma-Liban S.A.R.L.

celtrion inc-koreaMAH:hikma pharmaceuticals-

jordan trastuzumab korea DRUG

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Pharmacy TWFS nb.

Import/Export

nb.

Import/Export Date Tradename Strength Form Presentation Agent Manufacturer Ingredient Country TYPE

جدول تقدیم طلبات تسجیل االدویة و المستحضرات للتصنیف لعام 2019

20191129373 1771 21/11/2019

dolutegravir /lamivudine /tenofovir

disoproxil fumarate50mg/300mg/3

00mg tablets 30 MPC mylan laboratories limited

dolutegravir /lamivudine /tenofovir disoproxil fumarate India DRUG

201911239913 1772 21/11/2019lamivudine

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201911213750 1773 21/11/2019

emtricitabine/tenofovir disoproxil

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emtricitabine/tenofovir disoproxil

fumarate India DRUG

201911246309 1800 25/11/2019

dianatal obstetric gel 6tubes of 5ml

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201911246582 1801 26/11/2019 milkaid 120tablets MPCprakacre entreprises ltd -ukMAH:crosscare ltd -ireland uk CLASSIFICATION

201911246582 1801 26/11/2019 milkaid drops15ml MPCcrosscare ltd -ireland

MAH:crosscare ltd -uk uk CLASSIFICATION

201911245190 1827 28/11/2019 evamib 10mg/10mg film coated tablets 30 pharmaline pharmalineezetimibe

+atorvastatin Lebanon DRUG

Page 65: 2019 مﺎﻌﻟ ﻒﯿﻨﺼﺘﻠﻟ تاﺮﻀﺤﺘﺴﻤﻟا و …...krka d.d. novo mesto MAH: krka d.d. novo mesto - slovenia telmisartan + HCT slovenia DRUG 201711212219 62

65

Pharmacy TWFS nb.

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nb.

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جدول تقدیم طلبات تسجیل االدویة و المستحضرات للتصنیف لعام 2019

201911245193 1828 28/11/2019 evamib 10mg/20mg film coated tablets 30 pharmaline pharmalineezetimibe

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201911245191 1829 28/11/2019 evamib 10mg/40mg film coated tablets 30 pharmaline pharmalineezetimibe

+atorvastatin Lebanon DRUG

201911239660 1830 28/11/2019 nozamet 4mgorodispersible

films 10 pharmadex

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research -switzerlandMAH: LTS lohmann therapie

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201911239659 1831 28/11/2019 nozamet 8mgorodispersible

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research -switzerlandMAH: LTS lohmann therapie

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2019112319 1832 28/11/2019 tobrin eye ointment 5g catafagoegyptian international

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201911244977 1833 28/11/2019 diater prick novotech sal

diater laboratorio de diagnostico y aplicaciones

terapeutics spain CLASSIFICATION

20191124997 1834 29/11/2019 prof 400mgsolution for IV

injection 5vialsx4ml mersacotabuk pharmaceutical

manufacturing company ibuprofen Saudi Arabia DRUG

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66

Pharmacy TWFS nb.

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nb.

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جدول تقدیم طلبات تسجیل االدویة و المستحضرات للتصنیف لعام 2019

201911246314 1861 02/12/2019 hepaxane 2000IU

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MAH :chemi SPA-italy italfarmaco spa-italy

enoxaparin sodium Italy DRUG

201911246342 1862 02/12/2019 hepaxane 2000IU

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enoxaparin sodium Italy DRUG

201911246318 1863 02/12/2019 hepaxane 4000IU

(40mg/0.4ml)solution for

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MAH :chemi SPA-italy italfarmaco spa-italy

enoxaparin sodium Italy DRUG

201911246344 1864 02/12/2019 hepaxane 4000IU

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MAH :chemi SPA-italy italfarmaco spa-italy

enoxaparin sodium Italy DRUG

201911246327 1865 02/12/2019 hepaxane 6000IU

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injection 2prefilled syringesDroguerie Phenicia

MAH :chemi SPA-italy italfarmaco spa-italy

enoxaparin sodium Italy DRUG

201911246353 1866 02/12/2019 hepaxane 6000IU

(60mg/0.6ml)solution for

injection 10prefilled

syringesDroguerie Phenicia

MAH :chemi SPA-italy italfarmaco spa-italy

enoxaparin sodium Italy DRUG

201911246363 1867 02/12/2019 hepaxane 8000IU

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MAH :chemi SPA-italy italfarmaco spa-italy

enoxaparin sodium Italy DRUG

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67

Pharmacy TWFS nb.

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nb.

Import/Export Date Tradename Strength Form Presentation Agent Manufacturer Ingredient Country TYPE

جدول تقدیم طلبات تسجیل االدویة و المستحضرات للتصنیف لعام 2019

201911246357 1868 02/12/2019 hepaxane 8000IU

(80mg/0.8ml)solution for

injection 10prefilled

syringesDroguerie Phenicia

MAH :chemi SPA-italy italfarmaco spa-italy

enoxaparin sodium Italy DRUG

201911232926 1869 02/12/2019 aprepitant biogaran 80mg gelules 2 ctr

rontis hellas medical and pharmaceutical products SA-

greeceMAH: biogaran-france aprepitant Greece DRUG

201911232922 1870 02/12/2019 aprepitant biogaran 125mg-80mg gelules1 gelule 125mg +2gelules 80mg ctr

rontis hellas medical and pharmaceutical products SA-

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201911230779 1871 03/12/2019 Tipx 15mg

lyophilized powder for

injection 1vial century pharma

thymoorgan pharmazie GmbH-germany

MAH:hikma pharmaceuticals -jordan thiotepa Germany DRUG

201911244523 1872 04/12/2019articaine medis

adrenalinee 1/100000 injectable solution 50 cartridges of

1.8ml medispharm les laboratoires medis SAarticaine+adrenaline tunisia DRUG

20191124797 1873 05/12/2019 resincalcio powder for oral

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Mediterranean Pharmaceutical

Company laboratorios rubio sa

calcium polystyrene sulfonate Spain DRUG

201911245175 1874 05/12/2019 fibryga 1g

powde and solvent for solution for

injection /infusion

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for IV use

Mediterranean Pharmaceutical

Company octapharma AB human fibrinogen Sweden DRUG

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جدول تقدیم طلبات تسجیل االدویة و المستحضرات للتصنیف لعام 2019

201911247311 1875 05/12/2019 lactomil 1 400g ibn sina pharm pegah infant formula co iran classification

201911247887 1876 06/12/2019

abacavir sulfate/lamivudine

usp 600mg/300mg tablets 30

Mediterranean Pharmaceutical

Company mylan laboratories limited abacavir+lamivudine India DRUG

201911247884 1877 06/12/2019 efavirenz usp 600mg tablets 30

Mediterranean Pharmaceutical

Company mylan laboratories limited efavirenz India DRUG

201911246271 1878 06/12/2019 palocip-P 250mcg/5mlsolution for

injection 1vial unipharm cipla ltd palonosteron India DRUG