list of nationally authorised medicinal products · an agency of the european union +31 (0)88 781...
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© European Medicines Agency, 2019. Reproduction is authorised provided the source is acknowledged.
24 July 2019 EMA/480512/2019 Human Medicines Evaluation Division
List of nationally authorised medicinal products
Active substance: azathioprine
Procedure no.: PSUSA/00000275/201812
List of nationally authorised medicinal products EMA/480512/2019 Page 2/23
Product Name (in authorisation country)
MRP/DCP Authorisation number
National Authorisation Number
MAH of product in the member state
Member State where product is authorised
Azathioprine Tablets 50 mg not available PL 13606/0093 STRIDES PHARMA UK LIMITED
UK
Imuran 50 mg not available 59/0168/13-S ASPEN PHARMA TRADING LIMITED
SK
Imuran 25 mg not available 59/0188/70-CS ASPEN PHARMA TRADING LIMITED
SK
Aza-Q® 50 mg Tabletten not available 35480.00.00 JUTA PHARMA GMBH DE AZATHIOPRINE/FARMASYN, Επικαλυμμένα με λεπτό υμένιο δισκία, 50 mg
not available 29043/5-4-2016 FARMASYN S.A. GR
Immufalk 75 mg comprimidos recubiertos con pelicula
DE/H/5684/002 78165 DR FALK PHARMA GMBH ES
Azafalk 75 mg Filmtabletten DE/H/5684/002 1-31700 DR FALK PHARMA GMBH AT Azafalk 75 mg Filmtabletten DE/H/5684/002 81859.00.00 DR FALK PHARMA GMBH DE Azafalk 75 mg plėvele dengtos tabletės
DE/H/5684/002 LT/1/12/3074/006 DR FALK PHARMA GMBH LT
Azafalk 75 mg plėvele dengtos tabletės
DE/H/5684/002 LT/1/12/3074/005 DR FALK PHARMA GMBH LT
Azafalk 75 mg plėvele dengtos tabletės
DE/H/5684/002 LT/1/12/3074/001 DR FALK PHARMA GMBH LT
Azafalk 75 mg filmomhulde tabletten DE/H/5684/002 RVG 107494 DR FALK PHARMA GMBH NL Azafalk 75 mg plėvele dengtos tabletės
DE/H/5684/002 LT/1/12/3074/002 DR FALK PHARMA GMBH LT
Azafalk 75 mg plėvele dengtos tabletės
DE/H/5684/002 LT/1/12/3074/004 DR FALK PHARMA GMBH LT
Azafalk 75 mg plėvele dengtos tabletės
DE/H/5684/002 LT/1/12/3074/003 DR FALK PHARMA GMBH LT
List of nationally authorised medicinal products EMA/480512/2019 Page 3/23
Product Name (in authorisation country)
MRP/DCP Authorisation number
National Authorisation Number
MAH of product in the member state
Member State where product is authorised
Azafalk 75mg film-coated tablets DE/H/5684/002 PL 08637/0023 DR FALK PHARMA GMBH UK Azafalk 75 mg filmsko obložene tablete
DE/H/5684/002 H/12/00244/007 DR FALK PHARMA GMBH SI
Azafalk 75 mg filmsko obložene tablete
DE/H/5684/002 H/12/00244/008 DR FALK PHARMA GMBH SI
Azafalk 75 mg filmsko obložene tablete
DE/H/5684/002 H/12/00244/009 DR FALK PHARMA GMBH SI
Azafalk 75 mg filmsko obložene tablete
DE/H/5684/002 H/12/00244/010 DR FALK PHARMA GMBH SI
Azafalk 75 mg filmsko obložene tablete
DE/H/5684/002 H/12/00244/011 DR FALK PHARMA GMBH SI
Azafalk 75 mg filmsko obložene tablete
DE/H/5684/002 H/12/00244/012 DR FALK PHARMA GMBH SI
Azafalk 75 mg comprimidos revestidos por pelicula
DE/H/5684/002 5423876 DR FALK PHARMA GMBH PT
Azafalk 75 mg comprimidos revestidos por pelicula
DE/H/5684/002 5423868 DR FALK PHARMA GMBH PT
Azathioprin ”ratiopharm”, filmovertrukne tabletter
DK/H/0164/001 30549 RATIOPHARM GMBH DK
Azathioprin-ratiopharm® 50 mg Filmtabletten
DK/H/0164/002 47311.01.00 RATIOPHARM GMBH DE
Azathioprin ”ratiopharm”, filmovertrukne tabletter
DK/H/0164/002 30550 RATIOPHARM GMBH DK
Azathioprin-ratiopharm® 25 mg Filmtabletten
DK/H/0164/001 47311.00.00 RATIOPHARM GMBH DE
IMUREL 25 mg, comprimé pelliculé not available 34009 364 145 5 6 ASPEN PHARMA TRADING LIMITED
FR
IMUREL 25 mg, comprimé pelliculé not available 34009 364 142 6 6 ASPEN PHARMA FR
List of nationally authorised medicinal products EMA/480512/2019 Page 4/23
Product Name (in authorisation country)
MRP/DCP Authorisation number
National Authorisation Number
MAH of product in the member state
Member State where product is authorised
TRADING LIMITED IMUREL 25 mg, comprimé pelliculé not available 34009 364 143 2 7 ASPEN PHARMA
TRADING LIMITED FR
IMUREL 25 mg, comprimé pelliculé not available 34009 364 144 9 5 ASPEN PHARMA TRADING LIMITED
FR
IMUREL 50 mg, comprimé pelliculé not available 34009 364 149 0 7 ASPEN PHARMA TRADING LIMITED
FR
IMUREL 50 mg, comprimé pelliculé not available 34009 364 146 1 7 ASPEN PHARMA TRADING LIMITED
FR
IMUREL 50 mg, comprimé pelliculé not available 34009 364 147 8 5 ASPEN PHARMA TRADING LIMITED
FR
IMUREL 50 mg, comprimé pelliculé not available 34009 364 148 4 6 ASPEN PHARMA TRADING LIMITED
FR
IMUREL 50 mg, poudre pour solution injectable (IV)
not available 34009 561 936 5 3 ASPEN PHARMA TRADING LIMITED
FR
Azathioprin “Orifarm", filmovertrukne tabletter
DK/H/0650/001 35547 ORIFARM GENERICS A/S DK
Azathioprin Orifarm 50 mg filmdragerad tablett
DK/H/0650/001 22455 ORIFARM GENERICS A/S SE
Azathioprine Teva 25 mg, filmomhulde tabletten
not available RVG 106268 TEVA NEDERLAND B.V. NL
IMURAN mitis 25 mg, comprimés pelliculés
not available BE 151636 ASPEN PHARMA TRADING LIMITED
BE
IMURAN 50 mg, Filmtabletten not available BE 058177 ASPEN PHARMA TRADING LIMITED
BE
IMURAN mitis 25 mg, Filmtabletten not available BE 151636 ASPEN PHARMA TRADING LIMITED
BE
IMURAN 50 mg, Pulver zur Herstellung not available BE 095015 ASPEN PHARMA BE
List of nationally authorised medicinal products EMA/480512/2019 Page 5/23
Product Name (in authorisation country)
MRP/DCP Authorisation number
National Authorisation Number
MAH of product in the member state
Member State where product is authorised
einer Injektionslösung TRADING LIMITED IMURAN mitis 25 mg, filmomhulde tabletten
not available BE 151636 ASPEN PHARMA TRADING LIMITED
BE
IMURAN 50 mg, poudre pour solution injectable
not available BE 095015 ASPEN PHARMA TRADING LIMITED
BE
IMURAN 50 mg, poeder voor oplossing voor injectie
not available BE 095015 ASPEN PHARMA TRADING LIMITED
BE
IMURAN 50 mg, comprimés pelliculés not available BE 058177 ASPEN PHARMA TRADING LIMITED
BE
IMURAN 50 mg, filmomhulde tabletten not available BE 058177 ASPEN PHARMA TRADING LIMITED
BE
Azathioprin Heumann 50 mg Filmtabletten
DE/H/5059/001 63079.00.00 HEUMANN PHARMA GMBH & CO. GENERICA KG
DE
AZATHIOPRINE EG 50 MG, COMPRIME PELLICULE
not available NL33424 EG LABO LABORATOIRES EUROGENERICS
FR
Azafalk 100 mg plėvele dengtos tabletės
DE/H/5684/003 LT/1/12/3074/007 DR FALK PHARMA GMBH LT
Immufalk 100mg comprimidos recubiertos con pelicula
DE/H/5684/003 78164 DR FALK PHARMA GMBH ES
Azafalk 100 mg Filmtabletten DE/H/5684/003 81860.00.00 DR FALK PHARMA GMBH DE Azafalk 100 mg Filmtabletten DE/H/5684/003 1-31701 DR FALK PHARMA GMBH AT Azafalk 100 mg plėvele dengtos tabletės
DE/H/5684/003 LT/1/12/3074/008 DR FALK PHARMA GMBH LT
Azafalk 100 mg plėvele dengtos tabletės
DE/H/5684/003 LT/1/12/3074/009 DR FALK PHARMA GMBH LT
Azafalk 100 mg plėvele dengtos tabletės
DE/H/5684/003 LT/1/12/3074/010 DR FALK PHARMA GMBH LT
List of nationally authorised medicinal products EMA/480512/2019 Page 6/23
Product Name (in authorisation country)
MRP/DCP Authorisation number
National Authorisation Number
MAH of product in the member state
Member State where product is authorised
Azafalk 100 mg plėvele dengtos tabletės
DE/H/5684/003 LT/1/12/3074/011 DR FALK PHARMA GMBH LT
Azafalk 100 mg plėvele dengtos tabletės
DE/H/5684/003 LT/1/12/3074/012 DR FALK PHARMA GMBH LT
Azafalk 100mg film-coated tablets DE/H/5684/003 PL 08637/0024 DR FALK PHARMA GMBH UK Azafalk 100 mg comprimidos revestidos por pelicula
DE/H/5684/003 5423900 DR FALK PHARMA GMBH PT
Azafalk 100 mg filmomhulde tabletten DE/H/5684/003 RVG 107495 DR FALK PHARMA GMBH NL Azafalk 100 mg filmsko obložene tablete
DE/H/5684/003 H/12/00244/013 DR FALK PHARMA GMBH SI
Azafalk 100 mg filmsko obložene tablete
DE/H/5684/003 H/12/00244/014 DR FALK PHARMA GMBH SI
Azafalk 100 mg filmsko obložene tablete
DE/H/5684/003 H/12/00244/015 DR FALK PHARMA GMBH SI
Azafalk 100 mg filmsko obložene tablete
DE/H/5684/003 H/12/00244/016 DR FALK PHARMA GMBH SI
Azafalk 100 mg filmsko obložene tablete
DE/H/5684/003 H/12/00244/017 DR FALK PHARMA GMBH SI
Azafalk 100 mg filmsko obložene tablete
DE/H/5684/003 H/12/00244/018 DR FALK PHARMA GMBH SI
Imuran Tablets 25 mg not available PL 39699/0004 ASPEN PHARMA TRADING LIMITED
UK
Imuran Tablets 50mg not available PL 39699/0005 ASPEN PHARMA TRADING LIMITED
UK
Imuran Injection not available PL 39699/0003 ASPEN PHARMA TRADING LIMITED
UK
AZATIOPRINA ASPEN 50 mg compresse rivestite con film
not available 020957039 ASPEN PHARMA TRADING LIMITED
IT
List of nationally authorised medicinal products EMA/480512/2019 Page 7/23
Product Name (in authorisation country)
MRP/DCP Authorisation number
National Authorisation Number
MAH of product in the member state
Member State where product is authorised
IMURAN 50 mg, comprimés pelliculés not available 2008049750 ASPEN PHARMA TRADING LIMITED
LU
IMURAN 50 mg, Filmtabletten not available 2008049750 ASPEN PHARMA TRADING LIMITED
LU
IMURAN mitis 25 mg, comprimés pelliculés
not available 2008049749 ASPEN PHARMA TRADING LIMITED
LU
IMURAN mitis 25 mg, Filmtabletten not available 2008049749 ASPEN PHARMA TRADING LIMITED
LU
IMURAN 50 mg, Pulver zur Herstellung einer Injektionslösung
not available 2008049751 ASPEN PHARMA TRADING LIMITED
LU
IMURAN 50 mg, poudre pour solution injectable
not available 2008049751 ASPEN PHARMA TRADING LIMITED
LU
IMURAN 25 mg comprimidos revestidos por película
not available 8218313 ASPEN PHARMA TRADING LIMITED
PT
IMURAN 50 mg comprimidos revestidos por película
not available 8218305 ASPEN PHARMA TRADING LIMITED
PT
Imuger 25 mg film-coated tablets DK/H/0146/001 PA0577/032/001 MCDERMOTT LABORATORIES LTD
IE
Azathioprine Mylan 25 mg, filmomhulde tabletten
DK/H/0146/001 RVG 24721 MYLAN B.V. NL
Azatioprin ”Mylan”, filmovertrukne tabletter
DK/H/0146/001 13501 MYLAN AB DK
AZATHIOPRINE MYLAN 50 mg, comprimé pelliculé sécable
DK/H/0146/002 NL 25086 MYLAN S.A.S FR
Imuger 50 mg film-coated tablets DK/H/0146/002 PA0577/032/002 MCDERMOTT LABORATORIES LTD
IE
Azathioprine Mylan 50 mg, filmomhulde tabletten
DK/H/0146/002 RVG 24722 MYLAN B.V. NL
List of nationally authorised medicinal products EMA/480512/2019 Page 8/23
Product Name (in authorisation country)
MRP/DCP Authorisation number
National Authorisation Number
MAH of product in the member state
Member State where product is authorised
Azatioprin ”Mylan”, filmovertrukne tabletter
DK/H/0146/002 12530 MYLAN AB DK
Azafalk 25mg Filmtabletten DK/H/0146/001/MR 47309.00.00 DR FALK PHARMA GMBH DE Azafalk 50mg Filmtabletten DK/H/0146/002/MR 47309.01.00 DR FALK PHARMA GMBH DE IMURAN 50 mg apvalkotās tabletes not available 98-0510 ASPEN PHARMA
TRADING LIMITED LV
Azatioprin Mylan 50 mg tabletter not available 10428 MYLAN AB SE Azatioprin Mylan 25 mg tabletter not available 11073 MYLAN AB SE Imuran 50 mg, filmomhulde tablet not available RVG 05565 ASPEN PHARMA
TRADING LIMITED NL
Imuran 25 mg, filmomhulde tablet not available RVG 12476 ASPEN PHARMA TRADING LIMITED
NL
Imuran Film-coated Tablets 25 mg not available PA 1691/3/2 ASPEN PHARMA TRADING LIMITED
IE
Imuran Film-coated Tablets 50 mg not available PA 1691/3/3 ASPEN PHARMA TRADING LIMITED
IE
Imuran Powder for Solution for Injection or Infusion 50 mg
not available PA 1691/3/1 ASPEN PHARMA TRADING LIMITED
IE
Azathioprin - neuraxpharm 25 mg Filmtabletten
not available 97260.00.00 NEURAXPHARM ARZNEIMITTEL GMBH
DE
Azathioprin - neuraxpharm 50 mg Filmtabletten
not available 97261.00.00 NEURAXPHARM ARZNEIMITTEL GMBH
DE
Azathioprine Tablets 25 mg not available PL 04569/0234 GENERICS [UK] LIMITED UK Azathioprine Tablets 50 mg not available PL 04569/0073 GENERICS [UK] LIMITED UK Azathioprine 1A Pharma 25 mg, filmomhulde tabletten
NL/H/0326/001 RVG 24581 1 A PHARMA GMBH NL
AZATHIOPRINE 1A Pharma 50 MG, filmomhulde tabletten
NL/H/0326/002 RVG 24582 1 A PHARMA GMBH NL
List of nationally authorised medicinal products EMA/480512/2019 Page 9/23
Product Name (in authorisation country)
MRP/DCP Authorisation number
National Authorisation Number
MAH of product in the member state
Member State where product is authorised
Azathioprin Hexal 50 mg - Filmtabletten
NL/H/0326/002 1-24656 HEXAL PHARMA GMBH AT
Azathioprine Sandoz 50 mg filmomhulde tabletten
NL/H/0326/002 BE242584 SANDOZ N.V. BE
Azathioprine Sandoz 50 mg filmomhulde tabletten
NL/H/0326/002 BE277751 SANDOZ N.V. BE
Azathioprin HEXAL® 50 mg Filmtabletten
NL/H/0326/002 35481.00.01 HEXAL AG DE
Azathioprin HEXAL® 25 mg Filmtabletten
NL/H/0326/001 35481.01.01 HEXAL AG DE
AZATIOPRINA HEXAL 50 mg compresse rivestite con film
NL/H/0326/002 036292011 SANDOZ S.P.A. IT
AZATIOPRINA HEXAL 50 mg compresse rivestite con film
NL/H/0326/002 036292050 SANDOZ S.P.A. IT
AZATIOPRINA HEXAL 50 mg compresse rivestite con film
NL/H/0326/002 036292047 SANDOZ S.P.A. IT
AZATIOPRINA HEXAL 50 mg compresse rivestite con film
NL/H/0326/002 036292062 SANDOZ S.P.A. IT
AZATIOPRINA HEXAL 50 mg compresse rivestite con film
NL/H/0326/002 036292035 SANDOZ S.P.A. IT
AZATIOPRINA HEXAL 50 mg compresse rivestite con film
NL/H/0326/002 036292023 SANDOZ S.P.A. IT
Azathioprine 25mg Tablets NL/H/0326/001 PL 04416/1247 SANDOZ LTD UK Azathioprine 50mg Tablets NL/H/0326/002 PL 04416/1248 SANDOZ LTD UK Imuprin 50 mg επικαλυμμένα με υμένιο δισκία
not available 9030 REMEDICA LTD CY
Imurel 50 mg tabletter not available 5080 ASPEN PHARMA TRADING LIMITED
NO
List of nationally authorised medicinal products EMA/480512/2019 Page 10/23
Product Name (in authorisation country)
MRP/DCP Authorisation number
National Authorisation Number
MAH of product in the member state
Member State where product is authorised
IMURAN 50 mg comprimate filmate not available 10042/2017/01 ASPEN PHARMA TRADING LIMITED
RO
Imurel 25 mg tabletter not available 7259 ASPEN PHARMA TRADING LIMITED
NO
Immunoprin 50 mg DK/H/0843/001 44/0155/06-S SANDOZ PHARMACEUTICALS D.D.
SK
Immunoprin 50 mg - Filmtabletten DK/H/0843/001 1-26374 EBEWE PHARMA AT Azathioprin "Ebewe" DK/H/0843/001 35919 EBEWE PHARMA DK Azathioprin Ebewe 50 mg filmtabletta DK/H/0843/001 OGYI-T-20277/01 SANDOZ HUNGÁRIA KFT HU Azathioprin Ebewe 50 mg filmtabletta DK/H/0843/001 OGYI-T-20277/02 SANDOZ HUNGÁRIA KFT HU Imuran 50 mg plėvele dengtos tabletės
not available LT/1/94/1856/001 ASPEN PHARMA TRADING LIMITED
LT
Azathioprin - 1 A Pharma® 25 mg Filmtabletten
NL/H/0328/001 54697.00.00 1 A PHARMA GMBH DE
Azathioprin - 1 A Pharma® 50 mg Filmtabletten
NL/H/0328/002 54697.01.00 1 A PHARMA GMBH DE
Azathioprine 25 mg, filmomhulde tablet
NL/H/0328/001 RVG 27564 HEXAL AG NL
Azathioprine 50 mg, filmomhulde tablet
NL/H/0328/002 RVG 27565 HEXAL AG NL
Azaqvida 25 mg Filmtabletten not available 97609.00.00 AQVIDA GMBH DE Azaqvida 50 mg Filmtabletten not available 97610.00.00 AQVIDA GMBH DE Imurek 25 mg Filmtabletten not available 6101735.01.00 ASPEN PHARMA
TRADING LIMITED DE
Imurek 50 mg Filmtabletten not available 6101735.00.00 ASPEN PHARMA TRADING LIMITED
DE
Imurek i.v. 50 mg Pulver zur Herstellung einer Infusions- oder
not available 6101758.00.00 ASPEN PHARMA TRADING LIMITED
DE
List of nationally authorised medicinal products EMA/480512/2019 Page 11/23
Product Name (in authorisation country)
MRP/DCP Authorisation number
National Authorisation Number
MAH of product in the member state
Member State where product is authorised
Injektionslösung IMURAN 50 mg comprimate filmate not available 10042/2017/01 ASPEN PHARMA
TRADING LIMITED RO
ИМУРАН 50 mg филмирани таблетки not available 20020842 ASPEN PHARMA TRADING LIMITED
BG
Azathioprin Heumann 25 mg Filmtabletten
DE/H/4215/001/DC 93348.00.00 HEUMANN PHARMA GMBH & CO. GENERICA KG
DE
Azathioprin Heumann 75 mg Filmtabletten
DE/H/4215/002/DC 93349.00.00 HEUMANN PHARMA GMBH & CO. GENERICA KG
DE
Azathioprin Heumann 100 mg Filmtabletten
DE/H/4215/003 93350.00.00 HEUMANN PHARMA GMBH & CO. GENERICA KG
DE
AZA-effect pharma 50 mg Filmtabletten
not available 97853.00.00 EFFECT PHARMA GMBH DE
Imurel not available 870108 ASPEN PHARMA TRADING LIMITED
IS
Imurel not available 660887 ASPEN PHARMA TRADING LIMITED
IS
AZATHIOPRINE SANDOZ 25, FILMOMHULDE TABLETTEN 25 MG
NL/H/0327/001 RVG 27562 SANDOZ B.V. NL
AZATHIOPRINE SANDOZ 50, FILMOMHULDE TABLETTEN 50 MG
NL/H/0327/002 RVG 27563 SANDOZ B.V. NL
Azathioprine 50 mg Tablets DK/H/0840/001 PL 30306/0520 ACTAVIS GROUP PTC EHF.
UK
AZAFOR 50mg compresse rivestite con film
IT/H/0273/001 037534017 SOFAR S.P.A. IT
List of nationally authorised medicinal products EMA/480512/2019 Page 12/23
Product Name (in authorisation country)
MRP/DCP Authorisation number
National Authorisation Number
MAH of product in the member state
Member State where product is authorised
AZAFOR 50mg compresse rivestite con film
IT/H/0273/001 037534029 SOFAR S.P.A. IT
Imuran 25 mg not available 59/188/70-A/C ASPEN PHARMA TRADING LIMITED
CZ
Imuran 50 mg not available 59/188/70-B/C ASPEN PHARMA TRADING LIMITED
CZ
AZAMUN® 25 mg, filmdragerade tabletter
not available 11021 TAKEDA OY FI
AZAMUN® 50 mg, filmdragerade tabletter
not available 10104 TAKEDA OY FI
Azamun 50 mg -tabletti, kalvopäällysteinen
not available 10104 TAKEDA OY FI
Azamun 25 mg -tabletti, kalvopäällysteinen
not available 11021 TAKEDA OY FI
Azathioprin beta 50 mg Filmtabletten DE/H/3128/001 54699.01.00 BETAPHARM ARZNEIMITTEL GMBH
DE
Imuprin 50 mg film-coated tablets not available MA084/01101 REMEDICA LTD MT Azathioprine 50mg Film-coated Tablets not available PL 00530/0647 NORTON HEALTHCARE
LTD T/A IVAX PHARMACEUTICALS UK
UK
Azathioprine 25mg Film-coated Tablets not available PL 00530/0646 NORTON HEALTHCARE LTD T/A IVAX PHARMACEUTICALS UK
UK
Azathioprin ”Actavis”, filmovertrukne tabletter
DK/H/0655/001 35598 ACTAVIS GROUP PTC EHF.
DK
Azathioprin Actavis 50 mg filmdragerade tabletter
DK/H/0655/001 22463 ACTAVIS NORDIC A/S SE
Azathioprin AL 25 mg Filmtabletten not available 91115.00.00 ALIUD PHARMA GMBH DE
List of nationally authorised medicinal products EMA/480512/2019 Page 13/23
Product Name (in authorisation country)
MRP/DCP Authorisation number
National Authorisation Number
MAH of product in the member state
Member State where product is authorised
Azathioprin AL 50 mg Filmtabletten not available 91116.00.00 ALIUD PHARMA GMBH DE Imurek-50 mg Filmtabletten not available 13.362 ASPEN PHARMA
TRADING LIMITED AT
Azatioprina medac 25 mg comprimidos revestidos por película
DE/H/3039/001 5589619 MEDAC GESELLSCHAFT FÜR KLINISCHE SPEZIALPRÄPARATE MBH (WEDEL)
PT
Azatioprina medac 50 mg comprimidos revestidos por película
DE/H/3039/002 5589627 MEDAC GESELLSCHAFT FÜR KLINISCHE SPEZIALPRÄPARATE MBH (WEDEL)
PT
Azathioprine medac 50 mg filmdragerade tabletter
DE/H/3039/002 45353 MEDAC GESELLSCHAFT FÜR KLINISCHE SPEZIALPRÄPARATE MBH (WEDEL)
SE
Azamedac 25 mg Filmtabletten DE/H/3039/001 83625.00.00 MEDAC GESELLSCHAFT FÜR KLINISCHE SPEZIALPRÄPARATE MBH (WEDEL)
DE
Azamedac 50 mg Filmtabletten DE/H/3039/002 83626.00.00 MEDAC GESELLSCHAFT FÜR KLINISCHE SPEZIALPRÄPARATE MBH (WEDEL)
DE
Azathioprin medac 25 mg potahované tablety
DE/H/3039/001 59/242/13-C MEDAC GESELLSCHAFT FÜR KLINISCHE SPEZIALPRÄPARATE MBH (WEDEL)
CZ
Azathioprin medac 50 mg potahované tablety
DE/H/3039/002 59/243/13-C MEDAC GESELLSCHAFT FÜR KLINISCHE
CZ
List of nationally authorised medicinal products EMA/480512/2019 Page 14/23
Product Name (in authorisation country)
MRP/DCP Authorisation number
National Authorisation Number
MAH of product in the member state
Member State where product is authorised
SPEZIALPRÄPARATE MBH (WEDEL)
Azatioprin medac 50 mg tabletter, filmdrasjerte
DE/H/3039/002 10-8007 MEDAC GESELLSCHAFT FÜR KLINISCHE SPEZIALPRÄPARATE MBH (WEDEL)
NO
Azathioprin medac 50 mg tabletit, kalvopäällysteiset
DE/H/3039/002 29294 MEDAC GESELLSCHAFT FÜR KLINISCHE SPEZIALPRÄPARATE MBH (WEDEL)
FI
Azathioprin medac 25 mg tabletit, kalvopäällysteiset
DE/H/3039/001 29293 MEDAC GESELLSCHAFT FÜR KLINISCHE SPEZIALPRÄPARATE MBH (WEDEL)
FI
Azathioprin medac 25 mg filmom obalené tablety
DE/H/3039/001 59/0250/13-S MEDAC GESELLSCHAFT FÜR KLINISCHE SPEZIALPRÄPARATE MBH (WEDEL)
SK
Azathioprin medac 50 mg filmom obalené tablety
DE/H/3039/002 59/0251/13-S MEDAC GESELLSCHAFT FÜR KLINISCHE SPEZIALPRÄPARATE MBH (WEDEL)
SK
Azatioprina medac 25 mg comprimidos revestidos por película
DE/H/3039/001 DE/H/3039/001 MEDAC GESELLSCHAFT FÜR KLINISCHE SPEZIALPRÄPARATE MBH (WEDEL)
PT
Azatioprina medac 50 mg comprimidos revestidos por película
DE/H/3039/002 DE/H/3039/002 MEDAC GESELLSCHAFT FÜR KLINISCHE SPEZIALPRÄPARATE MBH
PT
List of nationally authorised medicinal products EMA/480512/2019 Page 15/23
Product Name (in authorisation country)
MRP/DCP Authorisation number
National Authorisation Number
MAH of product in the member state
Member State where product is authorised
(WEDEL) Azathioprin medac 50 mg filmdragerade tabletter
DE/H/3039/002 29294 MEDAC GESELLSCHAFT FÜR KLINISCHE SPEZIALPRÄPARATE MBH (WEDEL)
FI
Imuran 25 mg filmtabletta not available OGYI-T-665/02 ASPEN PHARMA TRADING LIMITED
HU
Imuran 50 mg filmtabletta not available OGYI-T-665/01 ASPEN PHARMA TRADING LIMITED
HU
IMURAN, 50 mg õhukese polümeerikattega tabletid
not available 101495 ASPEN PHARMA TRADING LIMITED
EE
Azapress Tablets 50 mg not available PL 40147/0009 ENNOGEN PHARMA LIMITED
UK
Azathioprine Tablets 50 mg not available PL 40147/0009 ENNOGEN PHARMA LIMITED
UK
Azaqvida 50 mg Filmtabletten not available 98242.00.00 AQVIDA GMBH DE Imuran 50 mg filmom obložene tablete not available HR-H-628872163 ASPEN PHARMA
TRADING LIMITED HR
Imuran Film-coated Tablets 25 mg not available PA 1691/3/2 ASPEN PHARMA TRADING LIMITED
IE
Imuran Film-coated Tablets 50 mg not available PA 1691/3/3 ASPEN PHARMA TRADING LIMITED
IE
Imuran Powder for Solution for Injection or Infusion 50 mg
not available PA 1691/3/1 ASPEN PHARMA TRADING LIMITED
IE
IMURAN 50 mg filmsko obložene tablete
not available H/93/00772/001 ASPEN PHARMA TRADING LIMITED
SI
Azathioprine 25 mg film-coated tablets not available PL 11311/0475 TILLOMED LABORATORIES LTD
UK
List of nationally authorised medicinal products EMA/480512/2019 Page 16/23
Product Name (in authorisation country)
MRP/DCP Authorisation number
National Authorisation Number
MAH of product in the member state
Member State where product is authorised
Azathioprine 50 mg film-coated tablets not available PL 11311/0476 TILLOMED LABORATORIES LTD
UK
Imurel 50 mg comprimidos recubiertos con película
not available 50.043 UCB PHARMA S.A. (MADRID ES)
ES
Imurel 50 mg polvo para solución inyectable
not available 51.003 UCB PHARMA S.A. (MADRID ES)
ES
Azathioprine 50 PCH, tabletten 50 mg. not available RVG 10467 PHARMACHEMIE B.V NL Imurel 50 mg filmdragerad tablett not available 8204 ASPEN PHARMA
TRADING LIMITED SE
Imurel 25 mg filmdragerad tablett not available 10577 ASPEN PHARMA TRADING LIMITED
SE
Imurel, tabletter, filmovertrukne not available 12943 ASPEN PHARMA TRADING LIMITED
DK
Imurel, tabletter, filmovertrukne not available 05209 ASPEN PHARMA TRADING LIMITED
DK
Azathioprine Teva 25 mg, filmomhulde tabletten
not available RVG 106268 TEVA NEDERLAND B.V. NL
Imuran, 25 mg, tabletki powlekane not available R/1442 ASPEN PHARMA TRADING LIMITED
PL
Imuran, 50 mg, tabletki powlekane not available R/2778 ASPEN PHARMA TRADING LIMITED
PL
AZATHIOPRINE/PHARMACHEMIE 50 mg δισκία
not available 88576/15/30 CHEMIPHARM S.G. DE TCHAVES & CIE E.E
GR
Immunoprin 75 mg õhukese polümeerikattega tabletid
AT/H/0270/001 710310 SANDOZ PHARMACEUTICALS D.D.
EE
Immunoprin 100 mg õhukese polümeerikattega tabletid
AT/H/0270/002 710510 SANDOZ PHARMACEUTICALS D.D.
EE
Immunoprin 100 mg, filmom obalené AT/H/0270/002 59/0714/10-S SANDOZ SK
List of nationally authorised medicinal products EMA/480512/2019 Page 17/23
Product Name (in authorisation country)
MRP/DCP Authorisation number
National Authorisation Number
MAH of product in the member state
Member State where product is authorised
tablety PHARMACEUTICALS D.D. IMMUNOPRIN 100 mg filmsko obložene tablete
AT/H/0270/002 H/11/00771/003 EBEWE PHARMA SI
IMMUNOPRIN 100 mg filmsko obložene tablete
AT/H/0270/002 H/11/00771/004 EBEWE PHARMA SI
IMMUNOPRIN 75 mg filmsko obložene tablete
AT/H/0270/001 H/11/00771/001 EBEWE PHARMA SI
IMMUNOPRIN 75 mg filmsko obložene tablete
AT/H/0270/001 H/11/00771/002 EBEWE PHARMA SI
Immunoprin 100 mg Filmtabletten AT/H/0270/002 1-29708 EBEWE PHARMA AT Immunoprin 75 mg Filmtabletten AT/H/0270/001 1-29707 EBEWE PHARMA AT Azathioprin Sandoz 100mg filmomhulde tabletten
AT/H/0270/002 BE383887 SANDOZ N.V. BE
Azathioprin HEXAL 75 mg Filmtabletten
AT/H/0270/001 76504.00.00 HEXAL AG DE
Azathioprin HEXAL 100 mg Filmtabletten
AT/H/0270/002 76505.00.00 HEXAL AG DE
Immunoprin 75 mg filmdragerad tablett
AT/H/0270/001 41673 EBEWE PHARMA SE
Immunoprin 100 mg filmdragerad tablett
AT/H/0270/002 41674 EBEWE PHARMA SE
ИМУНОПРИН 100 MG ФИЛМИРАНИ ТАБЛЕТКИ
AT/H/0270/002 20120356 EBEWE PHARMA BG
ИМУНОПРИН 75 MG ФИЛМИРАНИ ТАБЛЕТКИ
AT/H/0270/001 20120355 EBEWE PHARMA BG
AZATHIOPRINE VIS, 50 mg, tabletki not available R/2328 ZAKŁADY CHEMICZNO-FARMACEUTYCZNE "VIS" SPÓŁKA Z O. O.
PL
List of nationally authorised medicinal products EMA/480512/2019 Page 18/23
Product Name (in authorisation country)
MRP/DCP Authorisation number
National Authorisation Number
MAH of product in the member state
Member State where product is authorised
Azafalk 50 mg plėvele dengtos tabletės
DE/H/5684/004 LT/1/12/3074/013 DR FALK PHARMA GMBH LT
Azafalk 50 mg Filmtabletten DE/H/5684/004 135590 DR FALK PHARMA GMBH AT Azafalk 50 mg Filmtabletten DE/H/5684/004 90364.00.00 DR FALK PHARMA GMBH DE Azafalk 50mg film-coated tablets DE/H/5684/004 PL 08637/0026 DR FALK PHARMA GMBH UK Azalfalk 50 mg comprimidos revestidos por Película
DE/H/5684/004 5603550 DR FALK PHARMA GMBH PT
Azafalk 50 mg plėvele dengtos tabletės
DE/H/5684/004 LT/1/12/3074/014 DR FALK PHARMA GMBH LT
Azafalk 50 mg plėvele dengtos tabletės
DE/H/5684/004 LT/1/12/3074/015 DR FALK PHARMA GMBH LT
Azafalk 50 mg plėvele dengtos tabletės
DE/H/5684/004 LT/1/12/3074/016 DR FALK PHARMA GMBH LT
Azafalk 50 mg plėvele dengtos tabletės
DE/H/5684/004 LT/1/12/3074/017 DR FALK PHARMA GMBH LT
Azafalk 50 mg plėvele dengtos tabletės
DE/H/5684/004 LT/1/12/3074/018 DR FALK PHARMA GMBH LT
Azafalk 50 mg filmomhulde tabletten DE/H/5684/004 RVG 113802 DR FALK PHARMA GMBH NL Azafalk 50 mg filmsko obložene tablete
DE/H/5684/004 H/12/00244/001 DR FALK PHARMA GMBH SI
Azafalk 50 mg filmsko obložene tablete
DE/H/5684/004 H/12/00244/002 DR FALK PHARMA GMBH SI
Azafalk 50 mg filmsko obložene tablete
DE/H/5684/004 H/12/00244/003 DR FALK PHARMA GMBH SI
Azafalk 50 mg filmsko obložene tablete
DE/H/5684/004 H/12/00244/004 DR FALK PHARMA GMBH SI
Azafalk 50 mg filmsko obložene tablete
DE/H/5684/004 H/12/00244/005 DR FALK PHARMA GMBH SI
List of nationally authorised medicinal products EMA/480512/2019 Page 19/23
Product Name (in authorisation country)
MRP/DCP Authorisation number
National Authorisation Number
MAH of product in the member state
Member State where product is authorised
Azafalk 50 mg filmsko obložene tablete
DE/H/5684/004 H/12/00244/006 DR FALK PHARMA GMBH SI
Azalfalk 50 mg comprimidos revestidos por Película
DE/H/5684/004 5603543 DR FALK PHARMA GMBH PT
Azathioprine 50mg film coated tablets UK/H/0934/001 PL 20395/0066 RELON CHEM LIMITED UK Azathioprine 50mg film coated tablets UK/H/0934/001 PA 1128/4/1 RELON CHEM LIMITED IE Azathioprin STADA® 50 mg Filmtabletten
DE/H/3036/002 83193.00.00 STADAPHARM GMBH DE
Azathioprin STADA® 25 mg Filmtabletten
DE/H/3036/001 83192.00.00 STADAPHARM GMBH DE
Azathioprine CF 50 mg, filmomhulde tabletten
DE/H/3036/002 RVG 108784 CENTRAFARM B.V. NL
Azathioprine CF 25 mg, filmomhulde tabletten
DE/H/3036/001 RVG 108782 CENTRAFARM B.V. NL
Imuran Tablets 25 mg not available PL 39699/0004 ASPEN PHARMA TRADING LIMITED
UK
Imuran Tablets 50mg not available PL 39699/0005 ASPEN PHARMA TRADING LIMITED
UK
Imuran Injection not available PL 39699/0003 ASPEN PHARMA TRADING LIMITED
UK
Azathioprin AqVida 50 mg Filmtabletten
DE/H/3037/002 83195.00.00 AQVIDA GMBH DE
Azathioprin AqVida 25 mg Filmtabletten
DE/H/3037/001 83194.00.00 AQVIDA GMBH DE
Imasup 25 mg potahované tablety DE/H/3037/001 59/500/15-C PHARMASWISS ČESKÁ REPUBLIKA S.R.O.
CZ
Imasup 50 mg potahované tablety DE/H/3037/002 59/501/15-C PHARMASWISS ČESKÁ REPUBLIKA S.R.O.
CZ
List of nationally authorised medicinal products EMA/480512/2019 Page 20/23
Product Name (in authorisation country)
MRP/DCP Authorisation number
National Authorisation Number
MAH of product in the member state
Member State where product is authorised
Atioprin 25 mg filmtabletta DE/H/3037/001 OGYI-T-22927/01 PHARMASWISS ČESKÁ REPUBLIKA S.R.O.
HU
Atioprin 25 mg filmtabletta DE/H/3037/001 OGYI-T-22927/02 PHARMASWISS ČESKÁ REPUBLIKA S.R.O.
HU
Atioprin 25 mg filmtabletta DE/H/3037/001 OGYI-T-22927/03 PHARMASWISS ČESKÁ REPUBLIKA S.R.O.
HU
Atioprin 25 mg filmtabletta DE/H/3037/001 OGYI-T-22927/04 PHARMASWISS ČESKÁ REPUBLIKA S.R.O.
HU
Atioprin 25 mg filmtabletta DE/H/3037/001 OGYI-T-22927/05 PHARMASWISS ČESKÁ REPUBLIKA S.R.O.
HU
Atioprin 25 mg filmtabletta DE/H/3037/001 OGYI-T-22927/06 PHARMASWISS ČESKÁ REPUBLIKA S.R.O.
HU
Atioprin 50 mg filmtabletta DE/H/3037/002 OGYI-T-22927/07 PHARMASWISS ČESKÁ REPUBLIKA S.R.O.
HU
Atioprin 50 mg filmtabletta DE/H/3037/002 OGYI-T-22927/08 PHARMASWISS ČESKÁ REPUBLIKA S.R.O.
HU
Atioprin 50 mg filmtabletta DE/H/3037/002 OGYI-T-22927/09 PHARMASWISS ČESKÁ REPUBLIKA S.R.O.
HU
Atioprin 50 mg filmtabletta DE/H/3037/002 OGYI-T-22927/10 PHARMASWISS ČESKÁ REPUBLIKA S.R.O.
HU
Atioprin 50 mg filmtabletta DE/H/3037/002 OGYI-T-22927/11 PHARMASWISS ČESKÁ REPUBLIKA S.R.O.
HU
Atioprin 50 mg filmtabletta DE/H/3037/002 OGYI-T-22927/12 PHARMASWISS ČESKÁ REPUBLIKA S.R.O.
HU
Atsimutin 25 mg filmom obložene tablete
DE/H/3037/001 HR-H-555114709 PHARMASWISS ČESKÁ REPUBLIKA S.R.O.
HR
Atsimutin 50 mg filmom obložene tablete
DE/H/3037/002 HR-H-120877050 PHARMASWISS ČESKÁ REPUBLIKA S.R.O.
HR
List of nationally authorised medicinal products EMA/480512/2019 Page 21/23
Product Name (in authorisation country)
MRP/DCP Authorisation number
National Authorisation Number
MAH of product in the member state
Member State where product is authorised
Atsimutin 50 mg apvalkotās tabletes DE/H/3037/002 15-0273 PHARMASWISS ČESKÁ REPUBLIKA S.R.O.
LV
Atsimutin 50 mg plėvele dengtos tabletės
DE/H/3037/002 LT/1/15/3834/007 PHARMASWISS ČESKÁ REPUBLIKA S.R.O.
LT
Atsimutin 50 mg plėvele dengtos tabletės
DE/H/3037/002 LT/1/15/3834/008 PHARMASWISS ČESKÁ REPUBLIKA S.R.O.
LT
Atsimutin 50 mg plėvele dengtos tabletės
DE/H/3037/002 LT/1/15/3834/009 PHARMASWISS ČESKÁ REPUBLIKA S.R.O.
LT
Atsimutin 50 mg plėvele dengtos tabletės
DE/H/3037/002 LT/1/15/3834/010 PHARMASWISS ČESKÁ REPUBLIKA S.R.O.
LT
Atsimutin 50 mg plėvele dengtos tabletės
DE/H/3037/002 LT/1/15/3834/011 PHARMASWISS ČESKÁ REPUBLIKA S.R.O.
LT
Atsimutin 50 mg plėvele dengtos tabletės
DE/H/3037/002 LT/1/15/3834/012 PHARMASWISS ČESKÁ REPUBLIKA S.R.O.
LT
ATSIMUTIN, 25 mg õhukese polümeerikattega tabletid
DE/H/3037/001 891615 PHARMASWISS ČESKÁ REPUBLIKA S.R.O.
EE
ATSIMUTIN, 50 mg õhukese polümeerikattega tabletid
DE/H/3037/001 891715 PHARMASWISS ČESKÁ REPUBLIKA S.R.O.
EE
Atsimutin 50 mg comprimate filmate DE/H/3037/002 8474/2015/01 PHARMASWISS ČESKÁ REPUBLIKA S.R.O.
RO
Atsimutin 50 mg comprimate filmate DE/H/3037/002 8474/2015/02 PHARMASWISS ČESKÁ REPUBLIKA S.R.O.
RO
Atsimutin 50 mg comprimate filmate DE/H/3037/002 8474/2015/03 PHARMASWISS ČESKÁ REPUBLIKA S.R.O.
RO
Atsimutin 50 mg comprimate filmate DE/H/3037/002 8474/2015/04 PHARMASWISS ČESKÁ REPUBLIKA S.R.O.
RO
Atsimutin 50 mg comprimate filmate DE/H/3037/002 8474/2015/05 PHARMASWISS ČESKÁ REPUBLIKA S.R.O.
RO
List of nationally authorised medicinal products EMA/480512/2019 Page 22/23
Product Name (in authorisation country)
MRP/DCP Authorisation number
National Authorisation Number
MAH of product in the member state
Member State where product is authorised
Atsimutin 50 mg comprimate filmate DE/H/3037/002 8474/2015/06 PHARMASWISS ČESKÁ REPUBLIKA S.R.O.
RO
Atsimutin 25 mg comprimate filmate DE/H/3037/001 8473/2015/01 PHARMASWISS ČESKÁ REPUBLIKA S.R.O.
RO
Atsimutin 25 mg comprimate filmate DE/H/3037/001 8473/2015/02 PHARMASWISS ČESKÁ REPUBLIKA S.R.O.
RO
Atsimutin 25 mg comprimate filmate DE/H/3037/001 8473/2015/03 PHARMASWISS ČESKÁ REPUBLIKA S.R.O.
RO
Atsimutin 25 mg comprimate filmate DE/H/3037/001 8473/2015/04 PHARMASWISS ČESKÁ REPUBLIKA S.R.O.
RO
Atsimutin 25 mg comprimate filmate DE/H/3037/001 8473/2015/05 PHARMASWISS ČESKÁ REPUBLIKA S.R.O.
RO
Atsimutin 25 mg comprimate filmate DE/H/3037/001 8473/2015/06 PHARMASWISS ČESKÁ REPUBLIKA S.R.O.
RO
Imasup 25 mg filmom obalené tablety DE/H/3037/001 59/0078/16-S PHARMASWISS ČESKÁ REPUBLIKA S.R.O.
SK
Imasup 50 mg filmom obalené tablety DE/H/3037/002 59/0079/16-S PHARMASWISS ČESKÁ REPUBLIKA S.R.O.
SK
Atioprin, 25 mg, tabletki powlekane DE/H/3037/001 23092 PHARMASWISS ČESKÁ REPUBLIKA S.R.O.
PL
Atioprin, 50 mg, tabletki powlekane DE/H/3037/002 23093 PHARMASWISS ČESKÁ REPUBLIKA S.R.O.
PL
Azathioprin dura N 25 mg Filmtabletten Wirkstoff: Azathioprin
DE/H/5614/001 47315.00.00 MYLAN DURA GMBH DE
Azathioprin dura N 50 mg Filmtabletten Wirkstoff: Azathioprin
DE/H/5614/002 47315.01.00 MYLAN DURA GMBH DE
AZATHIOPRINE TEVA 50 mg, comprimé pelliculé
not available NL29846 TEVA SANTÉ FR
List of nationally authorised medicinal products EMA/480512/2019 Page 23/23
Product Name (in authorisation country)
MRP/DCP Authorisation number
National Authorisation Number
MAH of product in the member state
Member State where product is authorised
IMUREL 25 mg kalvopäällysteinen tabletti
not available 9809 ASPEN PHARMA TRADING LIMITED
FI
Imurel® 50 mg filmdragerade tabletter
not available 5204 ASPEN PHARMA TRADING LIMITED
FI
Imurel® 25 mg filmdragerade tabletter
not available 9809 ASPEN PHARMA TRADING LIMITED
FI
IMUREL 50 mg kalvopäällysteinen tabletti
not available 5204 ASPEN PHARMA TRADING LIMITED
FI