List of nationally authorised medicinal products
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1 14 January 2016 EMA/60776/2016 Procedure Management and Committees Support Active substance: Procedure no.: PSUSA/ / Churchill Place Canary Wharf London E14 5EU United Kingdom Telephone +44 (0) Facsimile +44 (0) Send a question via our website An agency of the European Union European Medicines Agency, Reproduction is provided the source is acknowledged.
2 A-Cnotren 45045/10/ Pharmathen Hellas S.A. Greece A-Cnotren 45047/10/ Pharmathen Hellas S.A. Greece A-Cnotren DK/H/889/01-02/MR 33495/ Pharmathen Hellas S.A. Greece Accuran 18066/ Nexus Medicals S.A. Greece Accutin & Sandoz A/S Denmark Acnemin & Laboratorios Viñas, S.A. Spain Acnenor DK/H/2242/001 & & Actavis Group Ptc Ehf. Denmark DK/H/2242/002 Acnetrait NL 26226, NL & NL Arrow Generiques France Acnetrait NL Arrow Generiques France Acnogen 38591/10/ & 38594/10/18- Genepharm S.A. Greece Actaven DK/H/2242/001 & & Actavis Group Ptc Ehf. Poland DK/H/2242/002 Aisoskin & Fidia Farmaceutici S.P.A Italy Aknenormin DE/H/1702/001 & 46/0129/05-S & 46/0130/05-S Almirall Hermal Gmbh Slovakia DE/H/1702/002 Aknenormin DE/H/1702/001 & 46/138/05-C & 46/139/05-C Almirall Hermal Gmbh Czech Republic DE/H/1702/002 Aknenormin DE/H/1702/001 & & Almirall Hermal Gmbh Germany DE/H/1702/002 Aknenormin DE/H/1702/001 & OGYI-T-10170/01 & OGYI-T-10171/01 Almirall Hermal Gmbh Hungary DE/H/1702/002 Aknenormin DE/H/1702/ & Almirall Hermal Gmbh Poland Axotret & Axxon Sp. Z O.O. Poland Ciscumed 5 mg - Kapseln AT/H/0164/ Ennogen Healthcare Ltd Austria EMA/60776/2016 Page 2/12
3 Ciscutan Pelpharma Handels Gmbh Austria Ciscutan & Pelpharma Handels Gmbh Austria Ciscutan AT/H/0293/001 & & Pelpharma Handels Gmbh Austria AT/H/0293/002 Contracne , Laboratoires Bailleul Sa France , , , , , , & Curacne FR/H/250/01, FR/H/250/02, 11918, 11919, & Pierre Fabre Dermatologie Poland FR/H/250/03 & FR/H/250/04 Curacne FR/H/250/01, FR/H/250/02, , , & 367 Pierre Fabre Dermatologie France FR/H/250/03 & FR/H/250/ Curacne FR/H/250/01, FR/H/250/02, 52744/ , 58331/ , Pierre Fabre Hellas / Greece Greece FR/H/250/03 & FR/H/250/ / & 58333/ Curacné FR/H/0250/002 46/056/06-C Pierre Fabre Dermatologie Czech Republic Curacné FR/H/0250/003 46/054/06-C Pierre Fabre Dermatologie Czech Republic Curacné FR/H/0250/004 46/095/08-C Pierre Fabre Dermatologie Czech Republic Curacne FR/H/250/ / Pierre Fabre Dermatologie Luxembourg Curacne FR/H/250/04 46/0119/08-S Pierre Fabre Dermatologie Slovakia Curacne Ge FR/H/250/01, FR/H/250/02 & 1128/ , 1128/ & Pierre Fabre Dermatologie Luxembourg FR/H/250/ / Decutan MA155/00501 & MA155/00502 Actavis Group Hf. Malta Decutan DK/H/0368/001 IS/1/02/035/01 Actavis Hf. Iceland Decutan DK/H/0368/002 IS/1/02/035/02 Actavis Hf. Iceland Dercutane & Industrial Farmaceutica Spain EMA/60776/2016 Page 3/12
4 Cantabria, S.A. Dercutane , & Industrial Farmaceutica Spain Cantabria, S.A. Inerta DK/H/2242/001 & OGYI-T-22560/01, OGYI-T-22560/02, Actavis Group Ptc Ehf. Hungary DK/H/2242/002 OGYI-T-22560/03, OGYI-T-22560/04, OGYI-T-22560/05, OGYI-T-22560/06-10, OGYI-T-22560/07, OGYI-T /08, OGYI-T-22560/09, OGYI- T-22560/10, OGYI-T-22560/11 & OGYI-T-22560/12 Isdiben UK/H/0504/001 & & Isdin, S.A. Spain UK/H/0504/002 Isdiben UK/H/3577/001, , , , Isdin S.R.L. Italy UK/H/3577/002 & UK/H/3577/ , , , , & Isdiben UK/H/3577/001 & & Isdin, S.A. Spain UK/H/3577/004 Isdiben UK/H/3577/ , & Isdin S.R.L. Italy Isoacne FR/H/250/01, FR/H/250/02, 67464, 67570, & Pierre Fabre Iberica / Spain Spain FR/H/250/03 & FR/H/250/04 Isocural FR/H/250/01, FR/H/250/02, BE280402, BE280411, BE & Pierre Fabre Benelux Belgium FR/H/250/03 & FR/H/250/04 BE Isoderm & Sun-Farm Sp. Z.O.O. Poland (Kolbiel) Isoderm Dermapharm Ag Germany & Isomacne DK/H/0368/001 & & Actavis Group Ptc Ehf. Denmark EMA/60776/2016 Page 4/12
5 DK/H/0368/002 Isoriac FR/H/250/02 & FR/H/250/ /M & /M Pierre Fabre Italia S.P.A. Italy Isosupra Lidose BE & BE Laboratoires Smb S.A. Belgium Isotret DK/H/0300/001 & & Hexal Ag Germany DK/H/0300/002 Isotretinoin Actavis DK/H/0297/001 & & Actavis Group Ptc Ehf. Finland DK/H/0297/002 Isotretinoin Actavis DK/H/0297/001 & & Actavis Deutschland Gmbh & Germany DK/H/0297/002 Co. Kg Isotretinoin Actavis DK/H/0297/001 & & Actavis Group Ptc Ehf. Denmark DK/H/1747/001 Isotretinoin Actavis DK/H/0297/ Actavis Group Ptc Ehf. Denmark Isotretinoin Actavis DK/H/1747/ Actavis Group Ptc Ehf. Finland Isotretinoin Actavis DK/H/2242/001 46/0418/13-S Actavis Group Ptc Ehf. Slovakia Isotretinoin Actavis DK/H/2242/001 & & Actavis Group Ptc Ehf. Sweden DK/H/2242/002 Isotretinoin Actavis DK/H/2242/002 46/0419/13-S Actavis Group Ptc Ehf. Slovakia Isotretinoin Alliance PL 16853/0132 & PL 16853/0133 Alliance Pharmaceuticals Ltd United Kingdom Pharmaceuticals Isotretinoin Ennogen PL 40739/0001 Ennogen Healthcare Limited United Kingdom Healthcare Isotretinoin Ennogen PL 40739/0002 Ennogen Healthcare Limited United Kingdom Healthcare Limited Isotretinoin Generics PL 4569/0723 Generics [uk] Limited United Kingdom Uk Isotretinoin Generics UK/H/3577/001, PL 04569/1343, PL 04569/1344, Generics [uk] Limited United Kingdom EMA/60776/2016 Page 5/12
6 [uk] UK/H/3577/002, PL 04569/1345 & PL 04569/1346 UK/H/3577/003 & UK/H/3577/004 Isotretinoin Generics UK/H/3577/ Generics [uk] Limited Poland [uk] Isotretinoin Jenson UK/H/3577/001, 19731, & Generics [uk] Limited Poland UK/H/3577/002 & UK/H/3577/004 Isotretinoin Orifarm DK/H/1060/001 & & Orifarm Generics A/S Norway DK/H/1060/002 Isotretinoin Orifarm DK/H/1060/001 & & Orifarm Generics A/S Denmark DK/H/1060/002 Isotretinoin Orifarm DK/H/1060/001 & & Orifarm Generics A/S Sweden DK/H/1060/002 Isotretinoin Orifarm DK/H/1060/ Orifarm Generics A/S Finland Isotretinoin Orion DK/H/889/01-02/MR Pharmathen S.A. Finland Isotretinoin Orion DK/H/889/01-02/MR & Pharmathen S.A. Denmark Isotretinoin Portfarma IS/1/08/142/01 & IS/1/08/142/02 Portfarma Ehf Iceland Isotretinoin Ranbaxy PL 14894/0161 & PL 14894/0162 Ranbaxy (Uk) Limited United Kingdom (Uk) Limited Isotretinoin DK-H & Ratiopharm Arzneimittel Austria Ratiopharm Vertriebs-Gmbh Isotretinoin DK-H Ratiopharm Gmbh Finland Ratiopharm Isotretinoin DK-H & Teva Denmark A/S Denmark Ratiopharm Isotretinoin DK-H & Ratiopharm Gmbh Germany EMA/60776/2016 Page 6/12
7 Ratiopharm Isotretinoin DK-H IS/1/14/036/01 Ratiopharm Gmbh Iceland Ratiopharm Isotretinoin Regiomedica Gmbh Germany Regiomedica Isotretinoin Sandoz Ltd NL/H/0593/001 & PL 04416/1032 & PL 04416/1033 Sandoz Ltd United Kingdom NL/H/0593/002 Isotretinoin-Teva OGYI-T-20238/01, OGYI-T-20238/02, Teva Gyógyszergyár Zrt Hungary OGYI-T-20238/03, OGYI-T-20238/04, OGYI-T-20238/05, OGYI-T-20238/06, OGYI-T-20238/07, OGYI-T-20238/08, OGYI-T-20238/09 & OGYI-T-20238/10 Isotretinoina Difa DK/H/1749/ , , , Difa Cooper S.P.A. Italy , , , , , & Isotretinoina Difa DK/H/0298/001, , , , Difa Cooper S.P.A. Italy Cooper DK/H/0298/ & DK/H/0298/ , /M, /M, /M, /M, /M & /M Isotretinoina Pierre FR/H/250/01, FR/H/250/02 & , & Pfdc / Portugal Portugal Fabre FR/H/250/03 Isotretinoina Stiefel UK/H/0327/ Stiefel Laboratories (Ireland) Italy Ltd Isotretinoína Actavis DK/H/0297/ Actavis A/S Sucursal Portugal Isotretinoína Generis , , , , Generis Farmacêutica, S.A. Portugal EMA/60776/2016 Page 7/12
8 , , & Isotretinoína Mer , , , Mer Medicamentos, Lda. Portugal , & Isotretinoína Orotrex , , , Laboratório Medinfar - Portugal & Produtos Farmacêuticos, S.A. Isotretinoïne 10 Pch NL-H RVG Pharmachemie B.V. Netherlands Isotretinoïne 20 Pch NL-H RVG Pharmachemie B.V. Netherlands Isotretinoïne Aurobindo DK/H/0297/001 & RVG & RVG Aurobindo Pharma B.V. Netherlands DK/H/0297/002 Isotretinoïne stada BE/H/0193/001 & 0019/ & 0019/ Eurogenerics Sa Luxembourg BE/H/0193/002 Isotretinoïne BE/H/0193/001, BE & BE Eurogenerics Sa Belgium Eurogenerics BE/H/0193/002 Isotretinoïne Mylan UK/H/0504/002 & RVG & RVG Mylan B.V. Netherlands UK/H/0504/003 Isotretinoïne Sandoz NL/H/0593/001 & RVG & RVG Sandoz B.V. Netherlands NL/H/0593/002 Isotretinoïne Sandoz NL/H/0593/002 BE Sandoz N.V. Belgium Isotrex Stiefel Laboratories (Ireland) Italy Ltd Isotrex Glaxosmithkline Pharma Austria Gmbh. Isotrex Stiefel Laboratories (Ireland) Denmark Ltd Isotrex Laboratorios Farmaceuticos Portugal EMA/60776/2016 Page 8/12
9 Stiefel (Portugal) Ltda Isotrex Glaxosmithkline Gmbh & Co. Germany Kg Isotrex Stiefel Farma, S.A. Spain Isotrex 7614 Stiefel Laboratories (Ireland) Poland Ltd Isotrex MA 300/00901 Glaxosmithkline Uk Limited Malta Isotrex PA 1077/122/1 Glaxosmithkline (Ireland) Ireland Limited Isotrex PL 19494/0063 Glaxosmithkline Uk Limited United Kingdom Isotrex UK/H/0327/001 & & Glaxosmithkline Gmbh & Co. Germany UK/H/0327/002 Kg Isotrex UK/H/0327/001 & PL 19494/0069 & PL 19494/0070 Glaxosmithkline Uk Limited United Kingdom UK/H/0327/002 Isotroin 20693, & S00714/ Iasis Pharma Cyprus Isotroin 76447/ , 76449/ & Iasis Pharma Greece 78135/ Isotrétinoïne BE/H/0193/001 BE Eurogenerics Sa Belgium Eurogenerics Izotek DK/H/0889/001 & & Pharmaswiss česká Poland DK/H/0889/002 Republika S.R.O. Izotziaja Ziaja Ltd Zakład Produkcji Poland Leków Sp Z O.O. Mayesta & Bama-Geve, S.L.U. Spain Pharmiso DK/H/0300/001 & & Hexal Ag Denmark DK/H/0300/002 Procuta , , Laboratoires Expanscience France EMA/60776/2016 Page 9/12
10 , , , , , , , , , , , & Procuta Laboratoires Expanscience France Reducar 39324/ & 41918/ Gap A.E. Greece Roaccutan UK/H/0666/001 OGYI-T-1278/01 Roche (Magyarország) Kft Hungary Roaccutan UK/H/0666/002 OGYI-T-1278/02 Roche (Magyarország) Kft Hungary Roaccutan UK/H/666/ Roche Oy Finland Roaccutan UK/H/666/ Roche Oy Finland Roaccutane Roche Bulgaria Eood Bulgaria Roaccutane 7449/2006/01 Roche Romania Srl Romania Roaccutane NL Societe D'etudes Et De France Recherches Pharmaceutiques (Serp) Roaccutane UPI /10-02/414 Roche D.O.O. Croatia Roaccutane NL/H/666/ Roche Eesti Oü Estonia Roaccutane NL/H/666/ Roche Eesti Oü Estonia Roaccutane UK-H-666 BE N.V. Roche S.A. Luxembourg Roaccutane UK-H-666 BE N.V. Roche S.A. Luxembourg Roaccutane UK/H/0666/001/ LT/1/05/0406/001 Uab roche Lietuva Lithuania Roaccutane UK/H/0666/001/ LT/1/05/0406/002 Uab roche Lietuva Lithuania Roaccutane UK/H/0666/001/ LT/1/05/0406/003 Uab roche Lietuva Lithuania EMA/60776/2016 Page 10/12
11 Roaccutane UK/H/0666/001/ LT/1/05/0406/004 Uab roche Lietuva Lithuania Roaccutane UK/H/0666/002/ LT/1/05/0406/005 Uab roche Lietuva Lithuania Roaccutane UK/H/0666/002/ LT/1/05/0406/006 Uab roche Lietuva Lithuania Roaccutane UK/H/0666/002/ LT/1/05/0406/007 Uab roche Lietuva Lithuania Roaccutane UK/H/0666/002/ LT/1/05/0406/008 Uab roche Lietuva Lithuania Roaccutane UK/H/ Roche Latvija Sia Latvia Roaccutane UK/H/666/001 & PA 50/53/4 & PA 50/53/5 Roche Products Ltd Ireland UK/H/666/002 Roaccutane UK/H/666/001 PL 00031/0617 Roche Products Ltd United Kingdom Roaccutane UK/H/666/002 PL 00031/0160 Roche Products Ltd United Kingdom Roaccutane UK/H/666/01 & UK/H/666/02 46/0360/05-S Roche Slovensko S.R.O. Slovakia Roaccutane UK/H/666/01 BE N.V. Roche S.A. Belgium Roaccutane UK/H/666/01/R/ I-214/12 Roche Farmacevtska Družba Slovenia D.O.O. Roaccutane UK/H/666/02 BE N.V. Roche S.A. Belgium Rocne 87229/ & 87230/ Pharmathen S.A. Greece Rotren & Sapiens Pharmaceuticals Ltd Cyprus Sotret 6765/2014/01 & 6766/2014/01 SC Terapia S.A. Romania Sotret OGYI-T- 8989/01, OGYI-T- 8989/02, SC Terapia S.A. Hungary OGYI-T- 8989/03, OGYI-T- 8989/04, OGYI-T- 8989/08, OGYI-T-8989/05, OGYI-T-8989/06 & OGYI-T-8989/07 Sτιefoτrex 65279/12/ Glaxosmithkline Aebe Greece Tretin 66319/14/ Target Pharma Single Greece Member Private Ltd Tretin 66320/14/ & 85176/14/07- Target Pharma Single Greece EMA/60776/2016 Page 11/12
12 Member Private Ltd Tretinex & Medana Pharma Spolka Poland Akcyjna Tretiosan DK/H/1748/ Hexal Ag Denmark Rotaxin & Hadjiconstantinou Bros Ltd Cyprus Roaccutane UK/H/0666/001 RVG Roche Nederland B.V. Netherlands Roaccutane UK/H/0666/002 RVG Roche Nederland B.V. Netherlands Isotrex 500μg/g gel 7614 Stiefel Laboratories (Ireland) Ireland Ltd Isotretinoin Orifarm DK/H/1060/ /MR , Orifarm Generics A/S Germany EMA/60776/2016 Page 12/12
List of nationally authorised medicinal products
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