List of nationally authorised medicinal products
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1 21 February 2018 EMA/270645/2015 Human Medicines Evaluation Division Active substance: interferon alpha-2a 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 authorised provided the source is acknowledged.
2 Roferon-A 3 miljoen Internationale Eenheden (IE) oplossing voor injectie in voorgevulde spuit Roferon-A 3 Millionen Internationale Einheiten (IE) Injektionslösung in Fertigspritze Roferon-A 6 miljoen Internationale Eenheden (IE) oplossing voor injectie in voorgevulde spuit Roferon-A 6 Millionen Internationale Einheiten (IE) Injektionslösung in Fertigspritze Roferon-A 9 miljoen Internationale Eenheden (IE) oplossing voor injectie in voorgevulde spuit Roferon-A 9 Millionen Internationale Einheiten (IE) Injektionslösung in Fertigspritze Roferon-A 3 milj. IU injektioneste, liuos, esitäytetyssä ruiskussa Roferon-A 3 milj. IU injektionsvätska, lösning, i förfylld spruta Roferon-A 6 milj. IU injektioneste, liuos, esitäytetyssä ruiskussa Roferon-A 6 milj. IU injektionsvätska, lösning, i förfylld spruta Roferon-A 9 milj. IU injektioneste, liuos, esitäytetyssä ruiskussa NL/H/0028/011 BE N.V. ROCHE S.A. BE NL/H/0028/011 BE N.V. ROCHE S.A. BE NL/H/28/13 BE N.V. ROCHE S.A. BE NL/H/28/13 BE N.V. ROCHE S.A. BE NL/H/0028/014 BE N.V. ROCHE S.A. BE NL/H/0028/014 BE N.V. ROCHE S.A. BE NL/H/0028/ ROCHE OY FI NL/H/0028/ ROCHE OY FI NL/H/0028/ ROCHE OY FI NL/H/0028/ ROCHE OY FI NL/H/0028/ ROCHE OY FI EMA/201520/2018 Page 2/15
3 ROFERON -A 9 milj. IU injektionsvätska, lösning, i förfylld spruta Roferon-A 3 Millionen Internationale Einheiten (IE) Injektionslösung in Fertigspritze Roferon-A 6 Millionen Internationale Einheiten (IE) Injektionslösung in Fertigspritze Roferon-A 9 Millionen Internationale Einheiten (IE) Injektionslösung in Fertigspritze Roferon-A 6 milhões de unidades Roferon-A 6 milhões de unidades Roferon-A 6 milhões de unidades Roferon-A 6 milhões de unidades Roferon-A 6 milhões de unidades Roferon-A 9 milhões de unidades NL/H/0028/ ROCHE OY FI NL/H/2008/ N.V. ROCHE S.A. LU NL/H/0028/ N.V. ROCHE S.A. LU NL/H/0028/ N.V. ROCHE S.A. LU NL/H/0028/ ROCHE FARMACÊUTICA PT NL/H/0028/ ROCHE FARMACÊUTICA PT NL/H/0028/ ROCHE FARMACÊUTICA PT NL/H/0028/ ROCHE FARMACÊUTICA PT NL/H/0028/ ROCHE FARMACÊUTICA PT NL/H/0028/ ROCHE FARMACÊUTICA PT EMA/201520/2018 Page 3/15
4 Roferon-A 9 milhões de unidades Roferon-A 9 milhões de unidades Roferon-A 9 milhões de unidades Roferon-A 9 milhões de unidades Roferon-A 3 εκατομμύρια διεθνείς μονάδες (MIU) ενέσιμο διάλυμα σε προγεμισμένη σύριγγα Roferon-A 4,5 εκατομμύρια διεθνείς μονάδες (MIU) ενέσιμο διάλυμα σε προγεμισμένη σύριγγα Roferon-A 3 mio i.e./0,5 ml raztopina za injiciranje v napolnjeni injekcijski brizgi NL/H/0028/ ROCHE FARMACÊUTICA PT NL/H/0028/ ROCHE FARMACÊUTICA PT NL/H/0028/ ROCHE FARMACÊUTICA PT NL/H/0028/ ROCHE FARMACÊUTICA PT NL/H/0028/ /12/ ROCHE (HELLAS) SA GR NL/H/028/ /12/ ROCHE (HELLAS) SA GR NL/H/0028/011 H/97/01370/001 ROCHE FARMACEVTSKA SI DRUŽBA D.O.O. Roferon-A 3 millió NE oldatos injekció NL/H/0028/011 OGYI-T-6145/10 ROCHE HU (MAGYARORSZÁG) KFT Roferon-A 3 mio i.e./0,5 ml raztopina za NL/H/0028/011 H/97/01370/017 ROCHE FARMACEVTSKA SI injiciranje v napolnjeni injekcijski brizgi DRUŽBA D.O.O. Roferon-A 3 mio i.e./0,5 ml raztopina za NL/H/0028/011 H/97/01370/016 ROCHE FARMACEVTSKA SI injiciranje v napolnjeni injekcijski brizgi DRUŽBA D.O.O. Roferon-A 3 mio i.e./0,5 ml raztopina za injiciranje v napolnjeni injekcijski brizgi NL/H/0028/011 H/97/01370/004 ROCHE FARMACEVTSKA DRUŽBA D.O.O. SI EMA/201520/2018 Page 4/15
5 Roferon-A 3 mio i.e./0,5 ml raztopina za injiciranje v napolnjeni injekcijski brizgi Roferon-A 3 mio i.e./0,5 ml raztopina za injiciranje v napolnjeni injekcijski brizgi Roferon-A 3 mio i.e./0,5 ml raztopina za injiciranje v napolnjeni injekcijski brizgi Roferon-A Roche 3 Mio I.E./0,5 ml Injektionslösung in einer Fertigspritze Roferon-A 6 MIU/0,5 ml 6 milionů mezinárodních jednotek (IU) Injekční roztok v předplněné injekční stříkačce Roferon-A 9 MIU/0,5 ml 9 milionů mezinárodních jednotek (IU) Injekční roztok v předplněné injekční stříkačce Roferon-A 3 MIU/0,5 ml 3 miliony mezinárodních jednotek (IU) Injekční roztok v předplněné injekční stříkačce Roferon-A 9 millions d unités internationales (UI) solution injectable en seringue pré-remplie Roferon-A, 9 miljonit rahvusvahelist ühikut (RÜ), süstelahus süstlis Roferon-A, 3 miljonit rahvusvahelist ühikut (RÜ), süstelahus süstlis Roferon-A 3 millions d'unités NL/H/0028/011 H/97/01370/005 ROCHE FARMACEVTSKA DRUŽBA D.O.O. SI NL/H/0028/011 H/97/01370/002 ROCHE FARMACEVTSKA SI DRUŽBA D.O.O. NL/H/0028/011 H/97/01370/003 ROCHE FARMACEVTSKA SI DRUŽBA D.O.O. NL/H/0028/ ROCHE AUSTRIA GMBH AT NL/H/0028/011 44/086/02-C ROCHE S. R. O. CZ NL/H/0028/014 44/087/02-C ROCHE S. R. O. CZ NL/H/0028/011 44/160/99-C ROCHE S. R. O. CZ NL/H/0028/014 BE N.V. ROCHE S.A. BE NL/H/0028/ ROCHE EESTI OÜ EE NL/H/0028/ ROCHE EESTI OÜ EE NL/H/0028/ ROCHE FR EMA/201520/2018 Page 5/15
6 Roferon-A 3 millions d'unités Roferon-A 3 millions d'unités Roferon-A 3 millions d'unités Roferon-A 3 millions d'unités ROFERON-A 4,5 millions d unités ROFERON-A 4,5 millions d unités ROFERON-A 4,5 millions d unités Roferon-A 4,5 millions d'unités internationales (MUI), solution injectable en ROFERON-A 4,5 millions d unités NL/H/0028/ ROCHE FR NL/H/0028/ ROCHE FR NL/H/0028/ ROCHE FR NL/H/0028/ ROCHE FR NL/H/0028/ ROCHE FR NL/H/0028/ ROCHE FR NL/H/0028/ ROCHE FR NL/H/0028/ ROCHE FR NL/H/0028/ ROCHE FR EMA/201520/2018 Page 6/15
7 ROFERON-A 6 millions d unités ROFERON-A 6 millions d unités ROFERON-A 6 millions d unités ROFERON-A 6 millions d unités ROFERON-A 6 millions d unités ROFERON-A 9 millions d unités ROFERON-A 9 millions d unités ROFERON-A 9 millions d unités ROFERON-A 9 millions d unités NL/H/0028/ ROCHE FR NL/H/028/ ROCHE FR NL/H/0028/ ROCHE FR NL/H/0028/ ROCHE FR NL/H/0028/ ROCHE FR NL/H/0028/ ROCHE FR NL/H/0028/ ROCHE FR NL/H/0028/ ROCHE FR NL/H/0028/ ROCHE FR EMA/201520/2018 Page 7/15
8 ROFERON-A 9 millions d unités Roferon-A EasyJect 4,5, IE, oplossing voor injectie in voorgevulde spuit Roferon-A EasyJect 9, IE, oplossing voor injectie in voorgevulde spuit Roferon-A EasyJect 6, IE, oplossing voor injectie in voorgevulde spuit Roferon-A EasyJect 3, IE, oplossing voor injectie in voorgevulde spuit Roferon-A 9 MIU / 0,5 ml injekcný roztok naplnený v injekcnej striekacke Roferon-A 3 MIU/0,5 ml injekčný roztok naplnený v injekčnej striekačke Roferon -A 4,5 Mio. I.E./0,5 ml Fertigspritze mit Injektionslösung Roferon -A 9 Mio. I.E./0,5 ml Fertigspritze mit Injektionslösung Roferon -A 6 Mio. I.E./0,5 ml Fertigspritze mit Injektionslösung Roferon -A 3 Mio. I.E./0,5 ml Fertigspritze mit Injektionslösung NL/H/0028/ ROCHE FR NL/H/0028/012 RVG ROCHE NEDERLAND B.V. NL NL/H/0028/014 RVG ROCHE NEDERLAND B.V. NL NL/H/0028/013 RVG ROCHE NEDERLAND B.V. NL NL/H/0028/011 RVG ROCHE NEDERLAND B.V. NL NL/H/0028/011 44/0371/05-S ROCHE SLOVENSKO SK S.R.O. NL/H/0028/011 44/0368/05-S ROCHE SLOVENSKO SK S.R.O. NL/H/0028/ ROCHE PHARMA AG DE NL/H/0028/ ROCHE PHARMA AG DE NL/H/0028/ ROCHE PHARMA AG DE NL/H/0028/ ROCHE PHARMA AG DE EMA/201520/2018 Page 8/15
9 Roferon-A 3 millones de unidades internacionales (UI) solución inyectable en jeringa precargada Roferon-A 4,5 millones de unidades internacionales (UI) solución inyectable en jeringa precargada Roferon-A 6 millones de unidades internacionales (UI) solución inyectable en jeringa precargada Roferon-A 9 millones de unidades internacionales (UI) solución inyectable en jeringa precargada Roferon-A 9 milioni di unità internazionali Roferon-A 3 milioni di unità internazionali Roferon-A 3 milioni di unità internazionali Roferon-A 9 milioni di unità internazionali Roferon-A 3 milioni di unità internazionali NL/H/0028/ ROCHE FARMA, S.A. ES NL/H/0028/ ROCHE FARMA, S.A. ES NL/H/0028/ ROCHE FARMA, S.A. ES NL/H/0028/ ROCHE FARMA, S.A. ES NL/H/0028/ ROCHE S.P.A. IT NL/H/0028/ ROCHE S.P.A. IT NL/H/0028/ ROCHE S.P.A. IT NL/H/0028/ ROCHE S.P.A. IT NL/H/0028/ ROCHE S.P.A. IT EMA/201520/2018 Page 9/15
10 Roferon-A 6 milioni di unità internazionali Roferon-A 9 milioni di unità internazionali Roferon-A 6 milioni di unità internazionali Roferon-A 3 milioni di unità internazionali Roferon-A 6 milioni di unità internazionali Roferon-A 3 milioni di unità internazionali Roferon-A 6 milioni di unità internazionali Roferon-A 9 milioni di unità internazionali Roferon-A 9 milioni di unità internazionali NL/H/0028/ ROCHE S.P.A. IT NL/H/0028/ ROCHE S.P.A. IT NL/H/0028/ ROCHE S.P.A. IT NL/H/0028/ ROCHE S.P.A. IT NL/H/0028/ ROCHE S.P.A. IT NL/H/0028/ ROCHE S.P.A. IT NL/H/0028/ ROCHE S.P.A. IT NL/H/0028/ ROCHE S.P.A. IT NL/H/0028/ ROCHE S.P.A. IT EMA/201520/2018 Page 10/15
11 Roferon-A 6 milioni di unità internazionali Roferon-A 3 million international units (IU) solution for injection in pre-filled syringe Roferon-A 4.5 million international units (IU) solution for injection in pre-filled syringe Roferon-A 9 million international units (IU) solution for injection in pre-filled syringe Roferon-A 6 million international units (IU) solution for injection in pre-filled syringe ROFERON-A 3 millions d unités ROFERON-A 3 millions d unités ROFERON-A 4,5 millions d unités ROFERON-A 4,5 millions d unités NL/H/0028/ ROCHE S.P.A. IT NL/H/0028/011 PL00031/0485 ROCHE PRODUCTS LTD UK NL/H/0028/012 PL00031/0486 ROCHE PRODUCTS LTD UK NL/H/0028/014 PL00031/0488 ROCHE PRODUCTS LTD UK NL/H/0028/013 PL00031/0487 ROCHE PRODUCTS LTD UK NL/H/0028/ ROCHE FR NL/H/0028/ ROCHE FR NL/H/0028/ ROCHE FR NL/H/0028/ ROCHE FR EMA/201520/2018 Page 11/15
12 ROFERON-A 6 millions d unités NL/H/0028/ ROCHE FR ROFERON-A 6 millions d unités NL/H/0028/ ROCHE FR ROFERON-A 9 millions d unités NL/H/0028/ ROCHE FR ROFERON-A 9 millions d unités NL/H/0028/ ROCHE FR Roferon-A 3 millió NE oldatos injekció NL/H/0028/011 OGYI-T-6145/02 ROCHE HU (MAGYARORSZÁG) KFT Roferon-A ROCHE 4,5 Mio I.E./0,5 ml - NL/H/0028/ ROCHE AUSTRIA GMBH AT Injektionslösung in einer Fertigspritze Roferon-A Roche 6 Mio. I.E./0,5 ml NL/H/0028/ ROCHE AUSTRIA GMBH AT Injektionslösung in einer Fertigspritze Roferon-A 3 miljoner Internationella NL/H/0028/ ROCHE AB SE Enheter (IE), injektionsvätska, lösning i förfylld spruta Roferon-A 3 millió NE oldatos injekció NL/H/0028/011 OGYI-T-6145/01 ROCHE HU (MAGYARORSZÁG) KFT Roferon-A 3 millió NE oldatos injekció NL/H/0028/011 OGYI-T-6145/03 ROCHE HU (MAGYARORSZÁG) KFT Roferon-A 3 millions d unités internationales (UI) solution injectable en seringue pré-remplie NL/H/2008/ N.V. ROCHE S.A. LU EMA/201520/2018 Page 12/15
13 Roferon-A 3 millions d unités internationales (UI) solution injectable en seringue pré-remplie Roferon-A 6 millions d unités internationales (UI) solution injectable en seringue pré-remplie Roferon-A 6 millions d unités internationales (UI) solution injectable en seringue pré-remplie Roferon-A 9 millions d unités internationales (UI) solution injectable en seringue pré-remplie Roferon-A 3 milhões de unidades Roferon-A 3 milhões de unidades Roferon-A 3 milhões de unidades Roferon-A 3 milhões de unidades Roferon-A 3 milhões de unidades Roferon-A 3 miljoni starptautisko vienību (SV) šķīdums injekcijām pilnšļircē NL/H/0028/011 BE N.V. ROCHE S.A. BE NL/H/0028/ N.V. ROCHE S.A. LU NL/H/0028/013 BE N.V. ROCHE S.A. BE NL/H/0028/ N.V. ROCHE S.A. LU NL/H/0028/ ROCHE FARMACÊUTICA PT NL/H/0028/ ROCHE FARMACÊUTICA PT NL/H/0028/ ROCHE FARMACÊUTICA PT NL/H/0028/ ROCHE FARMACÊUTICA PT NL/H/0028/ ROCHE FARMACÊUTICA PT NL/H/0028/ ROCHE LATVIJA SIA LV EMA/201520/2018 Page 13/15
14 Roferon-A 3 milioni di unità internazionali Roferon-A 3 milioni di unità internazionali Roferon-A 6 milioni di unità internazionali Roferon-A 9 milioni di unità internazionali Roferon-A 6 milioni di unità internazionali Roferon-A 9 milioni di unità internazionali Roferon-A 3 εκατομμύρια διεθνείς μονάδες (MIU) ενέσιμο διάλυμα σε προγεμισμένη σύριγγα Roferon-A 9 milioane UI/0,5 ml soluţie injectabilă Роферон-А 3 милиона IU/0,5 ml инжекционен разтвор в предварително напълнена спринцовка Roferon-A, 3 mln j.m./0,5 ml, roztwór do wstrzykiwań NL/H/0028/ ROCHE S.P.A. IT NL/H/0028/ ROCHE S.P.A. IT NL/H/0028/ ROCHE S.P.A. IT NL/H/0028/ ROCHE S.P.A. IT NL/H/0028/ ROCHE S.P.A. IT NL/H/0028/ ROCHE S.P.A. IT NL/H/0028/ G.A. STAMATIS & CO CY LTD not available 6286/2014/01 ROCHE ROMANIA SRL RO not available ROCHE BULGARIA EOOD BG not available 4651 ROCHE POLSKA SP.O.O. PL EMA/201520/2018 Page 14/15
15 Roferon-A, 6 mln j.m./0,5 ml, roztwór do wstrzykiwań Roferon-A, 9 mln j.m./0,5 ml, roztwór do wstrzykiwań Roceron 6 mill. IE/ml injeksjonsvæske, oppløsning i ferdigfylt sprøyte Roceron18 mill. IE/ml injeksjonsvæske, oppløsning i ferdigfylt sprøyte Roferon-A 3 milijuna internacionalnih jedinica (IU) otopina za injekciju u napunjenoj štrcaljki not available 4653 ROCHE POLSKA SP.O.O. PL not available 4654 ROCHE POLSKA SP.O.O. PL not available F. HOFFMANN-LA ROCHE NO AG not available F. HOFFMANN-LA ROCHE NO AG not available UP/I /13-02/236 ROCHE D.O.O. HR EMA/201520/2018 Page 15/15
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