21 February 2018 EMA/270645/2015 Human Medicines Evaluation Division

List of nationally authorised medicinal products

Active substance: interferon alpha-2a

Procedure no.: PSUSA/00009197/201706

30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom Telephone +44 (0)20 3660 6000 Facsimile +44 (0)20 3660 5525 Send a question via our website www.ema.europa.eu/contact

An agency of the European Union

© European Medicines Agency, 2018. Reproduction is authorised provided the source is acknowledged.

Product Name (in authorisation

MRP/DCP Authorisation

National Authorisation

MAH of product in the

Member State where

country)

number

Number

member state

product is authorised

Roferon-A 3 miljoen Internationale

NL/H/0028/011

BE207602

N.V. ROCHE S.A.

BE

NL/H/0028/011

BE207602

N.V. ROCHE S.A.

BE

NL/H/28/13

BE207627

N.V. ROCHE S.A.

BE

NL/H/28/13

BE207627

N.V. ROCHE S.A.

BE

NL/H/0028/014

BE207636

N.V. ROCHE S.A.

BE

NL/H/0028/014

BE207636

N.V. ROCHE S.A.

BE

NL/H/0028/011

16834

ROCHE OY

FI

NL/H/0028/011

16834

ROCHE OY

FI

NL/H/0028/013

16836

ROCHE OY

FI

NL/H/0028/013

16836

ROCHE OY

FI

NL/H/0028/014

16837

ROCHE OY

FI

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 List of nationally authorised medicinal products EMA/201520/2018

Page 2/15

Product Name (in authorisation

MRP/DCP Authorisation

National Authorisation

MAH of product in the

Member State where

country)

number

Number

member state

product is authorised

ROFERON®-A 9 milj. IU

NL/H/0028/014

16837

ROCHE OY

FI

NL/H/2008/11

2009030360

N.V. ROCHE S.A.

LU

NL/H/0028/013

2009030362

N.V. ROCHE S.A.

LU

NL/H/0028/014

2009030363

N.V. ROCHE S.A.

LU

NL/H/0028/013

2974483

ROCHE FARMACÊUTICA

PT

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 internacionais (MUI) solução injectável

QUÍMICA, LDA.

em seringa pré-cheia Roferon-A 6 milhões de unidades

NL/H/0028/013

2974582

internacionais (MUI) solução injectável

ROCHE FARMACÊUTICA

PT

QUÍMICA, LDA.

em seringa pré-cheia Roferon-A 6 milhões de unidades

NL/H/0028/013

2974681

internacionais (MUI) solução injectável

ROCHE FARMACÊUTICA

PT

QUÍMICA, LDA.

em seringa pré-cheia Roferon-A 6 milhões de unidades

NL/H/0028/013

2974780

internacionais (MUI) solução injectável

ROCHE FARMACÊUTICA

PT

QUÍMICA, LDA.

em seringa pré-cheia Roferon-A 6 milhões de unidades

NL/H/0028/013

2974889

internacionais (MUI) solução injectável

ROCHE FARMACÊUTICA

PT

QUÍMICA, LDA.

em seringa pré-cheia Roferon-A 9 milhões de unidades internacionais (MUI) solução injectável

NL/H/0028/014

2975183

ROCHE FARMACÊUTICA

PT

QUÍMICA, LDA.

em seringa pré-cheia

List of nationally authorised medicinal products EMA/201520/2018

Page 3/15

Product Name (in authorisation

MRP/DCP Authorisation

National Authorisation

MAH of product in the

Member State where

country)

number

Number

member state

product is authorised

Roferon-A 9 milhões de unidades

NL/H/0028/014

2975282

ROCHE FARMACÊUTICA

PT

internacionais (MUI) solução injectável

QUÍMICA, LDA.

em seringa pré-cheia Roferon-A 9 milhões de unidades

NL/H/0028/014

2975381

internacionais (MUI) solução injectável

ROCHE FARMACÊUTICA

PT

QUÍMICA, LDA.

em seringa pré-cheia Roferon-A 9 milhões de unidades

NL/H/0028/014

2974988

internacionais (MUI) solução injectável

ROCHE FARMACÊUTICA

PT

QUÍMICA, LDA.

em seringa pré-cheia Roferon-A 9 milhões de unidades

NL/H/0028/014

2975084

internacionais (MUI) solução injectável

ROCHE FARMACÊUTICA

PT

QUÍMICA, LDA.

em seringa pré-cheia Roferon-A 3 εκατομμύρια διεθνείς μονάδες

NL/H/0028/011

44839/12/22.10.2013

ROCHE (HELLAS) SA

GR

NL/H/028/011

62361/12/22.10.2013

ROCHE (HELLAS) SA

GR

NL/H/0028/011

H/97/01370/001

ROCHE FARMACEVTSKA

SI

Roferon-A 3 millió NE oldatos injekció

NL/H/0028/011

OGYI-T-6145/10

Roferon-A 3 mio i.e./0,5 ml raztopina za

NL/H/0028/011

H/97/01370/017

(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

DRUŽBA D.O.O. ROCHE

HU

(MAGYARORSZÁG) KFT injiciranje v napolnjeni injekcijski brizgi Roferon-A 3 mio i.e./0,5 ml raztopina za

injiciranje v napolnjeni injekcijski brizgi

List of nationally authorised medicinal products EMA/201520/2018

SI

DRUŽBA D.O.O. NL/H/0028/011

H/97/01370/016

injiciranje v napolnjeni injekcijski brizgi Roferon-A 3 mio i.e./0,5 ml raztopina za

ROCHE FARMACEVTSKA ROCHE FARMACEVTSKA

SI

DRUŽBA D.O.O. NL/H/0028/011

H/97/01370/004

ROCHE FARMACEVTSKA

SI

DRUŽBA D.O.O.

Page 4/15

Product Name (in authorisation

MRP/DCP Authorisation

National Authorisation

MAH of product in the

Member State where

country)

number

Number

member state

product is authorised

Roferon-A 3 mio i.e./0,5 ml raztopina za

NL/H/0028/011

H/97/01370/005

ROCHE FARMACEVTSKA

SI

injiciranje v napolnjeni injekcijski brizgi Roferon-A 3 mio i.e./0,5 ml raztopina za

DRUŽBA D.O.O. NL/H/0028/011

H/97/01370/002

ROCHE FARMACEVTSKA

NL/H/0028/011

H/97/01370/003

ROCHE FARMACEVTSKA

NL/H/0028/011

1-23200

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

BE207636

N.V. ROCHE S.A.

BE

NL/H/0028/014

184697

ROCHE EESTI OÜ

EE

NL/H/0028/011

184897

ROCHE EESTI OÜ

EE

NL/H/0028/011

34009 352 578 9 5

ROCHE

FR

injiciranje v napolnjeni injekcijski brizgi Roferon-A 3 mio i.e./0,5 ml raztopina za

DRUŽBA D.O.O.

injiciranje v napolnjeni injekcijski brizgi Roferon-A „Roche“ 3 Mio I.E./0,5 ml –

SI SI

DRUŽBA D.O.O.

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 internationales (UI), solution injectable en seringue préremplie

List of nationally authorised medicinal products EMA/201520/2018

Page 5/15

Product Name (in authorisation

MRP/DCP Authorisation

National Authorisation

MAH of product in the

Member State where

country)

number

Number

member state

product is authorised

Roferon-A 3 millions d'unités

NL/H/0028/011

34009 352 573 7 6

ROCHE

FR

NL/H/0028/011

34009 352 577 2 7

ROCHE

FR

NL/H/0028/011

34009 352 574 3 7

ROCHE

FR

NL/H/0028/011

34009 352 576 6 6

ROCHE

FR

NL/H/0028/012

34009 352 559 4 5

ROCHE

FR

NL/H/0028/012

34009 352 558 8 4

ROCHE

FR

NL/H/0028/012

34009 352 560 2 7

ROCHE

FR

NL/H/0028/012

34009 352 557 1 6

ROCHE

FR

NL/H/0028/012

34009 352 561 9 5

ROCHE

FR

internationales (UI), solution injectable en seringue préremplie Roferon-A 3 millions d'unités internationales (UI), solution injectable en seringue préremplie Roferon-A 3 millions d'unités internationales (UI), solution injectable en seringue préremplie Roferon-A 3 millions d'unités internationales (UI), solution injectable en seringue préremplie ROFERON-A 4,5 millions d’unités internationales (UI), solution injectable en seringue préremplie ROFERON-A 4,5 millions d’unités internationales (UI), solution injectable en seringue préremplie ROFERON-A 4,5 millions d’unités internationales (UI), solution injectable en seringue préremplie Roferon-A 4,5 millions d'unités internationales (MUI), solution injectable en seringue préremplie ROFERON-A 4,5 millions d’unités internationales (UI), solution injectable en seringue préremplie

List of nationally authorised medicinal products EMA/201520/2018

Page 6/15

Product Name (in authorisation

MRP/DCP Authorisation

National Authorisation

MAH of product in the

Member State where

country)

number

Number

member state

product is authorised

ROFERON-A 6 millions d’unités

NL/H/0028/013

34009 352 566 0 7

ROCHE

FR

NL/H/028/013

34009 352 564 8 5

ROCHE

FR

NL/H/0028/013

34009 352 565 4 6

ROCHE

FR

NL/H/0028/013

34009 352 562 5 6

ROCHE

FR

NL/H/0028/013

34009 352 563 1 7

ROCHE

FR

NL/H/0028/014

34009 352 570 8 6

ROCHE

FR

NL/H/0028/014

34009 352 568 3 6

ROCHE

FR

NL/H/0028/014

34009 352 567 7 5

ROCHE

FR

NL/H/0028/014

34009 352 572 0 8

ROCHE

FR

internationales (UI), solution injectable en seringue préremplie ROFERON-A 6 millions d’unités internationales (UI), solution injectable en seringue préremplie ROFERON-A 6 millions d’unités internationales (UI), solution injectable en seringue préremplie ROFERON-A 6 millions d’unités internationales (UI), solution injectable en seringue préremplie ROFERON-A 6 millions d’unités internationales (UI), solution injectable en seringue préremplie ROFERON-A 9 millions d’unités internationales (UI), solution injectable en seringue préremplie ROFERON-A 9 millions d’unités internationales (UI), solution injectable en seringue préremplie ROFERON-A 9 millions d’unités internationales (UI), solution injectable en seringue préremplie ROFERON-A 9 millions d’unités internationales (UI), solution injectable en seringue préremplie

List of nationally authorised medicinal products EMA/201520/2018

Page 7/15

Product Name (in authorisation

MRP/DCP Authorisation

National Authorisation

MAH of product in the

Member State where

country)

number

Number

member state

product is authorised

ROFERON-A 9 millions d’unités

NL/H/0028/014

34009 352 571 4 7

ROCHE

FR

NL/H/0028/012

RVG 24156

ROCHE NEDERLAND B.V.

NL

NL/H/0028/014

RVG 24158

ROCHE NEDERLAND B.V.

NL

NL/H/0028/013

RVG 24157

ROCHE NEDERLAND B.V.

NL

NL/H/0028/011

RVG 24155

ROCHE NEDERLAND B.V.

NL

NL/H/0028/011

44/0371/05-S

ROCHE SLOVENSKO

SK

internationales (UI), solution injectable en seringue préremplie Roferon-A EasyJect 4,5, 4.500.000 IE, oplossing voor injectie in voorgevulde spuit Roferon-A EasyJect 9, 9.000.000 IE, oplossing voor injectie in voorgevulde spuit Roferon-A EasyJect 6, 6.000.000 IE, oplossing voor injectie in voorgevulde spuit Roferon-A EasyJect 3, 3.000.000 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

S.R.O. NL/H/0028/011

44/0368/05-S

injekčný roztok naplnený v injekčnej

ROCHE SLOVENSKO

SK

S.R.O.

striekačke Roferon®-A 4,5 Mio. I.E./0,5 ml

NL/H/0028/012

45541.01.00

ROCHE PHARMA AG

DE

NL/H/0028/014

45541.03.00

ROCHE PHARMA AG

DE

NL/H/0028/013

45541.02.00

ROCHE PHARMA AG

DE

NL/H/0028/011

45541.00.00

ROCHE PHARMA AG

DE

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

List of nationally authorised medicinal products EMA/201520/2018

Page 8/15

Product Name (in authorisation

MRP/DCP Authorisation

National Authorisation

MAH of product in the

Member State where

country)

number

Number

member state

product is authorised

Roferon-A 3 millones de unidades

NL/H/0028/011

62.999

ROCHE FARMA, S.A.

ES

NL/H/0028/012

62.992

ROCHE FARMA, S.A.

ES

NL/H/0028/013

62.993

ROCHE FARMA, S.A.

ES

NL/H/0028/014

62.994

ROCHE FARMA, S.A.

ES

NL/H/0028/014

025839275

ROCHE S.P.A.

IT

NL/H/0028/011

025839123

ROCHE S.P.A.

IT

NL/H/0028/011

025839147

ROCHE S.P.A.

IT

NL/H/0028/014

025839299

ROCHE S.P.A.

IT

NL/H/0028/011

025839111

ROCHE S.P.A.

IT

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 (UI) soluzione iniettabile in siringa preriempita Roferon-A 3 milioni di unità internazionali (UI) soluzione iniettabile in siringa preriempita Roferon-A 3 milioni di unità internazionali (UI) soluzione iniettabile in siringa preriempita Roferon-A 9 milioni di unità internazionali (UI) soluzione iniettabile in siringa preriempita Roferon-A 3 milioni di unità internazionali (UI) soluzione iniettabile in siringa preriempita

List of nationally authorised medicinal products EMA/201520/2018

Page 9/15

Product Name (in authorisation

MRP/DCP Authorisation

National Authorisation

MAH of product in the

Member State where

country)

number

Number

member state

product is authorised

Roferon-A 6 milioni di unità internazionali

NL/H/0028/013

025839212

ROCHE S.P.A.

IT

NL/H/0028/014

025839301

ROCHE S.P.A.

IT

NL/H/0028/013

025839248

ROCHE S.P.A.

IT

NL/H/0028/011

025839150

ROCHE S.P.A.

IT

NL/H/0028/013

025839224

ROCHE S.P.A.

IT

NL/H/0028/011

025839135

ROCHE S.P.A.

IT

NL/H/0028/013

025839236

ROCHE S.P.A.

IT

NL/H/0028/014

025839287

ROCHE S.P.A.

IT

NL/H/0028/014

025839263

ROCHE S.P.A.

IT

(UI) soluzione iniettabile in siringa preriempita Roferon-A 9 milioni di unità internazionali (UI) soluzione iniettabile in siringa preriempita Roferon-A 6 milioni di unità internazionali (UI) soluzione iniettabile in siringa preriempita Roferon-A 3 milioni di unità internazionali (UI) soluzione iniettabile in siringa preriempita Roferon-A 6 milioni di unità internazionali (UI) soluzione iniettabile in siringa preriempita Roferon-A 3 milioni di unità internazionali (UI) soluzione iniettabile in siringa preriempita Roferon-A 6 milioni di unità internazionali (UI) soluzione iniettabile in siringa preriempita Roferon-A 9 milioni di unità internazionali (UI) soluzione iniettabile in siringa preriempita Roferon-A 9 milioni di unità internazionali (UI) soluzione iniettabile in siringa preriempita

List of nationally authorised medicinal products EMA/201520/2018

Page 10/15

Product Name (in authorisation

MRP/DCP Authorisation

National Authorisation

MAH of product in the

Member State where

country)

number

Number

member state

product is authorised

Roferon-A 6 milioni di unità internazionali

NL/H/0028/013

025839251

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/0028/011

3400930038208

ROCHE

FR

NL/H/0028/011

3400930038215

ROCHE

FR

NL/H/0028/012

3400930038222

ROCHE

FR

NL/H/0028/012

3400930038239

ROCHE

FR

(UI) soluzione iniettabile in siringa preriempita 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 internationales (UI), solution injectable en seringue préremplie ROFERON-A 3 millions d’unités internationales (UI), solution injectable en seringue préremplie ROFERON-A 4,5 millions d’unités internationales (UI), solution injectable en seringue préremplie ROFERON-A 4,5 millions d’unités internationales (UI), solution injectable en seringue préremplie

List of nationally authorised medicinal products EMA/201520/2018

Page 11/15

Product Name (in authorisation

MRP/DCP Authorisation

National Authorisation

MAH of product in the

Member State where

country)

number

Number

member state

product is authorised

ROFERON-A 6 millions d’unités

NL/H/0028/013

3400930038246

ROCHE

FR

NL/H/0028/013

3400930038253

ROCHE

FR

NL/H/0028/014

34009 300 382 7 7

ROCHE

FR

NL/H/0028/014

34009 300 382 8 4

ROCHE

FR

NL/H/0028/011

OGYI-T-6145/02

ROCHE

HU

internationales (UI), solution injectable en seringue préremplie ROFERON-A 6 millions d’unités internationales (UI), solution injectable en seringue préremplie ROFERON-A 9 millions d’unités internationales (UI), solution injectable en seringue préremplie ROFERON-A 9 millions d’unités internationales (UI), solution injectable en seringue préremplie Roferon-A 3 millió NE oldatos injekció

(MAGYARORSZÁG) KFT Roferon-A ROCHE 4,5 Mio I.E./0,5 ml -

NL/H/0028/012

1-23201

ROCHE AUSTRIA GMBH

AT

NL/H/0028/013

1-23202

ROCHE AUSTRIA GMBH

AT

NL/H/0028/0011

15444

ROCHE AB

SE

NL/H/0028/011

OGYI-T-6145/01

ROCHE

HU

Injektionslösung in einer Fertigspritze Roferon-A „Roche“ 6 Mio. I.E./0,5 ml – Injektionslösung in einer Fertigspritze Roferon-A 3 miljoner Internationella Enheter (IE), injektionsvätska, lösning i förfylld spruta Roferon-A 3 millió NE oldatos injekció

(MAGYARORSZÁG) KFT Roferon-A 3 millió NE oldatos injekció

NL/H/0028/011

OGYI-T-6145/03

ROCHE

Roferon-A 3 millions d’unités

NL/H/2008/11

2009030360

N.V. ROCHE S.A.

HU

(MAGYARORSZÁG) KFT LU

internationales (UI) solution injectable en seringue pré-remplie

List of nationally authorised medicinal products EMA/201520/2018

Page 12/15

Product Name (in authorisation

MRP/DCP Authorisation

National Authorisation

MAH of product in the

Member State where

country)

number

Number

member state

product is authorised

Roferon-A 3 millions d’unités

NL/H/0028/011

BE207602

N.V. ROCHE S.A.

BE

NL/H/0028/013

2009030362

N.V. ROCHE S.A.

LU

NL/H/0028/013

BE207627

N.V. ROCHE S.A.

BE

NL/H/0028/014

2009030363

N.V. ROCHE S.A.

LU

NL/H/0028/011

2973782

ROCHE FARMACÊUTICA

PT

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 internacionais (MUI) solução injectável

QUÍMICA, LDA.

em seringa pré-cheia Roferon-A 3 milhões de unidades

NL/H/0028/011

2973881

internacionais (MUI) solução injectável

ROCHE FARMACÊUTICA

PT

QUÍMICA, LDA.

em seringa pré-cheia Roferon-A 3 milhões de unidades

NL/H/0028/011

2973584

internacionais (MUI) solução injectável

ROCHE FARMACÊUTICA

PT

QUÍMICA, LDA.

em seringa pré-cheia Roferon-A 3 milhões de unidades

NL/H/0028/011

2973683

internacionais (MUI) solução injectável

ROCHE FARMACÊUTICA

PT

QUÍMICA, LDA.

em seringa pré-cheia Roferon-A 3 milhões de unidades

NL/H/0028/011

2973485

internacionais (MUI) solução injectável

ROCHE FARMACÊUTICA

PT

QUÍMICA, LDA.

em seringa pré-cheia Roferon-A 3 miljoni starptautisko vienību

NL/H/0028/006

05-0211

ROCHE LATVIJA SIA

LV

(SV) šķīdums injekcijām pilnšļircē

List of nationally authorised medicinal products EMA/201520/2018

Page 13/15

Product Name (in authorisation

MRP/DCP Authorisation

National Authorisation

MAH of product in the

Member State where

country)

number

Number

member state

product is authorised

Roferon-A 3 milioni di unità internazionali

NL/H/0028/011

025839364

ROCHE S.P.A.

IT

NL/H/0028/011

025839376

ROCHE S.P.A.

IT

NL/H/0028/013

025839388

ROCHE S.P.A.

IT

NL/H/0028/014

025839402

ROCHE S.P.A.

IT

NL/H/0028/013

025839390

ROCHE S.P.A.

IT

NL/H/0028/014

025839414

ROCHE S.P.A.

IT

NL/H/0028/011

20076

G.A. STAMATIS & CO

CY

(UI) soluzione iniettabile in siringa preriempita Roferon-A 3 milioni di unità internazionali (UI) soluzione iniettabile in siringa preriempita Roferon-A 6 milioni di unità internazionali (UI) soluzione iniettabile in siringa preriempita Roferon-A 9 milioni di unità internazionali (UI) soluzione iniettabile in siringa preriempita Roferon-A 6 milioni di unità internazionali (UI) soluzione iniettabile in siringa preriempita Roferon-A 9 milioni di unità internazionali (UI) soluzione iniettabile in siringa preriempita Roferon-A 3 εκατομμύρια διεθνείς μονάδες (MIU) ενέσιμο διάλυμα σε προγεμισμένη

LTD

σύριγγα Roferon-A 9 milioane UI/0,5 ml soluţie

not available

6286/2014/01

ROCHE ROMANIA SRL

RO

not available

20011284

ROCHE BULGARIA EOOD

BG

not available

4651

ROCHE POLSKA SP.O.O.

PL

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

List of nationally authorised medicinal products EMA/201520/2018

Page 14/15

Product Name (in authorisation

MRP/DCP Authorisation

National Authorisation

MAH of product in the

Member State where

country)

number

Number

member state

product is authorised

Roferon-A, 6 mln j.m./0,5 ml, roztwór do

not available

4653

ROCHE POLSKA SP.O.O.

PL

not available

4654

ROCHE POLSKA SP.O.O.

PL

not available

96-1010

F. HOFFMANN-LA ROCHE

NO

not available

96-1012

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,

AG

oppløsning i ferdigfylt sprøyte Roferon-A 3 milijuna internacionalnih

F. HOFFMANN-LA ROCHE

NO

AG not available

UP/I-530-09/13-02/236

ROCHE D.O.O.

HR

jedinica (IU) otopina za injekciju u napunjenoj štrcaljki

List of nationally authorised medicinal products EMA/201520/2018

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