Summary of Community decisions on marketing authorizations in respect of medicinal products from 15 January 2004 to 15 February 2004 (Published pursuant to Article 12 or Article 34 of Council Regulation (EEC) No 2309/93)
Date: 2004-02-27
Institutions: European Commission
Subjects: market approval, marketing, medicinal product

C 52/2

EN

Official Journal of the European Union

27.2.2004

Summary of Community decisions on marketing authorizations in respect of medicinal products
from 15 January 2004 to 15 February 2004

(Published pursuant to Article 12 or Article 34 of Council Regulation (EEC) No 2309/93 (1))

(2004/C 52/02)

— Issuing of a marketing authorization (Article 12 of Regulation (EEC) No 2309/93): Accepted

Date of the
decision

Name of the
medicinal product

Holder of the
marketing authorization

16.1.2004

Zevalin

Schering AG
Müllerstraße 170—178
D-13342 Berlin

Number of the
entry in the
Community Register

Date of
notification

EU/1/03/264/001

21.1.2004

— Modification of a marketing authorization (Article 12 of Regulation (EEC) No 2309/93):

Accepted

Date of the
decision

Name of the
medicinal product

Holder of the
marketing authorization

Number of the
entry in the
Community Register

Date of
notification

16.1.2004

Fabrazyme

16.1.2004

Replagal

16.1.2004

Enbrel

20.1.2004

DaTSCAN

20.1.2004

Paxene

20.1.2004

InductOs

(1) OJ L 214, 24.8.1993, p. 1.

Genzyme Europe BV
Gooimeer 10
1411 DD Naarden
Nederland

TKT Europe-5S AB
Rinkebyvägen 11B
S-182 36 Danderyd

Wyeth Europa Ltd
Huntercombe Lane South
Taplow
Maidenhead
Berkshire SL6 0PH
United Kingdom

Amersham plc
Amersham Place
Little Chalfont
Bucks
United Kingdom

Norton Healthcare Limited
Albert Basin
Royal Docks
London E16 2QJ
United Kingdom

Wyeth Europa Ltd
Huntercombe Lane South
Taplow
Maidenhead
Berkshire SL6 0PH
United Kingdom

EU/1/01/188/001-006

20.1.2004

EU/1/01/189/001-003

20.1.2004

EU/1/99/126/001-003

20.1.2004

EU/1/00/135/001-002

22.1.2004

EU/1/99/113/003-004

22.1.2004

EU/1/02/226/001

22.1.2004

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EN

Official Journal of the European Union

C 52/3

Date of the
decision

Name of the
medicinal product

Holder of the
marketing authorization

Number of the
entry in the
Community Register

Date of
notification

20.1.2004

Zeffix

20.1.2004

Lumigan

20.1.2004

Mabcampath

20.1.2004

Forsteo

27.1.2004

Ixense

27.1.2004

Protopic

27.1.2004

Cialis

Glaxo Group Ltd
Greenford Road
Greenford
Middlesex UB6 0NN
United Kingdom

Allergan Pharmaceuticals Ireland
Castlebar Road
Westport
Co. Mayo
Ireland

ILEX Pharmaceutical Ltd
1 & 3 Frederick Sanger Road
The Surrey Research Park
Guildford
Surrey GU2 7YD
United Kingdom

Eli Lilly Nederland BV
Grootslag 1-5
3991 RA Houten
Nederland

Takeda Europe R & D Centre Ltd
Savanah House
11/12 Charles II Street
London SW1Y 4QU
United Kingdom

Fujisawa GmbH
Neumarkter Straße 61
D-81673 München

Lilly ICOS Limited
25 New Street Square
London EC4A 3LN
United Kingdom

EU/1/99/114/001-003

22.1.2004

EU/1/02/205/001-002

22.1.2004

EU/1/01/193/001

22.1.2004

EU/1/03/247/001-002

22.1.2004

EU/1/01/181/001-007

29.1.2004

EU/1/02/201/001-006

29.1.2004

EU/1/02/237/001-004

29.1.2004

27.1.2004

Vivanza

Bayer AG
D-51368 Leverkusen

EU/1/03/249/001-012

29.1.2004

27.1.2004

NovoSeven

27.1.2004

Uprima

Novo Nordisk A/S
Novo Allé
DK-2880 Bagsværd

Abbott laboratories Ltd
Queenborough
Kent ME11 5EL
United Kingdom

EU/1/96/006/001-003

29.1.2004

EU/1/01/180/001-010

29.1.2004

27.1.2004

Tenecteplase

Boehringer Ingelheim International
GmbH
Binger Straße 173
D-55216 Ingelheim am Rhein

EU/1/00/168/001-006

29.1.2004

C 52/4

EN

Official Journal of the European Union

27.2.2004

Date of the
decision

Name of the
medicinal product

Holder of the
marketing authorization

27.1.2004

Revasc

Aventis Pharma SA
20, avenue Raymond Aron
F-92165 Antony Cedex

27.1.2004

Metalyse

27.1.2004

Infergen

Boehringer Ingelheim International
GmbH
Binger Straße 173
D-55216 Ingelheim am Rhein

Yamanouchi Europe BV
Elisabethhof 19
2353 EW Leiderdorp
Nederland

Number of the
entry in the
Community Register

Date of
notification

EU/1/97/043/001-002

29.1.2004

EU/1/00/169/001-006

29.1.2004

EU/1/98/087/001-003

29.1.2004

27.1.2004

Arava

Aventis Pharma Deutschland GmbH
D-65926 Frankfurt am Main

EU/1/99/118/001-010

30.1.2004

27.1.2004

Invirase

27.1.2004

Zerit

Roche Registration Limited
40 Broadwater Road
Welwyn Garden City
Hertfordshire AL7 3AY
United Kingdom

Bristol-Myers Squibb Pharma EEIG
141-149 Staines Road
Hounslow TW3 3JA
United Kingdom

EU/1/96/026/001

29.1.2004

EU/1/96/009/001-017

29.1.2004

27.1.2004

Infanrix Hexa

GlaxoSmithKline Biologicals SA
Rue de l'Institut 89
B-1330 Rixensart

EU/1/00/152/009-018

29.1.2004

27.1.2004

Taluvian

27.1.2004

Ammonaps

Abbott SpA
Campoverde di Aprilia
I-04010 Latina

Orphan Europe
Immeuble ‘Le Guillaumet’
F-92046 Paris La Défense

EU/1/01/182/001-010

29.1.2004

EU/1/99/120/001-004

29.1.2004

27.1.2004

Levitra

Bayer AG
D-51368 Leverkusen

EU/1/03/248/001-012

29.1.2004

27.1.2004

Beromun

27.1.2004

Viracept

27.1.2004

Bextra

Boehringer Ingelheim International
GmbH
Binger Straße 173
D-55216 Ingelheim am Rhein

EU/1/99/097/001

29.1.2004

Roche Registration Limited
40 Broadwater Road
Welwyn Garden City
Hertfordshire AL7 3AY
United Kingdom

Pharmacia-Pfizer EEIG
Hillbottom Road
High Wycombe
Bucks HP12 4PX
United Kingdom

EU/1/97/054/001,
EU/1/97/054/003-005

29.1.2004

EU/1/02/239/001-024

9.2.2004

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EN

Official Journal of the European Union

C 52/5

Date of the
decision

Name of the
medicinal product

Holder of the
marketing authorization

27.1.2004

Norvir

Abbott Laboratories Ltd
Queenborough
Kent ME11 5EL
United Kingdom

Number of the
entry in the
Community Register

EU/1/96/016/001,
EU/1/96/016/003

Date of
notification

29.1.2004

27.1.2004

Aldara

3M Santé
Boulevard de l'Oise
F-95029 Cergy Pontoise Cedex

EU/1/98/080/001

30.1.2004

27.1.2004

Renagel

Genzyme Europe BV
Gooimeer 10
1411 DD Naarden
Nederland

EU/1/99/123/001-011

29.1.2004

27.1.2004

Infanrix Hexa

GlaxoSmithKline Biologicals SA
Rue de l'Institut 89
B-1330 Rixensart

EU/1/00/152/009-018

29.1.2004

27.1.2004

NovoSeven

Novo Nordisk A/S
Novo Allé
DK-2880 Bagsværd

EU/1/96/006/

29.1.2004

27.1.2004

Tamiflu

27.1.2004

Cialis

27.1.2004

Ketek

27.1.2004

Levviax

29.1.2004

Rapamune

29.1.2004

Agenerase

29.1.2004

Epivir

Roche Registration Limited
40 Broadwater Road
Welwyn Garden City
Hertfordshire AL7 3AY
United Kingdom

Lilly ICOS Limited
25 New Street Square
London EC4A 3LN
United Kingdom

Aventis Pharma SA
20, avenue Raymond Aron
F-92160 Antony

Aventis Pharma SA
20, avenue Raymond Aron
F-92160 Antony

Wyeth Europa Ltd
Huntercombe Lane South
Taplow
Maidenhead
Berkshire SL6 0PH
United Kingdom

Glaxo Group Ltd
Greenford Road
Greenford
Middlesex UB6 0NN
United Kingdom

Glaxo Group Ltd
Greenford Road
Greenford
Middlesex UB6 0NN
United Kingdom

EU/1/02/222/001-002

29.1.2004

EU/1/02/237/001-004

29.1.2004

EU/1/01/191/001-004

29.1.2004

EU/1/01/192/001-004

29.1.2004

EU/1/01/171/001-010

3.2.2004

EU/1/00/148/001-004

3.2.2004

EU/1/96/015/001-005

3.2.2004

C 52/6

EN

Official Journal of the European Union

27.2.2004

Date of the
decision

Name of the
medicinal product

Holder of the
marketing authorization

29.1.2004

NeuroBloc

Elan Pharma International Ltd
WIL House
Shannon Business Park
Shannon
County Clare
Ireland

29.1.2004

Neulasta

29.1.2004

Neupopeg

Amgen Europe BV
Minervum 7061
4817 ZK Breda
Nederland

Dompé Biotec SpA
Via San Martino, 12
I-20122 Milano

Number of the
entry in the
Community Register

Date of
notification

EU/1/00/166/001-003

3.2.2004

EU/1/02/227/001

3.2.2004

EU/1/02/228/001

3.2.2004

29.1.2004

Hepsera

Gilead Sciences International Limited
Cambridge CB1 6GT
United Kingdom

EU/1/03/251/001

3.2.2004

29.1.2004

HEXAVAC

30.1.2004

Ziagen

30.1.2004

Fortovase

30.1.2004

Avonex

Aventis Pasteur MSD
8, rue Jonas Salk
F-69007 Lyon

Glaxo Group Ltd
Greenford Road
Greenford
Middlesex UB6 0NN
United Kingdom

Roche Registration Limited
40 Broadwater Road
Welwyn Garden City
Hertfordshire AL7 3AY
United Kingdom

Biogen France SA
‘Le Capitole’
55, avenue des Champs Pierreux
F-92012 Nanterre Cedex

EU/1/00/147/001-008

3.2.2004

EU/1/99/112/001-002

3.2.2004

EU/1/98/075/001-002

3.2.2004

EU/1/97/033/001-003

3.2.2004

30.1.2004

Twinrix Adult

GlaxoSmithKline Biologicals SA
Rue de l'Institut 89
B-1330 Rixensart

EU/1/96/020/001-009

3.2.2004

30.1.2004

TRIZIVIR

30.1.2004

Crivixan

Glaxo Group Ltd
Greenford Road
Greenford
Middlesex UB6 0NN
United Kingdom

Merck Sharp & Dohme Ltd
Hertford Road
Hoddesdon
Hertfordshire EN11 9BU
United Kingdom

EU/1/00/156/001-003

3.2.2004

EU/1/96/024/001-010

3.2.2004

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Official Journal of the European Union

C 52/7

Date of the
decision

Name of the
medicinal product

Holder of the
marketing authorization

30.1.2004

Viread

30.1.2004

Viread

30.1.2004

Kaletra

30.1.2004

Kaletra

4.2.2004

Viramune

5.2.2004

TRIZIVIR

5.2.2004

ViraferonPeg

5.2.2004

Temodal

5.2.2004

Sustiva

5.2.2004

CANCIDAS

5.2.2004

Combivir

5.2.2004

PegIntron

5.2.2004

Keppra

6.2.2004

Stocrin

Number of the
entry in the
Community Register

Date of
notification

EU/1/01/200/001

3.2.2004

EU/1/01/200/001

3.2.2004

EU/1/01/172/001-003

3.2.2004

EU/1/01/172/001-003

3.2.2004

Gilead Sciences International Limited
Cambridge CB1 6GT
United Kingdom

Gilead Sciences International Limited
Cambridge CB1 6GT
United Kingdom

Abbott laboratories Ltd
Queenborough
Kent ME11 5EL
United Kingdom

Abbott laboratories Ltd
Queenborough
Kent ME11 5EL
United Kingdom

Boehringer Ingelheim International
GmbH
Binger Straße 173
D-55216 Ingelheim am Rhein

EU/1/97/055/001-002

6.2.2004

Glaxo Group Ltd
Greenford Road
Greenford
Middlesex UB6 0NN
United Kingdom

Schering Plough Europe
Rue de Stalle 73
B-1180 Brussels

Schering Plough Europe
Rue de Stalle 73
B-1180 Brussels

Bristol-Myers Squibb Pharma EEIG
141-149 Staines Road
Hounslow TW3 3JA
United Kingdom

Merck Sharp & Dohme Ltd
Hertford Road
Hoddesdon
Hertfordshire EN11 9BU
United Kingdom

Glaxo Group Ltd
Greenford Road
Greenford
Middlesex UB6 0NN
United Kingdom

Schering Plough Europe
Rue de Stalle 73
B-1180 Brussels

UCB SA
Allée de la recherche 60
B-1070 Brussels

Merck Sharp & Dohme Ltd
Hertford Road
Hoddesdon
Hertfordshire EN11 9BU
United Kingdom

EU/1/00/156/001-003

9.2.2004

EU/1/00/132/001-050

9.2.2004

EU/1/98/096/001-008

9.2.2004

EU/1/99/110/001-009

9.2.2004

EU/1/01/196/001-003

9.2.2004

EU/1/98/058/001-002

9.2.2004

EU/1/00/131/001-050

9.2.2004

EU/1/00/146/001-027

9.2.2004

EU/1/99/111/001-009

10.2.2004

C 52/8

EN

Official Journal of the European Union

27.2.2004

Date of the
decision

Name of the
medicinal product

Holder of the
marketing authorization

12.2.2004

Neoclarytin

12.2.2004

Azomir

12.2.2004

Allex

12.2.2004

Aerius

12.2.2004

Opulis

Schering Plough Europe
Rue de Stalle 73
B-1180 Brussels

Schering Plough Europe
Rue de Stalle 73
B-1180 Brussels

Schering Plough Europe
Rue de Stalle 73
B-1180 Brussels

Schering Plough Europe
Rue de Stalle 73
B-1180 Brussels

Schering Plough Europe
Rue de Stalle 73
B-1180 Brussels

Number of the
entry in the
Community Register

Date of
notification

EU/1/00/161/001-034

16.2.2004

EU/1/00/157/001-034

16.2.2004

EU/1/00/159/001-034

16.2.2004

EU/1/00/160/001-034

16.2.2004

EU/1/00/158/001-034

16.2.2004

— Modification of a marketing authorization (Article 34 of Regulation (EEC) No 2309/93):

Accepted

Date of the
decision

Name of the
medicinal product

Holder of the
marketing authorization

27.1.2004

Nobivac Bb

Intervet International BV
Wim de Körverstraat 35
5831 AN Boxmeer
Nederland

Number of the
entry in the
Community Register

Date of
notification

EU/2/02/034/001

29.1.2004

27.1.2004

Econor

29.1.2004

Zubrin

29.1.2004

Nobilis 1B 4-91

Novartis Animal Health Austria GmbH
Biochemiestraße 10
A-6250 Kundl

EU/2/98/010/001-006,
EU/2/98/010/015-024

29.1.2004

Schering Plough Limited
Schering Plough House
Shire Park
Welwyn Garden City
Hertfordshire AL7 1TW
United Kingdom

Intervet International BV
Wim de Körverstraat 35
5831 AN Boxmeer
Nederland

EU/2/00/028/001-008

3.2.2004

EU/2/98/006/001-010

3.2.2004

Anyone wishing to consult the public assessment report on the medicinal products in question and the
decisions relating thereto is invited to contact:

The European Agency for the Evaluation of Medicinal products
7 Westferry Circus
Canary Wharf
London E14 4HB
United Kingdom.