Summary of Community decisions on marketing authorizations in respect of medicinal products from 15 December 2004 to 15 January 2005(Published pursuant to Article 12 or Article 34 of Council Regulation (EEC) No 2309/93)
Date: 2005-01-28
Institutions: European Commission
Subjects: market approval, marketing, medicinal product

C 23/2

EN

Official Journal of the European Union

28.1.2005

Summary of Community decisions on marketing authorizations in respect of medicinal products
from 15 December 2004 to 15 January 2005

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

(2005/C 23/02)

Issuing of a marketing authorization (Article 12 of Council 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

17.12.2004

Xeristar

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

EU/1/04/297/001-004

22.12.2004

17.12.2004

Cymbalta

17.12.2004

Kivexa

12.1.2004

Avastin

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

Glaxo Group Ltd,
Berkeley Avenue,
Greenford,
Middlesex UB6 0NN,
United Kingdom

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

EU/1/04/296/001-004

22.12.2004

EU/1/04/298/001-002

22.12.2004

EU/1/04/300/001-002

14.1.2005

Modification of a marketing authorization (Article 12 of Council 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

17.12.2004

Agenerase

17.12.2004

Fuzeon

17.12.2004

Kaletra

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

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

Abbott laboratories Ltd,
Queenborough,
Kent ME11 5EL,
United Kingdom

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

EU/1/00/148/001-004

22.12.2004

EU/1/03/252/001-003

22.12.2004

EU/1/01/172/001-003

22.12.2004

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EN

Official Journal of the European Union

C 23/3

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

17.12.2004

Epivir

17.12.2004

Telzir

17.12.2004

Invirase

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

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

Roche Registration Ltd.,
40, Broadwater Road,
Welwyn Garden City,
Hertfordshire, AL7 3AY,
United Kingdom

EU/1/96/015/001-005

22.12.2004

EU/1/04/282/001-002

22.12.2004

EU/1/96/026/001

22.12.2004

17.12.2004

Emtriva

Gilead Sciences International
Limited,
Cambridge CB1 6GT
United Kingdom

EU/1/03/261/001-003

22.12.2004

17.12.2004

NeuroBloc

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

EU/1/00/166/001-003

23.12.2004

17.12.2004

Reyataz

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

EU/1/03/267/001-007

22.12.2004

17.12.2004

Ziagen

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

EU/1/99/112/001-002

22.12.2004

17.12.2004

Rilutek

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

EU/1/96/010/001

22.12.2004

17.12.2004

Viracept

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

EU/1/97/054/001
EU/1/97/054/003-006

22.12.2004

C 23/4

EN

Official Journal of the European Union

28.1.2005

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

21.12.2004

Advate

Baxter AG,
Industriestraße 67,
A-1221 Wien

EU/1/03/271/001-004

23.12.2004

22.12.2004

Iscover

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

EU/1/98/070/001a-001b
EU/1/98/070/002a-002b
EU/1/98/070/003a-003b
EU/1/98/070/004a-004b

4.1.2005

EU/1/97/044/001-006

4.1.2005

22.12.2004

Tasmar

Valeant Pharmaceuticals Limited,
Cedarwood,
Chineham Business Park,
Crockford lane,
Basingstoke RG24 8WD,
United Kingdom

Roche Registration Ltd.,
40, Broadwater Road,
Welwyn Garden City,
Hertfordshire AL7 3AY,
United Kingdom

22.12.2004

Taxotere

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

EU/1/95/002/001-002

24.12.2004

5.1.2005

Crixivan

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

EU/1/96/024/001-005
EU/1/96/024/007-008
EU/1/96/024/010

7.1.2005

5.1.2005

Caelyx

Schering Plough Europe,
Rue de Stalle 73/Stallestraat, 73,
B-1180 Bruxelles/Brussel

EU/1/96/011/001-004

7.1.2005

5.1.2005

Taxotere

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

EU/1/95/002/001-002

7.1.2005

5.1.2005

Glivec

Novartis Europharm Limited,
Wimblehurst Road,
Horsham,
West Sussex RH12 5AB,
United Kingdom

EU/1/01/198/011-013

7.1.2005

5.1.2005

Sustiva

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

EU/1/99/110/001-009

7.1.2005

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Official Journal of the European Union

C 23/5

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

5.1.2005

Plavix

5.1.2005

Foscan

5.1.2005

Stocrin

5.1.2005

Trivizir

Sanofi Pharma Bristol-Myers Squibb
SNC,
174 avenue de France
F-75013 Paris

EU/1/98/069/001a-001b
EU/1/98/069/002a-002b
EU/1/98/069/003a-003b
EU/1/98/069/004a-004b

7.1.2005

Biolitec pharma (Ireland) ltd.,
Unit 2,
Broomhill Business Park,
Broomhill Road,
Tallaght,
Dublin 24,
Ireland

Biolitec pharma limited,
Research Avenue South,
Heriot-Watt Research Park,
Edinburgh,
EH14 4AP,
United Kingdom

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

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

EU/1/01/197/001-002

7.1.2005

EU/1/99/111/001-009

7.1.2005

EU/1/00/156/001-003

7.1.2005

5.1.2005

Caelyx

Schering Plough Europe,
Rue de Stalle 73/Stallestraat, 73,
B-1180 Bruxelles/Brussel

EU/1/96/011/001-004

7.1.2005

5.1.2005

Viramune

5.1.2005

Combivir

10.1.2005

Azomyr

10.1.2005

Aerius

10.1.2005

Neoclarityn

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

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

Schering Plough Europe,
Rue de Stalle 73/Stallestraat, 73,
B-1180 Bruxelles/Brussel

Schering Plough Europe,
Rue de Stalle 73/Stallestraat, 73,
B-1180 Bruxelles/Brussel

Schering Plough Europe,
Rue de Stalle 73/Stallestraat, 73,
B-1180 Bruxelles/Brussel

EU/1/97/055/001-002

7.1.2005

EU/1/98/058/001-002

7.1.2005

EU/1/00/157/001-034

12.1.2005

EU/1/00/160/001-034

12.1.2005

EU/1/00/161/001-034

12.1.2005

10.1.2005

Ketek

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

EU/1/01/191/001-005

12.1.2005

C 23/6

EN

Official Journal of the European Union

28.1.2005

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

10.1.2005

Levviax

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

EU/1/01/192/001-005

12.1.2005

10.1.2005

Glustin

10.1.2005

Actos

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

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

EU/1/00/151/001-013

12.1.2005

EU/1/00/150/001-015

12.1.2005

10.1.2005

Optisulin

Aventis Pharma Deutschland GmbH,
D-65926 Frankfurt am Main

EU/1/00/133/005-007

12.1.2005

10.1.2005

Fortovase

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

EU/1/98/075/001-002

12.1.2005

10.1.2005

Remicade

Centocor BV,
Einsteinweg 101,
2333 CB Leiden,
Nederland

EU/1/99/116/001-003

12.1.2005

10.1.2005

Viread

Gilead Sciences International
Limited,
Cambridge CB1 6GT
United Kingdom

EU/1/01/200/001

12.1.2005

10.1.2005

Vfend

10.1.2005

Avandia

Pfizer Limited,
Sandwich,
Kent CT13 9NJ,
United Kingdom

SmithKline Beecham plc,
980 Great West Road,
Brentford,
Middlesex TW8 9GS
United Kingdom

EU/1/02/212/001-026

12.1.2005

EU/1/00/137/001-012

12.1.2005

11.1.2005

Lantus

Aventis Pharma Deutschland GmbH,
D-65926 Frankfurt am Main

EU/1/00/134/005-011
EU/1/00/134/013-029

17.1.2005

12.1.2004

Aldurazyme

Genzyme Europe BV,
Gooimeer 10,
Naarden 1411 DD,
Nederland

EU/1/03/253/001-003

12.1.2005

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Official Journal of the European Union

C 23/7

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

12.1.2004

Quixidar

12.1.2004

Arixtra

12.1.2004

Kaletra

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

NV Organon,
PO Box 20,
Kloosterstraat 6,
5340 EB Oss,
Nederland

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

Sanofi-Synthelabo,
174 avenue de France,
F-75013 Paris

Abbott laboratories Ltd,
Queenborough,
Kent ME11 5EL,
United Kingdom

EU/1/02/207/001-017

14.1.2005

EU/1/02/206/001-017

14.1.2005

EU/1/01/172/001-003

17.1.2005

Modification of a marketing authorization (Article 34 of Council 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

5.1.2005

Advocate

5.1.2005

ProteqFlu Te

Bayer Healthcare AG,
D-51368 Leverkusen

Merial,
29 Avenue Tony Garnier,
F-69007 Lyon

EU/2/03/039/001-018

7.1.2005

EU/2/03/038/001-004

7.1.2005