Summary of Community Decisions on marketing authorisations in respect of medicinal products from 15 February to 15 March 2002 (Published pursuant to Article 12 or Article 34 of Council Regulation (EEC) No 2309/93)
Date: 2002-03-28
Institutions: European Commission
Subjects: market approval, marketing, medicinal product

C 77/32

EN

Official Journal of the European Communities

28.3.2002

Summary of Community Decisions on marketing authorisations in respect of medicinal products
from 15 February to 15 March 2002

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

(2002/C 77/06)

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

Date of the
decision

Name of the
medicinal product

Holder of the marketing authorisation

Number of the entry in the
Community Register

Date of
notification

28.2.2002

Protopic

28.2.2002

Protopy

5.3.2002

Trisenox

8.3.2002

Lumigan

Fujisawa GmbH
Levelingstraße 12
D-81673 München

Fujisawa GmbH
Levelingstraße 12
D-81673 München

Cell Therapeutics (UK) Limited
1 Ropemaker Street
London EC2Y 9HT
United Kingdom

Allergan Pharmaceuticals (Ireland) Ltd
Castlebar Road
Westport
County Mayo
Ireland

EU/1/02/201/001-004

5.3.2002

EU/1/02/202/001-004

5.3.2002

EU/1/02/204/001

7.3.2002

EU/1/02/205/001

12.3.2002

8.3.2002

Kineret

Amgen Europe BV
Minervum 7061
4817 ZK Breda
Nederland

EU/1/02/203/001-004

12.3.2002

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

Accepted

Date of the
decision

Name of the
medicinal product

Holder of the marketing authorisation

Number of the entry in the
Community Register

Date of
notification

5.2.2002

Cea-Scan

19.2.2002

Renagel

19.2.2002

Plavix

19.2.2002

Iscover

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

Immunomedics Europe
Haarlemmerstraat 30
2181 HC Hillegom
Nederland

Genzyme Europe BV
Gooimeer 10
1411 DD Naarden
Nederland

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

EU/1/96/023/001

19.2.2002

EU/1/99/123/001-011

22.2.2002

EU/1/98/069/001a,
001b, 002a, 002b, 003a,
003b

21.2.2002

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

EU/1/98/070/001a,
001b, 002a, 002b, 003a,
003b

22.2.2002

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C 77/33

Date of the
decision

Name of the
medicinal product

Holder of the marketing authorisation

Number of the entry in the
Community Register

Date of
notification

19.2.2002

Thyrogen

19.2.2002

SonoVue

Genzyme BV
Gooimeer 10
1411 DD Naarden
Nederland

Bracco International BV
Strawinskylaan 3051
1077 ZX Amsterdam
Nederland

EU/1/99/122/001-002

22.2.2002

EU/1/01/177/001-002

21.2.2002

19.2.2002

Caelyx

Schering Plough Europe
Rue de Stalle/Stallestraat 73
B-1180 Brussels

EU/1/96/011/001-004

21.2.2002

19.2.2002

Teslascan

19.2.2002

Gonal F

Amersham Health AS
Nycoveien 1-2
PO Box 4220
Nydalen
N-0401 Oslo

Serono Europe Limited
56 Marsh Wall
London E14 9TP
United Kingdom

EU/1/97/040/001-002

25.2.2002

EU/1/95/001/017-020

21.2.2002

19.2.2002

Refludan

Schering AG
D-13342 Berlin

EU/1/97/035/001-004

25.2.2002

19.2.2002

Vistide

Pharmacia Enterprises SA
6, Circuit de la Foire Internationale
L-1347 Luxembourg

EU/1/97/037/001

22.2.2002

19.2.2002

Thyrogen

19.2.2002

Prevenar

19.2.2002

Iscover

19.2.2002

Actos

19.2.2002

Mabthera

19.2.2002

Karvezide

Genzyme Europe BV
Gooimeer 10
1411 DD Naarden
Nederland

Wyeth-Lederle Vaccines SA
Rue du Bosquet 15
B-1348 Louvain-La-Neuve

EU/1/99/122/001-002

22.2.2002

EU/1/00/167/001-005

12.3.2002

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

EU/1/98/070/001a,
001b, 002a, 002b, 003a,
003b

22.2.2002

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

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/1/00/150/001-008

21.2.2002

EU/1/98/067/001-002

21.2.2002

EU/1/98/085/009-010

22.2.2002

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EN

Official Journal of the European Communities

28.3.2002

Date of the
decision

Name of the
medicinal product

Holder of the marketing authorisation

Number of the entry in the
Community Register

Date of
notification

19.2.2002

Arava

Aventis Pharma Deutschland GmbH
D–65926 Frankfurt am Main

EU/1/99/118/005-008

25.2.2002

19.2.2002

Karvea

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

EU/1/97/049/013-014

22.2.2002

19.2.2002

Arava

Aventis Pharma Deutschland GmbH
D-65926 Frankfurt am Main

EU/1/99/118/001-010

25.2.2002

19.2.2002

Foscan

19.2.2002

Aprovel

19.2.2002

Prevenar

19.2.2002

Neospect

19.2.2002

Coaprovel

QuantaNova Limited
Castle Business Park
Stirling FK9 4TF
United Kingdom

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

Wyeth-Lederle Vaccines SA
Rue du Bosquet 15
B-1348 Louvain-La-Neuve

Amersham Health AS
Nycoveien 1-2
PO Box 4220
Nydalen
N-0401 Oslo

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

EU/1/01/197/001-002

21.2.2002

EU/1/97/046/014-015

25.2.2002

EU/1/00/167/001-005

25.2.2002

EU/1/00/154/001-002

25.2.2002

EU/1/98/086/009-010

25.2.2002

28.2.2002

Refacto

Genetics Institute of Europe BV
Fraunhoferstraße 15
D-82152 Planegg/Martinsried

EU/1/99/103/001-003

5.3.2002

28.2.2002

Replagal

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

EU/1/01/189/001

5.3.2002

28.2.2002

Vaniqa

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

EU/1/01/173/001-003

5.3.2002

28.2.2002

Prevenar

Wyeth-Lederle Vaccines SA
Rue du Bosquet 15
B-1348 Louvain-La-Neuve

EU/1/00/167/001-005

5.3.2002

5.3.2002

Viagra

Pfizer Limited
Ramsgate Road
Sandwich
Kent CT13 9NJ
United Kingdom

EU/1/98/077/001-012

7.3.2002

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Official Journal of the European Communities

C 77/35

Date of the
decision

Name of the
medicinal product

Holder of the marketing authorisation

Number of the entry in the
Community Register

Date of
notification

5.3.2002

Patrex

5.3.2002

Prometax

5.3.2002

Synagis

5.3.2002

Rilutek

5.3.2002

Infergen

7.3.2002

Fabrazyme

Pfizer Limited
Ramsgate Road
Sandwich
Kent CT13 9NJ
United Kingdom

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

Abbott Laboratories Ltd
Queenborough
Kent ME11 5EL
United-Kingdom

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

Yamanouchi Europe BV
Elisabethhof 19
2353 EW Leiderdorp
Nederland

Genzyme Europe BV
Gooimeer 10
1411 DD Naarden
Nederland

EU/1/98/078/001-012

7.3.2002

EU/1/98/092/001-013

7.3.2002

EU/1/99/117/001-002

7.3.2002

EU/1/96/010/001

7.3.2002

EU/1/98/087/001-003

7.3.2002

EU/1/01/188/001-003

11.3.2002

8.3.2002

Avonex

Biogen France SA
55, avenue des Champs-Pierreux
F-92012 Nanterre Cedex

EU/1/97/033/001-002

12.3.2002

8.3.2002

Aprovel

8.3.2002

Karvea

8.3.2002

Karvezide

8.3.2002

Puregon

8.3.2002

Coaprovel

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

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

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

Organon NV
Postbus 20
5340 BH Oss
Nederland

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

EU/1/97/046/001-015

12.3.2002

EU/1/97/049/001-015

12.3.2002

EU/1/98/085/001-010

12.3.2002

EU/1/96/008/001-039

12.3.2002

EU/1/98/086/001-010

12.3.2002

C 77/36

EN

Official Journal of the European Communities

28.3.2002

Date of the
decision

Name of the
medicinal product

Holder of the marketing authorisation

Number of the entry in the
Community Register

Date of
notification

13.3.2002

Exelon

14.3.2002

Travatan

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

Alcon Laboratories (UK) Ltd
Boundary Way
Hemel Hempstead
Herts HP2 7UK
United Kingdom

EU/1/98/066/001-013

15.3.2002

EU/1/01/199/001-002

18.3.2002

— Issuing of a marketing authorisation (Article 34 of Regulation (EEC) No 2309/93): Accepted

Date of the
decision

Name of the
medicinal product

Holder of the marketing authorisation

Number of the entry in the
Community Register

Date of
notification

8.3.2002

Eurifel RCP
FelV

Merial
17, rue Bourgelat
F-69002 Lyon

EU/2/02/031/001-002

12.3.2002

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

Accepted

Date of the
decision

Name of the
medicinal product

Holder of the marketing authorisation

Number of the entry in the
Community Register

Date of
notification

13.3.2002

Metacam

Boehringer Ingelheim Vetmedica
GmbH
D-55216 Ingelheim am Rhein

EU/2/97/004/003-005

15.3.2002

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.