Summary of Community decisions on marketing authorizations in respect of medicinal products from 15 December 2003 to 15 January 2004 (Published pursuant to Article 12 or Article 34 of Council Regulation (EEC) No 2309/93)
Date: 2004-02-20
Institutions: European Commission
Subjects: harmonisation of standards, market approval, marketing, medicinal product

20.2.2004

EN

Official Journal of the European Union

C 44/3

Summary of Community decisions on marketing authorizations in respect of medicinal products
from 15 December 2003 to 15 January 2004

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

(2004/C 44/03)

— 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

22.12.2003

Plavix

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

Date of
notification

24.12.2003

22.12.2003

Fareston

Orion Corporation
Orionintie 1
FIN-02200 Espoo

EU/1/96/004/001-002

29.12.2003

22.12.2003

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

24.12.2003

9.1.2004

Cystagon

Orphan Europe
Immeuble ‘Le Guillaumet’
F-92046 Paris

EU/1/97/039/001-004

13.1.2004

9.1.2004

MabCampath

9.1.2004

Pritor

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

Glaxo Group Ltd
Greenford
Middlesex UB6 0NN
United Kingdom

EU/1/01/193/001

14.1.2004

EU/1/98/089/001-016

13.1.2004

9.1.2004

Micardis

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

EU/1/98/090/001-014

13.1.2004

9.1.2004

Kinzalmono

Bayer AG
D-51368 Leverkusen

EU/1/98/091/001-014

13.1.2004

12.1.2004

Avonex

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

EU/1/97/033/001-003

14.1.2004

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

C 44/4

EN

Official Journal of the European Union

20.2.2004

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

14.1.2004

Mabthera

14.1.2004

Trazec

14.1.2004

PEGASYS

14.1.2004

Combivir

14.1.2004

Starlix

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

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

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

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

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

EU/1/98/067/001-002

16.1.2004

EU/1/01/175/001-021

16.1.2004

EU/1/02/221/001-008

16.1.2004

EU/1/98/058/001-002

16.1.2004

EU/1/01/174/001-021

16.1.2004

14.1.2004

Viread

Gilead Sciences International Limited
Cambridge CB1 6GT
United Kingdom

EU/1/01/200/001

16.1.2004

14.1.2004

TRIZIVIR

Glaxo Group Ltd
Greenford
Middlesex UB6 0NN
United Kingdom

EU/1/00/156/001-003

16.1.2004

14.1.2004

Visudyne

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

EU/1/00/140/001

16.1.2004

14.1.2004

GONAL-f

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

EU/1/95/001/032

16.1.2004

20.2.2004

EN

Official Journal of the European Union

C 44/5

— Suspension of a marketing authorization (Article 18 of Regulation (EEC) No 2309/93)

Date of the
decision

Name of the
medicinal product

Holder of the
marketing authorization

14.1.2004

Tasmar

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

Number of the
entry in the
Community Register

Date of
notification

EU/1/97/044

16.1.2004

— 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

9.1.2004

Nobilis OR inac

Intervet International BV
Wim de Körverstraat 35
5831 AN Boxmeer
Nederland

Number of the
entry in the
Community Register

Date of
notification

EU/2/02/036/001-002

13.1.2004

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

Non-opposition to a notified concentration

(Case COMP/M.3362 — RBS/BSCH/Britax)

(2004/C 44/04)

(Text with EEA relevance)

On 4 February 2004, the Commission decided not to oppose the above notified concentration and to
declare it compatible with the common market. This decision is based on Article 6(1)(b) of Council
Regulation (EEC) No 4064/89. The full text of the decision is only available in English and will be
made public after it is cleared of any business secrets it may contain. It will be available:

— as a paper version through the sales offices of the Office for Official Publications of the European

Communities (see list on the last page),

— in electronic form in the ‘CEN’ version of the CELEX database, under document No 304M3362. CELEX

is the computerised documentation system of European Community law.

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