Summary of Community decisions on marketing authorisations in respect of medicinal products from 15 January to 15 February 2003 (Published pursuant to Article 12 or Article 34 of Council Regulation (EEC) No 2309/93)
Date: 2003-02-28
Institutions: European Commission
Subjects: market approval, marketing, medicinal product

28.2.2003

EN

Official Journal of the European Union

C 48/11

Summary of Community decisions on marketing authorisations in respect of medicinal products
from 15 January to 15 February 2003

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

(2003/C 48/04)

— 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

24.1.2003

Carbaglu

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

EU/1/02/246/001-002

28.1.2003

— 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

6.12.2002

Prevenar

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

EU/1/00/167/001-007

10.12.2002

16.1.2003

Rebif

16.1.2003

Karvea

23.1.2003

Neupopeg

23.1.2003

Cialis

23.1.2003

Metalyse

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

EU/1/98/063/001-006

20.1.2003

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

EU/1/97/049/001-015

20.1.2003

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

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

EU/1/02/228/001

27.1.2003

EU/1/02/237/001-004

27.1.2003

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

EU/1/00/169/001-006

27.1.2003

24.1.2003

Tenecteplase
Boehringer Ingelheim
Pharma KG

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

EU/1/00/168/001-006

27.1.2003

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

C 48/12

EN

Official Journal of the European Union

28.2.2003

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

24.1.2003

Taxotere

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

EU/1/95/002/001-002

27.1.2003

24.1.2003

Fabrazyme

28.1.2003

Replagal

28.1.2003

Rapamune

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

EU/1/01/188/001-006

27.1.2003

EU/1/01/189/001-003

30.1.2003

EU/1/01/171/001-010

30.1.2003

31.1.2003

Helixate
NexGen

Bayer AG
D-51368 Leverkusen

EU/1/00/144/001-003

4.2.2003

31.1.2003

Kogenate Bayer

Bayer AG
D-51368 Leverkusen

EU/1/00/143/001-003

4.2.2003

31.1.2003

Optruma

31.1.2003

Inductos

3.2.2003

Viracept

3.2.2003

Micardis

3.2.2003

Iscover

3.2.2003

Plavix

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

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

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

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

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

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

EU/1/98/074/001-004

4.2.2003

EU/1/02/226/001

4.2.2003

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

5.2.2003

EU/1/98/090/001-014

5.2.2003

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

5.2.2003

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

5.2.2003

28.2.2003

EN

Official Journal of the European Union

C 48/13

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

3.2.2003

Synagis

3.2.2003

Zavesca

3.2.2003

BeneFIX

6.2.2003

Viread

6.2.2003

Hycamtin

14.2.2003

Travatan

14.2.2003

Keppra

14.2.2003

Evista

14.2.2003

Optruma

Abbott Laboratories Ltd
Queenborough
Kent ME11 5EL
United Kingdom

Actelion Registration Ltd
90 Fetter Lane (ground floor)
London EC4A 7JP
United Kingdom

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

Gilead Sciences International Ltd
Cambridge CB1 6GT
United Kingdom

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

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

UCB SA
Allée de la recherche 60
B-1070 Bruxelles

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

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

EU/1/99/117/001-002

5.2.2003

EU/1/02/238/001

5.2.2003

EU/1/97/047/001-003

5.2.2003

EU/1/01/200/001

10.2.2003

EU/1/96/027/001,
EU/1/96/027/003-005

10.2.2003

EU/1/01/199/001-002

18.2.2003

EU/1/00/146/001-026

18.2.2003

EU/1/98/073/001-004

18.2.2003

EU/1/98/074/001-004

18.2.2003

14.2.2003

Arava

Aventis Pharma Deutschland GmbH
D-65926 Frankfurt am Main

EU/1/99/118/003-004,
EU/1/99/118/007-008,
EU/1/99/118/010

18.2.2003

— 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

24.1.2003

Nobilis OR inac

Intervet International BV
Wim de Körverstraat 35
5831 AN Boxmeer
Nederland

EU/2/02/036/001-002

28.1.2003

C 48/14

EN

Official Journal of the European Union

28.2.2003

— 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

14.2.2003

Eurican
Herpes 205

14.2.2003

Eurifel RCP
FelV

14.2.2003

Ibraxion

Merial
17, rue Bourgelat
F-69002 Lyon

Merial
17, rue Bourgelat
F-69002 Lyon

Merial
17, rue Bourgelat
F-69002 Lyon

EU/2/01/029/001-003

18.2.2003

EU/2/02/031/001-002

18.2.2003

EU/2/99/017/001-006

18.2.2003

14.2.2003

Suvaxyn
Aujeszky 783
+O/W

Fort Dodge Animal Health Holland
C. J. van Houtenlaan 36
1381 CP Weesp
Nederland

EU/2/98/009/001-006

18.2.2003

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.3027 — State Street Corporation/Deutsche Bank Global Securities)

(2003/C 48/05)

(Text with EEA relevance)

On 16 January 2003, 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 303M3027. CELEX

is the computerised documentation system of European Community law.

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