Summary of Community decisions on marketing authorisations in respect of medicinal products from 15 November to 15 December 2002 (Published pursuant to Article 12 or Article 34 of Council Regulation (EEC) No 2309/93) (Text with EEA relevance)
Date: 2003-01-07
Institutions: European Commission
Subjects: market approval, marketing, medicinal product

C 2/12

EN

Official Journal of the European Communities

7.1.2003

Summary of Community decisions on marketing authorisations in respect of medicinal products
from 15 November to 15 December 2002

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

(2003/C 2/04)

(Text with EEA relevance)

— 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

20.11.2002 Zavesca

Oxford Glyco Sciences (UK) Ltd
The Forum
86 Milton Park
Abingdon
Oxon OX14 4RY
United Kingdom

Number of
the entry in
the Community Register

Date of
notification

EU/1/02/238/001

21.11.2002

— 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

EU/1/02/219/004-006

21.11.2002

EU/1/96/010/001

21.11.2002

EU/1/98/073/001-004

21.11.2002

EU/1/96/022/001-018

21.11.2002

H. Lundbeck A/S
Ottiliavej 9
DK-2500 Valby

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

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

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

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

EU/1/96/009/001-009

21.11.2002

Eli Lilly UK Ltd
Kingsclere Road
Basingstoke
Hampshire
United Kingdom

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

EU/1/96/021/001-010

21.11.2002

EU/1/99/125/001-004

21.11.2002

20.11.2002

Ebixa

20.11.2002 Rilutek

20.11.2002

Evista

20.11.2002 Zyprexa

20.11.2002 Zerit

20.11.2002 Olansek

20.11.2002 Zyprexa Velotab

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

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Official Journal of the European Communities

C 2/13

Date of
the decision

Name of the
medicinal product

Holder of the marketing
authorisation

20.11.2002 Optison

26.11.2002 ViraferonPeg

26.11.2002

PegIntron

26.11.2002 Actos

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

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

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

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

Number of
the entry in
the Community Register

Date of
notification

EU/1/98/065/001-002

21.11.2002

EU/1/00/132/031-050

28.11.2002

EU/1/00/131/031-050

28.11.2002

EU/1/00/150/001-010

29.11.2002

27.11.2002

Tenecteplase
Boehringer Ingelheim
Pharma KG

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

EU/1/00/168/001-003

29.11.2002

27.11.2002 Metalyse

2.12.2002

Cellcept

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

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

EU/1/00/169/001-003

29.11.2002

EU/1/96/005/001
EU/1/96/005/003

4.12.2002

2.12.2002

Telmisartan
Boehringer Ingelheim
Pharma KG

Bayer AG
D-51368 Leverkusen

EU/1/98/091/001-014

4.12.2002

2.12.2002

Fabrazyme

3.12.2002

NeoRecormon

4.12.2002

Viagra

4.12.2002

Patrex

4.12.2002

SonoVue

Genzyme Europe BV
Gooimeer 10
1411 DD Naarden
Nederland

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

Pfizer Limited
Sandwich
Kent CT13 9NJ
United Kingdom

Pfizer Limited
Sandwich
Kent CT13 9NJ
United Kingdom

Bracco International BV
Strawinskylaan 3051
1077 ZX Amsterdam
Nederland

EU/1/01/188/004-006

4.12.2002

EU/1/97/031/001-013
EU/1/97/031/019-044

5.12.2002

EU/1/98/077/001-012

9.12.2002

EU/1/98/078/001-012

9.12.2002

EU/1/01/177/001-002

9.12.2002

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EN

Official Journal of the European Communities

7.1.2003

Date of
the decision

Name of the
medicinal product

Holder of the marketing
authorisation

4.12.2002

Sustiva

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

Number of
the entry in
the Community Register

Date of
notification

EU/1/99/110/001-009

9.12.2002

4.12.2002

BolusacPlus

Bayer AG
D-51368 Leverkusen

EU/1/02/214/001-010

9.12.2002

5.12.2002

Viramune

5.12.2002

IntronA

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

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

5.12.2002

Kogenate Bayer

5.12.2002

Helixate NexGen

Bayer AG
D-51368 Leverkusen

Bayer AG
D-51368 Leverkusen

5.12.2002

Viraferon

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

EU/1/97/055/001-002

9.12.2002

EU/1/99/127/001-044

9.12.2002

EU/1/00/143/001-003

9.12.2002

EU/1/00/144/001-003

9.12.2002

EU/1/99/128/001-037

9.12.2002

5.12.2002

Lantus

Aventis Pharma Deutschland GmbH
D-65926 Frankfurt am Main

EU/1/00/134/001-012

20.12.2002

5.12.2002

Foscan

5.12.2002

Enbrel

11.12.2002

Pritor

11.12.2002 Cerezyme

11.12.2002 Nyracta

11.12.2002 Avandia

Biolitec Pharma Ltd
Research Avenue South
Heriot-Watt
Research Park
Edinburgh EH14 4AP
United Kingdom

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

Glaxo Group Ltd
Greenford
Middlesex UB6 0NN
United Kingdom

Genzyme Europe BV
Gooimeer 10
1411 DD Naarden
Nederland

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

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

EU/1/01/197/001-002

9.12.2002

EU/1/99/126/001-003

10.12.2002

EU/1/98/089/001-014

13.12.2002

EU/1/97/053/001-005

13.12.2002

EU/1/00/139/001-012

13.12.2002

EU/1/00/137/001-012

13.12.2002

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Official Journal of the European Communities

C 2/15

Date of
the decision

Name of the
medicinal product

Holder of the marketing
authorisation

11.12.2002 Venvia

11.12.2002 Hycamtin

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

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

Number of
the entry in
the Community Register

Date of
notification

EU/1/00/138/001-012

13.12.2002

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

13.12.2002

— 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

11.12.2002

SevoFlo

Abbott Laboratories Ltd
Queenborough
Kent ME11 5EL
United Kingdom

Number of
the entry in
the Community Register

Date of
notification

EU/2/02/035/001-006

13.12.2002

— 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

20.11.2002

Eurifel FeLV

20.11.2002

Eurifel RCP FeLV

20.11.2002 Neocolipor

Merial
17, rue Bourgelat
F-69002 Lyon

Merial
17, rue Bourgelat
F-69002 Lyon

Rhône Mérieux (Merial)
17, rue Bourgelat
F-69002 Lyon

Number of
the entry in
the Community Register

Date of
notification

EU/2/00/019/001-004

21.11.2002

EU/2/02/031/001-002

21.11.2002

EU/2/98/008/001-004

21.11.2002

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.