Summary of Community decisions on marketing authorisations in respect of medicinal products from 15 October 2003 to 15 November 2003 (Published pursuant to Article 12 or Article 34 of Council Regulation (EEC) No 2309/93)
Date: 2003-11-28
Institutions: European Commission
Subjects: market approval, medicinal product

C 285/2

EN

Official Journal of the European Union

28.11.2003

Summary of Community decisions on marketing authorisations in respect of medicinal products
from 15 October 2003 to 15 November 2003

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

(2003/C 285/02)

— 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

17.10.2003

Stalevo

17.10.2003 Onsenal

20.10.2003 Avandamet

24.10.2003

Emtriva

11.11.2003

EMEND

Orion Corporation
Orionintie 1
FIN-02200 Espoo

Pharmacia-Pfizer EEIG
Hillbottom Road
High Wycombe Bucks HP12 4PX
United Kingdom

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

Gilead Sciences
International Limited
Cambridge CB1 6GT
United Kingdom

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

Number of the
entry in the
Community
Register

Date of
notification

EU/1/03/260/001-012

22.10.2003

EU/1/03/259/001-006

22.10.2003

EU/1/03/258/001-006

22.10.2003

EU/1/03/261/001-003

28.10.2003

EU/1/03/262/001-006

13.11.2003

— 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

EU/1/98/081/001-004

22.10.2003

EU/1/98/082/001-004

22.10.2003

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

Orion Corporation
Orionintie 1
FIN-02200 Espoo

Aventis Pharma Deutschland GmbH
D-65926 Frankfurt am Main

EU/1/00/134/005-007
en
EU/1/00/134/013-017

23.10.2003

Gilead Sciences International Limited
Cambridge CB1 6GT
United Kingdom

EU/1/01/200/001

22.10.2003

Abbott Laboratories Ltd
Queenborough
Kent ME11 5EL
United Kingdom

EU/1/99/117/001-002

22.10.2003

17.10.2003 Comtan

17.10.2003 Comtess

17.10.2003

Lantus

17.10.2003 Viread

20.10.2003

Synagis

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

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Official Journal of the European Union

C 285/3

Date of the
decision

Name of the
medicinal
product

Holder of the
marketing
authorisation

20.10.2003

Infergen

20.10.2003 Zenapax

20.10.2003 Remicade

Yamanouchi Europe BV
Elisabethhof 19
2353 EW Leiderdorp
Nederland

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

Centocor BV
Einsteinweg 101
2333 CB Leiden
Nederland

Number of the
entry in the
Community
Register

Date of
notification

EU/1/98/087/001-003

22.10.2003

EU/1/99/098/001-002

22.10.2003

EU/1/99/116/001-003

22.10.2003

20.10.2003 Arava

Aventis Pharma Deutschland GmbH
D-65926 Frankfurt am Main

EU/1/99/118/001-010

23.10.2003

20.10.2003

Somavert

20.10.2003 Cialis

20.10.2003

Foscan

20.10.2003

Simulect

24.10.2003

PegIntron

24.10.2003

Tracleer

24.10.2003 Arixtra

24.10.2003 Quixidar

24.10.2003

Bondromat

Pfizer Limited
Sandwich
Kent CT13 9NJ
United Kingdom

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

EU/1/02/240/001-004

22.10.2003

EU/1/02/237/001-004

22.10.2003

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

EU/1/01/197/001-002

22.10.2003

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

Schering Plough Europe
Rue de Stalle 73
B-1180 Bruxelles

Actelion Registration Ltd
BSI Building 13th Floor
389 Chiswick High Road
London W4 4AL
United Kingdom

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

NV Organon
PO Box 20
Kloosterstraat 6
5340 EB Oss
Nederland

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

EU/1/98/084/001-002

22.10.2003

EU/1/00/131/001-050

28.10.2003

EU/1/02/220/001-005

28.10.2003

EU/1/02/206/005-008

28.10.2003

EU/1/02/207/005-008

29.10.2003

EU/1/96/012/009-010

28.10.2003

C 285/4

EN

Official Journal of the European Union

28.11.2003

Date of the
decision

Name of the
medicinal
product

Holder of the
marketing
authorisation

24.10.2003 Ovitrelle

24.10.2003 Zerit

24.10.2003 Aldara

24.10.2003 Zyprexa Velotab

24.10.2003 ViraferonPeg

24.10.2003

Enbrel

24.10.2003 Vfend

24.10.2003

Travatan

24.10.2003 Zyprexa

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

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

3M Santé
Boulevard de l'Oise
F-95029 Cergy Pontoise Cedex

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

Schering Plough Europe
Rue de Stalle 73
B-1180 Bruxelles

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

Pfizer Limited
Sandwich
Kent CT13 9NJ
United Kingdom

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

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

Number of the
entry in the
Community
Register

Date of
notification

EU/1/00/165/007

28.10.2003

EU/1/96/009/001-009

28.10.2003

EU/1/98/080/001

28.10.2003

EU/1/99/125/001-004

28.10.2003

EU/1/00/132/001-050

28.10.2003

EU/1/99/126/003

28.10.2003

EU/1/02/212/001-025

28.10.2003

EU/1/01/199/001-002

28.10.2003

EU/1/96/022/001-018

28.10.2003

24.10.2003

Insuman

Aventis Pharma Deutschland GmbH
Brüningstraße 50
D-65926 Frankfurt am Main

EU/1/97/030/028-084

29.10.2003

31.10.2003

Bondronat

7.11.2003

Liprolog

7.11.2003

Tamiflu

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

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

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

EU/1/96/012/011-013

7.11.2003

EU/1/01/195/001-015

11.11.2003

EU/1/02/222/001-002

11.11.2003

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Official Journal of the European Union

C 285/5

Date of the
decision

Name of the
medicinal
product

Holder of the
marketing
authorisation

7.11.2003

Quixidar

7.11.2003

Liprolog

7.11.2003

Bondronat

7.11.2003

Arixtra

11.11.2003 Viagra

11.11.2003 Glivec

11.11.2003 Humalog

NV Organon
PO Box 20
Kloosterstraat 6
5340 EB Oss
Nederland

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

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

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

Pfizer Limited
Sandwich
Kent CT13 9NJ
United Kingdom

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

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

Number of the
entry in the
Community
Register

Date of
notification

EU/1/02/207/001-004

11.11.2003

EU/1/01/195/001-002,
EU/1/01/195/005,
EU/1/01/195/008-010
en EU/1/01/195/013

11.11.2003

EU/1/96/012/001-008

11.11.2003

EU/1/02/206/001-004

12.11.2003

EU/1/98/077/001-012

13.11.2003

EU/1/01/198/007-010

13.11.2003

EU/1/96/007/001-008
en
EU/1/96/007/010-028

13.11.2003

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

Rejected

Date of the
decision

Name of the
medicinal
product

Holder of the
marketing
authorisation

12.11.2003 Avonex

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

Number of the
entry in the
Community
Register

Date of
notification

EU/1/97/033/001-002

14.11.2003

— 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

11.11.2003 Draxxin

Pfizer Ltd
Ramsgate Road
Sandwich
Kent CT 13 9NJ
United Kingdom

Number of the
entry in the
Community
Register

Date of
notification

EU/2/03/041/001-005

13.11.2003

C 285/6

EN

Official Journal of the European Union

28.11.2003

— 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

17.10.2003 Gallivac HVT IBD

17.10.2003

EurifelFeLV

17.10.2003

ProteqFlu

17.10.2003

Proteqflu-Te

20.10.2003 Neocolipor

20.10.2003

Eurican Herpes 205

Merial
29, avenue Tony Garnier
F-69007 Lyon

Merial
29, avenue Tony Garnier
F-69007 Lyon

Merial
Laboratoire Porte des Alpes
rue de l'Aviation
F-69800 Saint-Priest

Merial
Laboratoire Porte des Alpes
rue de l'Aviation
F-69800 Saint-Priest

Merial
29, avenue Tony Garnier
F-69007 Lyon

Merial
29, avenue Tony Garnier
F-69007 Lyon

Number of the
entry in the
Community
Register

Date of
notification

EU/2/02/032/001

23.10.2003

EU/2/00/019/001-003

23.10.2003

EU/2/03/037/001-004

23.10.2003

EU/2/03/038/001-004

23.10.2003

EU/2/98/008/001-004

23.10.2003

EU/2/01/029/001-003

23.10.2003

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.

Summary of Community decisions on marketing authorisations in respect of medicinal products
from 15 October 2003 to 15 November 2003

(Decisions taken pursuant to Article 34 of Directive 2001/83/EC (1) or Article 38 of Directive 2001/82/EC (2))

— Issuing, maintenance or modification of a national marketing authorisation

(2003/C 285/03)

Date of the decision

Name(s) of the
medicinal product

Holder(s) of the marketing
authorisation

Member State concerned

Date of
notification

17.10.2003

Isotretinoin

See Annex I

See Annex I

22.10.2003

17.10.2003

Isotretinoin
(Roaccutane)

See Annex II

See Annex II

21.10.2003

(1) OJ L 311, 28.11.2001, p. 67.
(2) OJ L 311, 28.11.2001, p. 1.