Summary of Community decisions on marketing authorizations in respect of medicinal products from 15 June 2003 to 15 July 2003 (Published pursuant to Article 12 or Article 34 of Council Regulation (EEC) No 2309/93)
Date: 2003-07-25
Institutions: European Commission
Subjects: market approval, marketing standard, medicinal product, pharmaceutical legislation, public health

C 176/2

EN

Official Journal of the European Union

25.7.2003

Summary of Community decisions on marketing authorizations in respect of medicinal products
from 15 June 2003 to 15 July 2003

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

(2003/C 176/02)

— Issuing 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

Date of
notification

9.7.2003

Busilvex

Pierre Fabre Médicament
45, place Abel Gance
F-92654 Boulogne Billancourt Cedex

EU/1/03/254/001

11.7.2003

— 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

Date of
notification

13.6.2003

CEA-Scan

24.6.2003

Avonex

25.6.2003

Rebif

25.6.2003

MicardisPlus

25.6.2003

Metalyse

Immunomedics GmbH
Otto-Röhm-Straße 69
D-64293 Darmstadt

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

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

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

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

EU/1/96/023/001

20.6.2003

EU/1/97/033/003

26.6.2003

EU/1/98/063/001-006

27.6.2003

EU/1/02/213/001-010

27.6.2003

EU/1/00/169/001-006

27.6.2003

25.6.2003

Tenecteplase
Boehringer Ingelheim
Pharma GmbH & Co.
KG

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

EU/1/00/168/001-006

27.6.2003

25.6.2003

MabCampath

25.6.2003

Sustiva

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

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

EU/1/01/193/001

27.6.2003

EU/1/99/110/001-003,
EU/1/99/110/005

27.6.2003

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

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Official Journal of the European Union

C 176/3

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

25.6.2003

Stocrin

26.6.2003

Enbrel

26.6.2003

Crixivan

26.6.2003

Optruma

26.6.2003

Tracleer

26.6.2003

Rilutek

26.6.2003

Prometax

26.6.2003

Evista

26.6.2003

Thyrogen

26.6.2003

Aldara

30.6.2003

Viracept

30.6.2003

Exelon

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

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

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

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

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

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

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

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

Genzyme Europe BV
Gooimeer 10
Naarden 1411 DD
Nederland

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

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

EU/1/99/111/001-003,
EU/1/99/111/005

27.6.2003

EU/1/99/126/001-003

30.6.2003

EU/1/96/024/001-010

30.6.2003

EU/1/98/074/001-004

30.6.2003

EU/1/02/220/001-005

30.6.2003

EU/1/96/010/001

30.6.2003

EU/1/98/092/001-013

30.6.2003

EU/1/98/073/001-004

30.6.2003

EU/1/99/122/001-002

3.7.2003

EU/1/98/080/001

30.6.2003

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

3.7.2003

EU/1/98/066/001-013

3.7.2003

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EN

Official Journal of the European Union

25.7.2003

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

30.6.2003

Trizivir

30.6.2003

Synagis

30.6.2003

Fasturtec

30.6.2003

Zerit

30.6.2003

Glivec

30.6.2003

Rapamune

30.6.2003

Ceprotin

30.6.2003

NeoSpect

9.7.2003

Epivir

9.7.2003

Vfend

9.7.2003

Agenerase

9.7.2003

Viread

9.7.2003

Viramune

Glaxo Group Ltd
Greenford
Middlesex UB6 0NN
United Kingdom

Abbott laboratories Ltd
Queenborough
Kent ME11 5EL
United Kingdom

Sanofi Synthelabo
174, avenue de France
F-75013 Paris

EU/1/00/156/001-003

3.7.2003

EU/1/99/117/001-002

3.7.2003

EU/1/00/170/001-002

3.7.2003

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

EU/1/96/009/001-015

3.7.2003

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

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

Baxter AG
Industriesstraße 67
A-1220 Wien

Amersham Health AS
Nycoveien 1-2
PO Box 4220 Nydalen
NO-0401 Oslo

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

Pfizer Limited
Sandwich
Kent CT13 9NJ
United Kingdom

Glaxo Group Ltd
Greenford
Middlesex UB6 0NN
United Kingdom

EU/1/01/198/001-006

3.7.2003

EU/1/01/171/009-010

3.7.2003

EU/1/01/190/001-002

3.7.2003

EU/1/00/154/001-002

3.7.2003

EU/1/96/015/001-005

15.7.2003

EU/1/02/212/001-025

15.7.2003

EU/1/00/148/001-004

15.7.2003

Gilead Sciences International Limited
Cambridge CB1 6GT
United Kingdom

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

EU/1/01/200/001

15.7.2003

EU/1/97/055/001-002

15.7.2003

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Official Journal of the European Union

C 176/5

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

9.7.2003

Levviax

9.7.2003

Ketek

9.7.2003

Fortovase

Aventis Pharma SA
20, Avenue Raymond Aron
F-92160 Antony

Aventis Pharma SA
20, Avenue Raymond Aron
F-92160 Antony

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

EU/1/01/192/001-004

15.7.2003

EU/1/01/191/001-004

15.7.2003

EU/1/98/075/001-002

15.7.2003

9.7.2003

Sustiva

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

EU/1/99/110/001-009

15.7.2003

9.7.2003

Viread

Gilead Sciences International Limited
Cambridge CB1 6GT
United Kingdom

EU/1/01/200/001

15.7.2003

9.7.2003

Invirase

9.7.2003

Stocrin

9.7.2003

Foscan

9.7.2003

Kaletra

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

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

biolitec pharma limited
Research Avenue South
Heriot-Watt Research Park
Edinburgh EH14 4AP
United Kingdom

Abbott laboratories Ltd
Queenborough
Kent ME11 5EL
United Kingdom

EU/1/96/026/001

15.7.2003

EU/1/99/111/001-009

15.7.2003

EU/1/01/197/001-002

15.7.2003

EU/1/01/172/001-003

15.7.2003

10.7.2003

Viread

Gilead Sciences International Limited
Cambridge CB1 6GT
United Kingdom

EU/1/01/200/001

14.7.2003

10.7.2003

Remicade

14.7.2003

Glivec

Centocor BV
Einsteinweg 101
2333 CB Leiden
Nederland

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

EU/1/99/116/001-003

14.7.2003

EU/1/01/198/001-006

16.7.2003

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Official Journal of the European Union

25.7.2003

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

14.7.2003

Renagel

14.7.2003

Norvir

14.7.2003

Refludan

14.7.2003

Ziagen

15.7.2003

Cystagon

15.7.2003

Neurobloc

Genzyme Europe BV
Gooimeer 10
1411 DD Naarden
Nederland

Abbott laboratories Ltd
Queenborough
Kent ME11 5EL
United Kingdom

Schering AG
Müllerstraße 170—178
D-13342 Berlin

Glaxo Group Ltd
Greenford
Middlesex UB6 0NN
United Kingdom

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

Elan Pharma International Ltd
WIL House
Shannon Business Park
Shannon
County Clare
Ireland

EU/1/99/123/001-011

16.7.2003

EU/1/96/016/001,
EU/1/96/016/003

16.7.2003

EU/1/97/035/001-004

16.7.2003

EU/1/99/112/001-002

16.7.2003

EU/1/97/039/001-004

17.7.2003

EU/1/00/166/001-003

17.7.2003

— 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

Number of the entry in
the Community Register

Date of
notification

26.6.2003

Dexdomitor

30.6.2003

Porcilis Pesti

10.7.2003

Nobilis IB 4-91

Orion Corporation
Orionintie 1
FIN-02200 Espoo

Intervet International BV
Wim de Körverstraat 35
5831 AN Boxmeer
Nederland

Intervet International BV
Wim de Körverstraat 35
5831 AN Boxmeer
Nederland

EU/2/02/033/001

30.6.2003

EU/2/99/016/001-006

3.7.2003

EU/2/98/006/001-010

14.7.2003

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.