Summary of Community decisions on marketing authorizations in respect of medicinal products from 15 September 2003 to 15 October 2003 (Published pursuant to Article 12 or Article 34 of Council Regulation (EEC) No 2309/93)
Date: 2003-10-31
Institutions: European Commission
Subjects: market approval, marketing standard, medicinal product, pharmaceutical legislation

C 262/2

EN

Official Journal of the European Union

31.10.2003

Summary of Community decisions on marketing authorizations in respect of medicinal products
from 15 September 2003 to 15 October 2003

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

(2003/C 262/02)

— 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

16.9.2003

Ventavis

Schering AG
Müllerstraße 170—178
D-13342 Berlin

EU/1/03/255/001-003

18.9.2003

— 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

16.9.2003

BeneFix

16.9.2003

Emadine

16.9.2003

Prevenar

16.9.2003

Zerene

16.9.2003

Glustin

16.9.2003

Somavert

16.9.2003

Actos

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

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

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

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

Wyeth Research (UK) Ltd
Huntercombe Lane South
Taplow
Maidenhead
Berkshire SL6 0PH
United Kingdom

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

Pharmacia Enterprises SA
6, circuit de la Foire Internationale
BP 2507
L-1347 Luxembourg

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

EU/1/97/047/001-003

18.9.2003

EU/1/98/095/001-002

18.9.2003

EU/1/00/167/001-007

18.9.2003

EU/1/99/099/001-006

18.9.2003

EU/1/00/151/009-013

18.9.2003

EU/1/02/240/004

18.9.2003

EU/1/00/150/011-015

18.9.2003

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Official Journal of the European Union

C 262/3

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

16.9.2003

Sonata

16.9.2003

Infanrix HepB

16.9.2003

NeuroBloc

16.9.2003

Infanrix penta

16.9.2003

Vfend

22.9.2003

Prometax

22.9.2003

Protopy

22.9.2003

Protopic

22.9.2003

Luveris

22.9.2003

Daquiran

22.9.2003

Tracleer

22.9.2003

Visudyne

2.10.2003

Karvezide

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

GlaxoSmithKline Biologicals SA
Rue de l'Institut 89
B-1330 Rixensart

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

GlaxoSmithKline Biologicals SA
Rue de l'Institut 89
B-1330 Rixensart

Pfizer Limited
Sandwich
Kent CT13 9NJ
United Kingdom

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

Fujisawa GmbH
Neumarkter Straße 61
D-81673 München

Fujisawa GmbH
Neumarkter Straße 61
D-81673 München

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

Dr. Karl Thomae GmbH
Birkendorfferstraße 65
D-88397 Biberach/Riss

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

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

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

EU/1/99/102/001-008

18.9.2003

EU/1/97/048/001-014

18.9.2003

EU/1/00/166/001-003

18.9.2003

EU/1/00/153/001-010

18.9.2003

EU/1/02/212/001-024

18.9.2003

EU/1/98/092/001-013

24.9.2003

EU/1/02/202/001-006

24.9.2003

EU/1/02/201/001-006

24.9.2003

EU/1/00/155/001-006

24.9.2003

EU/1/97/052/001-006
EU/1/97/052/009-010

24.9.2003

EU/1/02/220/001-005

24.9.2003

EU/1/00/140/001

24.9.2003

EU/1/98/085/001-010

6.10.2003

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Official Journal of the European Union

31.10.2003

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

2.10.2003

Coaprovel

2.10.2003

ViraferonPeg

2.10.2003

Pegintron

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

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

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

EU/1/98/086/001-010

6.10.2003

EU/1/99/132/001-050

6.10.2003

EU/1/00/131/001-050

6.10.2003

2.10.2003

INOmax

AGA AB
S-181 81 Lidingö

EU/1/01/194/001-002

6.10.2003

2.10.2003

Sifrol

3.10.2003

Crixivan

3.10.2003

Evra

3.10.2003

Tritanrix HepB

3.10.2003

Replagal

3.10.2003

Rebetol

3.10.2003

Cotronak

3.10.2003

Ferriprox

8.10.2003

Prandin

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

EU/1/97/050/001-006
-009-012

6.10.2003

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

Janssen-Cilag International NV
Turnhoutseweg 30
B-2340 Beerse

GlaxoSmithKline Biologicals SA
Rue de l'Institut 89
B-1330 Rixensart

TKT Europe-5S AB
Rinkebyvägen 11B
S-182 36 Danderyd

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

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

Apotex Europe Ltd
Rowan House
41 London Street
Reading
Berkshire RG1 4PS
United Kingdom

Novo Nordisk A/S
Novo Allé
DK-2880 Bagsværd

EU/1/96/024/010

7.10.2003

EU/1/02/223/001-003

7.10.2003

EU/1/96/014/001-003

7.10.2003

EU/1/01/189/001-003

8.10.2003

EU/1/99/107/001-003

7.10.2003

EU/1/99/106/001-003

7.10.2003

EU/1/99/108/001

7.10.2003

EU/1/00/162/001-018

10.10.2003

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C 262/5

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

8.10.2003

Levviax

8.10.2003

Ketek

8.10.2003

Xenical

8.10.2003

Zavesca

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

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

EU/1/01/192/001-004

10.10.2003

EU/1/01/191/001-004

10.10.2003

EU/1/98/071/001-006

10.10.2003

EU/1/02/238/001

10.10.2003

8.10.2003

Avonex

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

EU/1/97/033/003

10.10.2003

8.10.2003

NovoMix 30

8.10.2003

NovoNorm

8.10.2003

Xenical

8.10.2003

Iscover

8.10.2003

Taxotere

8.10.2003

Trisenox

8.10.2003

NovoSeven

8.10.2003

Plavix

Novo Nordisk A/S
Novo Allé
DK-2880 Bagsværd

Novo Nordisk A/S
Novo Allé
DK-2880 Bagsværd

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

EU/1/00/142/009-010

10.10.2003

EU/1/98/076/001-002,
004-009, 011-016,
018-021

10.10.2003

EU/1/98/071/001-006

10.10.2003

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

EU/1/98/070-001a-001b,
002a-002b, 003a-003b,
004a-004b

10.10.2003

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

Cell Therapeutics (UK) Limited
1 Ropemaker Street
London EC2Y 9HT
United Kingdom

Novo Nordisk A/S
Novo Allé
DK-2880 Bagsværd

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

EU/1/95/002/001-002

10.10.2003

EU/1/02/204/001

10.10.2003

EU/1/96/006/001

10.10.2003

EU/1/98/069/001a-001b,
002a-002b, 003a-003b,
004a-004b

10.10.2003

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31.10.2003

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

8.10.2003

Zyprexa Velotab

8.10.2003

Zyprexa

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

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

EU/1/99/125/001-004

10.10.2003

EU/1/96/022/001-018

10.10.2003

— 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

18.9.2003

Porcilis AR-T-DF

22.9.2003

Ibraxion

8.10.2003

Metacam

8.10.2003

Metacam

Intervet International BV
Wim de Körverstraat 35
5831 AN Boxmeer
Nederland

Merial
29, avenue Tony Garnier
F-69007 Lyon

Boehringer Ingelheim
Vetmedica GmbH
D-55216 Ingelheim am Rhein

Boehringer Ingelheim
Vetmedica GmbH
D-55216 Ingelheim am Rhein

EU/2/00/026/001-004

22.9.2003

EU/2/99/017/001-006

23.9.2003

EU/2/97/004/006

10.10.2003

EU/2/97/004/009

10.10.2003

8.10.2003

Eurifel RCP
FeLV

Merial
17, rue Bourgelat
F-69002 Lyon

EU/2/00/031/001-002

10.10.2003

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.