Summary of Community decisions on marketing authorizations in respect of medicinal products from 1 September 2005 to 30 September 2005(Published pursuant to Article 12 or Article 34 of Council Regulation (EEC) No 2309/93)
Date: 2005-10-28
Institutions: European Commission
Subjects: market approval, marketing, marketing standard, medicinal product, pharmaceutical legislation, veterinary medicinal product

C 268/2

EN

Official Journal of the European Union

28.10.2005

Summary of Community decisions on marketing authorizations in respect of medicinal products
from 1 September 2005 to 30 September 2005

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

(2005/C 268/02)

— Issuing of a marketing authorization (Article 12 of Council Regulation (EEC) No 2309/93):

Accepted

Date of the
decision

Name of the
medicinal
product

19.9.2005

Tarceva

Holder of the marketing authorization

Number of the entry in the
Community Register

Date of
notification

Roche Registration Limited, 40
Broadwater Road, Welwyn Garden
City, UK-Hertfordshire AL7 3AY

EU/1/05/311/001-003

21.9.2005

— Modification of a marketing authorization (Article 12 of Council 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

5.9.2005

Ventavis

Schering AG, Müllerstraße 170-
178, DE-13342 Berlin

EU/1/03/255//001-003

8.9.2005

5.9.2005

Trazec

Novartis
Europharm Limited,
Wimblehurst Road, Horsham, UK-
West Sussex RH12 5AB

EU/1/01/175/001-021

8.9.2005

5.9.2005

Forsteo

Eli Lilly Nederland B.V., Grootslag
1-5, NL-3991 RA Houten

EU/1/03/247/001-002

7.9.2005

5.9.2005

Starlix

Novartis
Europharm Limited,
Wimblehurst Road, Horsham, UK-
West Sussex RH12 5AB

EU/1/01/174/001-021

8.9.2005

7.9.2005

DaTSCAN

GE Healthcare Limited, UK-Little
Chalfont Bucks HP7 9NA

EU/1/00/135/001-002

9.9.2005

7.9.2005

Emtriva

7.9.2005

KOGENATE
Bayer

7.9.2005

Helixate
NexGen

Gilead
Limited, UK-Cambridge CB1 6GT

International

Sciences

EU/1/03/261/001-003

9.9.2005

Bayer AG, DE-51368 Leverkusen

EU/1/00/143/001-006

9.9.2005

Bayer AG, DE-51368 Leverkusen

EU/1/00/144/001-003

9.9.2005

8.9.2005

Nespo

Dompé Biotec S.p.A., Via San
Martino, 12, IT-20122 Milano

EU/1/01/184/001-056

13.9.2005

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

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Official Journal of the European Union

C 268/3

Date of the
decision

Name of the
medicinal
product

8.9.2005

Herceptin

Holder of the marketing authorization

Number of the entry in the
Community Register

Date of
notification

Roche Registration Limited, 40
Broadwater Road, Welwyn Garden
City, UK-Hertfordshire AL7 3AY

EU/1/00/145/001

13.9.2005

8.9.2005

Xagrid

Shire
Pharmaceutical Contracts
Ltd, Hampshire International Busi-
ness Park, Chineham, Basingstoke,
UK-Hampshire RG24 8EP

EU/1/04/295/001

13.9.2005

8.9.2005

Kivexa

Group

Glaxo
Berkeley
Avenue, Greenford, UK-Middlesex
UB6 0NN

Ltd,

EU/1/04/298/001-002

13.9.2005

8.9.2005

Ziagen

Glaxo Group Ltd, Greenford, UK-
Middlesex UB6 0NN

EU/1/99/112/001-002

13.9.2005

8.9.2005

Aranesp

Amgen Europe B.V., Minervum
7061, NL-4817 ZK Breda

EU/1/01/185/001-056

13.9.2005

8.9.2005

Karvezide

Bristol-Myers Squibb Pharma EEIG,
Uxbridge Business Park, Sanderson
Road, UK-Uxbridge UD8 1DH

EU/1/98/085/001-020

13.9.2005

8.9.2005

CoAprovel

Sanofi
Squibb
France, FR-75013 Paris

Pharma
SNC, 174 avenue

Bristol-Myers
de

EU/1/98/086/001-020

13.9.2005

8.9.2005

PegIntron

Schering Plough Europe, Rue de
Stalle, 73, BE-1180 Bruxelles —
Stallestraat, 73, BE-1180 Brussel

EU/1/00/131/001-050

13.9.2005

8.9.2005

ViraferonPeg

Schering Plough Europe, Rue de
Stalle, 73, BE-1180 Bruxelles —
Stallestraat, 73, BE-1180 Brussel

EU/1/00/132/001-050

13.9.2005

8.9.2005

Raptiva

Serono Europe Limited, 56, Marsh
Wall, UK-London E14 9TP

EU/1/04/291/001-002

14.9.2005

8.9.2005

Pylobactell

Torbet Laboratories Limited, Unit
14D, Wendover Road, Rackheath
Industrial Estate, Norwich, UK-
Norfolk NR13 6LH

EU/1/98/064/001

13.9.2005

13.9.2005

Infanrix Hexa

GlaxoSmithKline Biologicals S.A.,
l'Institut 89, BE-1330
rue de
Rixensart

EU/1/00/152/001-018

14.9.2005

C 268/4

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Official Journal of the European Union

28.10.2005

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

13.9.2005

Somavert

Pfizer Limited, Sandwich, UK-Kent,
CT13 9NJ

EU/1/02/240/001-004

14.9.2005

13.9.2005

Hepsera

Gilead
Limited, UK-Cambridge CB1 6GT

International

Sciences

EU/1/03/251/001

15.9.2005

13.9.2005

Erbitux

Merck KGaA, Frankfurter Straße
250, DE-64293 Darmstadt

EU/1/04/281/001

14.9.2005

13.9.2005

Dynepo

Shire
Pharmaceutical Contracts
Ltd, Hampshire International Busi-
ness Park, Chineham, Basingstoke,
UK-Hampshire RG24 8EP
Aventis Pharma S.A., 20 Avenue
Raymond Aron, Antony Cedex FR-
92165

EU/1/02/211/001-009

15.9.2005

13.9.2005

Infanrix Penta GlaxoSmithKline Biologicals

EU/1/00/153/001-010

14.9.2005

s.a.,
l'Institut 89, BE-1330

rue de
Rixensart

13.9.2005

Mimpara

Amgen Europe B.V., Minervum
7061, NL-4817 ZK Breda

EU/1/04/292/001-012

14.9.2005

13.9.2005

Avandamet

SmithKline Beecham plc, 980
Great West Road, Brentford, UK-
Middlesex TW8 9GS

EU/1/03/258/013-014

14.9.2005

13.9.2005

Karvea

Bristol-Myers Squibb Pharma EEIG,
141-149 Staines Road, UK-Houn-
slow TW3 3JA

EU/1/97/049/001-030

15.9.2005

13.9.2005

Keppra

13.9.2005

Keppra

13.9.2005

Aprovel

15.9.2005

Hepsera

BE-1070

UCB S.A., Allée de la recherche,
Bruxelles —
60,
BE-1070
60,
Researchdreef,
Brussel

BE-1070

UCB S.A., Allée de la recherche,
Bruxelles —
60,
Researchdreef,
BE-1070
60,
Brussel

Sanofi
Squibb
France, FR-75013 Paris

Pharma
SNC, 174 avenue

Bristol-Myers
de

Gilead
Limited, UK-Cambridge CB1 6GT

International

Sciences

EU/1/00/146/001-029

16.9.2005

EU/1/00/146/001-027

16.9.2005

EU/1/97/046/001-030

15.9.2005

EU/1/03/251/001

20.9.2005

15.9.2005

Cymbalta

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

EU/1/04/296/001-006

20.9.2005

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C 268/5

Date of the
decision

Name of the
medicinal
product

15.9.2005

Ariclaim

Holder of the marketing authorization

Number of the entry in the
Community Register

Date of
notification

Boehringer Ingelheim International
GmbH, Binger Straße 173, DE-
55216 Ingelheim am Rhein

EU/1/04/283/001-007

20.9.2005

15.9.2005

Yentreve

Eli Lilly Nederland B.V., Grootslag
1-5, NL-3991 RA Houten

EU/1/04/280/001-007

20.9.2005

15.9.2005

Xeristar

Boehringer Ingelheim International
GmbH, Binger Straße 173, DE-
55216 Ingelheim am Rhein

EU/1/04/297/001-006

20.9.2005

15.9.2005

Bonviva

Roche Registration Limited, 40
Broadwater Road, Welwyn Garden
City, UK-Hertfordshire AL7 3AY

EU/1/03/265/003-004

20.9.2005

15.9.2005

Bondenza

Roche Registration Limited, 40
Broadwater Road, Welwyn Garden
City, UK-Hertfordshire AL7 3AY

EU/1/03/266/003-004

20.9.2005

15.9.2005

Myocet

Elan Pharma
International Ltd.,
WIL House, Shannon Business
Park, Shannon, IE-County Clare

EU/1/00/141/001

20.9.2005

15.9.2005

NovoMix

Novo Nordisk A/S, Novo Allé, DK-
2880 Bagsvaerd

EU/1/00/142/004-005
EU/1/00/142/009-010

20.9.2005

16.9.2005

REYATAZ

Bristol-Myers Squibb Pharma EEIG,
141-149 Staines Road, UK-Houn-
slow TW3 3JA

EU/1/03/267/001-007

20.9.2005

19.9.2005

Ariclaim

Boehringer Ingelheim International
GmbH, Binger Straße 173, DE-
55216 Ingelheim am Rhein

EU/1/04/283/001-007

21.9.2005

19.9.2005

Arava

Pharma

Aventis
Deutschland
GmbH, DE-65926 Frankfurt am
Main

EU/1/99/118/001-010

21.9.2005

19.9.2005

Yentreve

Eli Lilly Nederland B.V., Grootslag
1-5, NL-3991 RA Houten

EU/1/04/280/001-007

21.9.2005

19.9.2005

Hexavac

Sanofi Pasteur MSD, SNC, 8, rue
Jonas Salk, FR-69007 Lyon

EU/1/00/147/001-012

21.9.2005

22.9.2005

Iscover

Bristol-Myers Squibb Pharma EEIG,
Uxbridge Business Park, Sanderson
Road, UK-Uxbridge UD8 1DH

EU/1/98/070/001a — 001b
EU/1/98/070/002a — 002b
EU/1/98/070/003a — 003b
EU/1/98/070/004a — 001b

26.9.2005

C 268/6

EN

Official Journal of the European Union

28.10.2005

Date of the
decision

Name of the
medicinal
product

22.9.2005

Plavix

Holder of the marketing authorization

Number of the entry in the
Community Register

Date of
notification

Sanofi
Squibb
France, FR-75013 Paris

Pharma
SNC, 174 avenue

Bristol-Myers
de

EU/1/98/069/001a — 001b
EU/1/98/069/002a — 002b
EU/1/98/069/003a — 003b
EU/1/98/069/004a — 001b

26.9.2005

29.9.2005

Remicade

Centocor B.V., Einsteinweg 101,
NL-2333 CB Leiden

EU/1/99/116/001-003

4.10.2005

— Withdrawal of a marketing authorization (Article 12 of Council Regulation (EEC) No 2309/93)

Date of the
decision

Name of the
medicinal
product

22.9.2005

CEA-Scan

Holder of the marketing authorization

Number of the entry in the
Community Register

Date of
notification

Immunomedics
Röhm-Straße
Darmstadt

GmbH, Otto-
DE-64293

69,

EU/1/96/023/001

27.9.2005

— Modification of a marketing authorization (Article 34 of Council 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

19.9.2005

Pirsue

PFIZER Ltd, Ramsgate Road, Sand-
wich, UK-Kent CT13 9NJ

EU/2/00/027/001-003

21.9.2005

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 Medicines Agency
7, Westferry Circus, Canary Wharf
UK-London E14 4HB