Summary of Community decisions on marketing authorizations in respect of medicinal products from 1.10.2006 to 31.10.2006 (Published pursuant to Article 13 or Article 38 of Regulation (EC) No 726/2004 of the European Parliament and of the Council)
Date: 2006-11-24
Institutions: European Commission
Subjects: market approval, marketing standard, medicinal product, pharmaceutical legislation

24.11.2006

EN

Official Journal of the European Union

C 287/7

Summary of Community decisions on marketing authorizations in respect of medicinal products
from 1.10.2006 to 31.10.2006

(Published pursuant to Article 13 or Article 38 of Regulation (EC) No 726/2004 of the European Parliament and
of the Council (1))

(2006/C 287/03)

— Modification of a marketing authorization (Article 13 of Regulation (EC) No 726/2004 of the

European Parliament and of the Council): 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

4.10.2006

Abilify

4.10.2006

Abilify

6.10.2006

Travatan

11.10.2006

Invirase

17.10.2006

Cetrotide

19.10.2006 Zometa

19.10.2006 Zevalin

20.10.2006 Herceptin

Otsuka Pharmaceutical Europe Ltd
Hunton House
Highbridge Business Park
Oxford Road
Uxbridge
Middlesex UB8 1HU
United Kingdom

Otsuka Pharmaceutical Europe Ltd
Hunton House
Highbridge Business Park
Oxford Road
Uxbridge
Middlesex UB8 1HU
United Kingdom

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

Roche Registration Limited
6 Falcon Way
Shire Park
Welwyn Garden City AL7 1TW
United Kingdom

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

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

Schering AG
Müllerstrasse 170-178
D-13342 Berlin

Roche Registration Limited
6 Falcon Way
Shire Park
Welwyn Garden City AL7 1TW
United Kingdom

(1) OJ L 136 of 30 April 2004, page 1

EU/1/04/276/036

6.10.2006

EU/1/04/276/036

6.10.2006

EU/1/01/199/001-002

10.10.2006

EU/1/96/026/001-002

13.10.2006

EU/1/99/100/001-003

19.10.2006

EU/1/01/176/001-006

23.10.2006

EU/1/03/264/001

23.10.2006

EU/1/00/145/001

24.10.2006

C 287/8

EN

Official Journal of the European Union

24.11.2006

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

20.10.2006

PritorPlus

Bayer HealthCare AG
D-51368 Leverkusen

EU/1/02/215/001-012

24.10.2006

20.10.2006

Enbrel

20.10.2006

Caelyx

20.10.2006 Avonex

20.10.2006

Faslodex

20.10.2006 ViraferonPeg

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

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

Biogen Idec Ltd
5 Roxborough Way
Foundation Park
Maidenhead
Berkshire SL6 3UD
United Kingdom

AstraZeneca UK Limited
Alderley Park
Macclesfield
Cheshire SK10 4TG
United Kingdom

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

EU/1/99/126/001-018

24.10.2006

EU/1/96/011/001-004

24.10.2006

EU/1/97/033/001-003

24.10.2006

EU/1/03/269/001

24.10.2006

EU/1/00/132/001-050

24.10.2006

23.10.2006

Taxotere

Aventis Pharma S.A., 20 Avenue
Raymond Aron, Antony Cedex 92165,
France

EU/1/95/002/001-002

25.10.2006

23.10.2006

PhotoBarr

23.10.2006 Dynepo

24.10.2006

PegIntron

24.10.2006 AVANDIA

Axcan Pharma International BV
Engelenkampstraat 72
6131 JJ Sittard
Nederland

Shire Pharmaceutical Contracts Ltd
Hampshire International Business Park
Chineham
Basingstoke
Hampshire RG24 8EP
United Kingdom

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

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

EU/1/04/272/001-002

25.10.2006

EU/1/02/211/001-005

26.10.2006

EU/1/00/131/001-050

25.10.2006

EU/1/00/137/002-018

26.10.2006

24.11.2006

EN

Official Journal of the European Union

C 287/9

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

24.10.2006 Aclasta

24.10.2006

Prometax

24.10.2006

Invanz

24.10.2006 Apidra

24.10.2006

Fuzeon

24.10.2006 Avandamet

26.10.2006

Ketek

26.10.2006

Levviax

26.10.2006 Actos

26.10.2006 Glustin

26.10.2006

Sustiva

26.10.2006

Stocrin

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

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

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

Sanofi-Aventis Deutschland GmbH
Brueningstrasse, 50
D-65926 Frankfurt am Main

Roche Registration Limited
6 Falcon Way
Shire Park
Welwyn Garden City AL7 1TW
United Kingdom

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

Aventis Pharma S.A.
20 Avenue Raymond Aron
F-92160 Antony

Aventis Pharma S.A.
20 Avenue Raymond Aron
F-92160 Antony

Takeda Global Research and Development
Centre (Europe) Ltd, Arundel Great Court
2 Arundel Street
London WC2R 3DA
United Kingdom

Takeda Global Research and Development
Centre (Europe) Ltd
Arundel Great Court
2 Arundel Street
London WC2R 3DA
United Kingdom

Bristol-Myers Squibb Pharma EEIG
Uxbridge Business Park
Sanderson Road
Uxbridge UD8 1DH
United Kingdom

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

EU/1/05/308/001-002

26.10.2006

EU/1/98/092/001-018

26.10.2006

EU/1/02/216/001-002

26.10.2006

EU/1/04/285/013-020

26.10.2006

EU/1/03/252/001-003

26.10.2006

EU/1/03/258/001-022

26.10.2006

EU/1/01/191/001-005

30.10.2006

EU/1/01/192/001-005

30.10.2006

EU/1/00/150/001-024

30.10.2006

EU/1/00/151/001-022

30.10.2006

EU/1/99/110/001-009

30.10.2006

EU/1/99/111/001-009

30.10.2006

C 287/10

EN

Official Journal of the European Union

24.11.2006

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

26.10.2006

Exelon

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

EU/1/98/066/001-018

30.10.2006

26.10.2006 Helixate
NexGen

Bayer AG
D-51368 Leverkusen,

EU/1/00/144/001-003

30.10.2006

26.10.2006 Vfend

27.10.2006

Pritor

27.10.2006 Ariclaim

27.10.2006 Rebetol

27.10.2006 Remicade

27.10.2006 Avaglim

EU/1/02/212/001-026

30.10.2006

EU/1/98/089/001-019

31.10.2006

EU/1/04/283/001-007

31.10.2006

Pfizer Limited, Sandwich
Kent CT13 9NJ
United Kingdom

Bayer HealthCare AG
D-51368 Leverkusen

Eli Lilly Nederland B.V.
Grootslag 1-5
3991 RA Houten
Nederland
Boehringer Ingelheim International GmbH
Binger Strasse 173
D-55216 Ingelheim am Rhein

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

Centocor B.V.
Einsteinweg 101
2333 CB Leiden
Nederland

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

EU/1/99/107/001-005

31.10.2006

EU/1/99/116/001-003

31.10.2006

EU/1/06/349/001-008

31.10.2006

27.10.2006 Viramune

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

EU/1/97/055/001-003

31.10.2006

27.10.2006

Invirase

27.10.2006

Tracleer

30.10.2006

FOSAVANCE

30.10.2006

Lyrica

Roche Registration Limited
6 Falcon Way
Shire Park
Welwyn Garden City AL7 1TW
United Kingdom

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

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

PFIZER Ltd, Ramsgate Road
Sandwich
Kent CT 13 9NJ
United Kingdom

EU/1/96/026/001-002

31.10.2006

EU/1/02/220/001-005

31.10.2006

EU/1/05/310/001-005

1.11.2006

EU/1/04/279/001-035

1.11.2006

24.11.2006

EN

Official Journal of the European Union

C 287/11

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

30.10.2006 NutropinAq

IPSEN Limited, 190 Bath Road
Slough, Berkshire SLI 3XE
United Kingdom

30.10.2006

Keppra

30.10.2006 Noxafil

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

SP Europe
Rue de Stalle, 73
B-1180 Bruxelles
Stallestraat 73
B-1180 Brussel

30.10.2006

Posaconazole
SP

SP Europe
Rue de Stalle 73
B-1180 Bruxelles
Stallestraat 73 — B-1180 Brussel

30.10.2006 Nespo

30.10.2006 Aranesp

31.10.2006

Lantus

31.10.2006

Insuman

31.10.2006 Optruma

31.10.2006

Evista

31.10.2006

Telzir

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

Amgen Europe B.V.
Minervum 7061
4817 ZK Breda
Nederland

Sanofi-Aventis Deutschland GmbH
D-65926 Frankfurt am Main

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

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

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

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

EU/1/00/164/003-005

1.11.2006

EU/1/00/146/001-030

3.11.2006

EU/1/05/320/001

2.11.2006

EU/1/05/321/001

2.11.2006

EU/1/01/184/001-068

2.11.2006

EU/1/01/185/001-068

1.11.2006

EU/1/00/134/001-037

14.11.2006

EU/1/97/030/065-084

6.11.2006

EU/1/98/074/001-004

6.11.2006

EU/1/98/073/001-004

6.11.2006

EU/1/04/282/001-002

7.11.2006

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
London E14 4HB
United Kingdom