Summary of Community decisions on marketing authorizations in respect of medicinal products from  1 November 2005  to  19 November 2005 (Published pursuant to Article 12 or Article 34 of Council Regulation (EEC) No 2309/93)
Date: 2005-12-30
Institutions: European Commission
Subjects: market approval, medicinal product, pharmaceutical legislation

C 334/32

EN

Official Journal of the European Union

30.12.2005

Summary of Community decisions on marketing authorizations in respect of medicinal products
from 1 November 2005 to 19 November 2005

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

(2005/C 334/06)

— 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

7.11.2005

Abilify

Pharmaceutical

Otsuka
Ltd,
Commonwealth House, 2 Chalkhill Road,
Hammersmith, London W6 8DW, United
Kingdom

Europe

EU/1/04/276/001-032

9.11.2005

7.11.2005

Kivexa

Glaxo Group Ltd, Berkeley Avenue,
Greenford, Middlesex UB6 0NN, United
Kingdom

EU/1/04/298/001-002

9.11.2005

7.11.2005

Ziagen

Glaxo Group Ltd, Greenford, Middlesex
UB6 0NN, United Kingdom

EU/1/99/112/001-002

9.11.2005

7.11.2005

Rapamune

Wyeth Europa
Limited, Huntercombe
Lane South, Taplow, Maidenhead, Berk-
shire, SL6 0PH, United Kingdom

EU/1/01/171/001-012

9.11.2005

7.11.2005

Xagrid

Pharmaceutical

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

Contracts

EU/1/04/295/001

9.11.2005

7.11.2005

Emend

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

EU/1/03/262/001-006

9.11.2005

15.11.2005

Levitra

Bayer AG, D-51368 Leverkusen

EU/1/03/248/001-012

18.11.2005

15.11.2005

Cialis -

Lilly ICOS Limited, St Bride's House — 10
Salisbury Square — London EC4Y 8EH —
United Kingdom

EU/1/02/237/001-005

18.11.2005

15.11.2005

Taxotere

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

EU/1/95/002/001-002

18.11.2005

15.11.2005 NeuroBloc

Solstice Neurosciences
House, Wilton Place, Dublin 2, Ireland

Ltd,

Fitzwilton

EU/1/00/166/001-003

21.11.2005

15.11.2005 Vivanza —

Bayer AG, D-51368 Leverkusen

EU/1/03/249/001-012

18.11.2005

15.11.2005 Viagra

Pfizer Limited, Sandwich, Kent CT13 9NJ,
United Kingdom

EU/1/98/077/001-012

18.11.2005

15.11.2005

PegIntron

15.11.2005

CellCept

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

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

EU/1/00/131/001-050

18.11.2005

EU/1/96/005/001-006

18.11.2005

15.11.2005

Ebixa

H. Lundbeck A/S, Ottiliavej 9, DK-2500
Valby

EU/1/02/219/001-013

18.11.2005

15.11.2005 Arava

Aventis Pharma Deutschland GmbH, D-
65926 Frankfurt am Main

EU/1/99/118/001-010

18.11.2005

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

30.12.2005

EN

Official Journal of the European Union

C 334/33

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

15.11.2005 Avandamet

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

EU/1/03/258/001-014

18.11.2005

15.11.2005 Xigris

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

EU/1/02/225/001-002

18.11.2005

15.11.2005

Emtriva

15.11.2005 Viramune

15.11.2005

Tracleer

15.11.2005 Viraferonpeg

Gilead
Cambridge CB1 6GT United Kingdom

International

Sciences

Limited,

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

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

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

EU/1/03/261/001-003

18.11.2005

EU/1/97/055/001-003

18.11.2005

EU/1/02/220/001-005

18.11.2005

EU/1/00/132/001-050

18.11.2005

15.11.2005 Zevalin

Schering AG, Müllerstrasse 170-178, D —
13342 Berlin

EU/1/03/264/001

18.11.2005

15.11.2005 Ariclaim

15.11.2005 Mabthera

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

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

EU/1/04/283/001-007

18.11.2005

EU/1/98/067/001-002

18.11.2005

15.11.2005 Advate

Baxter AG,
Wien

Industriestraße 67, A-1221

EU/1/03/271/001-004

18.11.2005

15.11.2005

Temodal

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

EU/1/98/096/001-008

18.11.2005

15.11.2005

Somavert

Pfizer Limited, Sandwich, Kent, CT13 9NJ,
United Kingdom

EU/1/02/240/001-004

23.11.2005

15.11.2005 Axura

Merz
Ecken-
Pharmaceuticals GmbH,
heimer Landstr. 100-104, D-60318 Frank-
furt/Main

EU/1/02/218/001-011

18.11.2005

16.11.2005 NovoSeven

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

EU/1/96/006/001-003

21.11.2005

16.11.2005

Truvada

Sciences

Gilead
Limited,
Granta Park Abington Cambridge CB1
6GT United Kingdom

International

EU/1/04/305/001

18.11.2005

17.11.2005

Lyrica

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

EU/1/04/279/001-032

18.11.2005

17.11.2005

Integrilin

Glaxo Group Ltd, Berkeley Avenue,
Greenford, Middlesex UB6 0NN, United
Kingdom

EU/1/99/109/001-002

21.11.2005

17.11.2005

Yentreve

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

EU/1/04/280/001-007

21.11.2005

17.11.2005 NeoRecormon

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

EU/1/97/031/001-003
EU/1/97/031/019-046

21.11.2005

17.11.2005 REYATAZ

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

EU/1/03/267/001-007

21.11.2005

C 334/34

EN

Official Journal of the European Union

30.12.2005

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

17.11.2005

Panretin

Innovis
Ligand Pharmaceuticals UK Ltd,
House, 108 High Street, Crawley, West
Sussex RH10 1BB, United Kingdom

EU/1/00/149/001

21.11.2005

17.11.2005 Agenerase

Glaxo Group Ltd, Greenford, Middlesex
UB6 0NN, United Kingdom

EU/1/00/148/001-004

21.11.2005

17.11.2005

Infanrix Hexa

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

EU/1/00/152/001-018

21.11.2005

17.11.2005

Infanrix Penta

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

EU/1/00/153/001-010

21.11.2005

17.11.2005

Emselex

Novartis Europharm Limited, Wimble-
hurst Road, Horsham, West Sussex RH12
5AB, United Kingdom

EU/1/04/294/001-028

21.11.2005

— Suspension of a marketing authorization (Article 18 of Council Regulation (EEC) No 2309/93)

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

17.11.2005 Hexavac

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

EU/1/00/147/001-012

21.11.2005

— 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

17.11.2005

Pruban

Intervet International BV, Wim de Körver-
straat 35, 5831 AN Boxmeer, Nederland

EU/2/00/024/001

21.11.2005

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
London E14 4HB
United Kingdom