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Document 52006XC1124(02)

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)

OJ C 287, 24.11.2006, p. 7–11 (ES, CS, DA, DE, ET, EL, EN, FR, IT, LV, LT, HU, NL, PL, PT, SK, SL, FI, SV)

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

Otsuka Pharmaceutical Europe Ltd

Hunton House

Highbridge Business Park

Oxford Road

Uxbridge

Middlesex UB8 1HU

United Kingdom

EU/1/04/276/036

6.10.2006

4.10.2006

Abilify

Otsuka Pharmaceutical Europe Ltd

Hunton House

Highbridge Business Park

Oxford Road

Uxbridge

Middlesex UB8 1HU

United Kingdom

EU/1/04/276/036

6.10.2006

6.10.2006

Travatan

Alcon Laboratories (UK) Ltd.

Boundary Way

Hemel Hempstead

Herts HP2 7UD

United Kingdom

EU/1/01/199/001-002

10.10.2006

11.10.2006

Invirase

Roche Registration Limited

6 Falcon Way

Shire Park

Welwyn Garden City AL7 1TW

United Kingdom

EU/1/96/026/001-002

13.10.2006

17.10.2006

Cetrotide

Serono Europe Ltd.

56, Marsh Wall

London E14 9TP

United Kingdom

EU/1/99/100/001-003

19.10.2006

19.10.2006

Zometa

Novartis Europharm Limited

Wimblehurst Road

Horsham

West Sussex RH12 5AB

United Kingdom

EU/1/01/176/001-006

23.10.2006

19.10.2006

Zevalin

Schering AG

Müllerstrasse 170-178

D-13342 Berlin

EU/1/03/264/001

23.10.2006

20.10.2006

Herceptin

Roche Registration Limited

6 Falcon Way

Shire Park

Welwyn Garden City AL7 1TW

United Kingdom

EU/1/00/145/001

24.10.2006

20.10.2006

PritorPlus

Bayer HealthCare AG

D-51368 Leverkusen

EU/1/02/215/001-012

24.10.2006

20.10.2006

Enbrel

Wyeth Europa Limited

Huntercombe Lane South

Taplow

Maidenhead

Berkshire, SL6 0PH

United Kingdom

EU/1/99/126/001-018

24.10.2006

20.10.2006

Caelyx

Schering Plough Europe

Rue de Stalle 73

B-1180 Bruxelles

Stallestraat 73

B-1180 Brussel

EU/1/96/011/001-004

24.10.2006

20.10.2006

Avonex

Biogen Idec Ltd

5 Roxborough Way

Foundation Park

Maidenhead

Berkshire SL6 3UD

United Kingdom

EU/1/97/033/001-003

24.10.2006

20.10.2006

Faslodex

AstraZeneca UK Limited

Alderley Park

Macclesfield

Cheshire SK10 4TG

United Kingdom

EU/1/03/269/001

24.10.2006

20.10.2006

ViraferonPeg

Schering Plough Europe

Rue de Stalle, 73

B-1180 Bruxelles

Stallestraat 73

B-1180 Brussel

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

Axcan Pharma International BV

Engelenkampstraat 72

6131 JJ Sittard

Nederland

EU/1/04/272/001-002

25.10.2006

23.10.2006

Dynepo

Shire Pharmaceutical Contracts Ltd

Hampshire International Business Park

Chineham

Basingstoke

Hampshire RG24 8EP

United Kingdom

EU/1/02/211/001-005

26.10.2006

24.10.2006

PegIntron

Schering Plough Europe

Rue de Stalle, 73

B-1180 Bruxelles

Stallestraat 73

B-1180 Brussel

EU/1/00/131/001-050

25.10.2006

24.10.2006

AVANDIA

SmithKline Beecham plc

980 Great West Road

Brentford

Middlesex TW8 9GS

United Kingdom

EU/1/00/137/002-018

26.10.2006

24.10.2006

Aclasta

Novartis Europharm Limited

Wimblehurst Road

Horsham West

Sussex RH12 5AB

United Kingdom

EU/1/05/308/001-002

26.10.2006

24.10.2006

Prometax

Novartis Europharm Limited

Wimblehurst Road

Horsham West

Sussex RH12 5AB

United Kingdom

EU/1/98/092/001-018

26.10.2006

24.10.2006

Invanz

Merck Sharp & Dohme Ltd

Hertford Road

Hoddesdon

Hertfordshire EN11 9BU

United Kingdom

EU/1/02/216/001-002

26.10.2006

24.10.2006

Apidra

Sanofi-Aventis Deutschland GmbH

Brueningstrasse, 50

D-65926 Frankfurt am Main

EU/1/04/285/013-020

26.10.2006

24.10.2006

Fuzeon

Roche Registration Limited

6 Falcon Way

Shire Park

Welwyn Garden City AL7 1TW

United Kingdom

EU/1/03/252/001-003

26.10.2006

24.10.2006

Avandamet

SmithKline Beecham plc

980 Great West Road

Brentford

Middlesex TW8 9GS

United Kingdom

EU/1/03/258/001-022

26.10.2006

26.10.2006

Ketek

Aventis Pharma S.A.

20 Avenue Raymond Aron

F-92160 Antony

EU/1/01/191/001-005

30.10.2006

26.10.2006

Levviax

Aventis Pharma S.A.

20 Avenue Raymond Aron

F-92160 Antony

EU/1/01/192/001-005

30.10.2006

26.10.2006

Actos

Takeda Global Research and Development Centre (Europe) Ltd, Arundel Great Court

2 Arundel Street

London WC2R 3DA

United Kingdom

EU/1/00/150/001-024

30.10.2006

26.10.2006

Glustin

Takeda Global Research and Development Centre (Europe) Ltd

Arundel Great Court

2 Arundel Street

London WC2R 3DA

United Kingdom

EU/1/00/151/001-022

30.10.2006

26.10.2006

Sustiva

Bristol-Myers Squibb Pharma EEIG

Uxbridge Business Park

Sanderson Road

Uxbridge UD8 1DH

United Kingdom

EU/1/99/110/001-009

30.10.2006

26.10.2006

Stocrin

Merck Sharp & Dohme Ltd

Hertford Road

Hoddesdon

Hertfordshire EN11 9BU

United Kingdom

EU/1/99/111/001-009

30.10.2006

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

Pfizer Limited, Sandwich

Kent CT13 9NJ

United Kingdom

EU/1/02/212/001-026

30.10.2006

27.10.2006

Pritor

Bayer HealthCare AG

D-51368 Leverkusen

EU/1/98/089/001-019

31.10.2006

27.10.2006

Ariclaim

Eli Lilly Nederland B.V.

Grootslag 1-5

3991 RA Houten

Nederland

Boehringer Ingelheim International GmbH

Binger Strasse 173

D-55216 Ingelheim am Rhein

EU/1/04/283/001-007

31.10.2006

27.10.2006

Rebetol

Schering Plough Europe

Rue de Stalle 73

B-1180 Bruxelles

Stallestraat, 73

B-1180 Brussel

EU/1/99/107/001-005

31.10.2006

27.10.2006

Remicade

Centocor B.V.

Einsteinweg 101

2333 CB Leiden

Nederland

EU/1/99/116/001-003

31.10.2006

27.10.2006

Avaglim

SmithKline Beecham plc

980 Great West Road

Brentford

Middlesex TW8 9GS

United Kingdom

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

Roche Registration Limited

6 Falcon Way

Shire Park

Welwyn Garden City AL7 1TW

United Kingdom

EU/1/96/026/001-002

31.10.2006

27.10.2006

Tracleer

Actelion Registration Ltd

BSI Building 13th Floor

389 Chiswick High Road

London W4 4AL

United Kingdom

EU/1/02/220/001-005

31.10.2006

30.10.2006

FOSAVANCE

Merck Sharp & Dohme Ltd

Hertford Road

Hoddesdon

Hertfordshire EN11 9BU

United Kingdom

EU/1/05/310/001-005

1.11.2006

30.10.2006

Lyrica

PFIZER Ltd, Ramsgate Road

Sandwich

Kent CT 13 9NJ

United Kingdom

EU/1/04/279/001-035

1.11.2006

30.10.2006

NutropinAq

IPSEN Limited, 190 Bath Road

Slough, Berkshire SLI 3XE

United Kingdom

EU/1/00/164/003-005

1.11.2006

30.10.2006

Keppra

UCB S.A.

Allée de la recherche 60

B-Bruxelles 1070

Researchdreef, 60

B-Brussel 1070

EU/1/00/146/001-030

3.11.2006

30.10.2006

Noxafil

SP Europe

Rue de Stalle, 73

B-1180 Bruxelles

Stallestraat 73

B-1180 Brussel

EU/1/05/320/001

2.11.2006

30.10.2006

Posaconazole SP

SP Europe

Rue de Stalle 73

B-1180 Bruxelles

Stallestraat 73 — B-1180 Brussel

EU/1/05/321/001

2.11.2006

30.10.2006

Nespo

Dompé Biotec S.p.A.

Via San Martino 12

I-20122 Milano

EU/1/01/184/001-068

2.11.2006

30.10.2006

Aranesp

Amgen Europe B.V.

Minervum 7061

4817 ZK Breda

Nederland

EU/1/01/185/001-068

1.11.2006

31.10.2006

Lantus

Sanofi-Aventis Deutschland GmbH

D-65926 Frankfurt am Main

EU/1/00/134/001-037

14.11.2006

31.10.2006

Insuman

Aventis Pharma Deutschland GmbH

Brueningstrasse 50

D-65926 Frankfurt am Main

EU/1/97/030/065-084

6.11.2006

31.10.2006

Optruma

Eli Lilly Nederland BV

Grootslag 1-5

3991 RA Houten

Nederland

EU/1/98/074/001-004

6.11.2006

31.10.2006

Evista

Eli Lilly Nederland BV

Grootslag 1-5

3991 RA Houten

Nederland

EU/1/98/073/001-004

6.11.2006

31.10.2006

Telzir

Glaxo Group Ltd.

Greenford Road

Greenford

Middlesex UB6 0NN

United Kingdom

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

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

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