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Document 52006XC1229(03)

Summary of Community decisions on marketing authorizations in respect of medicinal products from 1 November 2006 to 30 November 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 321, 29.12.2006, p. 13–18 (ES, CS, DA, DE, ET, EL, EN, FR, IT, LV, LT, HU, NL, PL, PT, SK, SL, FI, SV)

29.12.2006   

EN

Official Journal of the European Union

C 321/13


Summary of Community decisions on marketing authorizations in respect of medicinal products from 1 November 2006 to 30 November 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 321/06)

—   Issuing 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

INN (International Non-Proprietary Name)

Holder of the marketing authorization

Number of the entry in the Community Register

Pharmaceutical form

ATC code (Anatomical Therapeutic Chemical Code)

Date of notification

20.11.2006

BYETTA

exenatide

Eli Lilly Nederland B.V.

Grootslag 1-5

3991 RA Houten

Nederland

EU/1/06/362/001-004

Solution for injection

A10BX04

22.11.2006

20.11.2006

Sprycel

dasatinib

Bristol-Myers Squibb Pharma EEIG

Uxbridge Business Park

Sanderson Road

Uxbridge UD8 1DH

United Kingdom

EU/1/06/363/001-009

Film-coated tablet

L01XX

22.11.2006

—   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

7.11.2006

Exubera

PFIZER Ltd

Ramsgate Road

Sandwich Kent CT 13 9NJ

United Kingdom

EU/1/05/327/001-018

9.11.2006

7.11.2006

Humira

Abbott Laboratories Ltd.

Queenborough

Kent ME11 5EL

United Kingdom

EU/1/03/256/001-010

9.11.2006

7.11.2006

Trudexa

Abbott Laboratories Ltd.

Queenborough Kent ME11 5EL

United Kingdom

EU/1/03/257/001-010

9.11.2006

14.11.2006

Humalog

Eli Lilly Nederland B.V.

Grootslag 1-5

3991 RA Houten

Nederland

EU/1/96/007/015-017

EU/1/96/007/026-028

16.11.2006

14.11.2006

Zevalin

Schering AG

Müllerstrasse 170-178

D-13342 Berlin

EU/1/03/264/001

16.11.2006

20.11.2006

Crixivan

Merck Sharp & Dohme Ltd.

Hertford Road

Hoddesdon

Hertfordshire EN11 9BU

United-Kingdom

EU/1/96/024/001-005

EU/1/96/024/007-008

EU/1/96/024/010

22.11.2006

20.11.2006

Hycamtin

SmithKline Beecham plc

980 Great West Road

Brentford Middlesex TW8 9GS

United Kingdom

EU/1/96/027/001

EU/1/96/027/003-005

22.11.2006

20.11.2006

Yttriga

QSA Global GmbH

Gieselweg 1

D-38110 Braunschweig

EU/1/05/322/001

22.11.2006

20.11.2006

Liprolog

Eli Lilly Nederland BV

Grootslag 1-5

3991 RA Houten

Nederland

EU/1/01/195/005-007

EU/1/01/195/013-015

22.11.2006

20.11.2006

Protopic

Astellas Pharma GmbH

Neumarkter Str. 61

D-81673 München

EU/1/02/201/001-006

22.11.2006

20.11.2006

Protopy

Astellas Pharma GmbH

Neumarkter Str. 61

D-81673 München

EU/1/02/202/001-006

22.11.2006

20.11.2006

Norvir

Abbott laboratories Ltd

Queenborough

Kent ME11 5EL

United-Kingdom

EU/1/96/016/001

EU/1/96/016/003

22.11.2006

22.11.2006

TRIZIVIR

Glaxo Group Ltd

Greenford

Middlesex UB6 0NN

United Kingdom

EU/1/00/156/002-003

24.11.2006

22.11.2006

Evista

Eli Lilly Nederland BV

Grootslag 1-5

3991 RA Houten

Nederland

EU/1/98/073/001-004

24.11.2006

22.11.2006

Optruma

Eli Lilly Nederland BV

Grootslag 1-5

3991 RA Houten

Nederland

EU/1/98/074/001-004

24.11.2006

22.11.2006

PEGASYS

Roche Registration Limited

6 Falcon Way

Shire Park

Welwyn Garden City, AL7 1TW

United Kingdom

EU/1/02/221/01-010

24.11.2006

22.11.2006

Tarceva

Roche Registration Limited

6 Falcon Way

Shire Park

Welwyn Garden City AL7 1TW

United Kingdom

EU/1/05/311/001-003

24.11.2006

22.11.2006

Invirase

Roche Registration Limited

6 Falcon Way

Shire Park

Welwyn Garden City AL7 1TW

United Kingdom

EU/1/96/026/001-002

24.11.2006

22.11.2006

Hycamtin

SmithKline Beecham plc

980 Great West Road

Brentford

Middlesex TW8 9GS

United Kingdom

EU/1/96/027/001

EU/1/96/027/003-005

24.11.2006

22.11.2006

Avandamet

SmithKline Beecham plc

980 Great West Road

Brentford

Middlesex TW8 9GS

United Kingdom

EU/1/03/258/001-022

24.11.2006

22.11.2006

AVANDIA

SmithKline Beecham plc

980 Great West Road

Brentford

Middlesex TW8 9GS

United Kingdom

EU/1/00/137/002-018

24.11.2006

24.11.2006

Ariclaim

Eli Lilly Nederland B.V.

Grootslag 1-5

3991 RA Houten

Nederland

EU/1/04/283/001-007

28.11.2006

24.11.2006

Avaglim

SmithKline Beecham plc

980 Great West Road

Brentford

Middlesex TW8 9GS

United Kingdom

EU/1/06/349/001-008

28.11.2006

24.11.2006

Stocrin

Merck Sharp & Dohme Ltd

Hertford Road

Hoddesdon

Hertfordshire EN11 9BU

United Kingdom

EU/1/99/111/010-011

28.11.2006

24.11.2006

Pedea

Orphan Europe SARL

Immeuble ‘Le Guillaumet’

F-92046 Paris-La-Défense

EU/1/04/284/001

28.11.2006

24.11.2006

Aptivus

Boehringer Ingelheim International GmbH

Binger Strasse 173

D-55216 Ingelheim am Rhein

EU/1/05/315/001

28.11.2006

24.11.2006

Replagal

Shire Human Genetic Therapies AB

Rinkebyvägen 11B

S-182 36 Danderyd

EU/1/01/189/001-006

28.11.2006

24.11.2006

Levitra

Bayer AG

D-51368 Leverkusen,

EU/1/03/248/001-012

28.11.2006

24.11.2006

Vivanza

Bayer AG

D-51368 Leverkusen

EU/1/03/249/001-012

28.11.2006

24.11.2006

Xeristar

Boehringer Ingelheim International GmbH

Binger Strasse 173

D-55216 Ingelheim am Rhein

EU/1/04/297/001-008

28.11.2006

24.11.2006

Cymbalta

Eli Lilly Nederland BV

Grootslag 1-5

3991 RA Houten

Nederland

EU/1/04/296/001-008

28.11.2006

28.11.2006

Ziagen

Glaxo Group Ltd, Greenford

Middlesex UB6 0NN

United Kingdom

EU/1/99/112/001-002

1.12.2006

28.11.2006

Glivec

Novartis Europharm Limited

Wimblehurst Road

Horsham

West Sussex RH12 5AB

United Kingdom

EU/1/01/198/001-013

1.12.2006

28.11.2006

Tysabri

Elan Pharma International Ltd.

Monksland

Athlone

County Westmeath

Ireland

EU/1/06/346/001

4.12.2006

28.11.2006

Ebixa

H. Lundbeck A/S, Ottiliavej 9

DK-2500 Valby

EU/1/02/219/001-015

1.12.2006

28.11.2006

Axura

Merz Pharmaceuticals GmbH

Eckenheimer Landstr. 100-104

D-60318 Frankfurt/Main

EU/1/02/218/001-011

1.12.2006

28.11.2006

Kepivance

Amgen Europe B.V.

Minervum 7061

4817 ZK Breda

Nederland

EU/1/05/314/001

1.12.2006

28.11.2006

Nespo

Dompé Biotec S.p.A.

Via San Martino 12

I-20122 Milano

EU/1/01/184/001-068

1.12.2006

28.11.2006

Kivexa

Glaxo Group Ltd

Berkeley Avenue

Greenford

Middlesex UB6 0NN

United Kingdom

EU/1/04/298/001-002

1.12.2006

28.11.2006

YENTREVE

Eli Lilly Nederland B.V.

Grootslag 1-5

3991 RA Houten

Nederland

EU/1/04/280/001-008

1.12.2006

28.11.2006

Abilify

Otsuka Pharmaceutical Europe Ltd

Hunton House

Highbridge Business Park

Oxford Road

Uxbridge

Middlesex UB8 1HU

United Kingdom

EU/1/04/276/001-036

1.12.2006

29.11.2006

Enbrel

Wyeth Europa Limited

Huntercombe Lane South

Taplow

Maidenhead,

Berkshire, SL6 0PH

United Kingdom

EU/1/99/126/001-018

1.12.2006

29.11.2006

Aldara

Laboratoires 3M Santé

Boulevard de l'Oise

F-95029 Cergy Pontoise Cedex

EU/1/98/080/001

1.12.2006

29.11.2006

Foscan

Biolitec pharma Ltd

United Drug House

Magna Drive

Dublin 24

Ireland

EU/1/01/197/001-002

1.12.2006

29.11.2006

Emselex

Novartis Europharm Limited

Wimblehurst Road

Horsham

West Sussex RH12 5AB

United Kingdom

EU/1/04/294/001-028

1.12.2006

29.11.2006

Aranesp

Amgen Europe B.V.

Minervum 7061

4817 ZK Breda

Nederland

EU/1/01/185/001-068

1.12.2006

—   Withdrawal of a marketing authorization (Article 13 of Regulation (EC) No 726/2004 of the European Parliament and of the Council)

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

14.11.2006

Monotard

Novo Nordisk A/S

Novo Allé

DK-2880 Bagsværd

EU/1/02/235/001-004

16.11.2006

14.11.2006

Ultratard

Novo Nordisk A/S

Novo Allé

DK-2880 Bagsværd

EU/1/02/236/001-004

16.11.2006

—   Issuing of a marketing authorization (Article 38 of Regulation (EC) No 726/2004 of the European Parliament and of the Council): Accepted

Date of the decision

Name of the medicinal product

INN (International Non-Proprietary Name)

Holder of the marketing authorization

Number of the entry in the Community Register

Pharmaceutical form

ATC code (Anatomical Therapeutic Chemical Code)

Date of notification

14.11.2006

Yarvitan

Mitratapide

Janssen Animal Health B.V.B.A.

Turnhoutseweg, 30

B-2340 Beerse

EU/2/06/063/001-003

Oral solution

QA08AB90

16.11.2006

—   Modification of a marketing authorization (Article 38 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

20.11.2006

Virbagen Omega

VIRBAC S.A.

1ere Avenue 2065 m L.I.D.

F-06516 Carros

EU/2/01/030/001-004

22.11.2006

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, 30.4.2004, p. 1.


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