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 )
Date: 2006-12-29
Institutions: European Commission
Subjects: EU Member State, market approval, marketing standard, medicinal product, pharmaceutical legislation, withdrawal from the market

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)

20.11.2006

BYETTA

exenatide

20.11.2006

Sprycel

dasatinib

Holder of the marketing
authorization

Number of the entry in the
Community Register

Pharmaceutic-
al form

ATC code
(Anatomical
Therapeutic
Chemical
Code)

Date of
notification

EU/1/06/362/001-004

Solution for
injection

A10BX04

22.11.2006

EU/1/06/363/001-009

Film-coated
tablet

L01XX

22.11.2006

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

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

— 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

7.11.2006

Exubera

7.11.2006

Humira

Holder of the marketing authorization

Number of the entry in the
Community Register

Date of
notification

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

Abbott Laboratories Ltd.
Queenborough
Kent ME11 5EL
United Kingdom

EU/1/05/327/001-018

9.11.2006

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

14.11.2006

Zevalin

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

Schering AG
Müllerstrasse 170-178
D-13342 Berlin

(1) OJ L 136, 30.4.2004, p. 1.

EU/1/96/007/015-017
EU/1/96/007/026-028

16.11.2006

EU/1/03/264/001

16.11.2006

C 321/14

EN

Official Journal of the European Union

29.12.2006

Date of the
decision

Name of the
medicinal
product

20.11.2006

Crixivan

20.11.2006

Hycamtin

20.11.2006

Yttriga

20.11.2006

Liprolog

20.11.2006

Protopic

20.11.2006

Protopy

20.11.2006

Norvir

22.11.2006

TRIZIVIR

22.11.2006

Evista

22.11.2006

Optruma

22.11.2006

PEGASYS

22.11.2006

Tarceva

Holder of the marketing authorization

Number of the entry in the
Community Register

Date of
notification

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

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

QSA Global GmbH
Gieselweg 1
D-38110 Braunschweig

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

Astellas Pharma GmbH
Neumarkter Str. 61
D-81673 München

Astellas Pharma GmbH
Neumarkter Str. 61
D-81673 München

Abbott laboratories Ltd
Queenborough
Kent ME11 5EL
United-Kingdom

Glaxo Group Ltd
Greenford
Middlesex UB6 0NN
United Kingdom

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

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

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

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

EU/1/96/024/001-005
EU/1/96/024/007-008
EU/1/96/024/010

22.11.2006

EU/1/96/027/001
EU/1/96/027/003-005

22.11.2006

EU/1/05/322/001

22.11.2006

EU/1/01/195/005-007
EU/1/01/195/013-015

22.11.2006

EU/1/02/201/001-006

22.11.2006

EU/1/02/202/001-006

22.11.2006

EU/1/96/016/001
EU/1/96/016/003

22.11.2006

EU/1/00/156/002-003

24.11.2006

EU/1/98/073/001-004

24.11.2006

EU/1/98/074/001-004

24.11.2006

EU/1/02/221/01-010

24.11.2006

EU/1/05/311/001-003

24.11.2006

29.12.2006

EN

Official Journal of the European Union

C 321/15

Date of the
decision

Name of the
medicinal
product

22.11.2006

Invirase

22.11.2006

Hycamtin

22.11.2006

Avandamet

22.11.2006

AVANDIA

24.11.2006

Ariclaim

24.11.2006

Avaglim

24.11.2006

Stocrin

24.11.2006

Pedea

24.11.2006

Aptivus

Holder of the marketing authorization

Number of the entry in the
Community Register

Date of
notification

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

EU/1/96/026/001-002

24.11.2006

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

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

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

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

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

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

Orphan Europe SARL
Immeuble ‘Le Guillaumet’
F-92046 Paris-La-Défense

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

EU/1/96/027/001
EU/1/96/027/003-005

24.11.2006

EU/1/03/258/001-022

24.11.2006

EU/1/00/137/002-018

24.11.2006

EU/1/04/283/001-007

28.11.2006

EU/1/06/349/001-008

28.11.2006

EU/1/99/111/010-011

28.11.2006

EU/1/04/284/001

28.11.2006

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

C 321/16

EN

Official Journal of the European Union

29.12.2006

Date of the
decision

Name of the
medicinal
product

24.11.2006

Xeristar

24.11.2006

Cymbalta

28.11.2006

Ziagen

28.11.2006

Glivec

28.11.2006

Tysabri

Holder of the marketing authorization

Number of the entry in the
Community Register

Date of
notification

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

EU/1/04/297/001-008

28.11.2006

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

Glaxo Group Ltd, Greenford
Middlesex UB6 0NN
United Kingdom

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

Elan Pharma International Ltd.
Monksland
Athlone
County Westmeath
Ireland

EU/1/04/296/001-008

28.11.2006

EU/1/99/112/001-002

1.12.2006

EU/1/01/198/001-013

1.12.2006

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

28.11.2006

Nespo

28.11.2006

Kivexa

28.11.2006

YENTREVE

28.11.2006

Abilify

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

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

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

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

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

EU/1/05/314/001

1.12.2006

EU/1/01/184/001-068

1.12.2006

EU/1/04/298/001-002

1.12.2006

EU/1/04/280/001-008

1.12.2006

EU/1/04/276/001-036

1.12.2006

29.12.2006

EN

Official Journal of the European Union

C 321/17

Date of the
decision

Name of the
medicinal
product

29.11.2006

Enbrel

Holder of the marketing authorization

Number of the entry in the
Community Register

Date of
notification

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

29.11.2006

Emselex

29.11.2006

Aranesp

Biolitec pharma Ltd
United Drug House
Magna Drive
Dublin 24
Ireland

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

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

EU/1/01/197/001-002

1.12.2006

EU/1/04/294/001-028

1.12.2006

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

14.11.2006

Monotard

14.11.2006

Ultratard

Holder of the marketing authorization

Number of the entry in the
Community Register

Date of
notification

Novo Nordisk A/S
Novo Allé
DK-2880 Bagsværd

Novo Nordisk A/S
Novo Allé
DK-2880 Bagsværd

EU/1/02/235/001-004

16.11.2006

EU/1/02/236/001-004

16.11.2006

— Issuing of a marketing authorization (Article 38 of Regulation (EC) No 726/2004 of the Euro-

pean Parliament and of the Council): Accepted

Date of the
decision

Name of the
medicinal
product

INN
(International
Non-
Proprietary
Name)

14.11.2006

Yarvitan

Mitratapide

Holder of the marketing
authorization

Number of the entry in the
Community Register

Pharmaceutic-
al form

ATC code
(Anatomical
Therapeutic
Chemical
Code)

Date of
notification

Janssen Animal Health
B.V.B.A.
Turnhoutseweg, 30
B-2340 Beerse

EU/2/06/063/001-003

Oral solu-
tion

QA08AB90

16.11.2006

C 321/18

EN

Official Journal of the European Union

29.12.2006

— 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

20.11.2006

Virbagen
Omega

Holder of the marketing authorization

Number of the entry in the
Community Register

Date of
notification

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 deci-
sions relating thereto is invited to contact:
The European Medicines Agency
7, Westferry Circus, Canary Wharf
London E14 4HB
United Kingdom