Summary of Community decisions on marketing authorizations in respect of medicinal products from  1 June 2006  to  30 June 2006 (Published pursuant to Article 13 or Article 38 of Regulation (EC) No 726/2004 of the European Parliament and of the Council)
Date: 2006-07-28
Institutions: European Commission
Subjects: EU Member State, market approval, marketing, medicinal product, pharmaceutical legislation

Summary of Community decisions on marketing authorizations in respect of medicinal
products from 1 June 2006 to 30 June 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 176/09)

— 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-Proprie-
tary 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

19.6.2006

ACOMPLIA

rimonabant

19.6.2006

Zimulti

rimonabant

26.6.2006

Baraclude

entecavir

27.6.2006

Avaglim

rosiglitazone/glimépiride

27.6.2006

RotaTeq

Rotavirus vaccine (live,
oral)

27.6.2006

Tysabri

natalizumab

Sanofi-Aventis
174, avenue de France
F-75013 Paris

Sanofi-Aventis
174, avenue de France
F-75013 Paris

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

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

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

Elan Pharma International Ltd
Monksland
Athlone
County Westmeath
Ireland

EU/1/06/344/001-009

Film-coated tablet

(Non applicable)

21.6.2006

EU/1/06/345/001-009

Film-coated tablet

(Non applicable)

21.6.2006

EU/1/06/343/001-004
EU/1/06/343/005

Film-coated tablet
Oral solution

J05AF10

28.6.2006

EU/1/06/349/001-008

Film-coated tablet

(Non applicable)

29.6.2006

EU/1/06/348/001-002

Oral solution

(Non applicable)

29.6.2006

EU/1/06/346/001

Concentrate for solution
for infusion

L04AA23

30.6.2006

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

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C 176/20

EN

Official Journal of the European Union

28.7.2006

— Modification of a marketing authorization (Article 13 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

Holder of the marketing authorization

Number of the entry in the
Community Register

Date of
notification

1.6.2006

Zometa

1.6.2006

Humira

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

Abbott Laboratories Ltd.
Queenborough
Kent ME11 5EL
United Kingdom

EU/1/01/176/001-006

5.6.2006

EU/1/03/256/001-006

5.6.2006

1.6.2006

Betaferon

Schering Aktiengesellschaft
D-13342 Berlin

EU/1/95/003/003-004

6.6.2006

2.6.2006

Avandamet

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

8.6.2006

Dynepo

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

EU/1/03/258/001-022

8.6.2006

EU/1/02/211/001-005

12.6.2006

8.6.2006

Ventavis

Schering AG
Müllerstrasse 170-178
D-13342 Berlin

EU/1/03/255/001-003

12.6.2006

8.6.2006

Karvea

8.6.2006

Viagra

12.6.2006

Cialis

12.6.2006

Vivanza

12.6.2006

Levitra

12.6.2006

Zerene

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

EU/1/97/049/001-033

12.6.2006

Pfizer Limited
Sandwich
Kent CT13 9NJ
United Kingdom

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

Bayer AG
D-51368 Leverkusen

Bayer AG
D-51368 Leverkusen

Wyeth Research (UK) Limited
Huntercombe Lane South
Taplow
Maidenhead
Berkshire SL6 0PH
United Kingdom

EU/1/98/077/001-012

12.6.2006

EU/1/02/237/001-005

14.6.2006

EU/1/03/249/001-012

16.6.2006

EU/1/03/248/001-012

16.6.2006

EU/1/99/099/001-006

14.6.2006

28.7.2006

EN

Official Journal of the European Union

C 176/21

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

12.6.2006

Protopy

12.6.2006

Protopic

12.6.2006

Sonata

16.6.2006

DaTSCAN

16.6.2006

Revatio

19.6.2006

DepoCyte

26.6.2006

Bondronat

Astellas Pharma GmbH
Neumarkter Str. 61
D-81673 München

Astellas Pharma GmbH
Neumarkter Str. 61
D-81673 München

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

GE Healthcare Limited
Little Chalfont
Bucks HP7 9NA
United Kingdom

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

SkyePharma PLC
105 Piccadilly
London W1J 7NJ
United Kingdom

EU/1/02/202/001-006

14.6.2006

EU/1/02/201/001-006

14.6.2006

EU/1/99/102/001-008

14.6.2006

EU/1/00/135/001-002

20.6.2006

EU/1/05/318/001

20.6.2006

EU/1/01/187/001

21.6.2006

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

EU/1/96/012/004
EU/1/96/012/009-013

28.6.2006

26.6.2006

GONAL-f

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

26.6.2006

Tracleer

26.6.2006

Renagel

26.6.2006

Carbaglu

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

Genzyme Europe B.V.
Gooimeer 10
Naarden 1411 DD
Nederland

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

28.6.2006

EU/1/95/001/001
EU/1/95/001/003-005
EU/1/95/001/009
EU/1/95/001/012
EU/1/95/001/021-022
EU/1/95/001/025-028
EU/1/95/001/031-035

EU/1/02/220/001-005

28.6.2006

EU/1/99/123/001-011

28.6.2006

EU/1/02/246/001-003

28.6.2006

C 176/22

EN

Official Journal of the European Union

28.7.2006

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

26.6.2006

Iscover

26.6.2006 Micardis

26.6.2006 MicardisPlus

26.6.2006

Plavix

26.6.2006

Zenapax

27.6.2006

Kaletra

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

EU/1/98/070/001a-001b
EU/1/98/070/002a-002b
EU/1/98/070/003a-003b
EU/1/98/070/004a-004b

28.6.2006

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

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

Sanofi Pharma Bristol-Myers
Squibb SNC
174 avenue de France
F-75013 Paris

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

Abbott laboratories Ltd
Queenborough
Kent ME11 5EL
United Kingdom

EU/1/98/090/015-016

28.6.2006

EU/1/02/213/011-012

28.6.2006

EU/1/98/069/001a-001b
EU/1/98/069/002a-002b
EU/1/98/069/003a-003b
EU/1/98/069/004a-004b

28.6.2006

EU/1/99/098/001-002

28.6.2006

EU/1/01/172/004-005

29.6.2006

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

pean 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

26.6.2006

Fortovase

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

EU/1/98/075/001-002

28.6.2006

— 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-Proprie-
tary 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

19.6.2006

Convenia

cefovecine

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

EU/2/06/059/001

Powder and solvent for
solution for injection

QJ01DD91

21.6.2006

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

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