Summary of Community decisions on marketing authorizations in respect of medicinal products from 1 April 2007 to 30 April 2007 (Published pursuant to Article 13 or Article 38 of Regulation (EC) No 726/2004 of the European Parliament and of the Council)
Date: 2007-05-25
Institutions: European Commission
Subjects: EU Member State, market approval, marketing standard, medicinal product, pharmaceutical legislation

Summary of Community decisions on marketing authorizations in respect of medicinal products
from 1 April 2007 to 30 April 2007

(Published pursuant to Article 13 or Article 38 of Regulation (EC) No 726/2004 of the European Parliament and of
the Council (1))

(2007/C 115/03)

— Issuing of a marketing authorization (Article 13 of Regulation (EC) No 726/2004): 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

20.4.2007

TOVIAZ

fesoterodine

20.4.2007

Docetaxel
Winthrop

docetaxel

23.4.2007

Advagraf

Tacrolimus

24.4.2007

Sebivo

telbivudine

Schwarz Pharma AG
Alfred-Nobel Straße 10
D-40789 Monheim

Aventis Pharma S.A.
20, avenue Raymond Aron
F-92165 Antony Cedex

Astellas Pharma GmbH
Neumarkter Str. 61
D-81673 München

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

EU/1/07/386/001-010

Prolonged-release
tablets

G04B D11

24.4.2007

EU/1/07/384/001-002

Concentrate
and
solvent for solution for
infusion

L01CD02

24.4.2007

EU/1/07/387/001-008

Prolonged release hard
capsules

L04AA05

25.4.2007

EU/1/07/388/001

Film-coated tablet

J05AF11

26.4.2007

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

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C 115/4

EN

Official Journal of the European Union

25.5.2007

— Modification of a marketing authorization (Article 13 of Regulation (EC) No 726/2004):

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

2.4.2007

Dynepo

2.4.2007

Prevenar

2.4.2007

Xigris

2.4.2007

AZILECT

2.4.2007

Enbrel

4.4.2007

Cerezyme

11.4.2007

Panretin

11.4.2007

TARGRETIN

13.4.2007

Infanrix Penta

13.4.2007

Infanrix Hexa

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

Wyeth-Lederle Vaccines S.A.
Rue du Bosquet 15
B-1348 Louvain-La-Neuve

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

Teva Pharma GmbH
Kandelstraße 10
D-79199 Kirchzarten

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

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

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

Eisai Ltd
3 Shortlands
London W6 8EE
United Kingdom

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

Eisai Ltd
3 Shortlands
London W6 8EE
United Kingdom

GlaxoSmithKline Biologicals s.a.
rue de l'Institut 89
B-1330 Rixensart

GlaxoSmithKline Biologicals s.a.
rue de l'Institut 89
B-1330 Rixensart

EU/1/02/211/001-005
EU/1/02/211/010-012

4.4.2007

EU/1/00/167/001-007

4.4.2007

EU/1/02/225/001-002

4.4.2007

EU/1/04/304/001-007

4.4.2007

EU/1/99/126/013-018

4.4.2007

EU/1/97/053/001-005

11.4.2007

EU/1/00/149/001

13.4.2007

13.4.2007

EU/1/01/178/001

13.4.2007

13.4.2007

EU/1/00/153/001-010

17.4.2007

EU/1/00/152/001-018

17.4.2007

25.5.2007

EN

Official Journal of the European Union

C 115/5

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

13.4.2007

Foscan

13.4.2007

Revatio

13.4.2007

Glivec

17.4.2007

Cystagon

17.4.2007

Teslascan

17.4.2007

Dynepo

20.4.2007

Quixidar

20.4.2007

Arixtra

20.4.2007

Omnitrope

23.4.2007

Azomyr

23.4.2007

Neoclarityn

23.4.2007

Aerius

Biolitec pharma Ltd
United Drug House
Magna Drive
Dublin 24
Ireland

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

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

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

GE Healthcare AS
Nycoveien 1-2
P.O.Box 4220 Nydalen
N-0401 Oslo

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

Glaxo Group Ltd
Greenford
Middlesex UB6 0NN
United Kingdom

Glaxo Group Ltd
Greenford
Middlesex UB6 0NN
United Kingdom

Sandoz GmbH
Biochemiestraße 10
A-6250 Kundl

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

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

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

EU/1/01/197/001-002

18.4.2007

EU/1/05/318/001

17.4.2007

EU/1/01/198/001-013

17.4.2007

EU/1/97/039/001-004

19.4.2007

EU/1/97/040/001-002

19.4.2007

EU/1/02/211/001-005
EU/1/02/211/010-012

19.4.2007

EU/1/02/207/001-020

24.4.2007

EU/1/02/206/001-020

24.4.2007

EU/1/06/332/004-006

24.4.2007

EU/1/00/157/035-067

25.4.2007

EU/1/00/161/035-067

25.4.2007

EU/1/00/160/037-069

25.4.2007

C 115/6

EN

Official Journal of the European Union

25.5.2007

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

23.4.2007

Temodal

23.4.2007

Dynastat

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

Pfizer Ltd
Ramsgate Road
Sandwich
Kent CT13 9NJ
United Kingdom

EU/1/98/096/009-012

25.4.2007

EU/1/02/209/001-008

25.4.2007

23.4.2007

M-M-RVAXPRO Sanofi Pasteur MSD

EU/1/06/337/001-013

25.4.2007

23.4.2007

Avastin

SNC
8, rue Jonas Salk
F-69007 Lyon

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

EU/1/04/300/001-002

25.4.2007

23.4.2007

Kinzalkomb

Bayer HealthCare AG
D-51368 Leverkusen

EU/1/02/214/001-010

25.4.2007

23.4.2007

MicardisPlus

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

EU/1/02/213/001-016

25.4.2007

24.4.2007

Macugen

24.4.2007

Kineret

24.4.2007

Truvada

24.4.2007

Herceptin

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

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

Gilead Sciences International
Limited
Cambridge CB21 6G
United Kingdom

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

EU/1/05/325/001

26.4.2007

EU/1/02/203/001-004

26.4.2007

EU/1/04/305/001

26.4.2007

EU/1/00/145/001

26.4.2007

24.4.2007

NovoMix

Novo Nordisk A/S
Novo Allé
DK-2880 Bagsvaerd

EU/1/00/142/004-005
EU/1/00/142/009-010

26.4.2007

24.4.2007

Aldara

Laboratoires 3M Santé
Boulevard de l'Oise
F-95029 Cergy Pontoise Cedex

EU/1/98/080/001

26.4.2007

25.5.2007

EN

Official Journal of the European Union

C 115/7

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

24.4.2007

DaTSCAN

25.4.2007

Bondenza

25.4.2007

Bonviva

25.4.2007

Xigris

25.4.2007

Emtriva

26.4.2007

Baraclude

26.4.2007

Lysodren

26.4.2007

Champix

26.4.2007

REYATAZ

GE Healthcare Limited
Little Chalfont
Bucks HP7 9NA
United Kingdom

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

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

Gilead Sciences International
Limited
Cambridge CB21 6GT
United Kingdom

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

Laboratoire HRA Pharma
15, rue Béranger
F-75003 Paris

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

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

EU/1/00/135/001-002

26.4.2007

EU/1/03/266/001-006

30.4.2007

EU/1/03/265/001-006

30.4.2007

EU/1/02/225/001-002

27.4.2007

EU/1/03/261/001-003

27.4.2007

EU/1/06/343/001-005

30.4.2007

EU/1/04/273/001

30.4.2007

EU/1/06/360/001-011

30.4.2007

EU/1/03/267/001-007

30.4.2007

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

13.4.2007

Slentrol

Dirlotapide

Pfizer Ltd
Ramsgate Road
Sandwich
Kent CT13 9NJ
United Kingdom

EU/2/07/071/001-003 Oral solution

QA08AB91

17.4.2007

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25.5.2007

EN

Official Journal of the European Union

C 115/9

— Modification of a marketing authorization (Article 38 of Regulation (EC) No 726/2004):

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

20.4.2007

Metacam

Boehringer Ingelheim Vetmedica
GmbH
D-55216 Ingelheim am Rhein

EU/2/97/004/012-013
EU/2/97/004/026

24.4.2007

24.4.2007

Oxyglobin

Biopure Netherlands B.V.
Drentestraat 24BG
1083HK Amsterdam
Nederland

EU/2/99/015/001

26.4.2007

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