Summary of Community decisions on marketing authorizations in respect of medicinal products from  1 February 2006  to  28 February 2006 (Published pursuant to Article 13 or Article 38 of Regulation (EC) No 726/2004 of the European Parliament and of the Council)
Date: 2006-03-31
Institutions: European Commission
Subjects: market approval, medicinal product, pharmaceutical legislation

Summary of Community decisions on marketing authorizations in respect of medicinal products
from 1 February 2006 to 28 February 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 78/03)

— 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

15.2.2006

Neupro

Rotigotine

21.2.2006

Rotarix

Rotavirus vaccine, live

Schwarz Pharma Ltd
Shannon
Industrial Estate
Co.Clare
Ireland

GlaxoSmithKline Biologicals SA
rue de l'Institut 89
B-1330 Rixensart

EU/1/05/331/001-013

Transdermal patch

N04BC09

17.2.2006

EU/1/05/330/001-004

Powder and solvent for
oral suspension

J07BH01

23.2.2006

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

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C 78/16

EN

Official Journal of the European Union

31.3.2006

— 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

2.2.2006

Fareston

9.2.2006

NovoSeven

9.2.2006

Aerius

9.2.2006

Neoclarityn

9.2.2006

Azomyr

9.2.2006

Humalog

9.2.2006

Xeloda

9.2.2006

Replagal

9.2.2006

Fasturtec

9.2.2006

Kepivance

Orion Corporation
Orionintie 1
FIN-02200 Espoo

Novo Nordisk A/S
Novo Allé
DK-2880 Bagsværd

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

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

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

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

Roche Registration Limited
40 Broadwater Road
Welwyn Garden City
Hertfordshire AL7 3AY
United Kingdom

TKT Europe AB
Rinkebyvägen 11B
S-182 36 Danderyd

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

Amgen Europe BV
Minervum 7061
4817 ZK Breda
Nederland

EU/1/96/004/001-002

6.2.2006

EU/1/96/006/001-003

13.2.2006

EU/1/00/160/001-034

13.2.2006

EU/1/00/161/001-034

13.2.2006

EU/1/00/157/001-034

13.2.2006

13.2.2006

EU/1/96/007/002
EU/1/96/007/004-006
EU/1/96/007/008
EU/1/96/007/010-011
EU/1/96/007/015-021
EU/1/96/007/023-028

EU/1/00/163/001-002

13.2.2006

EU/1/01/189/001-006

13.2.2006

EU/1/00/170/001-002

13.2.2006

EU/1/05/314/001

13.2.2006

13.2.2006

Metalyse

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

EU/1/00/169/004-006

15.2.2006

13.2.2006

Fabrazyme

13.2.2006

Liprolog

Genzyme Europe BV
Gooimeer 10
Naarden 1411 DD
Nederland

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

EU/1/01/188/001-006

15.2.2006

EU/1/01/195/001-015

15.2.2006

31.3.2006

EN

Official Journal of the European Union

C 78/17

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

13.2.2006

InductOs

13.2.2006

HBVAXPRO

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

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

14.2.2006

Insuman

Aventis Pharma Deutschland GmbH
Brueningstraße 50
D-65926 Frankfurt am Main

EU/1/02/226/001

15.2.2006

EU/1/01/183/020-029

16.2.2006

16.2.2006

EU/1/97/030/030
EU/1/97/030/035
EU/1/97/030/040
EU/1/97/030/045
EU/1/97/030/050
EU/1/97/030/055-084

EU/1/97/044/001-008

16.2.2006

EU/1/98/089/011-014
EU/1/98/089/017-019

21.2.2006

EU/1/97/054/001
EU/1/97/054/003-006

2.3.2006

EU/1/04/293/001-012

2.3.2006

Valeant Pharmaceuticals Limited
Cedarwood
Chineham Business Park
Crockford lane
Basingstoke RG24 8WD
United Kingdom

Glaxo Group Ltd
Greenford
Middlesex UB6 0NN
United Kingdom

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

Dompé Biotec SpA
Via San Martino, 12
I-20122 Milano

Gilead Sciences International Limited
Granta Park Abington Cambridge
CB1 6GT
United Kingdom

EU/1/04/305/001

2.3.2006

Nycomed Austria GmbH
St.-Peter-Straße 25
A-4020 Linz

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

Amgen Europe BV
Minervum 7061
4817 ZK Breda
Nederland

EU/1/04/277/001-004

2.3.2006

EU/1/97/047/001-003

2.3.2006

EU/1/01/185/001-056

2.3.2006

14.2.2006

Tasmar

17.2.2006

Pritor

28.2.2006

Viracept

28.2.2006

Parareg

28.2.2006

Truvada

28.2.2006

TachoSil

28.2.2006

BeneFIX

28.2.2006

Aranesp

C 78/18

EN

Official Journal of the European Union

31.3.2006

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

28.2.2006

Lysodren

28.2.2006

Glivec

28.2.2006

Xagrid

28.2.2006

Exelon

Laboratoire HRA Pharma
19 rue Frédérick Lemaître
F-75020 Paris

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

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

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

EU/1/04/273/001

6.3.2006

EU/1/01/198/001-013

2.3.2006

EU/1/04/295/001

2.3.2006

EU/1/98/066/001-018

2.3.2006

28.2.2006

Viread

Gilead Sciences International Limited
Cambridge CB1 6GT
United Kingdom

EU/1/01/200/001

2.3.2006

28.2.2006

Telzir

28.2.2006

Nespo

28.2.2006

Rapamune

28.2.2006

Mimpara

28.2.2006

Remicade

Glaxo Group Ltd
Greenford Road, Greenford
Middlesex UB6 0NN
United Kingdom

Dompé Biotec SpA
Via San Martino, 12
I-20122 Milano

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

Amgen Europe BV
Minervum 7061
4817 ZK Breda
Nederland

Centocor BV
Einsteinweg 101
2333 CB Leiden
Nederland

EU/1/04/282/001-002

2.3.2006

EU/1/01/184/001-056

2.3.2006

EU/1/01/171/001-012

2.3.2006

EU/1/04/292/001-012

2.3.2006

EU/1/99/116/001-003

2.3.2006

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

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

2.2.2006

Theryttrex

MDS Nordion SA
Zoning Industriel
B-6220 Fleurus

EU/1/02/245/001

6.2.2006

31.3.2006

EN

Official Journal of the European Union

C 78/19

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

2.2.2006

Daquiran

Dr. Karl Thomae GmbH
Birkendorfferstr. 65
D-88397 Biberach/Riss

EU/1/97/052/001-006
EU/1/97/052/009-010

6.2.2006

— 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

2.2.2006

Aivlosin

3.2.2006

Econor

8.2.2006

Porcilis
DF

AR-T

8.2.2006

Pirsue

13.2.2006

ProteqFlu Te

13.2.2006

Advasure

13.2.2006

ProteqFlu

28.2.2006

Stronghold

ECO Animal Health Ltd
78 Coombe Road New Malden
Surrey KT3 4QS
United Kingdom

Novartis Animal Health Austria
GmbH
Biochemiestraße 10
A-6250 Kundl

Intervet International BV
Wim de Körverstraat 35
5831 AN Boxmeer
Nederland

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

Merial
29 Avenue Tony Garnier
F-69007 Lyon

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

Merial
29 avenue Tony Garnier
F-69007 Lyon

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

EU/2/04/044/001-005

6.2.2006

EU/2/98/010/004-006
EU/2/98/010/017-018
EU/2/98/010/023-024

7.2.2006

EU/2/00/026/001-004

10.2.2006

EU/2/00/027/001-003

10.2.2006

EU/2/03/038/005

16.2.2006

EU/2/00/025/001-004

15.2.2006

EU/2/03/037/005

16.2.2006

EU/2/99/014/001-012

2.3.2006

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