Summary of Community decisions on marketing authorizations in respect of medicinal products from  1.3.2006  to  31.3.2006 (Published pursuant to Article 13 or Article 38 of Regulation (EC) No 726/2004 of the European Parliament and of the Council)
Date: 2006-04-28
Institutions: European Commission
Subjects: market approval, marketing standard, medicinal product, pharmaceutical legislation

C 102/2

EN

Official Journal of the European Union

28.4.2006

Summary of Community decisions on marketing authorizations in respect of medicinal products
from 1.3.2006 to 31.3.2006

(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 102/02)

— 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-
Proprietary Name)

Holder of the marketing
authorization

Number of the entry in
the Community Register

Pharmaceutical
form

29.3.2006 Myozyme

alglucosidase alpha

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

EU/1/06/333/001-003

Powder for
concentrate for
solution for
infusion

ATC code
(Anatomical
Therapeutic
Chemical
Code)

Date of
notification

A16AB07

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

2.3.2006

Prometax

8.3.2006

Litak

9.3.2006

Kentera

13.3.2006

Cellcept

13.3.2006

Enbrel

15.3.2006

Angiox

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

Holder of the marketing authorization

Number of the entry in
the Community Register

Date of
notification

EU/1/98/092/001-018

6.3.2006

EU/1/04/275/001-002

10.3.2006

EU/1/03/270/001-003

13.3.2006

EU/1/96/005/001-006

15.3.2006

EU/1/99/126/001-011

15.3.2006

EU/1/04/289/001-002

17.3.2006

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

Lipomed GmbH
Schönaugasse 11
D-79713 Bad Säckingen

Nicobrand Limited
189 Casteroe Road
Coleraine
Northern Ireland BT51 3 RP

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

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

The Medicines Company UK Ltd
Suite B
Park House
11 Milton Park
Abingdon
Oxfordshire OX14 4RS
United Kingdom

28.4.2006

EN

Official Journal of the European Union

C 102/3

Date of the
decision

Name of the
medicinal
product

20.3.2006

CoAprovel

Holder of the marketing authorization

Number of the entry in
the Community Register

Date of
notification

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

EU/1/98/086/001-022

22.3.2006

20.3.2006

Karvezide

Bristol-Myers Squibb Pharma EEIG
141-149 Staines Road
Hounslow TW3 3JA
United Kingdom

EU/1/98/085/001-022

22.3.2006

20.3.2006

Glivec

20.3.2006

Zyprexa

20.3.2006

Prialt

20.3.2006

Lyrica

20.3.2006

Mabthera

21.3.2006

NutropinAq

21.3.2006

Exubera

22.3.2006

Kinzalmono

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

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

Elan Pharma International Ltd
WIL House
Shannon Business Park
Shannon
County Clare
Ireland

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

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

IPSEN Limited
190 Bath Road
Slough
Berkshire
SLI 3XE
United Kingdom

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

Aventis/Pfizer EEIG
Ramsgate Road
Sandwich
Kent CT13 9NJ
United Kingdom

Bayer HealthCare AG
D-51368 Leverkusen

Bayer AG
D-51368 Leverkusen

EU/1/01/198/001-013

22.3.2006

EU/1/96/022/016-017

22.3.2006

EU/1/04/302/004

22.3.2006

EU/1/04/279/001-032

22.3.2006

EU/1/98/067/001-002

22.3.2006

EU/1/00/164/003-005

23.3.2006

EU/1/05/327/001-017

23.3.2006

EU/1/98/091/001-014

24.3.2006

C 102/4

EN

Official Journal of the European Union

28.4.2006

Date of the
decision

Name of the
medicinal
product

22.3.2006

NeoSpect

22.3.2006

Tarceva

22.3.2006

Kinzalkomb

22.3.2006

Pritor

22.3.2006

PritorPlus

22.3.2006

Levviax

22.3.2006

Ketek

22.3.2006

Avonex

23.3.2006

Cancidas

Holder of the marketing authorization

Number of the entry in
the Community Register

Date of
notification

CIS bio international
Route Nationale 306
Saclay
Boite Postale 32
F-91192 Gifsur-Yvette

Amersham Health AS
Nycoveien 1-2
P.O. Box 4220 Nydalen
N-0401 Oslo

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

Bayer HealthCare AG
D-51368 Leverkusen

Bayer AG
D-51368 Leverkusen

Bayer HealthCare AG
D-51368 Leverkusen

Glaxo Group Ltd
Greenford
Middlesex UB6 0NN
United Kingdom

Bayer HealthCare AG
D-51368 Leverkusen

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

Aventis Pharma S.A.
20, Avenue Raymond Aron
F-92160 Antony

Aventis Pharma S.A.
20, Avenue Raymond Aron
F-92160 Antony

Biogen Idec Ltd
5 Roxborough Way
Foundation Park
Maidenhead
Berkshire
SL6 3UD
United Kingdom

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

EU/1/00/154/001-002

24.3.2006

EU/1/05/311/001-003

24.3.2006

EU/1/02/214/001-010

24.3.2006

EU/1/98/089/001-019

24.3.2006

EU/1/02/215/001-012

24.3.2006

EU/1/01/192/001-005

24.3.2006

EU/1/01/191/001-005

24.3.2006

EU/1/97/033/001-003

24.3.2006

EU/1/01/196/001-003

28.3.2006

28.4.2006

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Official Journal of the European Union

C 102/5

Date of the
decision

Name of the
medicinal
product

29.3.2006

Actos

29.3.2006

IntronA

29.3.2006

Parareg

29.3.2006

Mimpara

29.3.2006

Viraferon

29.3.2006

Glustin

Holder of the marketing authorization

Number of the entry in
the Community Register

Date of
notification

Takeda Europe R&D Centre Ltd
Arundel Great Court
2 Arundel Street
London WC2R 3DA
United Kingdom

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

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

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

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

Takeda Europe R&D Centre Ltd
Arundel Great Court
2 Arundel Street
London WC2R 3DA
United Kingdom

EU/1/00/150/001-024

31.3.2006

EU/1/99/127/001-044

31.3.2006

EU/1/04/293/001-012

31.3.2006

EU/1/04/292/001-012

31.3.2006

EU/1/99/128/001-037

31.3.2006

EU/1/00/151/001-022

31.3.2006

29.3.2006

Ariclaim

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

EU/1/04/283/001-007

31.3.2006

29.3.2006

Raptiva

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

EU/1/04/291/001-002

5.4.2006

29.3.2006

Hepsera

Gilead Sciences International Limited
Cambridge CB1 6GT
United Kingdom

EU/1/03/251/001

31.3.2006

29.3.2006

Erbitux

Merck KGaA
Frankfurter Straße 250
D-64293 Darmstadt

EU/1/04/281/001

31.3.2006

29.3.2006

Keppra

UCB S.A.
Allée de la recherche, 60/Researchdreef, 60
B-1070 Bruxelles/Brussel

EU/1/00/146/030

31.3.2006

29.3.2006

Rebetol

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

EU/1/99/107/001-005

30.3.2006

29.3.2006

Protopy

29.3.2006

Protopic

Astellas Pharma GmbH
Neumarkter Str. 61
D-81673 München

Astellas Pharma GmbH
Neumarkter Str. 61
D-81673 München

EU/1/02/202/001-006

31.3.2006

EU/1/02/201/001-006

31.3.2006

C 102/6

EN

Official Journal of the European Union

28.4.2006

Date of the
decision

Name of the
medicinal
product

29.3.2006

Aptivus

29.3.2006

Bondenza

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/1/05/315/001

31.3.2006

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

EU/1/03/266/005-006

31.3.2006

29.3.2006

Xeristar

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

EU/1/04/297/001-007

31.3.2006

29.3.2006

YENTREVE

29.3.2006

Prialt

29.3.2006

NovoMix

29.3.2006

Cymbalta

29.3.2006

Pedea

29.3.2006

Bonviva

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

Elan Pharma International Ltd
WIL House
Shannon Business Park
Shannon
County Clare
Ireland

Novo Nordisk A/S
Novo Allé
DK-2880 Bagsværd

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

Orphan Europe
Immeuble «Le Guillaumet»
F-92046 Paris La Défense

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

EU/1/04/280/001-007

31.3.2006

EU/1/04/302/001-004

3.4.2006

EU/1/00/142/004-005
EU/1/00/142/009-022

31.3.2006

EU/1/04/296/001-007

31.3.2006

EU/1/04/284/001

31.3.2006

EU/1/03/265/005-006

31.3.2006

29.3.2006

NovoRapid

Novo Nordisk A/S
Novo Allé
DK-2880 Bagsværd

EU/1/99/119/001
EU/1/99/119/003
EU/1/99/119/005-014

31.3.2006

29.3.2006

InductOs

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

EU/1/02/226/001

31.3.2006

29.3.2006

Truvada

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

EU/1/04/305/001

31.3.2006

28.4.2006

EN

Official Journal of the European Union

C 102/7

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

Accepted

Date of the
decision

Name of the
medicinal
product

15.3.2006

Zubrin

21.3.2006

Porcilis Pesti

Holder of the marketing authorization

Number of the entry in
the Community Register

Date of
notification

Schering Plough Limited
Schering Plough House
Shire Park
Welwyn Garden City
Hertfordshire
AL7 1TW
United Kingdom

Intervet International B.V.
Wim de Körverstraat 35
5831 AN Boxmeer
Nederland

EU/2/00/028/002-008

17.3.2006

EU/2/99/016/001-006

23.3.2006

23.3.2006

METACAM

Boehringer Ingelheim Vetmedica GmbH
D-55216 Ingelheim am Rhein

EU/2/97/004/016-023

28.3.2006

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