Summary of Community decisions on marketing authorizations in respect of medicinal products from  1 April 2006  to  30 April 2006 (Published pursuant to Article 13 or Article 38 of Regulation (EC) No 726/2004 of the European Parliament and of the Council)
Date: 2006-05-25
Institutions: European Commission
Subjects: market approval, marketing standard, medicinal product, pharmaceutical legislation

Summary of Community decisions on marketing authorizations in respect of medicinal products
from 1 April 2006 to 30 April 2006

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

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

(2006/C 124/03)

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

ATC code (Anatomical
Therapeutic Chemical Code)

Date of
notification

6.4.2006

ProQuad

Measles, Mumps, Rubella
and Varicella Vaccine
(Live)

12.4.2006 Omnitrope

Somatropin

24.4.2006

Valtropin

Somatropin

24.4.2006

Preotact

Parathyroid hormone

24.4.2006

DuoTrav

Travoprost/Timolol

24.4.2006

Tygacil

Tigecycline

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

Sandoz GmbH
Biochemiestraße 10
A-6250 Kundl

BioPartners GmbH
Eisenstraße 3
D-65428 Rüsselsheim

Nycomed Danmark ApS
Langebjerg 1
DK-4000 Roskilde

Alcon Laboratories (UK)
Ltd
Boundary Way
Hemel Hempstead
Herts HP2 7UD
United Kingdom

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

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

EU/1/05/323/001-011

Powder and solvent for suspen-
sion for injection

J07BD54

10.4.2006

EU/1/06/332/001-003

Powder and solvent for solu-
tion for injection

H01AC01

EU/1/06/335/001

Powder and solvent for solu-
tion for injection (multi-use)

H01A C01

EU/1/06/339/001-002

powder and solvent for sol for
injection

H05 AA03

20.4.2006

26.4.2006

26.4.2006

EU/1/06/338/001-003

Eye drops, solution

S01ED51

26.4.2006

EU/1/06/336/001

Powder for solution for infu-
sion

(Non applicable)

26.4.2006

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25.5.2006

EN

Official Journal of the European Union

C 124/5

— 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

3.4.2006

Kogenate Bayer

3.4.2006

Helixate NexGen

3.4.2006

Enbrel

6.4.2006

NeuroBloc

6.4.2006

Sifrol

6.4.2006

Rapamune

6.4.2006

Kaletra

6.4.2006

Mirapexin

10.4.2006

Trizivir

10.4.2006

Zerit

12.4.2006

Prevenar

Bayer HealthCare AG
D-51368 Leverkusen
Bayer AG
D-51368 Leverkusen

Bayer HealthCare AG
D-51368 Leverkusen
Bayer AG
D-51368 Leverkusen

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

Solstice Neurosciences Ltd
Fitzwilton House
Wilton Place, Dublin 2,
Ireland

EU/1/00/143/001-006

5.4.2006

EU/1/00/144/001-003

5.4.2006

EU/1/99/126/001-011

5.4.2006

EU/1/00/166/001-003

10.4.2006

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

EU/1/97/050/001-006
EU/1/97/050/009-012

10.4.2006

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

Abbott laboratories Ltd
Queenborough
Kent ME11 5EL
United Kingdom

EU/1/01/171/001
EU/1/01/171/007-012

10.4.2006

EU/1/01/172/001-003

10.4.2006

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

EU/1/97/051/001-006
EU/1/97/051/009-012

10.4.2006

Glaxo Group Ltd
Greenford
Middlesex UB6 0NN
United Kingdom

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

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

EU/1/00/156/001-002

13.4.2006

EU/1/96/009/001-009

13.4.2006

EU/1/00/167/001-007

19.4.2006

C 124/6

EN

Official Journal of the European Union

25.5.2006

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

18.4.2006

Vaniqa

EU/1/01/173/001-003

20.4.2006

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

18.4.2006 Orfadin

Swedish Orphan International AB
Drottninggatan 98
S-111 60 Stockholm

EU/1/04/303/001-003

20.4.2006

18.4.2006

Telzir

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

EU/1/04/282/001-002

20.4.2006

24.4.2006

Zavesca

24.4.2006

SonoVue

24.4.2006

Xigris

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

Bracco International BV
Strawinskylaan 3051
1077 ZX Amsterdam
Nederland

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

EU/1/02/238/001

26.4.2006

EU/1/01/177/001-002

26.4.2006

EU/1/02/225/001-002

26.4.2006

24.4.2006

Ammonaps

EU/1/99/120/001-004

26.4.2006

Swedish Orphan International AB
Drottninggatan 98
S-111 60 Stockholm
Orphan Europe, Immeuble ‘Le
Guillaumet’
F-92046 Paris La Défense

24.4.2006

Trazec

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

EU/1/01/175/001, EU/
1/01/175/004-008,
EU/1/01/175/011-015
EU/1/01/175/018-021

26.4.2006

24.4.2006

Starlix

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

EU/1/01/174/001-021

26.4.2006

25.5.2006

EN

Official Journal of the European Union

C 124/7

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

24.4.2006

Trisenox

24.4.2006

Zometa

24.4.2006

TARGRETIN

24.4.2006

Xolair

27.4.2006

Emtriva

Cephalon UK Ltd
20 Alan Turing Road
Surrey Research Park
Guildford
Surrey, GU2 7YF
United Kingdom
Cell Therapeutics (UK) Limited
100 Pall Mall
London SW1Y 5HP
United Kingdom

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

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

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

Gilead Sciences International
Limited
Cambridge CB1 6GT
United Kingdom

EU/1/02/204/001

27.4.2006

EU/1/01/176/001-006

26.4.2006

EU/1/01/178/001

26.4.2006

EU/1/05/319/001-004

26.4.2006

EU/1/03/261/001-002

2.5.2006

27.4.2006

Aldara

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

EU/1/98/080/001

2.5.2006

27.4.2006

Comtess

Orion Corporation, Orionintie 1
FIN-02200 Espoo

EU/1/98/082/001-004

2.5.2006

27.4.2006

Rebetol

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

EU/1/99/107/001-005

2.5.2006

27.4.2006

Axura

Merz Pharmaceuticals GmbH
Eckenheimer Landstr. 100-104,
D-60318 Frankfurt/Main

EU/1/02/218/001-011

2.5.2006

27.4.2006

Abilify

EU/1/04/276/033-035

2.5.2006

Otsuka Pharmaceutical Europe Ltd
Commonwealth House
2 Chalkhill Road
Hammersmith
London W6 8DW
United Kingdom

C 124/8

EN

Official Journal of the European Union

25.5.2006

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

27.4.2006

Lumigan

Allergan Pharmaceuticals Ireland
Castlebar Road
Westport
Co. Mayo
Ireland

EU/1/02/205/001-002

2.5.2006

27.4.2006

Ebixa

H. Lundbeck A/S, Ottiliavej 9
DK-2500 Valby

EU/1/02/219/001-013

1.5.2006

27.4.2006

Levviax

27.4.2006

Ketek

27.4.2006

Taxotere

Aventis Pharma SA
20 Avenue Raymond Aron
F-92160 Antony

Aventis Pharma SA
20 Avenue Raymond Aron
F-92160 Antony

Aventis Pharma SA
20 avenue Raymond Aron
F-92165 Antony Cedex

EU/1/01/192/001-005

2.5.2006

EU/1/01/191/001-005

2.5.2006

EU/1/95/002/001-002

4.5.2006

27.4.2006

Fasturtec

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

EU/1/00/170/001-002

2.5.2006

27.4.2006

PegIntron

27.4.2006

ViraferonPeg

27.4.2006

Viraferon

27.4.2006

IntronA

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

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

EU/1/00/131/001-050

2.5.2006

EU/1/00/132/001-050

2.5.2006

EU/1/99/128/001-037

2.5.2006

EU/1/99/127/001-044

2.5.2006

27.4.2006

Keppra

UCB SA
Allée de la recherche, 60
B-1070 Bruxelles

EU/1/00/146/001-030

2.5.2006

— 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-
Proprietary 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

10.4.2006

Flexicam

Meloxicam

Omnipharm Ltd, The
Spire
Egypt Road
Nottingham NG7 7GD
United Kingdom

EU/2/06/058/001-003

oral suspension

QM01AC06

13.4.2006

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C 124/10

EN

Official Journal of the European Union

25.5.2006

— 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

10.4.2006

Porcilis Porcoli

18.4.2006

Eurican Herpes 205

24.4.2006

Sevoflo

Intervet International BV
(NL)
Wim de Körverstraat 35
5831 AN Boxmeer
Nederland

Merial, 29 avenue Tony
Garnier
F-69007 Lyon

Abbott laboratories Ltd
Queenborough
Kent ME11 5EL
United Kingdom

EU/2/96/001/001-010

13.4.2006

EU/2/01/029/001-003

20.4.2006

EU/2/02/035/007

26.4.2006

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