Summary of Community decisions on marketing authorizations in respect of medicinal products from 1 November 2007 to 30 November 2007 (Published pursuant to Article 13 or Article 38 of Regulation (EC) No 726/2004 of the European Parliament and of the Council)
Date: 2007-12-28
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 November 2007 to 30 November 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 316/05)

— 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

ATC code
(Anatomical
Therapeutic
Chemical Code)

Date of
notification

14.11.2007

Olanzapine
Neopharma

Olanzapine

14.11.2007

Eucreas

Vildagliptin/Metformin hydrochloride

19.11.2007

Tasigna

Nilotinib

19.11.2007

TORISEL

Temsirolimus

23.11.2007

Cyanokit

Hydroxocobalamin

Neopharma Limited
57 High Street
Odiham
Hampshire RG29 1LF
United Kingdom

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

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

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

Merck Santé s.a.s.
37, rue Saint-Romain
F-69379 Lyon Cedex 08

EU/1/07/426/001-011

Coated tablets

N05AH03

16.11.2007

EU/1/07/425/001-018

Film-coated tablets

(Non applicable)

16.11.2007

EU/1/07/422/001-004

Capsule, hard

L01XE08

21.11.2007

EU/1/07/424/001

Concentrate and diluent
for
infu-
solution for
sion

(Non applicable)

21.11.2007

EU/1/07/420/001

Powder for solution for
infusion

V03AB33

27.11.2007

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

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28.12.2007

EN

Official Journal of the European Union

C 316/43

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

Accepted

Date of the
decision

Name of the
medicinal
product

8.11.2007

PhotoBarr

Holder of the marketing authorization

Number of the entry in the
Community Register

Date of
notification

Axcan Pharma International BV
Engelenkampstraat 72
6131 JJ Sittard
Nederland

EU/1/04/272/001-002

12.11.2007

8.11.2007

Arava

Sanofi-Aventis Deutschland GmbH
D-65926 Frankfurt am Main

EU/1/99/118/001-010

12.11.2007

12.11.2007

Tandemact

13.11.2007

Combivir

13.11.2007

Betaferon

13.11.2007

Kepivance

Takeda Global Research and
Development Centre (Europe) Ltd
Arundel Great Court
2 Arundel Street
London WC2R 3DA
United Kingdom

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

Bayer Schering Pharma AG
Müllerstraße 170-178
D-13342 Berlin

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

EU/1/06/366/001-016

14.11.2007

EU/1/98/058/001-002

16.11.2007

EU/1/95/003/003-006

15.11.2007

EU/1/05/314/001

15.11.2007

14.11.2007

Optisulin

Sanofi-Aventis Deutschland GmbH
D-65926 Frankfurt am Main

EU/1/00/133/001-008

16.11.2007

19.11.2007

Pegasys

19.11.2007

Mabthera

19.11.2007

Enbrel

19.11.2007

Evista

19.11.2007

Optruma

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

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

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

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

EU/1/02/221/001-010

21.11.2007

EU/1/98/067/001-002

21.11.2007

EU/1/99/126/001-018

21.11.2007

EU/1/98/073/001-004

21.11.2007

EU/1/98/074/001-004

21.11.2007

C 316/44

EN

Official Journal of the European Union

28.12.2007

Date of the
decision

Name of the
medicinal
product

19.11.2007

Ferriprox

20.11.2007

Rapamune

20.11.2007

Norvir

20.11.2007

Glivec

20.11.2007

Kaletra

20.11.2007

Neulasta

20.11.2007

Vivanza

20.11.2007

Ziagen

20.11.2007

Neupopeg

20.11.2007

Lucentis

21.11.2007

AVANDIA

21.11.2007

Telzir

Holder of the marketing authorization

Number of the entry in the
Community Register

Date of
notification

Apotex Europe B.V.
Darwingweg 20
2333 CR Leiden
Nederland

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

Abbott Laboratories Ltd
Queenborough
Kent ME11 5EL
United Kingdom

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

Abbott Laboratories Ltd
Queenborough
Kent ME11 5EL
United Kingdom

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

Bayer AG
D-51368 Leverkusen

Glaxo Group Ltd
Greenford
Middlesex UB6 0NN
United Kingdom

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

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

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

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

EU/1/99/108/002-003

21.11.2007

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

22.11.2007

EU/1/96/016/001
EU/1/96/016/003-004

22.11.2007

EU/1/01/198/001-015

22.11.2007

EU/1/01/172/001-005

22.11.2007

EU/1/02/227/001-003

22.11.2007

EU/1/03/249/001-012

22.11.2007

EU/1/99/112/001-002

22.11.2007

EU/1/02/228/001-003

22.11.2007

EU/1/06/374/001

22.11.2007

EU/1/00/137/002-018

23.11.2007

EU/1/04/282/001-002

23.11.2007

28.12.2007

EN

Official Journal of the European Union

C 316/45

Date of the
decision

Name of the
medicinal
product

21.11.2007

Zyprexa
Velotab

21.11.2007

TRIZIVIR

21.11.2007

Ionsys

21.11.2007

Zyprexa

21.11.2007

Zerene

21.11.2007

Sonata

Holder of the marketing authorization

Number of the entry in the
Community Register

Date of
notification

EU/1/99/125/001-016

23.11.2007

EU/1/00/156/002-003

23.11.2007

EU/1/05/326/001

26.11.2007

23.11.2007

EU/1/96/022/002
EU/1/96/022/004
EU/1/96/022/006
EU/1/96/022/008-012
EU/1/96/022/014
EU/1/96/022/016-017
EU/1/96/022/019-034

EU/1/99/099/001-006

23.11.2007

EU/1/99/102/001-008

23.11.2007

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

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

Janssen-Cilag International NV
Turnhoutseweg, 30
B-2340 Beerse

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

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

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

21.11.2007

Levitra

Bayer AG
D-51368 Leverkusen

EU/1/03/248/001-013

23.11.2007

21.11.2007

Baraclude

22.11.2007

SUTENT

22.11.2007

Busilvex

22.11.2007

Ariclaim

23.11.2007

Avaglim

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

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

Pierre Fabre Médicament
45, Place Abel Gance
F-92654 Boulogne Billancourt
Cedex

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

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

EU/1/06/343/001-005

23.11.2007

EU/1/06/347/001-003

26.11.2007

EU/1/03/254/001

26.11.2007

EU/1/04/283/001-007

26.11.2007

EU/1/06/349/001-010

27.11.2007

C 316/46

EN

Official Journal of the European Union

28.12.2007

Date of the
decision

Name of the
medicinal
product

23.11.2007

Combivir

Holder of the marketing authorization

Number of the entry in the
Community Register

Date of
notification

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

EU/1/98/058/001-002

27.11.2007

23.11.2007

Docetaxel
Winthrop

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

EU/1/07/384/001-002

27.11.2007

23.11.2007

Lantus

Sanofi-Aventis Deutschland GmbH
D-65926 Frankfurt am Main

EU/1/00/134/001-037

27.11.2007

23.11.2007

Taxotere

29.11.2007

Raptiva

30.11.2007

Tandemact

30.11.2007

Macugen

30.11.2007

Truvada

30.11.2007

Agenerase

30.11.2007

Remicade

30.11.2007

Azopt

EU/1/95/002/001-002

27.11.2007

EU/1/04/291/001-002

3.12.2007

EU/1/06/366/005-016

4.12.2007

EU/1/05/325/001-002

4.12.2007

EU/1/04/305/001

4.12.2007

EU/1/00/148/001-004

4.12.2007

EU/1/99/116/001-003

4.12.2007

EU/1/00/129/001-003

4.12.2007

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

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

Takeda Global Research and
Development Centre (Europe) Ltd
Arundel Great Court
2 Arundel Street
London WC2R 3DA
United Kingdom

Pfizer Limited
Ramsgate Road
Sandwich
Kent CT13 9NJ
United Kingdom

Gilead Sciences International
Limited
Cambridge CB21 6GT
United Kingdom

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

Centocor B.V.
Einsteinweg 101
2333 CB Leiden
Nederland

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

— 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

14.11.2007

Meloxivet

Meloxicam

Janssen Pharmaceutica N.V.
Turnhoutseweg 30
B-2340 Beerse

EU/2/07/077/001-005

Oral suspension

QM01AC06

16.11.2007

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

Accepted

Date of the
decision

Name of the
medicinal
product

6.11.2007

SevoFlo

13.11.2007

Quadrisol

Holder of the marketing authorization

Number of the entry in the
Community Register

Date of
notification

Abbott Laboratories Ltd
Queenborough
Kent ME11 5EL
United Kingdom

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

EU/2/02/035/001-007

8.11.2007

EU/2/97/005/001-009

15.11.2007

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

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