Summary of Community decisions on marketing authorizations in respect of medicinal products from 1 December 2007 to 31 December 2007 (Published pursuant to Article 13 or Article 38 of Regulation (EC) No 726/2004 of the European Parliament and of the Council )
Date: 2008-01-25
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 December 2007 to 31 December 2007

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

(2008/C 19/04)

— 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 Thera-
peutic Chemical Code)

Date of notification

11.12.2007

NEVANAC

Nepafenac

11.12.2007

Pioglitazone/
metformin hydro-
chloride Takeda

Pioglitazone/metformin
hydrochloride

12.12.2007

Olanzapine Teva

Olanzapine

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

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

Teva Pharma B.V.
Computerweg 10
3542 DR Utrecht
Nederland

13.12.2007

Atripla

Efavirenz/emtricitabine/
tenofovir disoproxil
fumarate

Bristol-Myers Squibb Gilead Sciences
And Merck Sharp & Dohme Limited
Unit 13
Stillorgan Industrial Park
Blackrock, Co.Dublin
Ireland

18.12.2007

Retacrit

Epoetin zeta

HOSPIRA Enterprises B.V.
Taurusavenue 19-21b
2132 LS Hoofddorp
Nederland

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

EU/1/07/433/001

Eye drops, suspension

S01BC10

13.12.2007

EU/1/07/421/001-009

Film-coated tablet

A10BD05

13.12.2007

EU/1/07/427/001-022

Film-coated tablet

N05AH03

14.12.2008

EU/1/07/427023-037

Orodispersible tablets

EU/1/07/430/001

Film-coated tablet

J05AR06

18.12.2008

EU/1/07/431/001-019

Solution for injection

B03XA01

20.12.2007

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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 Thera-
peutic Chemical Code)

Date of notification

18.12.2007

Silapo

Epoetin zeta

20.12.2007

ISENTRESS

Raltegravir

STADA Arzneimittel AG
Stadastraße 2-18
D-61118 Bad Vilbel

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

EU/1/07/432/001-019

Solution for injection

B03XA01

20.12.2007

EU/1/07/436/001-002

Film-coated tablets

J05AX08

2.1.2008

— 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

11.12.2007

RotaTeq

11.12.2007

TARGRETIN

11.12.2007

Quintanrix

11.12.2007

Tandemact

11.12.2007

Procomvax

11.12.2007

Prevenar

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

Eisai Limited
3, Shortlands
London W6 8EE
United Kingdom

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

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

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

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

EU/1/06/348/001-002

13.12.2007

EU/1/01/178/001

13.12.2007

EU/1/04/301/001-005

13.12.2007

EU/1/06/366/005-016

13.12.2007

EU/1/99/104/001

13.12.2007

EU/1/00/167/001-007

13.12.2007

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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

12.12.2007

Quadramet

12.12.2007

Sonata

14.12.2007

Avastin

14.12.2007

Ariclaim

14.12.2007

Caelyx

14.12.2007

Diacomit

14.12.2007

RotaTeq

14.12.2007

Rebif

CIS bio international
Boite Postale 32
F-91192 Gif-sur-Yvette

Meda AB
Pipers väg 2A
S-170 09 Solna

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

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

Biocodex
7, avenue Gallieni
F-94250 Gentilly

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

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

EU/1/97/057/001

14.12.2007

EU/1/99/102/001-008

17.12.2007

14.12.2007

EU/1/04/300/001-002

18.12.2007

EU/1/04/283/008-012

18.12.2007

EU/1/96/011/001-004

18.12.2007

EU/1/06/367/001-012

18.12.2007

EU/1/06/348/001-002

18.12.2007

EU/1/98/063/001-007

18.12.2007

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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

14.12.2007

Velcade

18.12.2007

Tracleer

18.12.2007

Xelevia

18.12.2007

Infanrix Penta

18.12.2007

Lyrica

18.12.2007

Prezista

18.12.2007

Betaferon

18.12.2007

Helixate NexGen

18.12.2007

KOGENATE Bayer

18.12.2007

Zonegran

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

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

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

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

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

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

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

Bayer HealthCare AG
D-51368 Leverkusen

Bayer HealthCare AG
D-51368 Leverkusen

Eisai Limited
3, Shortlands
London W6 8EE
United Kingdom

EU/1/04/274/001

18.12.2007

EU/1/02/220/001-005

20.12.2007

EU/1/07/382/001-018

20.12.2007

EU/1/00/153/001-010

20.12.2007

EU/1/04/279/001-043

21.12.2007

EU/1/06/380/001

20.12.2007

EU/1/95/003/003-006

20.12.2007

EU/1/00/144/004

20.12.2007

EU/1/00/143/010-011

20.12.2007

EU/1/04/307/001-013

20.12.2007

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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

18.12.2007

NovoMix

18.12.2007

Insuman

18.12.2007

Truvada

19.12.2007

CUBICIN

19.12.2007

Humira

19.12.2007

Tygacil

19.12.2007

MabCampath

19.12.2007

Lucentis

19.12.2007

REYATAZ

Novo Nordisk A/S
Novo Allé
DK-2880 Bagsværd

Sanofi-Aventis Deutschland GmbH
D-65926 Frankfurt am Main

Gilead Sciences International Limited
Cambridge CB21 6GT
United Kingdom

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

Abbott Laboratories Ltd
Queenborough
Kent ME11 5EL
United Kingdom

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

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

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

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

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

EU/1/97/030/028-109
EU/1/97/030/085-139

20.12.2007

20.12.2007

EU/1/04/305/001

20.12.2007

EU/1/05/328/001-002

21.12.2007

EU/1/03/256/001-010

21.12.2007

EU/1/06/336/001

21.12.2007

EU/1/01/193/001-002

21.12.2007

EU/1/06/374/001

21.12.2007

EU/1/03/267/001-007

21.12.2007

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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

19.12.2007

Januvia

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

EU/1/07/383/001-018

21.12.2007

19.12.2007

Aptivus

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

EU/1/05/315/001

21.12.2007

20.12.2007

Infanrix Hexa

20.12.2007

Aldurazyme

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

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

EU/1/00/152/001-018

24.12.2007

EU/1/03/253/001-003

24.12.2007

20.12.2007

Insulin Human Winthrop

Sanofi-Aventis Deutschland GmbH
D-65926 Frankfurt am Main

EU/1/06/368/001-087

27.12.2007

21.12.2007

Remicade

21.12.2007

Keppra

21.12.2007

Mimpara

21.12.2007

Macugen

Centocor B.V.
Einsteinweg 101
2333 CB Leiden
Nederland

UCB Pharma SA.
Allée de la Recherche 60
B-1070 Bruxelles
Researchdreef, 60
B-1070 Brussel

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

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

EU/1/99/116/001-003

27.12.2007

EU/1/00/146/001-030

26.12.2007

EU/1/04/292/001-012

27.12.2007

EU/1/05/325/002

2.1.2008

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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

21.12.2007

Somavert

21.12.2007

Parareg

21.12.2007

GONAL-F

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

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

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

21.12.2007

HBVAXPRO

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

EU/1/02/240/001-004

27.12.2007

EU/1/04/293/001-012

2.1.2008

EU/1/95/001/001
EU/1/95/001/003-005
EU/1/95/001/009
EU/1/95/001/012
EU/1/95/001/021-022
EU/1/95/001/025-028
EU/1/95/001/031-035

EU/1/01/183/001
EU/1/01/183/004-005
EU/1/01/183/007-008
EU/1/01/183/011
EU/1/01/183/013
EU/1/01/183/015
EU/1/01/183/018-029

2.1.2008

26.12.2007

— 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

18.12.2007

Levviax

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

EU/1/01/192/001-005

20.12.2007

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— 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

14.12.2007

Suprelorin

19.12.2007

Aivlosin

Cyton Biosciences Ltd
Hyland Mews
21 High Street
Clifton
Bristol BS8 2YF
United Kingdom

VIRBAC S.A.
1ère Avenue 2065 m L.I.D
F-06516 Carros

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

EU/2/07/072/001-002

18.12.2007

EU/2/04/044/001-006

21.12.2007

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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