Summary of Community decisions on marketing authorizations in respect of medicinal products from 1 April 2008 to 30 April 2008 (Published pursuant to Article 13 or Article 38 of Regulation (EC) No 726/2004 of the European Parliament and of the Council )
Date: 2008-05-30
Institutions: European Commission
Subjects: EU Member State, market approval, marketing standard, medicinal product, pharmaceutical legislation, withdrawal from the market

Summary of Community decisions on marketing authorizations in respect of medicinal products
from 1 April 2008 to 30 April 2008

(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 132/03)

— 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-Proprietary
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

4.4.2008

Effentora

Fentanyl citrate

16.4.2008

Thalidomide Pharmion

Thalidomide

21.4.2008

Volibris

Ambrisentan

21.4.2008

Adenuric

Febuxostat

25.4.2008 Mycamine

Micafungin

Cephalon Europe
5, Rue Charles Martigny
F-94700 Maisons Alfort

Pharmion Ltd
Riverside House
Riverside Walk
Windsor SL4 1NA
United Kingdom

Glaxo Group Ltd
Greenford
Middlesex UB6 0NN
United Kingdom

Ipsen Manufacturing Ireland Ltd (IMIL)
Blanchardstown Industrial Park
Snugboro Road
Dublin 15
Ireland

Astellas Pharma GmbH
Neumarkter Str. 61
D-81673 München

25.4.2008

Privigen

Human normal immuno-
globulin (IVIg)

CSL Behring GmbH
Emil von Behring Straße 76
D-35041 Marburg

EU/1/08/441/001-010

Buccal tablet

N02AB03

9.4.2008

EU/1/08/443/001

Capsule, hard

L04AX02

18.4.2008

EU/1/08/451/001-004

Film coated tablets

C02KX02

24.4.2008

EU/1/08/447/001-004

Film coated tablet

M04AA03

23.4.2008

EU/1/08/448/001-002

Powder
infusion

for

solution for

J02AX05

29.4.2008

EU/1/08/446/001-003

Solution for infusion

J06BA02

29.4.2008

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30.5.2008

EN

Official Journal of the European Union

C 132/5

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

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

14.4.2008 Mylotarg

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

—

16.4.2008

— 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

1.4.2008

PritorPlus

1.4.2008

Kineret

1.4.2008

Hepsera

2.4.2008

Forsteo

2.4.2008

Zalasta

2.4.2008

Osigraft

4.4.2008

Karvezide

4.4.2008

Pergoveris

4.4.2008

TachoSil

4.4.2008

Bondronat

Bayer HealthCare AG
D-51368 Leverkusen

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

EU/1/02/215/015-021

3.4.2008

EU/1/02/203/001-004

3.4.2008

Gilead Sciences International Limited
Cambridge CB21 6GT
United Kingdom

EU/1/03/251/001-002

4.4.2008

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

KRKA, d.d.
Novo mesto
Šmarješka cesta 6
SLO-8501 Novo mesto

Howmedica International S. de R.L.
Division of Stryker Corporation
Raheen Industrial Estate
Raheen
Limerick
Ireland

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

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

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

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

EU/1/03/247/001-002

4.4.2008

EU/1/07/415/001-056

4.4.2008

EU/1/01/179/001

4.4.2008

EU/1/98/085/001-034

9.4.2008

EU/1/07/396/001-003

9.4.2008

EU/1/04/277/001-004

9.4.2008

EU/1/96/012/009-010

9.4.2008

C 132/6

EN

Official Journal of the European Union

30.5.2008

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

4.4.2008

CoAprovel

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

EU/1/98/086/001-034

9.4.2008

4.4.2008

Glustin

8.4.2008

Remicade

8.4.2008

Alimta

8.4.2008

Inovelon

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

Centocor B.V.
Einsteinweg 101
2333 CB Leiden
Nederland

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

Eisai Limited
3, Shortlands
London W6 8EE
United Kingdom

EU/1/00/151/001-024

9.4.2008

EU/1/99/116/001-003

10.4.2008

EU/1/04/290/001-002

10.4.2008

EU/1/06/378/001-016

10.4.2008

8.4.2008

Rebetol

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

EU/1/99/107/001-005

10.4.2008

10.4.2008

Gardasil

10.4.2008

Silgard

14.4.2008

Intrinsa

14.4.2008

Livensa

14.4.2008

ViraferonPeg

14.4.2008

PegIntron

14.4.2008

Revasc

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

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

Procter & Gamble Pharmaceuticals UK Ltd
Rusham Park Technical Centre
Whitehall Lane
Egham
Surrey TW20 9NW
United Kingdom

Procter & Gamble Pharmaceuticals —
Germany GmbH
Dr Otto-Röhm-Straße 2-4
D-64331 Weiterstadt

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

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

Canyon Pharmaceuticals Ltd
20-22 Bedford Row
London WC1R 4JS
United Kingdom

EU/1/06/357/001-021

15.4.2008

EU/1/06/358/001-021

14.4.2008

EU/1/06/352/001-003

16.4.2008

EU/1/06/351/001-003

16.4.2008

EU/1/00/132/001-050

16.4.2008

EU/1/00/131/001-050

16.4.2008

EU/1/97/043/001-003

16.4.2008

30.5.2008

EN

Official Journal of the European Union

C 132/7

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

14.4.2008

Plavix

16.4.2008

Iscover

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

EU/1/98/069/008-010

16.4.2008

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

EU/1/98/070/008-010

18.4.2008

17.4.2008

Ebixa

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

17.4.2008

REYATAZ

18.4.2008

Ariclaim

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

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

EU/1/02/219/001-021

21.4.2008

EU/1/03/267/008-009

21.4.2008

EU/1/04/283/001-012

22.4.2008

18.4.2008

Zevalin

Bayer Schering Pharma AG
D-13342 Berlin

EU/1/03/264/001

22.4.2008

18.4.2008

Nexavar

18.4.2008

Levemir

18.4.2008

Insulatard

18.4.2008

Neupopeg

Bayer HealthCare AG
D-51368 Leverkusen

Novo Nordisk A/S
Novo Allé
DK-2880 Bagsværd

Novo Nordisk A/S
Novo Allé
DK-2880 Bagsværd

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

EU/1/06/342/001

22.4.2008

EU/1/04/278/004-006

22.4.2008

EU/1/02/233/013-015

22.4.2008

EU/1/02/228/001-003

23.4.2008

18.4.2008 M-M-RVAXPRO

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

EU/1/06/337/001-013

23.4.2008

18.4.2008

NovoMix

21.4.2008

Stalevo

21.4.2008

Neulasta

21.4.2008

Xeristar

Novo Nordisk A/S
Novo Allé
DK-2880 Bagsværd

Orion Corporation
Orionintie 1
FI-02200 Espoo

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

EU/1/00/142/009-010
EU/1/00/142/014-016
EU/1/00/142/020-022

22.4.2008

EU/1/03/260/019-023

23.4.2008

EU/1/02/227/001-003

23.4.2008

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

EU/1/04/297/001-008

23.4.2008

C 132/8

EN

Official Journal of the European Union

30.5.2008

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

21.4.2008

Cymbalta

21.4.2008

Rapamune

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

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

EU/1/04/296/001-009

23.4.2008

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

24.4.2008

21.4.2008

REYATAZ

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

EU/1/03/267/001-009

24.4.2008

21.4.2008

Velcade

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

EU/1/04/274/001-002

23.4.2008

21.4.2008

Hepsera

Gilead Sciences International Limited
Cambridge CB21 6GT
United Kingdom

EU/1/03/251/001-002

23.4.2008

21.4.2008

Forsteo

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

EU/1/03/247/001-002

23.4.2008

22.4.2008

Invega

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

EU/1/07/395/001-064

24.4.2008

22.4.2008 Wilzin

Orphan Europe S.àr.l.
Gaulle
F-92800 Puteaux

EU/1/04/286/001-002

24.4.2008

22.4.2008

IntronA

22.4.2008

Viraferon

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

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

EU/1/99/127/001-044

24.4.2008

EU/1/99/128/001-037

24.4.2008

22.4.2008

Rilutek

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

EU/1/96/010/001

24.4.2008

22.4.2008

Intrinsa

Procter & Gamble Pharmaceuticals UK Ltd
Rusham Park Technical Centre
Whitehall Lane
Egham Surrey TW20 9NW
United Kingdom

EU/1/06/352/001-003

24.4.2008

22.4.2008

Tritanrix HepB

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

EU/1/96/014/001-003

24.4.2008

30.5.2008

EN

Official Journal of the European Union

C 132/9

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

22.4.2008

Aptivus

22.4.2008

Zyprexa

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

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

23.4.2008

Viread

Gilead Sciences International Limited
Cambridge CB21 6GT
United Kingdom

23.4.2008

Remicade

23.4.2008

Emselex

23.4.2008 MIRCERA

23.4.2008

YENTREVE

23.4.2008

Zyprexa Velotab

23.4.2008

Visudyne

23.4.2008

Ferriprox

23.4.2008

NovoRapid

23.4.2008

Rotateq

25.4.2008

Cystagon

Centocor B.V.
Einsteinweg 101
2333 CB Leiden
Nederland

Novartis Europharm Limited
Wimblehurst Road
Horsham
West Sussex RH12 5AB
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

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

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

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

Novo Nordisk A/S
Novo Allé
DK-2880 Bagsværd

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

Orphan Europe S.à.rl.
Immeuble Le Wilson
70, Avenue du Général de Gaulle
F-92800 Puteaux

EU/1/05/315/001

24.4.2008

24.4.2008

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/1/01/200/001-002

25.4.2008

EU/1/99/116/001-003

25.4.2008

EU/1/04/294/001-028

25.4.2008

EU/1/07/400/001-016

25.4.2008

EU/1/04/280/001-008

25.4.2008

EU/1/99/125/001-016

25.4.2008

EU/1/00/140/001

25.4.2008

EU/1/99/108/001-003

25.4.2008

EU/1/99/119/009-011
EU/1/99/119/015

25.4.2008

EU/1/06/348/001-002

25.4.2008

EU/1/97/039/001-004

29.4.2008

C 132/10

EN

Official Journal of the European Union

30.5.2008

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

25.4.2008

NovoSeven

25.4.2008

TESAVEL

25.4.2008

Tysabri

25.4.2008

Protaphane

25.4.2008

Livensa

Novo Nordisk A/S
Novo Allé
DK-2880 Bagsværd

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

Elan Pharma International Ltd
Monksland
Athlone
County Westmeath
Ireland

Novo Nordisk A/S
Novo Allé
DK-2880 Bagsværd

Procter & Gamble Pharmaceuticals —
Germany GmbH
Dr Otto-Röhm-Straße 2-4
D-64331 Weiterstadt

EU/1/96/006/004-006

29.4.2008

EU/1/07/435/001-018

29.4.2008

EU/1/06/346/001

30.4.2008

EU/1/02/234/013-015

29.4.2008

EU/1/06/351/001-003

29.4.2008

— 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

10.4.2008

Previcox

10.4.2008

Clomicalm

16.4.2008

Rabigen SAG2

17.4.2008

Virbagen Omega

25.4.2008

ProteqFlu Te

25.4.2008

ProteqFlu

Merial
29, Avenue Tony Garnier
F-69007 Lyon

Novartis Tiergesundheit GmbH
Zielstattstraße 40
D-81379 München

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

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

Merial
29, Avenue Tony Garnier
F-69007 Lyon

Merial
29, Avenue Tony Garnier
F-69007 Lyon

EU/2/04/045/001-007

15.4.2008

EU/2/98/007/001-003

14.4.2008

EU/2/00/021/001-002

21.4.2008

EU/2/01/030/001-004

21.4.2008

EU/2/03/038/005

29.4.2008

EU/2/03/037/005

29.4.2008

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