Summary of Community decisions on marketing authorizations in respect of medicinal products from 1 January 2009 to 31 January 2009 (Published pursuant to Article 13 or Article 38 of Regulation (EC) No 726/2004 of the European Parliament and of the Council)
Date: 2009-02-27
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 January 2009 to 31 January 2009

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

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

(2009/C 48/04)

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

16.1.2009

RoActemra

Tocilizumab

16.1.2009

Rasilez HCT

Aliskiren hemifumarate/
hydrochlorothiazide

16.1.2009

STELARA

Ustekinumab

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

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

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

EU/1/08/492/001-006

Concentrate for solution
for infusion

L04AC07

20.1.2009

EU/1/08/491/001-080

Film-coated tablet

C09XA52

20.1.2009

EU/1/08/494/001-002

Solution for injection

L04AC05

20.1.2009

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

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27.2.2009

EN

Official Journal of the European Union

C 48/5

— 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

5.1.2009

Tasigna

5.1.2009

Irbesartan HCT
BMS

6.1.2009

ECALTA

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

Bristol-Myers Squibb Pharma EEIG
Uxbridge Business Park
Sanderson Road
Uxbridge UB8 1DH
United Kingdom

Pfizer Limited
Ramsgate Road
Sandwich
Kent CT13 9NJ
United Kingdom

EU/1/07/422/001-004

8.1.2009

EU/1/06/369/011-028

7.1.2009

EU/1/07/416/001

8.1.2009

6.1.2009

Prevenar

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

EU/1/00/167/001-008

8.1.2009

6.1.2009

Alimta

7.1.2009

Humalog

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

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

7.1.2009

Irbesartan HCT
Winthrop

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

EU/1/04/290/001-002

8.1.2009

9.1.2009

EU/1/96/007/002
EU/1/96/007/004-006
EU/1/96/007/008
EU/1/96/007/010-011
EU/1/96/007/015-021
EU/1/96/007/023-030
EU/1/96/007/037-038

EU/1/06/377/011-028

9.1.2009

7.1.2009

Levemir

Novo Nordisk A/S
Novo Allé
DK-2880 Bagsværd

EU/1/04/278/001-009

9.1.2009

7.1.2009

Zevalin

Bayer Schering Pharma AG
D-13342 Berlin

EU/1/03/264/001

12.1.2009

7.1.2009

ISENTRESS

7.1.2009

TORISEL

7.1.2009

Retacrit

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

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

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

EU/1/07/436/001-002

9.1.2009

EU/1/07/424/001

9.1.2009

EU/1/07/431/001-025

12.1.2009

C 48/6

EN

Official Journal of the European Union

27.2.2009

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

7.1.2009

BYETTA

7.1.2009

Xolair

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

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

EU/1/06/362/001-004

9.1.2009

EU/1/05/319/001-004

9.1.2009

9.1.2009

Sprycel

Bristol-Myers Squibb Pharma EEIG
Uxbridge Business Park
Sanderson Road
Uxbridge UB8 1DH
United Kingdom

EU/1/06/363/010-011

13.1.2009

9.1.2009

IntronA

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

EU/1/99/127/001-044

13.1.2009

9.1.2009

Rilutek

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

EU/1/96/010/001

13.1.2009

9.1.2009

Xyrem

UCB Pharma Ltd
208 Bath Road
Slough
Berkshire SL1 3WE
United Kingdom

EU/1/05/312/001

13.1.2009

12.1.2009

Invega

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

EU/1/07/395/077-095

14.1.2009

12.1.2009

Invega

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

EU/1/07/395/001-095

14.1.2009

13.1.2009

Emadine

15.1.2009

Sprycel

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

Bristol-Myers Squibb Pharma EEIG
Uxbridge Business Park
Sanderson Road
Uxbridge UB8 1DH
United Kingdom

EU/1/98/095/001-004

15.1.2009

EU/1/06/363/001-011

20.1.2009

16.1.2009

Cyanokit

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

EU/1/07/420/001

21.1.2009

27.2.2009

EN

Official Journal of the European Union

C 48/7

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

16.1.2009

Rebif

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

EU/1/98/063/008-010

20.1.2009

16.1.2009

Regranex

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

EU/1/99/101/001

20.1.2009

20.1.2009

Alli

20.1.2009

Sebivo

Glaxo Group Limited
Berkeley Avenue
Greenford
Middlesex UB6 0NN
United Kingdom

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

EU/1/07/401/007-010

22.1.2009

EU/1/07/388/003

22.1.2009

22.1.2009

Temodal

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

EU/1/98/096/001-022

27.1.2009

23.1.2009

Tysabri

26.1.2009

Synagis

Elan Pharma International Ltd
Monksland
Athlone
County Westmeath
Ireland

Abbott Laboratories Ltd
Queenborough
Kent ME11 5EL
United Kingdom

EU/1/06/346/001

27.1.2009

EU/1/99/117/001-002

28.1.2009

26.1.2009

Keppra

UCB Pharma S.A.
Allée de la Recherche 60/Research-
dreef, 60
B-1070 Bruxelles/Brussel

EU/1/00/146/001-030

28.1.2009

26.1.2009

Zostavax

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

EU/1/06/341/001-013

28.1.2009

26.1.2009

Plavix

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

26.1.2009

Volibris

Glaxo Group Ltd
Greenford
Middlesex UB6 0NN
United Kingdom

28.1.2009

EU/1/98/069/001a
EU/1/98/069/002a
EU/1/98/069/003a
EU/1/98/069/004a
EU/1/98/069/005a
EU/1/98/069/006a
EU/1/98/069/007a
EU/1/98/069/011a
EU/1/98/069/011b

EU/1/08/451/001-004

28.1.2009

C 48/8

EN

Official Journal of the European Union

27.2.2009

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

26.1.2009

Fasturtec

26.1.2009

Prometax

26.1.2009

Zavesca

26.1.2009

Mirapexin

26.1.2009

Tamiflu

27.1.2009

Tritanrix HepB

27.1.2009

Thelin

27.1.2009

PritorPlus

27.1.2009

Hepsera

27.1.2009

Viramune

27.1.2009

MicardisPlus

27.1.2009

Iscover

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

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

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

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

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

GlaxoSmithKline Biologicals S.A.
rue de l'Institut, 89
B-1330 Rixensart

Encysive (UK) Limited
Alder Castle House
10 Noble Street
London EC2V 7QJ
United Kingdom

Bayer HealthCare AG
D-51368 Leverkusen

EU/1/00/170/001-002

28.1.2009

EU/1/98/092/001-018

28.1.2009

EU/1/02/238/001

28.1.2009

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

28.1.2009

EU/1/02/222/001-004

28.1.2009

EU/1/96/014/001-003

29.1.2009

EU/1/06/353/001-005

29.1.2009

EU/1/02/215/001-021

29.1.2009

Gilead Sciences International Limited
Cambridge CB21 6GT
United Kingdom

EU/1/03/251/001-002

29.1.2009

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

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

Bristol-Myers Squibb Pharma EEIG
Uxbridge Business Park
Sanderson Road
Uxbridge UB8 1DH
United Kingdom

EU/1/97/055/001-003

29.1.2009

EU/1/02/213/001-023

29.1.2009

29.1.2009

EU/1/98/070/001a
EU/1/98/070/002a
EU/1/98/070/003a
EU/1/98/070/004a
EU/1/98/070/005a
EU/1/98/070/006a
EU/1/98/070/007a
EU/1/98/070/011a
EU/1/98/070/011b

27.2.2009

EN

Official Journal of the European Union

C 48/9

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

27.1.2009

Tarceva

27.1.2009

Invirase

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

EU/1/05/311/001-003

29.1.2009

EU/1/96/026/001-002

29.1.2009

28.1.2009

Diacomit

Biocodex
7, avenue Gallieni
F-94250 Gentilly

EU/1/06/367/001-012

30.1.2009

29.1.2009

Prezista

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

EU/1/06/380/002-003

2.2.2009

29.1.2009

Aloxi

Helsinn Birex Pharmaceuticals Ltd
Damastown
Mulhuddart
Dublin 15
Republic of Ireland

EU/1/04/306/001

2.2.2009

29.1.2009

Kinzalkomb

Bayer HealthCare AG
D-51368 Leverkusen

EU/1/02/214/001-015

2.2.2009

29.1.2009

Sprycel

30.1.2009

Exelon

Bristol-Myers Squibb Pharma EEIG
Uxbridge Business Park
Sanderson Road
Uxbridge UB8 1DH
United Kingdom

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

EU/1/06/363/001-011

2.2.2009

EU/1/98/066/001-018

4.2.2009

30.1.2009

NeuroBloc

Eisai Limited
3, Shortlands
London W6 8EE
United Kingdom

EU/1/00/166/001-003

3.2.2009

30.1.2009

Sifrol

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

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

4.2.2009

30.1.2009

Thalidomide
Celgene

Celgene Europe Limited
Riverside House
Riverside Walk
Windsor SL4 1NA
United Kingdom

EU/1/08/443/001

3.2.2009

C 48/10

EN

Official Journal of the European Union

27.2.2009

— 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

16.1.2009

Zimulti

16.1.2009

ACOMPLIA

30.1.2009

Velosulin

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

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

Novo Nordisk A/S
Novo Allé
DK-2880 Bagsværd

EU/1/06/345/001-011

20.1.2009

EU/1/06/344/001-011

20.1.2009

EU/1/02/232/001-003

3.2.2009

— Suspension of a marketing authorization (Article 20 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

16.1.2009

Ionsys

Janssen-Cilag International NV
Turnhoutseweg 30
B-2340 Beerse

EU/1/05/326/001

20.1.2009

— 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

12.1.2009

Porcilis PCV

Porcine circovirus type 2 ORF2
subunit antigen

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

EU/2/08/091/001-010

Emulsion for injection

QI09AA07

14.1.2009

— 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

13.1.2009

Novem

20.1.2009

Fevaxyn Pentofel

Boehringer Ingelheim Vetmedica
GmbH
D-55216 Ingelheim am Rhein

Fort Dodge Laboratories Ireland
Finisklin Industrial Estate — Sligo
Ireland

EU/2/04/042/001-004

16.1.2009

EU/2/96/002/001-003

22.1.2009

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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