Summary of Community decisions on marketing authorizations in respect of medicinal products from  1 August 2007 to 31 August 2007 (Published pursuant to Article 13 or Article 38 of Regulation (EC) No 726/2004 of the European Parliament and of the Council )
Date: 2007-09-28
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 August 2007 to 31 August 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 228/02)

— 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
Therapeutic
Chemical Code)

Date of
notification

3.8.2007

INCRELEX

Mecasermin

Tercica Europe Limited
2 Harbourmaster Place
International Financial Services Centre
Dublin 1
Ireland

EU/1/07/402/001

Solution for injection

H01AC03

7.8.2007

22.8.2007

Enviage

Aliskiren

22.8.2007

Riprazo

Aliskiren

22.8.2007

Sprimeo

Aliskiren

22.8.2007

Rasilez

Aliskiren

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

Novartis Europharm Limited
Wimblehurst Road
Horsham
West Sussex RH12 5AB
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

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

EU/1/07/406/001-020

Film-coated tablet

C09XA02

24.8.2007

EU/1/07/409/001-020

Film-coated tablet

C09XA02

24.8.2007

EU/1/07/407/001-020

Film-coated tablet

C09XA02

24.8.2007

EU/1/07/405/001-020

Film-coated tablet

C09XA02

24.8.2007

C

2
2
8
/
2

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N

O

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E
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a
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U
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2
8
9
2
0
0
7

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
Therapeutic
Chemical Code)

Date of
notification

22.8.2007

Tekturna

Aliskiren

22.8.2007

Atriance

Nelarabine

23.8.2007

Flebogammadif

Human normal immu-
noglobulin

28.8.2007

Abseamed

Epoetin alfa

28.8.2007

Binocrit

Epoetin alfa

28.8.2007

Epoetin alfa hexal

Epoetin alfa

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

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

Instituto Grifols S.A.
Can Guasch
2 — Parets del Vallès
E-08150 Barcelona

Medice Arzneimittel Pütter GmbH & Co
KG
Kuhloweg 37
D-58638 Iserlohn

Sandoz GmbH
Biochemiestrasse 10
A-6250 Kundl

HEXAL Biotech Forschungs GmbH
Industriestrasse 25
D-83607 Holzkirchen

EU/1/07/408/001-020

Film-coated tablet

C09XA02

24.8.2007

EU/1/07/403/001

Solution for infusion

L01BB07

24.8.2007

EU/1/07/404/001-005

Solution for infusion

J06BA02

27.8.2007

EU/1/07/412/001-016

Solution for injection in
a pre-filled syringe

B03XA01

31.8.2007

EU/1/07/410/001-016

Solution for injection in
a pre-filled syringe

B03XA01

31.8.2007

EU/1/07/411/001-016

Solution for injection in
a pre-filled syringe

B03XA01

3.9.2007

.

.

2
8
9
2
0
0
7

E
N

O

f
f
i
c
i
a
l

J
o
u
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n
a
l

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f

t
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C

2
2
8
/
3

C 228/4

EN

Official Journal of the European Union

28.9.2007

— 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

1.8.2007

Keppra

3.8.2007

TachoSil

7.8.2007

BeneFIX

10.8.2007

Norvir

10.8.2007

Fasturtec

10.8.2007

Ceprotin

10.8.2007

Cellcept

10.8.2007

Rebif

UCB S.A.
Allée de la Recherche, 60
B-1070 Bruxelles
Researchdreef, 60
B-1070 Brussel

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

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

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

Abbott laboratories Ltd
Queenborough
Kent ME11 5EL
United Kingdom

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

Baxter AG
Industriestraße 67
A-1220 Vienna

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

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

EU/1/00/146/001-030

3.8.2007

EU/1/04/277/001-004

7.8.2007

EU/1/97/047/001-007

9.8.2007

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

14.8.2007

EU/1/00/170/001-002

14.8.2007

EU/1/01/190/001-002

14.8.2007

EU/1/96/005/001-006

14.8.2007

EU/1/98/063/001-007

14.8.2007

10.8.2007

Tritanrix HepB

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

EU/1/96/014/001-003

14.8.2007

10.8.2007

Cialis

20.8.2007

Actos

EU/1/02/237/001-008

22.8.2007

EU/1/00/150/001-024

22.8.2007

Lilly ICOS Limited
St Bride's House
10 Salisbury Square
London EC4Y 8EH
United Kingdom

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

28.9.2007

EN

Official Journal of the European Union

C 228/5

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

20.8.2007

Glustin

20.8.2007

Competact

21.8.2007

Forsteo

21.8.2007

Nexavar

21.8.2007

Opatanol

21.8.2007

NeuroBloc

21.8.2007

Avastin

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

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

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

Bayer HealthCare AG
D-51368 Leverkusen

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

Solstice Neurosciences Ltd
Fitzwilton House
Wilton Place
Dublin 2
Ireland

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

EU/1/00/151/001-022

22.8.2007

EU/1/06/354/001-009

22.8.2007

EU/1/03/247/001-002

23.8.2007

EU/1/06/342/001

23.8.2007

EU/1/02/217/001-002

23.8.2007

EU/1/00/166/001-003

23.8.2007

EU/1/04/300/001-002

23.8.2007

21.8.2007

Kiovig

Baxter AG
Industriestraße 67
A-1220 Vienna

EU/1/05/329/001-005

23.8.2007

22.8.2007

Sprycel

22.8.2007

Luminity

22.8.2007

Emtriva

22.8.2007

Baraclude

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

Bristol-Myers Squibb Pharma
Belgium Sprl
Chaussée de la Hulpe, 185
B-1170 Brussel

Gilead Sciences International
Limited
Cambridge CB21 6GT
United Kingdom

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

EU/1/06/363/001-009

24.8.2007

EU/1/06/361/001-002

24.8.2007

EU/1/03/261/001-003

24.8.2007

EU/1/06/343/001-005

24.8.2007

C 228/6

EN

Official Journal of the European Union

28.9.2007

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

23.8.2007

Inovelon

23.8.2007

Stocrin

23.8.2007

Sustiva

23.8.2007

Orfadin

27.8.2007

Kivexa

27.8.2007

Ziagen

27.8.2007

Rapamune

27.8.2007

Prezista

27.8.2007

NovoMix

27.8.2007

Invanz

27.8.2007

Tandemact

27.8.2007

Ebixa

29.8.2007

Enbrel

Eisai Limited, 3
Shortlands
London W6 8EE
United Kingdom

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

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

Swedish Orphan International AB
Drottninggatan 98
S-111 60 Stockholm

Glaxo Group Ltd
Greenford
Middlesex UB6 0NN
United Kingdom

Glaxo Group Ltd
Greenford
Middlesex UB6 0NN
United Kingdom

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

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

Novo Nordisk A/S
Novo Allé
DK-2880 Bagsværd

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

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

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

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

EU/1/06/378/001-016

28.8.2007

EU/1/99/111/001-011

28.8.2007

EU/1/99/110/001-009

28.8.2007

EU/1/04/303/001-003

27.8.2007

EU/1/04/298/001-002

29.8.2007

EU/1/99/112/001-002

29.8.2007

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

29.8.2007

EU/1/06/380/001

29.8.2007

EU/1/00/142/004-005
EU/1/00/142/009-022

29.8.2007

EU/1/02/216/001-002

29.8.2007

EU/1/06/366/001-004

29.8.2007

EU/1/02/219/001-015

29.8.2007

EU/1/99/126/001-018

31.8.2007

28.9.2007

EN

Official Journal of the European Union

C 228/7

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

28.8.2007

Cymbalta

28.8.2007

Xeristar

28.8.2007

YENTREVE

28.8.2007

Ariclaim

29.8.2007

Stalevo

29.8.2007

Exubera

29.8.2007

Vistide

29.8.2007

Evoltra

29.8.2007

Xelevia

29.8.2007

Januvia

29.8.2007

Quixidar

29.8.2007

Quixidar

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

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

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

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

Orion Corporation
Orionintie 1
FIN-02200 Espoo

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

Pfizer Enterprises SARL
51, Avenue Kennedy
Rond Point du Kirchberg
L-1855 Luxembourg

Bioenvision Limited
Bassett House
5 Southwell Park Road
Camberley
Surrey GU15 3PU
United Kingdom

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

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

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

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

EU/1/04/296/001-009

31.8.2007

EU/1/04/297/001-008

31.8.2007

EU/1/04/280/001-008

31.8.2007

EU/1/04/283/001-007

31.8.2007

EU/1/03/260/001-018

31.8.2007

EU/1/05/327/001-018

31.8.2007

EU/1/97/037/001

31.8.2007

EU/1/06/334/001-004

31.8.2007

EU/1/07/382/001-018

31.8.2007

EU/1/07/383/001-018

31.8.2007

EU/1/02/207/001-004

31.8.2007

EU/1/02/207/001-004

31.8.2007

C 228/8

EN

Official Journal of the European Union

28.9.2007

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

29.8.2007

Arixtra

29.8.2007

Arixtra

30.8.2007

Fuzeon

30.8.2007

BYETTA

30.8.2007

Agenerase

30.8.2007

Aranesp

30.8.2007

NovoRapid

30.8.2007

Nespo

30.8.2007

Zyprexa

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

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

EU/1/02/206/001-004

31.8.2007

EU/1/02/206/001-004

31.8.2007

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

EU/1/03/252/001-003

5.9.2007

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

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

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

Novo Nordisk A/S
Novo Allé
DK-2880 Bagsværd

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

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

EU/1/06/362/001-004

5.9.2007

EU/1/00/148/001-004

5.9.2007

EU/1/01/185/001-073

5.9.2007

EU/1/99/119/001
EU/1/99/119/003
EU/1/99/119/005-014

5.9.2007

EU/1/01/184/001-073

5.9.2007

5.9.2007

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/1/99/125/001-016

5.9.2007

30.8.2007

Zyprexa Velotab

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

30.8.2007

InductOs

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

EU/1/02/226/001

5.9.2007

28.9.2007

EN

Official Journal of the European Union

C 228/9

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

30.8.2007

Aldara

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

EU/1/98/080/001

5.9.2007

31.8.2007

Karvea

31.8.2007

Aprovel

31.8.2007

CUBICIN

31.8.2007

Glustin

31.8.2007

Mimpara

31.8.2007

Parareg

31.8.2007

Epivir

31.8.2007

Zimulti

31.8.2007

ACOMPLIA

Meda AB
Pipers väg 2A
S-170 73 Solna

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

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

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

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

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

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

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

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

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

5.9.2007

EU/1/97/049/001-039

6.9.2007

EU/1/97/046/001-039

5.9.2007

EU/1/05/328/001-002

5.9.2007

EU/1/00/151/001-024

5.9.2007

EU/1/04/292/001-012

6.9.2007

EU/1/04/293/001-012

6.9.2007

EU/1/96/015/001-005

6.9.2007

EU/1/06/345/001-011

6.9.2007

EU/1/06/344/001-011

6.9.2007

31.8.2007

Prevenar

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

EU/1/00/167/001-007

6.9.2007

C 228/10

EN

Official Journal of the European Union

28.9.2007

— 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

6.8.2007

Viracept

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

EU/1/97/054/001
EU/1/97/054/003-005

8.8.2007

— 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

2.8.2007

Dexdomitor

13.8.2007

Advocate

23.8.2007

PRAC-TIC

27.8.2007

Yarvitan

Orion Corporation
Orionintie 1
FIN-02200 Espoo

Bayer HealthCare AG
D-51368 Leverkusen

Novartis Sanidad Animal S.L.
Calle de la Marina, 206
E-08013 Barcelona

Janssen Animal Health B.V.B.A.
Turnhoutseweg, 30
B-2340 Beerse
Janssen Pharmaceutica N.V.
Turnhoutseweg, 30
B-2340 Beerse

EU/2/02/033/001

6.8.2007

EU/2/03/039/001-030

15.8.2007

EU/2/06/066/001-012

27.8.2007

EU/2/06/063/001-003

29.8.2007

29.8.2007

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