Summary of Community decisions on marketing authorizations in respect of medicinal products from 1.7.2006 to 31.7.2006 (Published pursuant to Article 13 or Article 38 of Regulation (EC) No 726/2004 of the European Parliament and of the Council)
Date: 2006-09-08
Institutions: European Commission
Subjects: market approval, marketing standard, medicinal product, pharmaceutical legislation

Summary of Community decisions on marketing authorizations in respect of medicinal
products from 1.7.2006 to 31.7.2006

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

(2006/C 217/03)

— Issuing of a marketing authorization (Article 13 of Regulation (EC) No 726/2004 of the European Parliament and of the Council): Accepted

Date of the
decision

Name of the
medicinal
product

INN
(International Non-Proprietary
Name)

19.7.2006

SUTENT

sunitinib

19.7.2006

Nexavar

Sorafenib

28.7.2006

ATryn

antithrombin alfa

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

Bayer HealthCare AG
D-51368 Leverkusen

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

Holder of the marketing authorization

Number of the entry in the
Community Register

Pharmaceutical form

ATC code
(Anatomical Therapeutic
Chemical Code)

EU/1/06/347/001-003

Capsule, hard

L01XE04

Date of
notification

24.7.2006

EU/1/06/342/001

Film-coated tablet

L01XE05

21.7.2006

EU/1/06/355/001-003

Powder for solution for
infusion

B01AB02

2.8.2006

28.7.2006

Livensa

testosterone

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

EU/1/06/351/001-003

Transdermal patch

G03BA03

1.8.2006

28.7.2006

Savene

Dexrazoxane

TopoTarget A/S
Fruebjergvej 3
DK-Denmark

EU/1/06/350/001

Powder for concentrate and
diluent for solution for infu-
sion

V03AF02

2.8.2006

28.7.2006

Intrinsa

testosterone

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

(1) OJ L 136, 30 April 2004, p. 1.

EU/1/06/352/001-003

Transdermal patch

G03BA03

3.8.2006

.

.

8
9
2
0
0
6

E
N

O

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5

Date of the
decision

Name of the
medicinal
product

INN
(International Non-Proprietary
Name)

28.7.2006

Competact

Pioglitazone/metformin

Holder of the marketing authorization

Number of the entry in the
Community Register

Pharmaceutical form

ATC code
(Anatomical Therapeutic
Chemical Code)

Date of
notification

EU/1/06/354/001-009

Film-coated tablet

(Non applicable)

1.8.2006

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

C

2
1
7
/
6

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

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h
e

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8
9
2
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6

8.9.2006

EN

Official Journal of the European Union

C 217/7

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

European Parliament and of the Council): 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

4.7.2006

Remicade

4.7.2006

Avastin

4.7.2006

Taxotere

4.7.2006

Zeffix

4.7.2006

Dynastat

4.7.2006

Lyrica

6.7.2006

Mabthera

Centocor B.V.
Einsteinweg 101
2333 CB Leiden
Nederland

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

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

Glaxo Group Ltd.
Greenford
Middlesex UB6 0NN
United Kingdom

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

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

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

EU/1/99/116/001-003

6.7.2006

EU/1/04/300/001-002

6.7.2006

EU/1/95/002/001-002

6.7.2006

EU/1/99/114/001-003

6.7.2006

EU/1/02/209/001-008

6.7.2006

EU/1/04/279/001-035

6.7.2006

EU/1/98/067/001-002

10.7.2006

6.7.2006

REYATAZ

Bristol-Myers Squibb Pharma EEIG
141-149 Staines Road
Hounslow TW3 3JA
United Kingdom

EU/1/03/267/001-007

10.7.2006

6.7.2006

Arava

Sanofi-Aventis Deutschland GmbH
D-65926 Frankfurt am Main

EU/1/99/118/001-010

10.7.2006

6.7.2006

Levemir

11.7.2006

Comtess

Novo Nordisk A/S
Novo Allé
DK-2880 Bagsværd

Orion Corporation
Orionintie 1
FIN-02200 Espoo

EU/1/04/278/001-009

10.7.2006

EU/1/98/082/001-005

13.7.2006

C 217/8

EN

Official Journal of the European Union

8.9.2006

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

11.7.2006

Fareston

11.7.2006

Stalevo

11.7.2006

Trisenox

12.7.2006

AVANDIA

13.7.2006

Starlix

13.7.2006

Trazec

13.7.2006 Mimpara

13.7.2006

Parareg

14.7.2006

Revasc

19.7.2006

PegIntron

19.7.2006

Viraferon

Orion Corporation
Orionintie 1
FIN-02200 Espoo

Orion Corporation
Orionintie 1
FIN-02200 Espoo

Cephalon UK Ltd.
20 Alan Turing Road
Surrey Research Park
Guildford
Surrey
GU2 7YF
United Kingdom

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

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

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

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

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

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

EU/1/96/004/001-002

13.7.2006

EU/1/03/260/001-015

13.7.2006

EU/1/02/204/001

13.7.2006

EU/1/00/137/002-018

14.7.2006

EU/1/01/174/001-021

17.7.2006

EU/1/01/175/001-021

17.7.2006

EU/1/04/292/001-012

17.7.2006

EU/1/04/293/001-012

17.7.2006

EU/1/97/043/001-003

20.7.2006

EU/1/00/131/001-050

25.7.2006

EU/1/99/128/001-037

25.7.2006

8.9.2006

EN

Official Journal of the European Union

C 217/9

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

19.7.2006

IntronA

19.7.2006

ViraferonPeg

20.7.2006

Avandamet

20.7.2006

GONAL-f

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

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

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

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

20.7.2006

Actos

20.7.2006

Glustin

20.7.2006

Tractocile

20.7.2006

NovoRapid

20.7.2006

Pegasys

20.7.2006

Fuzeon

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

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

Ferring AB
Soldattorpsvägen 5
Box 30 047
S-20061 Limhamn

Novo Nordisk A/S
Novo Allé
DK-2880 Bagsværd

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/1/99/127/001-044

25.7.2006

EU/1/00/132/001-050

25.7.2006

EU/1/03/258/001-022

26.7.2006

26.7.2006

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/1/00/150/001-024

26.7.2006

EU/1/00/151/001-022

26.7.2006

EU/1/99/124/001-002

27.7.2006

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

26.7.2006

EU/1/02/221/001-010

26.7.2006

EU/1/03/252/001-003

26.7.2006

C 217/10

EN

Official Journal of the European Union

8.9.2006

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

EU/1/00/146/001-030

28.7.2006

EU/1/99/117/001-002

28.7.2006

EU/1/99/107/001-005

28.7.2006

EU/1/01/186/001-002

28.7.2006

EU/1/05/328/001-002

28.7.2006

EU/1/01/189/001-006

1.8.2006

EU/1/00/141/001

1.8.2006

25.7.2006

Keppra

25.7.2006

Synagis

25.7.2006

Rebetol

25.7.2006

Nonafact

25.7.2006

CUBICIN

28.7.2006

Replagal

28.7.2006 Myocet

UCB S.A.
Allée de la recherche, 60
B-1070 Bruxelles

Abbott laboratories Ltd.
Queenborough
Kent ME11 5EL
United Kingdom

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

Sanquin
Plesmanlaan 125
1066 CX Amsterdam
Nederland

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

Chiron Corporation Ltd.
Symphony House
7 Cowley Business Park
High Street
Cowley
Uxbridge
UB8 2AD
United Kingdom

TKT Europe AB
Rinkebyvägen 11B
S-182 36 Danderyd

Zeneus Pharma Limited
The Magdalen Centre
Oxford Science Park
Oxford
OX4 4GA
United Kingdom

Elan Pharma International Ltd.
WIL House
Shannon Business Park
Shannon
County Clare
Ireland

28.7.2006

INOmax

INO Therapeutics AB
S-181 81 Lidingö

EU/1/01/194/001-002

2.8.2006

28.7.2006

Rilutek

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

EU/1/96/010/001

2.8.2006

28.7.2006

Epivir

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

EU/1/96/015/001-005

2.8.2006

8.9.2006

EN

Official Journal of the European Union

C 217/11

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

28.7.2006

Fabrazyme

28.7.2006

DaTSCAN

28.7.2006

Velcade

28.7.2006

REYATAZ

28.7.2006

Kineret

28.7.2006

Procomvax

28.7.2006 MabCampath

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

GE Healthcare Limited
Little Chalfont
Bucks HP7 9NA
United Kingdom

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

Bristol-Myers Squibb Pharma EEIG
141-149 Staines Road
Hounslow TW3 3JA
United Kingdom

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

Sanofi Pasteur MSD S.N.C.
8, rue Jonas Salk
F-69007 Lyon

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

EU/1/01/188/001-006

2.8.2006

EU/1/00/135/001-002

2.8.2006

EU/1/04/274/001

2.8.2006

EU/1/03/267/001-007

2.8.2006

EU/1/02/203/001-004

2.8.2006

EU/1/99/104/001

2.8.2006

EU/1/01/193/001-002

3.8.2006

28.7.2006

Tritanrix HepB

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

EU/1/96/014/001-003

3.8.2006

28.7.2006

Ceprotin

28.7.2006 Myozyme

28.7.2006

Prialt

28.7.2006

Rapamune

28.7.2006

Bonviva

Baxter AG
Industriesstrasse 67
A-1220 Vienna

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

Elan Pharma International Ltd.
WIL House
Shannon Business Park
Shannon
County Clare
Ireland

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

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

EU/1/01/190/001-002

2.8.2006

EU/1/06/333/001-003

2.8.2006

EU/1/04/302/001-004

2.8.2006

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

2.8.2006

EU/1/03/265/001-006

2.8.2006

C 217/12

EN

Official Journal of the European Union

8.9.2006

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

28.7.2006

Bondenza

28.7.2006

Cialis

28.7.2006

Norvir

28.7.2006

Vivanza

28.7.2006

Levitra

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

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

Abbott laboratories Ltd.
Queenborough
Kent ME11 5EL
United Kingdom

Bayer AG
D-51368 Leverkusen

Bayer AG
D-51368 Leverkusen

EU/1/03/266/001-006

2.8.2006

EU/1/02/237/001-005

2.8.2006

EU/1/96/016/001
EU/1/96/016/003

2.8.2006

EU/1/03/249/001-012

2.8.2006

EU/1/03/248/001-013

2.8.2006

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

European Parliament and of the Council): 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

11.7.2006

Dexdomitor

Orion Corporation
Orionintie 1
FIN-02200 Espoo

14.7.2006

Vaxxitek HVT+
IBD

Merial
29, avenue Tony Garnier
F-69007 Lyon

20.7.2006

Porcilis Porcoli

20.7.2006

Rabigen SAG2

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

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

EU/2/02/033/001

13.7.2006

EU/2/02/032/001

18.7.2006

EU/2/96/001/003-010

26.7.2006

EU/2/00/021/001-002

26.7.2006

Anyone wishing to consult the public assessment report on the medicinal products in question and the
decisions relating thereto is invited to contact:
The European Medicines Agency
7, Westferry Circus, Canary Wharf
London E14 4HB
United Kingdom