Summary of Community decisions on marketing authorizations in respect of medicinal products from 1 January 2007 to 31 January 2007 (Published pursuant to Article 13 or Article 38 of Regulation (EC) No 726/2004 of the European Parliament and of the Council )
Date: 2007-02-23
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 January 2007 to 31 January 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 39/09)

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

Holder of the marketing authorization

Number of the entry in the
Community Register

Pharmaceutical form

EU/1/06/364/001-005

Tablet

ATC code
(Anatomical
Therapeutic
Chemical Code)

(Non applic-
able)

Date of
notification

9.1.2007

Date of the
decision

Name of the
medicinal
product

INN
(International Non-Proprietary
Name)

4.1.2007

ADROVANCE Alendronate sodium/Colecal-

ciferol

4.1.2007

Diacomit

Stiripentol

8.1.2007

Elaprase

Idursulfase

8.1.2007

Tandemact

Pioglitazone/Glimepiride

16.1.2007

Inovelon

rufinamide

16.1.2007

Dafiro

amlodipine/valsartan

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

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

Biocodex
7, avenue Gallieni
F-94250 Gentilly

Shire Human Genetic Therapies AB
Rinkebyvägen 11B
SE-182 36 Danderyd

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

Eisai Limited
3, Shortlands
London W6 8EE
United Kingdom

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

EU/1/06/367/001-006

Capsule

N03AX17

9.1.2007

EU/1/06/367/007-012

Powder for oral suspension

EU/1/06/365/001-003

Concentrate for solution for
infusion

A16AB09

10.1.2007

EU/1/06/366/001-004

Tablet

(Non applic-
able)

10.1.2007

EU/1/06/378/001-016

Film-coated tablet

N03AF03

18.1.2007

EU/1/06/371/001-024

Film-coated tablet

C09DB01

18.1.2007

.

.

2
3
2
2
0
0
7

E
N

O

f
f
i
c
i
a
l

J
o
u
r
n
a
l

o
f

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h
e

E
u
r
o
p
e
a
n
U
n
o
n

i

C

3
9
/
7

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

16.1.2007

Copalia

amlodipine/valsartan

17.1.2007

Exforge

amlodipine/valsartan

17.1.2007

Imprida

amlodipine/valsartan

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

17.1.2007

Insulin
Human
Winthrop

insulin human

Sanofi-Aventis Deutschland GmbH
D-65926 Frankfurt am Main

EU/1/06/372/001-024

Film-coated tablet

C09DB01

18.1.2007

EU/1/06/370/001-024

Film-coated tablet

C09DB01

19.1.2007

EU/1/06/373/001-024

Film-coated tablet

C09DB01

19.1.2007

Solution for injection

A10AB01

2.2.2007

Suspension for injection

OptiSet, solution for injection

EU/1/06/368/001-002
EU/1/06/368/011-015
EU/1/06/368/056-057

EU/1/06/368/003-010
EU/1/06/368/020-024
EU/1/06/368/029-033
EU/1/06/368/038-042
EU/1/06/368/047-051

EU/1/06/368/016-019
EU/1/06/368/025-028
EU/1/06/368/034-037
EU/1/06/368/043-046
EU/1/06/368/052-055

C

3
9
/
8

E
N

O

f
f
i
c
i
a
l

J
o
u
r
n
a
l

o
f

t
h
e

E
u
r
o
p
e
a
n
U
n
o
n

i

19.1.2007

Irbesartan
BMS

irbesartan

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

EU/1/06/375/001-015

Tablet

C09CA04

23.1.2007

EU/1/06/375/016-033

Film-coated tablets

.

.

2
3
2
2
0
0
7

Holder of the marketing authorization

Number of the entry in the
Community Register

Pharmaceutical form

Date of the
decision

19.1.2007

Name of the
medicinal
product

INN
(International Non-Proprietary
Name)

Irbesartan
Hydrochloro-
thiazide BMS

irbesartan/hydrochlorothia-
zide

19.1.2007

Irbesartan
Winthrop

Irbesartan

19.1.2007

Irbesartan
Hydrochloro-
thiazide
Winthrop

irbesartan/hydrochlorothia-
zide

22.1.2007

Lucentis

ranibizumab

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

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

ATC code
(Anatomical
Therapeutic
Chemical Code)

Date of
notification

C09DA04

23.1.2007

.

.

2
3
2
2
0
0
7

EU/1/06/369/001-010
EU/1/06/369/011-028

Tablet
Film-coated tablets

EU/1/06/376/001-015
EU/1/06/376/016-033

Tablet
Film-coated tablets

C09CA04

23.1.2007

EU/1/06/377/001-010
EU/1/06/377/011-028

Tablet
Film-coated tablets

C09DA04

23.1.2007

EU/1/06/374/001

Solution for injection

S01LA04

24.1.2007

E
N

O

f
f
i
c
i
a
l

J
o
u
r
n
a
l

o
f

t
h
e

E
u
r
o
p
e
a
n
U
n
o
n

i

C

3
9
/
9

C 39/10

EN

Official Journal of the European Union

23.2.2007

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

pean Parliament and of the Council): Rejected

Date of the
decision

Name of the
medicinal
product

16.1.2007

Thymanax

16.1.2007

Valdoxan

Holder of the marketing authorization

Number of the entry in the
Community Register

Date of
notification

Les Laboratoires Servier
22, rue Garnier
F-92200 Neuilly-sur-Seine

Les Laboratoires Servier
22, rue Garnier
F-92200 Neuilly-sur-Seine

—

—

18.1.2007

18.1.2007

— 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

3.1.2007

MicardisPlus

Holder of the marketing authorization

Number of the entry in the
Community Register

Date of
notification

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

EU/1/02/213/001-016

9.1.2007

3.1.2007

Neulasta

3.1.2007

Neupopeg

3.1.2007

Invirase

3.1.2007

Ceprotin

3.1.2007

Ambirix

3.1.2007

Velcade

3.1.2007

Zostavax

3.1.2007

Nexavar

3.1.2007

Telzir

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

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

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

Baxter AG
Industriesstrasse 67
A-1220 Vienna

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

Janssen-Cilag International NV
Turnhoutseweg 30
B-2340 Beerse

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

Bayer HealthCare AG
D-51368 Leverkusen

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

EU/1/02/227/001-003

9.1.2007

EU/1/02/228/001-003

9.1.2007

EU/1/96/026/001-002

9.1.2007

EU/1/01/190/001-002

9.1.2007

EU/1/02/224/ 001-005

9.1.2007

EU/1/04/274/001

9.1.2007

EU/1/06/341/001-013

9.1.2007

EU/1/06/342/001

9.1.2007

EU/1/04/282/001-002

9.1.2007

23.2.2007

EN

Official Journal of the European Union

C 39/11

Date of the
decision

4.1.2007

Name of the
medicinal
product

Twinrix
Paediatric

4.1.2007

NovoSeven

4.1.2007

PEGASYS

Holder of the marketing authorization

Number of the entry in the
Community Register

Date of
notification

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

Novo Nordisk A/S
Novo Allé
DK-2880 Bagsværd

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

EU/1/97/029/001-010

9.1.2007

EU/1/96/006/001-003

9.1.2007

EU/1/02/221/001-010

9.1.2007

4.1.2007

Kinzalmono

Bayer HealthCare AG
D-51368 Leverkusen

EU/1/98/091/001-014

9.1.2007

4.1.2007

Twinrix Adult GlaxoSmithKline Biologicals s.a.

EU/1/96/020/001-009

9.1.2007

rue de l'Institut 89
B-1330 Rixensart

4.1.2007

NeoRecormon Roche Registration Limited

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

EU/1/97/031/001-003
EU/1/97/031/019-046

9.1.2007

4.1.2007

Micardis

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

EU/1/98/090/001-020

9.1.2007

4.1.2007

Rebetol

4.1.2007

Competact

4.1.2007

Remicade

4.1.2007

Ketek

4.1.2007

Levviax

4.1.2007

Temodal

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

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

Centocor B.V.
Einsteinweg 101
2333 CB Leiden
Nederland

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

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

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

EU/1/99/107/001-005

9.1.2007

EU/1/06/354/001-009

9.1.2007

EU/1/99/116/001-003

9.1.2007

EU/1/01/191/001-005

9.1.2007

EU/1/01/192/001-005

9.1.2007

EU/1/98/096/001-008

9.1.2007

C 39/12

EN

Official Journal of the European Union

23.2.2007

Date of the
decision

Name of the
medicinal
product

4.1.2007

Keppra

4.1.2007

Kinzalkomb

8.1.2007

PritorPlus

8.1.2007

Pritor

8.1.2007

DepoCyte

8.1.2007

Agenerase

8.1.2007

IntronA

Holder of the marketing authorization

Number of the entry in the
Community Register

Date of
notification

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

Bayer HealthCare AG
D-51368 Leverkusen

Bayer HealthCare AG
D-51368 Leverkusen

Bayer HealthCare AG
D-51368 Leverkusen

SkyePharma PLC
105 Piccadilly
London W1J 7NJ
United Kindgom

Glaxo Group Ltd
Greenford
Middlesex UB6 0NN
United Kingdom

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

EU/1/00/146/001-030

10.1.2007

EU/1/02/214/001-010

9.1.2007

EU/1/02/215/001-014

10.1.2007

EU/1/98/089/001-022

10.1.2007

EU/1/01/187/001

10.1.2007

EU/1/00/148/001-004

10.1.2007

EU/1/99/127/001-044

10.1.2007

8.1.2007

Viread

Gilead Sciences International Limited
Cambridge CB1 6GT
United Kingdom

EU/1/01/200/001

10.1.2007

9.1.2007

Puregon

9.1.2007

Neupro

9.1.2007

Viraferon

9.1.2007

Thyrogen

11.1.2007

Karvezide

Organon N.V.
P.O. Box 20
5340 BH Oss
Nederland

Schwarz Pharma Ltd
Shannon, Industrial Estate
Co.Clare
Ireland

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

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

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

EU/1/96/008/001-041

11.1.2007

EU/1/05/331/001-037

11.1.2007

EU/1/99/128/001-037

11.1.2007

EU/1/99/122/001-002

11.1.2007

EU/1/98/085/001-028

15.1.2007

11.1.2007

CoAprovel

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

EU/1/98/086/001-028

15.1.2007

23.2.2007

EN

Official Journal of the European Union

C 39/13

Date of the
decision

Name of the
medicinal
product

11.1.2007

Sutent

11.1.2007

Viracept

11.1.2007

Invirase

11.1.2007

Karvezide

12.1.2007

MabThera

12.1.2007

Truvada

12.1.2007

Emtriva

12.1.2007

Norvir

15.1.2007

Stocrin

15.1.2007

Viramune

15.1.2007

Sustiva

Holder of the marketing authorization

Number of the entry in the
Community Register

Date of
notification

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

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

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

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

Gilead Sciences International Limited
Granta Park Abington
Cambridge CB1 6GT
United Kingdom

Gilead Sciences International Limited
Granta Park Abington
Cambridge CB1 6GT
United Kingdom

Abbott laboratories Ltd
Queenborough
Kent ME11 5EL
United-Kingdom

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

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

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

EU/1/06/347/001-003

15.1.2007

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

15.1.2007

EU/1/96/026/001-002

15.1.2007

EU/1/98/085/001-028

15.1.2007

EU/1/98/067/001-002

16.1.2007

EU/1/04/305/001

16.1.2007

EU/1/03/261/001-003

16.1.2007

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

16.1.2007

EU/1/99/111/001-011

18.1.2007

EU/1/97/055/001-003

18.1.2007

EU/1/99/110/001-009

18.1.2007

C 39/14

EN

Official Journal of the European Union

23.2.2007

Date of the
decision

Name of the
medicinal
product

15.1.2007

Viread

Holder of the marketing authorization

Number of the entry in the
Community Register

Date of
notification

Gilead Sciences International Limited
Cambridge CB1 6GT
United Kingdom

EU/1/01/200/001

18.1.2007

16.1.2007

Insuman

Sanofi-Aventis Deutschland GmbH
D-65926 Frankfurt am Main

EU/1/97/030/028-084

2.2.2007

16.1.2007

Kaletra

Abbott Laboratories Ltd
Queenborough
Kent ME11 5EL
United Kingdom

EU/1/01/172/001-005

18.1.2007

17.1.2007

REYATAZ

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

EU/1/03/267/001-007

19.1.2007

17.1.2007

Revatio

17.1.2007

SUTENT

17.1.2007

Kivexa

17.1.2007

Lyrica

17.1.2007

Advate

17.1.2007

Ziagen

18.1.2007

Telzir

18.1.2007

Avaglim

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

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

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

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

Baxter AG
Industriestraße 67
A-1221 Wien

Glaxo Group Ltd
Greenford
Middlesex UB6 0NN
United Kingdom

Glaxo Group Ltd
Greenford
Middlesex UB6 0NN
United Kingdom

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

EU/1/05/318/001

19.1.2007

EU/1/06/347/001-003

19.1.2007

EU/1/04/298/001-002

19.1.2007

EU/1/04/279/001-035

19.1.2007

EU/1/03/271/001-004

19.1.2007

EU/1/99/112/001-002

19.1.2007

EU/1/04/282/001-002

22.1.2007

EU/1/06/349/001-008

22.1.2007

23.2.2007

EN

Official Journal of the European Union

C 39/15

Date of the
decision

Name of the
medicinal
product

18.1.2007

Enbrel

19.1.2007

Zerit

24.1.2007

Stalevo

24.1.2007

Paxene

24.1.2007

Comtess

24.1.2007

Fuzeon

24.1.2007

TRIZIVIR

24.1.2007

Agenerase

24.1.2007

Fabrazyme

24.1.2007

Tarceva

24.1.2007

Avandamet

24.1.2007

Aptivus

Holder of the marketing authorization

Number of the entry in the
Community Register

Date of
notification

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

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

Orion Corporation
Orionintie 1
FIN-02200 Espoo

Norton Healthcare Limited
Albert Basin
Royal Docks
London E16 2QJ
United Kingdom

Orion Corporation
Orionintie 1
FIN-02200 Espoo

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

Glaxo Group Ltd
Greenford
Middlesex UB6 0NN
United Kingdom

Glaxo Group Ltd
Greenford
Middlesex UB6 0NN
United Kingdom

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

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

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

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

EU/1/99/126/001-018

22.1.2007

EU/1/96/009/001-009

23.1.2007

EU/1/03/260/001-015

26.1.2007

EU/1/99/113/001-004

26.1.2007

EU/1/98/082/001-003
EU/1/98/082/005

26.1.2007

EU/1/03/252/001-003

26.1.2007

EU/1/00/156/002-003

26.1.2007

EU/1/00/148/001-004

26.1.2007

EU/1/01/188/001-006

26.1.2007

EU/1/05/311/001-003

26.1.2007

EU/1/03/258/001-022

26.1.2007

EU/1/05/315/001

26.1.2007

C 39/16

EN

Official Journal of the European Union

23.2.2007

Holder of the marketing authorization

Number of the entry in the
Community Register

Date of
notification

Date of the
decision

Name of the
medicinal
product

24.1.2007

Nexavar

24.1.2007

Crixivan

25.1.2007

Evra

25.1.2007

Epivir

26.1.2007

Alimta

26.1.2007

Actos

26.1.2007

Combivir

Bayer HealthCare AG
D-51368 Leverkusen

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

Janssen-Cilag International NV
Turnhoutseweg 30
B-2340 Beerse

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

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

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

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

26.1.2007

Helixate
NexGen

Bayer HealthCare AG
D-51368 Leverkusen

26.1.2007

TARGRETIN

Ligand Pharmaceuticals UK Ltd
Innovis House
108 High Street
Crawley
West Sussex RH10 1BB
United Kingdom

29.1.2007

KOGENATE
Bayer

Bayer HealthCare AG
D-51368 Leverkusen

31.1.2007

Avonex

Biogen Idec Ltd
5 Roxborough Way
Foundation Park
Maidenhead
Berkshire SL6 3UD
United Kindgom

EU/1/06/342/001

26.1.2007

EU/1/96/024/001-005
EU/1/96/024/007-008
EU/1/96/024/010

26.1.2007

EU/1/02/223/001-003

29.1.2007

EU/1/96/015/001-005

29.1.2007

EU/1/04/290/001

30.1.2007

EU/1/00/150/001-024

30.1.2007

EU/1/98/058/001-002

30.1.2007

EU/1/00/144/001-003

30.1.2007

EU/1/01/178/001

30.1.2007

EU/1/00/143/001-009

31.1.2007

EU/1/97/033/001-003

2.2.2007

— Issuing 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

INN
(International Non-Proprietary
Name)

9.1.2007

Cortavance

Hydrocortisone aceponate

11.1.2007

Yposane

Osaterone acetate

15.1.2007

Meloxicam
CEVA

Meloxicam

Holder of the marketing authorization

Number of the entry in the
Community Register

Pharmaceutical form

ATC code
(Anatomical
Therapeutic
Chemical Code)

Date of
notification

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

CEVA SANTE ANIMALE
Z.I. la Ballastière
F-33500 Libourne

EU/2/06/069/001

Cutaneous spray, solution

QD07AC

11.1.2007

EU/2/06/068/001-004

Tablets

QG04CX

15.1.2007

EU/2/06/070/001-003

oral suspension

QM01AC06

18.1.2007

— 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

4.1.2007

Previcox

16.1.2007

Equilis StrepE

11.1.2007

Gonazon

16.1.2007

Profender

Holder of the marketing authorization

Number of the entry in the
Community Register

Date of
notification

Merial
29, avenue Tony Garnier
F-69007 Lyon

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

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

Bayer HealthCare AG
D-51368 Leverkusen

EU/2/04/045/001-006

9.1.2007

EU/2/04/043/001

18.1.2007

EU/2/03/040/002

15.1.2007

EU/2/05/054/001-017

18.1.2007

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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