23.2.2007   

EN

Official Journal of the European Union

C 39/7


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

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

4.1.2007

ADROVANCE

Alendronate sodium/Colecalciferol

Merck Sharp & Dohme Ltd

Hertford Road

Hoddesdon

Hertfordshire EN11 9BU

United Kingdom

EU/1/06/364/001-005

Tablet

(Non applicable)

9.1.2007

4.1.2007

Diacomit

Stiripentol

Biocodex

7, avenue Gallieni

F-94250 Gentilly

EU/1/06/367/001-006

Capsule

N03AX17

9.1.2007

EU/1/06/367/007-012

Powder for oral suspension

8.1.2007

Elaprase

Idursulfase

Shire Human Genetic Therapies AB

Rinkebyvägen 11B

SE-182 36 Danderyd

EU/1/06/365/001-003

Concentrate for solution for infusion

A16AB09

10.1.2007

8.1.2007

Tandemact

Pioglitazone/Glimepiride

Takeda Global Research and Development Centre (Europe) Ltd

Arundel Great Court

2 Arundel Street

London WC2R 3DA

United Kingdom

EU/1/06/366/001-004

Tablet

(Non applicable)

10.1.2007

16.1.2007

Inovelon

rufinamide

Eisai Limited

3, Shortlands

London W6 8EE

United Kingdom

EU/1/06/378/001-016

Film-coated tablet

N03AF03

18.1.2007

16.1.2007

Dafiro

amlodipine/valsartan

Novartis Europharm Limited

Wimblehurst Road

Horsham

West Sussex RH12 5AB

United Kingdom

EU/1/06/371/001-024

Film-coated tablet

C09DB01

18.1.2007

16.1.2007

Copalia

amlodipine/valsartan

Novartis Europharm Limited

Wimblehurst Road

Horsham

West Sussex RH12 5AB

United Kingdom

EU/1/06/372/001-024

Film-coated tablet

C09DB01

18.1.2007

17.1.2007

Exforge

amlodipine/valsartan

Novartis Europharm Limited

Wimblehurst Road

Horsham

West Sussex RH12 5AB

United Kingdom

EU/1/06/370/001-024

Film-coated tablet

C09DB01

19.1.2007

17.1.2007

Imprida

amlodipine/valsartan

Novartis Europharm Limited

Wimblehurst Road

Horsham

West Sussex RH12 5AB

United Kingdom

EU/1/06/373/001-024

Film-coated tablet

C09DB01

19.1.2007

17.1.2007

Insulin Human Winthrop

insulin human

Sanofi-Aventis Deutschland GmbH

D-65926 Frankfurt am Main

EU/1/06/368/001-002

EU/1/06/368/011-015

EU/1/06/368/056-057

Solution for injection

A10AB01

2.2.2007

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

Suspension for injection

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

OptiSet, solution for injection

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

19.1.2007

Irbesartan Hydrochlorothiazide BMS

irbesartan/hydrochlorothiazide

Bristol-Myers Squibb Pharma EEIG

Uxbridge Business Park

Sanderson Road

Uxbridge UD8 1DH

United Kingdom

EU/1/06/369/001-010

Tablet

C09DA04

23.1.2007

EU/1/06/369/011-028

Film-coated tablets

19.1.2007

Irbesartan Winthrop

Irbesartan

SANOFI PHARMA BRISTOL MYERS SQUIBB SNC

174, avenue de France

F-75013 Paris

EU/1/06/376/001-015

Tablet

C09CA04

23.1.2007

EU/1/06/376/016-033

Film-coated tablets

19.1.2007

Irbesartan Hydrochlorothiazide Winthrop

irbesartan/hydrochlorothiazide

SANOFI PHARMA BRISTOL MYERS SQUIBB SNC

174, avenue de France

F-75013 Paris

EU/1/06/377/001-010

Tablet

C09DA04

23.1.2007

EU/1/06/377/011-028

Film-coated tablets

22.1.2007

Lucentis

ranibizumab

Novartis Europharm Limited

Wimblehurst Road

Horsham

West Sussex RH12 5AB

United Kingdom

EU/1/06/374/001

Solution for injection

S01LA04

24.1.2007

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

16.1.2007

Thymanax

Les Laboratoires Servier

22, rue Garnier

F-92200 Neuilly-sur-Seine

18.1.2007

16.1.2007

Valdoxan

Les Laboratoires Servier

22, rue Garnier

F-92200 Neuilly-sur-Seine

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

Holder of the marketing authorization

Number of the entry in the Community Register

Date of notification

3.1.2007

MicardisPlus

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

Amgen Europe B.V.

Minervum 7061

4817 ZK Breda

Nederland

EU/1/02/227/001-003

9.1.2007

3.1.2007

Neupopeg

Dompé Biotec S.p.A.

Via San Martino 12

I-20122 Milano

EU/1/02/228/001-003

9.1.2007

3.1.2007

Invirase

Roche Registration Limited

6 Falcon Way

Shire Park

Welwyn Garden City

AL7 1TW

United Kingdom

EU/1/96/026/001-002

9.1.2007

3.1.2007

Ceprotin

Baxter AG

Industriesstrasse 67

A-1220 Vienna

EU/1/01/190/001-002

9.1.2007

3.1.2007

Ambirix

GlaxoSmithKline Biologicals s.a.

rue de l'Institut 89

B-1330 Rixensart

EU/1/02/224/ 001-005

9.1.2007

3.1.2007

Velcade

Janssen-Cilag International NV

Turnhoutseweg 30

B-2340 Beerse

EU/1/04/274/001

9.1.2007

3.1.2007

Zostavax

Sanofi Pasteur MSD, SNC

8, rue Jonas Salk

F-69007 Lyon

EU/1/06/341/001-013

9.1.2007

3.1.2007

Nexavar

Bayer HealthCare AG

D-51368 Leverkusen

EU/1/06/342/001

9.1.2007

3.1.2007

Telzir

Glaxo Group Ltd

Greenford Road

Greenford

Middlesex UB6 0NN

United Kingdom

EU/1/04/282/001-002

9.1.2007

4.1.2007

Twinrix Paediatric

GlaxoSmithKline Biologicals s.a.

rue de l'Institut 89

B-1330 Rixensart

EU/1/97/029/001-010

9.1.2007

4.1.2007

NovoSeven

Novo Nordisk A/S

Novo Allé

DK-2880 Bagsværd

EU/1/96/006/001-003

9.1.2007

4.1.2007

PEGASYS

Roche Registration Limited

6 Falcon Way

Shire Park

Welwyn Garden City

AL7 1TW

United Kingdom

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.

rue de l'Institut 89

B-1330 Rixensart

EU/1/96/020/001-009

9.1.2007

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

Schering Plough Europe

Rue de Stalle, 73

B-1180 Bruxelles

Stallestraat 73

B-1180 Brussel

EU/1/99/107/001-005

9.1.2007

4.1.2007

Competact

Takeda Global Research and Development Centre (Europe) Ltd

Arundel Great Court

2 Arundel Street

London WC2R 3DA

United Kingdom

EU/1/06/354/001-009

9.1.2007

4.1.2007

Remicade

Centocor B.V.

Einsteinweg 101

2333 CB Leiden

Nederland

EU/1/99/116/001-003

9.1.2007

4.1.2007

Ketek

Aventis Pharma S.A.

20, Avenue Raymond Aron

F-92160 Antony

EU/1/01/191/001-005

9.1.2007

4.1.2007

Levviax

Aventis Pharma S.A.

20, Avenue Raymond Aron

F-92160 Antony

EU/1/01/192/001-005

9.1.2007

4.1.2007

Temodal

Schering Plough Europe

Rue de Stalle, 73

B-1180 Bruxelles

Stallestraat 73

B-1180 Brussel

EU/1/98/096/001-008

9.1.2007

4.1.2007

Keppra

UCB S.A.

Allée de la recherche, 60

B-1070 Bruxelles

Researchdreef 60

B-1070 Brussel

EU/1/00/146/001-030

10.1.2007

4.1.2007

Kinzalkomb

Bayer HealthCare AG

D-51368 Leverkusen

EU/1/02/214/001-010

9.1.2007

8.1.2007

PritorPlus

Bayer HealthCare AG

D-51368 Leverkusen

EU/1/02/215/001-014

10.1.2007

8.1.2007

Pritor

Bayer HealthCare AG

D-51368 Leverkusen

EU/1/98/089/001-022

10.1.2007

8.1.2007

DepoCyte

SkyePharma PLC

105 Piccadilly

London W1J 7NJ

United Kindgom

EU/1/01/187/001

10.1.2007

8.1.2007

Agenerase

Glaxo Group Ltd

Greenford

Middlesex UB6 0NN

United Kingdom

EU/1/00/148/001-004

10.1.2007

8.1.2007

IntronA

Schering Plough Europe

Rue de Stalle, 73

B-1180 Bruxelles

Stallestraat 73

B-1180 Brussel

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

Organon N.V.

P.O. Box 20

5340 BH Oss

Nederland

EU/1/96/008/001-041

11.1.2007

9.1.2007

Neupro

Schwarz Pharma Ltd

Shannon, Industrial Estate

Co.Clare

Ireland

EU/1/05/331/001-037

11.1.2007

9.1.2007

Viraferon

Schering Plough Europe

Rue de Stalle, 73

B-1180 Bruxelles

Stallestraat 73

B-1180 Brussel

EU/1/99/128/001-037

11.1.2007

9.1.2007

Thyrogen

Genzyme Europe B.V.

Gooimeer 10

1411 DD Naarden

Nederland

EU/1/99/122/001-002

11.1.2007

11.1.2007

Karvezide

Bristol-Myers Squibb Pharma EEIG

Uxbridge Business Park

Sanderson Road

Uxbridge UD8 1DH

United Kingdom

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

11.1.2007

Sutent

Pfizer Ltd

Ramsgate Road

Sandwich

Kent CT 13 9NJ

United Kingdom

EU/1/06/347/001-003

15.1.2007

11.1.2007

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

15.1.2007

11.1.2007

Invirase

Roche Registration Limited

6 Falcon Way

Shire Park

Welwyn Garden City

AL7 1TW

United Kingdom

EU/1/96/026/001-002

15.1.2007

11.1.2007

Karvezide

Bristol-Myers Squibb Pharma EEIG

Uxbridge Business Park

Sanderson Road

Uxbridge UD8 1DH

United Kingdom

EU/1/98/085/001-028

15.1.2007

12.1.2007

MabThera

Roche Registration Limited

6 Falcon Way

Shire Park

Welwyn Garden City

AL7 1TW

United Kingdom

EU/1/98/067/001-002

16.1.2007

12.1.2007

Truvada

Gilead Sciences International Limited

Granta Park Abington

Cambridge CB1 6GT

United Kingdom

EU/1/04/305/001

16.1.2007

12.1.2007

Emtriva

Gilead Sciences International Limited

Granta Park Abington

Cambridge CB1 6GT

United Kingdom

EU/1/03/261/001-003

16.1.2007

12.1.2007

Norvir

Abbott laboratories Ltd

Queenborough

Kent ME11 5EL

United-Kingdom

EU/1/96/016/001

EU/1/96/016/003-004

16.1.2007

15.1.2007

Stocrin

Merck Sharp & Dohme Ltd

Hertford Road

Hoddesdon

Hertfordshire EN11 9BU

United Kingdom

EU/1/99/111/001-011

18.1.2007

15.1.2007

Viramune

Boehringer Ingelheim International GmbH

Binger Strasse 173

D-55216 Ingelheim am Rhein

EU/1/97/055/001-003

18.1.2007

15.1.2007

Sustiva

Bristol-Myers Squibb Pharma EEIG

Uxbridge Business Park

Sanderson Road

Uxbridge UD8 1DH

United Kingdom

EU/1/99/110/001-009

18.1.2007

15.1.2007

Viread

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

Pfizer Ltd

Ramsgate Road

Sandwich

Kent CT 13 9NJ

United Kingdom.

EU/1/05/318/001

19.1.2007

17.1.2007

SUTENT

Pfizer Ltd

Ramsgate Road

Sandwich

Kent CT 13 9NJ

United Kingdom

EU/1/06/347/001-003

19.1.2007

17.1.2007

Kivexa

Glaxo Group Ltd

Berkeley Avenue

Greenford

Middlesex UB6 0NN

United Kingdom

EU/1/04/298/001-002

19.1.2007

17.1.2007

Lyrica

Pfizer Ltd

Ramsgate Road

Sandwich

Kent CT 13 9NJ

United Kingdom

EU/1/04/279/001-035

19.1.2007

17.1.2007

Advate

Baxter AG

Industriestraße 67

A-1221 Wien

EU/1/03/271/001-004

19.1.2007

17.1.2007

Ziagen

Glaxo Group Ltd

Greenford

Middlesex UB6 0NN

United Kingdom

EU/1/99/112/001-002

19.1.2007

18.1.2007

Telzir

Glaxo Group Ltd

Greenford

Middlesex UB6 0NN

United Kingdom

EU/1/04/282/001-002

22.1.2007

18.1.2007

Avaglim

SmithKline Beecham plc

980 Great West Road

Brentford

Middlesex TW8 9GS

United Kingdom

EU/1/06/349/001-008

22.1.2007

18.1.2007

Enbrel

Wyeth Europa Limited

Huntercombe Lane South

Taplow

Maidenhead

Berkshire SL6 0PH

United Kingdom

EU/1/99/126/001-018

22.1.2007

19.1.2007

Zerit

Bristol-Myers Squibb Pharma EEIG

Uxbridge Business Park

Sanderson Road

Uxbridge UD8 1DH

United Kingdom

EU/1/96/009/001-009

23.1.2007

24.1.2007

Stalevo

Orion Corporation

Orionintie 1

FIN-02200 Espoo

EU/1/03/260/001-015

26.1.2007

24.1.2007

Paxene

Norton Healthcare Limited

Albert Basin

Royal Docks

London E16 2QJ

United Kingdom

EU/1/99/113/001-004

26.1.2007

24.1.2007

Comtess

Orion Corporation

Orionintie 1

FIN-02200 Espoo

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

26.1.2007

24.1.2007

Fuzeon

Roche Registration Limited

6 Falcon Way

Shire Park

Welwyn Garden City AL7 1TW

United Kingdom

EU/1/03/252/001-003

26.1.2007

24.1.2007

TRIZIVIR

Glaxo Group Ltd

Greenford

Middlesex UB6 0NN

United Kingdom

EU/1/00/156/002-003

26.1.2007

24.1.2007

Agenerase

Glaxo Group Ltd

Greenford

Middlesex UB6 0NN

United Kingdom

EU/1/00/148/001-004

26.1.2007

24.1.2007

Fabrazyme

Genzyme Europe B.V.

Gooimeer 10

1411 DD Naarden

Nederland

EU/1/01/188/001-006

26.1.2007

24.1.2007

Tarceva

Roche Registration Limited

6 Falcon Way

Shire Park

Welwyn Garden City AL7 1TW

United Kingdom

EU/1/05/311/001-003

26.1.2007

24.1.2007

Avandamet

SmithKline Beecham plc

980 Great West Road

Brentford

Middlesex TW8 9GS

United Kingdom

EU/1/03/258/001-022

26.1.2007

24.1.2007

Aptivus

Boehringer Ingelheim International GmbH

Binger Strasse 173

D-55216 Ingelheim am Rhein

EU/1/05/315/001

26.1.2007

24.1.2007

Nexavar

Bayer HealthCare AG

D-51368 Leverkusen

EU/1/06/342/001

26.1.2007

24.1.2007

Crixivan

Merck Sharp & Dohme Ltd

Hertford Road

Hoddesdon

Hertfordshire EN11 9BU

United-Kingdom

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

26.1.2007

25.1.2007

Evra

Janssen-Cilag International NV

Turnhoutseweg 30

B-2340 Beerse

EU/1/02/223/001-003

29.1.2007

25.1.2007

Epivir

Glaxo Group Ltd

Greenford Road

Greenford

Middlesex UB6 0NN

United Kingdom

EU/1/96/015/001-005

29.1.2007

26.1.2007

Alimta

Eli Lilly Nederland B.V.

Grootslag 1-5

3991 RA Houten

Nederland

EU/1/04/290/001

30.1.2007

26.1.2007

Actos

Takeda Global Research and Development Centre (Europe) Ltd

Arundel Great Court

2 Arundel Street

London WC2R 3DA

United Kingdom

EU/1/00/150/001-024

30.1.2007

26.1.2007

Combivir

Glaxo Group Ltd

Greenford Road

Greenford

Middlesex UB6 0NN

United Kingdom

EU/1/98/058/001-002

30.1.2007

26.1.2007

Helixate NexGen

Bayer HealthCare AG

D-51368 Leverkusen

EU/1/00/144/001-003

30.1.2007

26.1.2007

TARGRETIN

Ligand Pharmaceuticals UK Ltd

Innovis House

108 High Street

Crawley

West Sussex RH10 1BB

United Kingdom

EU/1/01/178/001

30.1.2007

29.1.2007

KOGENATE Bayer

Bayer HealthCare AG

D-51368 Leverkusen

EU/1/00/143/001-009

31.1.2007

31.1.2007

Avonex

Biogen Idec Ltd

5 Roxborough Way

Foundation Park

Maidenhead

Berkshire SL6 3UD

United Kindgom

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)

Holder of the marketing authorization

Number of the entry in the Community Register

Pharmaceutical form

ATC code

(Anatomical Therapeutic Chemical Code)

Date of notification

9.1.2007

Cortavance

Hydrocortisone aceponate

VIRBAC S.A.

1ère Avenue 2065 m L.I.D

F-06516 Carros

EU/2/06/069/001

Cutaneous spray, solution

QD07AC

11.1.2007

11.1.2007

Yposane

Osaterone acetate

VIRBAC S.A.

1ère Avenue 2065 m L.I.D

F-06516 Carros

EU/2/06/068/001-004

Tablets

QG04CX

15.1.2007

15.1.2007

Meloxicam CEVA

Meloxicam

CEVA SANTE ANIMALE

Z.I. la Ballastière

F-33500 Libourne

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

Holder of the marketing authorization

Number of the entry in the Community Register

Date of notification

4.1.2007

Previcox

Merial

29, avenue Tony Garnier

F-69007 Lyon

EU/2/04/045/001-006

9.1.2007

16.1.2007

Equilis StrepE

Intervet International B.V.

Wim de Körverstraat 35

5831 AN Boxmeer

Nederland

EU/2/04/043/001

18.1.2007

11.1.2007

Gonazon

Intervet International B.V.

Wim de Körverstraat 35

5831 AN Boxmeer

Nederland

EU/2/03/040/002

15.1.2007

16.1.2007

Profender

Bayer HealthCare AG

D-51368 Leverkusen

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 decisions relating thereto is invited to contact:

The European Medicines Agency

7, Westferry Circus, Canary Wharf

London E14 4HB

United Kingdom


(1)  OJ L 136, 30.4.2004, p. 1.