Summary of Community decisions on marketing authorizations in respect of medicinal products from 1 March 2007 to 31 March 2007 (Published pursuant to Article 13 or Article 38 of Regulation (EC) No 726/2004 of the European Parliament and of the Council )
Date: 2007-04-27
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 March 2007 to 31 March 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 92/15)

— 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)

21.3.2007

Daronrix

A/Viet Nam/1194/
2004 (H5N1) whole
virus inactivated
antigen

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

EU/1/06/381/001-008

Suspension for
tion

injec-

J07BB01

Date of notification

23.3.2007

21.3.2007

Xelevia

sitagliptin

21.3.2007

Januvia

sitagliptin

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

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

EU/1/07/382/001-018

Film-coated tablets

A10BH01

23.3.2007

EU/1/07/383/001-018

Film-coated tablets

A10BH01

23.3.2007

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

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C 92/16

EN

Official Journal of the European Union

27.4.2007

— 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

1.3.2007

Kinzalmono

Bayer HealthCare AG
D-51368 Leverkusen

EU/1/98/091/001-014

5.3.2007

1.3.2007

Epivir

1.3.2007

Xyrem

1.3.2007

Integrilin

1.3.2007

PEGASYS

1.3.2007

Truvada

1.3.2007

Travatan

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

EU/1/96/015/001-005

5.3.2007

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

Glaxo Group Ltd
Berkeley Avenue
Greenford
Middlesex UB6 0NN
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

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

EU/1/05/312/001

5.3.2007

EU/1/99/109/001-002

5.3.2007

EU/1/02/221/001-010

5.3.2007

EU/1/04/305/001

5.3.2007

EU/1/01/199/001-002

5.3.2007

5.3.2007

Kinzalkomb

Bayer HealthCare AG
D-51368 Leverkusen

EU/1/02/214/001-010

7.3.2007

5.3.2007

MicardisPlus

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

EU/1/02/213/001-016

7.3.2007

5.3.2007

Humira

5.3.2007

NovoSeven

5.3.2007

Trudexa

Abbott laboratories Ltd,
Queenborough
Kent ME11 5EL
United Kingdom

Novo Nordisk A/S
Novo Allé
DK-2880 Bagsværd

Abbott laboratories Ltd
Queenborough
Kent ME11 5EL
United Kingdom

EU/1/03/256/001-010

7.3.2007

EU/1/96/006/001-003

8.3.2007

EU/1/03/257/001-010

7.3.2007

27.4.2007

EN

Official Journal of the European Union

C 92/17

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

5.3.2007

Metalyse

5.3.2007

Refludan

5.3.2007

Micardis

5.3.2007

Corlentor

6.3.2007

Aprovel

6.3.2007

Karvea

6.3.2007

Procolaran

6.3.2007

Bondronat

6.3.2007

Onsenal

7.3.2007

Angiox

9.3.2007

Prevenar

9.3.2007

Savene

9.3.2007

Herceptin

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

EU/1/00/169/004-006

7.3.2007

Pharmion Limited
Riverside House
Riverside Walk
Windsor SL4 1NA
United Kingdom

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

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

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

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

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

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

Pharmacia-Pfizer EEIG
Ramsgate Road
Sanwich CT13 9NJ
United Kingdom

The Medicines Company UK Ltd
Suite B
Park House
11 Milton Park
Abingdon
Oxfordshire OX14 4RS
United Kingdom

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

TopoTarget A/S
Fruebjergvej 3
DK-2100 København Ø

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

EU/1/97/035/001-004

7.3.2007

EU/1/98/090/001-020

7.3.2007

EU/1/05/317/001-014

7.3.2007

EU/1/97/046/001-033

8.3.2007

EU/1/97/049/001-033

8.3.2007

EU/1/05/316/001-014

8.3.2007

EU/1/96/012/004
EU/1/96/012/009-013

8.3.2007

EU/1/03/259/001-006

8.3.2007

EU/1/04/289/001-002

9.3.2007

EU/1/00/167/001-007

13.3.2007

EU/1/06/350/001

13.3.2007

EU/1/00/145/001

13.3.2007

C 92/18

EN

Official Journal of the European Union

27.4.2007

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

14.3.2007

Synagis

14.3.2007

Alimta

14.3.2007

Liprolog

14.3.2007

Vasovist

20.3.2007

Kineret

20.3.2007

GONAL-f

21.3.2007

Aptivus

21.3.2007

Invanz

23.3.2007

Emselex

27.3.2007

Zimulti

27.3.2007

ACOMPLIA

27.3.2007

Emtriva

27.3.2007

Avastin

Abbott laboratories Ltd
Queenborough
Kent ME11 5EL
United Kingdom

Eli Lilly Nederland BV
Grootslag 1-5
3991 RA Houten
Nederland

Eli Lilly Nederland BV
Grootslag 1-5
3991 RA Houten
Nederland

Schering AG
Müllerstraβe 172-178
D-13342 Berlin

Amgen Europe BV
Minervum 7061
4817 ZK Breda
Nederland

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

EU/1/99/117/001-002

16.3.2007

EU/1/04/290/001

16.3.2007

EU/1/01/195/001-015

16.3.2007

EU/1/05/313/001-009

16.3.2007

EU/1/02/203/001-004

22.3.2007

EU/1/95/001/033-035

23.3.2007

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

EU/1/05/315/001

23.3.2007

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

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

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

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

Gilead Sciences International
Limited
Cambridge CB1 6GT
United Kingdom

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

EU/1/02/216/001-002

23.3.2007

EU/1/04/294/001-028

27.3.2007

EU/1/06/345/001-009

29.3.2007

EU/1/06/344/001-009

29.3.2007

EU/1/03/261/001-003

29.3.2007

EU/1/04/300/001-002

29.3.2007

27.4.2007

EN

Official Journal of the European Union

C 92/19

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

27.3.2007

Mabthera

27.3.2007

Remicade

27.3.2007

Liprolog

27.3.2007

REYATAZ

27.3.2007

Optruma

28.3.2007

Xagrid

28.3.2007

Xeloda

28.3.2007

Kaletra

28.3.2007

Rebif

28.3.2007

Evista

28.3.2007

Glivec

28.3.2007

NeuroBloc

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

Centocor BV
Einsteinweg 101
2333 CB Leiden
Nederland

Eli Lilly Nederland BV
Grootslag 1-5
3991 RA Houten
Nederland

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

Eli Lilly Nederland BV
Grootslag 1-5
3991 RA Houten
Nederland

Shire Pharmaceutical Contracts Ltd
Hampshire International Business
Park
Chineham
Basingstoke
Hampshire RG24 8EP
United Kingdom

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

Abbott laboratories Ltd
Queenborough
Kent ME11 5EL
United Kingdom

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

Eli Lilly Nederland BV
Grootslag 1-5
3991 RA Houten
Nederland

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

Solstice Neurosciences Ltd
Fitzwilton House
Wilton Place
Dublin 2
Ireland

EU/1/98/067/001-002

29.3.2007

EU/1/99/116/001-003

29.3.2007

EU/1/01/195/001-015

29.3.2007

EU/1/03/267/001-007

29.3.2007

EU/1/98/074/001-004

30.3.2007

EU/1/04/295/001

30.3.2007

EU/1/00/163/001-002

30.3.2007

EU/1/01/172/001-005

30.3.2007

EU/1/98/063/001-007

30.3.2007

EU/1/98/073/001-004

30.3.2007

EU/1/01/198/001-013

30.3.2007

EU/1/00/166/001-003

30.3.2007

C 92/20

EN

Official Journal of the European Union

27.4.2007

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

28.3.2007

Zonegran

28.3.2007

Tamiflu

28.3.2007

Humalog

29.3.2007

Humalog

29.3.2007

Dynastat

29.3.2007

DaTSCAN

29.3.2007

InductOs

Eisai Limited
3 Shortlands
London W6 8EE
United Kingdom

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

Eli Lilly Nederland BV
Grootslag 1-5
3991 RA Houten
Nederland

Eli Lilly Nederland BV
Grootslag 1-5
3991 RA Houten
Nederland

Pfizer Ltd
Ramsgate Road
Sandwich
Kent CT13 9NJ
United Kingdom

GE Healthcare Limited
Little Chalfont
Bucks HP7 9NA
United Kingdom

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

EU/1/04/307/001-013

30.3.2007

EU/1/02/222/001-002

30.3.2007

30.3.2007

2.4.2007

EU/1/96/007/002
EU/1/96/007/004
EU/1/96/007/011
EU/1/96/007/015
EU/1/96/007/020-021
EU/1/96/007/023
EU/1/96/007/026

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/1/02/209/001-008

2.4.2007

EU/1/00/135/001-002

2.4.2007

EU/1/02/226/001

2.4.2007

29.3.2007

Betaferon

Schering Aktiengesellschaft
D-13342 Berlin

EU/1/95/003/003-006

2.4.2007

29.3.2007

Rapamune

29.3.2007

Invirase

29.3.2007

Revatio

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

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

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

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

4.4.2007

EU/1/96/026/001-002

2.4.2007

EU/1/05/318/001

4.4.2007

27.4.2007

EN

Official Journal of the European Union

C 92/21

— 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

14.3.2007

Previcox

14.3.2007

Nobivac Piro

Merial
29 avenue Tony Garnier
F-69007 Lyon

Intervet International BV
Wim de Körverstraat 35
5831 AN Boxmeer
Nederland

EU/2/04/045/007

16.3.2007

EU/2/04/046/001-003

16.3.2007

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