Summary of Community decisions on marketing authorizations in respect of medicinal products from 1 January 2008 to 31 January 2008 (Published pursuant to Article 13 or Article 38 of Regulation (EC) No 726/2004 of the European Parliament and of the Council )
Date: 2008-02-29
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 January 2008 to 31 January 2008

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

(2008/C 56/07)

— 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-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

10.1.2008

TESAVEL

Sitagliptin

11.1.2008

Abraxane

Paclitaxel

11.1.2008

IVEMEND

Fosaprepitant dimeglumine

11.1.2008

Avamys

Fluticasone furoate

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

Abraxis BioScience Limited
West Forest Gate
Wellington Road
Wokingham
Berkshire RG40 2AQ
United Kingdom

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

Glaxo Group Ltd
Greenford
Middlesex UB6 0NN
United Kingdom

EU/1/07/435/001-018

Film-coated tablet

A10BH01

14.1.2008

EU/1/07/428/001

Powder for suspension for infusion

L01CD01

15.1.2008

EU/1/07/437/001-002

Powder for solution for infusion

(Non applicable)

16.1.2008

EU/1/07/434/001-003

Nasal spray suspension

R01AD12

16.1.2008

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

11.1.2008

Natalizumab

Elan Pharma Ltd
Norton Green Road
Stevenage
Herts SG1 2BA
United Kingdom

—

15.1.2008

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

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C 56/6

EN

Official Journal of the European Union

29.2.2008

— 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

8.1.2008

Puregon

8.1.2008

DepoCyte

10.1.2008

Prezista

10.1.2008

Velcade

10.1.2008

Viramune

10.1.2008

Viracept

10.1.2008

Angiox

11.1.2008

Thelin

11.1.2008

Irbesartan HCT
BMS

14.1.2008

Optaflu

Organon N.V.
Kloosterstraat 6
Postbus 20
5340 BH Oss
Nederland

SkyePharma PLC
105 Piccadilly
London W1J 7NJ
United Kingdom

Pacira Limited
MG House
Rumbolds Hill
Midhurst
West Sussex GU29 9BY
United Kingdom

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

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

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

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

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

Encysive (UK) Limited
Alder Castle House
10 Noble Street
London EC2V 7QJ
United Kingdom

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

Novartis Vaccines and Diagnostics
GmbH & Co. KG
Emil-von-Behring-Straße 76
D-35041 Marburg

EU/1/96/008/001-041

10.1.2008

EU/1/01/187/001

10.1.2008

EU/1/06/380/001

14.1.2008

EU/1/04/274/001

14.1.2008

EU/1/97/055/001-003

14.1.2008

EU/1/97/054/001
EU/1/97/054/004-005

14.1.2008

EU/1/04/289/001-002

14.1.2008

EU/1/06/353/001-005

15.1.2008

EU/1/06/369/001-028

15.1.2008

EU/1/07/394/001-006

16.1.2008

29.2.2008

EN

Official Journal of the European Union

C 56/7

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

17.1.2008

Zyprexa

17.1.2008

Zyprexa Velotab

17.1.2008

Neulasta

17.1.2008

Neupopeg

17.1.2008

Evoltra

17.1.2008

Humira

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

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

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

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

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

Abbott laboratories Ltd
Queenborough
Kent ME11 5EL
United Kingdom

21.1.2008

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

21.1.2008

EU/1/02/227/001-003

21.1.2008

EU/1/02/228/001-003

21.1.2008

EU/1/06/334/001-004

21.1.2008

EU/1/03/256/001-010

21.1.2008

17.1.2008

Twinrix Adult

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

EU/1/96/020/001-009

21.1.2008

18.1.2008

Telzir

18.1.2008

Dynepo

18.1.2008

Zerene

EU/1/04/282/001-002

22.1.2008

EU/1/02/211/001-005
EU/1/02/211/010-012

22.1.2008

EU/1/99/099/001-006

22.1.2008

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

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

Wyeth Research (UK) Limited
Huntercombe Lane South
Taplow
Maidenhead
Berkshire SL6 0PH
United Kingdom

Meda AB
Pipers väg 2A
S-170 09 Solna

C 56/8

EN

Official Journal of the European Union

29.2.2008

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

18.1.2008

Orgalutran

18.1.2008

Mabthera

18.1.2008

Tarceva

22.1.2008

Alimta

22.1.2008

Twinrix Paediatric

25.1.2008

Avastin

25.1.2008

Xagrid

25.1.2008

Osseor

25.1.2008

Protelos

25.1.2008

Exubera

25.1.2008

Galvus

N.V. Organon
P.O. Box 20
Kloosterstraat 6
5340 BH Oss
Nederland

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

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

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

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

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

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

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

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

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

EU/1/00/130/001-002

22.1.2008

EU/1/98/067/001-002

22.1.2008

EU/1/05/311/001-003

22.1.2008

EU/1/04/290/001-002

25.1.2008

EU/1/97/029/001-010

24.1.2008

EU/1/04/300/001-002

29.1.2008

EU/1/04/295/001

29.1.2008

EU/1/04/287/001-006

29.1.2008

EU/1/04/288/001-006

29.1.2008

EU/1/05/327/001-018

29.1.2008

EU/1/07/414/001-017

29.1.2008

29.2.2008

EN

Official Journal of the European Union

C 56/9

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

25.1.2008

SUTENT

25.1.2008

Advagraf

25.1.2008

Onsenal

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

Astellas Pharma GmbH
Neumarkter Str. 61
D-81673 München

Astellas Pharma Europe B.V.
Elisabethhof 19
2353 EW Leiderdorp
Nederland

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

Pfizer Limited
Ramsgate Road
Sandwich
Kent CT13 9NJ
United Kingdom

EU/1/06/347/001-003

29.1.2008

EU/1/07/387/001-010

29.1.2008

EU/1/03/259/001-006

29.1.2008

28.1.2008

Irbesartan Hydro-
chlorothiazide
Winthrop

SANOFI PHARMA BRISTOL
MYERS SQUIBB SNC
174, avenue de France
F-75013 Paris

EU/1/06/377/001-028

30.1.2008

28.1.2008

Macugen

28.1.2008

Vfend

28.1.2008

ViraferonPeg

28.1.2008

PegIntron

28.1.2008

IntronA

28.1.2008

Viraferon

28.1.2008

Agenerase

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

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

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

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

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

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

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

EU/1/05/325/002

30.1.2008

EU/1/02/212/001-026

30.1.2008

EU/1/00/132/001-050

30.1.2008

EU/1/00/131/001-050

30.1.2008

EU/1/99/127/001-044

30.1.2008

EU/1/99/128/001-037

30.1.2008

EU/1/00/148/001-004

30.1.2008

C 56/10

EN

Official Journal of the European Union

29.2.2008

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

28.1.2008

BYETTA

29.1.2008

Liprolog

31.1.2008

Dynastat

31.1.2008

Xeloda

31.1.2008

Humalog

31.1.2008

Naglazyme

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

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

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

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

BioMarin Europe Limited
Axtell House
23-24 Warwick Street
London W1B 5NQ
United Kingdom

EU/1/06/362/001-004

30.1.2008

EU/1/01/195/001-021

31.1.2008

EU/1/02/209/001-008

4.2.2008

EU/1/00/163/001-002

4.2.2008

4.2.2008

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/1/96/007/023-038

EU/1/05/324/001

4.2.2008

— Issuing of a marketing authorization (Article 38 of Regulation (EC) No 726/2004): 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

10.1.2008

Rheumocam

Meloxicam

31.1.2008

Nobilis Influenza
H5N6

Inactivated whole avian influenza
virus
antigen of H5 subtype
(strain H5N6, A/duck/Potsdam/
2243/84), inducing an HI titre of
≥ 6,0 log2 as tested according to
the potency test

Chanelle Pharmaceuticals
Manufacturing Limited
Loughrea
Co. Galway
Ireland

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

EU/2/07/078/001-003

Oral suspension

QM01AC06

15.1.2008

EU/2/07/076/001-004

Emulsion for injection

QI01AA23

4.2.2008

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C 56/12

EN

Official Journal of the European Union

29.2.2008

— 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

3.1.2008

ProMeris

Fort Dodge Animal Health Holland
C.J. van Houtenlaan 36
1381 CP Weesp
Nederland

EU/2/06/064/001-004

7.1.2008

10.1.2008

Nobilis OR Inac

11.1.2008

ProteqFlu Te

14.1.2008

ProteqFlu

15.1.2008

Dicural

17.1.2008

Cerenia

22.1.2008

Purevax FelV

22.1.2008

Purevax RCP FelV

22.1.2008

Purevax RCCh

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

Merial
29, Avenue Tony Garnier
F-69007 Lyon

Merial
29, Avenue Tony Garnier
F-69007 Lyon

EU/2/02/036/001-002

14.1.2008

EU/2/03/038/005

15.1.2008

EU/2/03/037/005

16.1.2008

Fort Dodge Animal Health Holland
C.J. van Houtenlaan 36
1381 CP Weesp
Nederland

EU/2/97/003/001-018

17.1.2008

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

Merial
29, Avenue Tony Garnier
F-69007 Lyon

Merial
29, Avenue Tony Garnier
F-69007 Lyon

Merial
29, Avenue Tony Garnier
F-69007 Lyon

EU/2/06/062/001-005

21.1.2008

EU/2/00/019/005-007

25.1.2008

EU/2/04/048/001-002

25.1.2008

EU/2/04/049/001-002

25.1.2008

22.1.2008

Purevax RCPCH
FelV

Merial
29, Avenue Tony Garnier
F-69007 Lyon

EU/2/04/047/001-002

25.1.2008

22.1.2008

Purevax RCPCh

22.1.2008

ProteqFlu

22.1.2008

ProteqFlu-Te

Merial
29, Avenue Tony Garnier
F-69007 Lyon

Merial
29, Avenue Tony Garnier
F-69007 Lyon

Merial
29, Avenue Tony Garnier
F-69007 Lyon

EU/2/04/050/001-002

25.1.2008

EU/2/03/037/005

25.1.2008

EU/2/03/038/005

25.1.2008

29.2.2008

EN

Official Journal of the European Union

C 56/13

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

22.1.2008

Purevax RC

25.1.2008

Purevax RCP

Merial
29, Avenue Tony Garnier
F-69007 Lyon

Merial
29, Avenue Tony Garnier
F-69007 Lyon

EU/2/04/051/001-002

25.1.2008

EU/2/04/052/001-002

29.1.2008

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