Summary of Community decisions on marketing authorizations in respect of medicinal products from 1 December 2008 to 31 December 2008 (Published pursuant to Article 13 or Article 38 of Regulation (EC) No 726/2004 of the European Parliament and of the Council )
Date: 2009-01-30
Institutions: European Commission
Subjects: EU Member State, market approval, marketing standard, medicinal product, pharmaceutical legislation, withdrawal from the market

Summary of Community decisions on marketing authorizations in respect of medicinal products
from 1 December 2008 to 31 December 2008

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

(2009/C 24/06)

— 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

1.12.2008

Irbesartan Krka

Irbesartan

1.12.2008

Vildagliptin/
metformin
hydrochloride
Novartis

Vildagliptin/metformin hydrochloride

1.12.2008

Zomarist

Vildagliptin/metformin hydrochloride

2.12.2008

Kuvan

Sapropterin dihydrochloride

17.12.2008

Vidaza

Azacitidine

18.12.2008

Pramipexole
Teva

Pramipexole

KRKA d.d.
Šmarješka cesta 6
SLO-8501 Novo mesto

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

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

Merck KgaA
Frankfurter Straße 250
D-64293 Darmstadt

Celgene Europe Ltd
Riverside House
Riverside Walk
Windsor SL4 1NA
United Kingdom

Teva Pharma B.V.
Computerweg 10
DR Utrecht 3542
Nederland

EU/1/08/480/001-018

Film-coated tablet

C09CA04

3.12.2008

EU/1/08/484/001-018

Film-coated tablet

A10BD08

3.12.2008

EU/1/08/483/001-018

Film-coated tablet

A10BD08

3.12.2008

EU/1/08/481/001-003

Soluble tablet

A16AX07

4.12.2008

EU/1/08/488/001

Powder for suspension
for injection

L01BC07

22.12.2008

EU/1/08/490/001-016

Tablet

N04B C05

23.12.2008

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(1) OJ L 136, 30.4. 2004, p. 1.

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30.1.2009

EN

Official Journal of the European Union

C 24/9

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

Accepted

Date of the
decision

Name of the
medicinal
product

1.12.2008

Sustiva

2.12.2008

Axura

2.12.2008

Ebixa

2.12.2008

Herceptin

Holder of the marketing authorization

Number of the entry in the
Community Register

Date of
notification

EU/1/99/110/001-009

3.12.2008

EU/1/02/218/001-029

4.12.2008

EU/1/02/219/001-049

4.12.2008

EU/1/00/145/001

4.12.2008

Bristol-Myers Squibb Pharma EEIG
Uxbridge Business Park
Sanderson Road
Uxbridge UB8 1DH
United Kingdom

Merz Pharmaceuticals GmbH
Eckenheimer Landstr. 100-104
D-60318 Frankfurt/Main

H. Lundbeck A/S
Ottiliavej 9
DK-2500 Valby

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

2.12.2008

Rebetol

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

EU/1/99/107/001-005

4.12.2008

4.12.2008

Xigris

4.12.2008

Visudyne

4.12.2008

Noxafil

4.12.2008

Ammonaps

5.12.2008

Optimark

5.12.2008

ViraferonPeg

5.12.2008

Norvir

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

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

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

Swedish Orphan International AB
Drottninggatan 98
S-111 60 Stockholm

Covidien Deutschland GmbH
Gewerbepark 1
D-93333 Neustadt/Donau

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

Abbott Laboratories Ltd
Queenborough
Kent ME11 5EL
United Kingdom

EU/1/02/225/001-002

9.12.2008

EU/1/00/140/001

9.12.2008

EU/1/05/320/001

9.12.2008

EU/1/99/120/001-004

10.12.2008

EU/1/07/398/001-014

9.12.2008

EU/1/00/132/001-050

9.12.2008

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

9.12.2008

5.12.2008

PegIntron

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

EU/1/00/131/001-050

9.12.2008

C 24/10

EN

Official Journal of the European Union

30.1.2009

Date of the
decision

Name of the
medicinal
product

5.12.2008

MabCampath

12.12.2008

Mixtard

Holder of the marketing authorization

Number of the entry in the
Community Register

Date of
notification

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

Novo Nordisk A/S
Novo Allé
DK-2880 Bagsværd

EU/1/01/193/001-002

9.12.2008

EU/1/02/231/033-035

16.12.2008

16.12.2008

Prezista

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

EU/1/06/380/001

18.12.2008

16.12.2008

Faslodex

16.12.2008

Somavert

AstraZeneca UK Limited
Alderley Park
Macclesfield
Cheshire SK10 4TG
United Kingdom

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

EU/1/03/269/001

18.12.2008

EU/1/02/240/001-004

18.12.2008

17.12.2008

Temodal

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

EU/1/98/096/001-012

22.12.2008

17.12.2008

Fareston

17.12.2008

NovoNorm

17.12.2008

Actrapid

17.12.2008

Prandin

17.12.2008

Avandia

17.12.2008

Hepsera

17.12.2008

Exjade

Orion Corporation
Orionintie 1
FIN-02200 Espoo

Novo Nordisk A/S
Novo Allé
DK-2880 Bagsværd

Novo Nordisk A/S
Novo Allé
DK-2880 Bagsværd

Novo Nordisk A/S
Novo Allé
DK-2880 Bagsværd

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

Gilead Sciences International
Limited
Cambridge CB21 6GT
United Kingdom

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

EU/1/96/004/001-002

22.12.2008

EU/1/98/076/004-006
EU/1/98/076/011-013
EU/1/98/076/018-020
EU/1/98/076/022-024

22.12.2008

EU/1/02/230/013-015

22.12.2008

EU/1/00/162/003-005
EU/1/00/162/009-011
EU/1/00/162/015-017
EU/1/00/162/019-021

22.12.2008

EU/1/00/137/002-018

22.12.2008

EU/1/03/251/001-002

22.12.2008

EU/1/06/356/001-009

22.12.2008

30.1.2009

EN

Official Journal of the European Union

C 24/11

Date of the
decision

Name of the
medicinal
product

17.12.2008

Avonex

17.12.2008

Actraphane

19.12.2008

Tysabri

22.12.2008

Telzir

22.12.2008

Arixtra

22.12.2008

Lyrica

22.12.2008

Cholestagel

22.12.2008

Vectibix

22.12.2008

Prezista

22.12.2008

Invanz

22.12.2008

Cerezyme

22.12.2008

Atripla

Holder of the marketing authorization

Number of the entry in the
Community Register

Date of
notification

EU/1/97/033/002-004

22.12.2008

EU/1/02/229/033-035

22.12.2008

EU/1/06/346/001

23.12.2008

EU/1/04/282/001-002

24.12.2008

EU/1/02/206/001-020

24.12.2008

EU/1/04/279/001-043

24.12.2008

EU/1/03/268/001-004

24.12.2008

EU/1/07/423/001-003

24.12.2008

EU/1/06/380/001

24.12.2008

EU/1/02/216/001-002

24.12.2008

EU/1/97/053/001-005

24.12.2008

EU/1/07/430/001-002

5.1.2009

Biogen Idec Ltd
Innovation House
70 Norden Road
Maidenhead
Berkshire SL6 4AY
United Kingdom

Novo Nordisk A/S
Novo Allé
DK-2880 Bagsværd

Elan Pharma International Ltd
Monksland
Athlone County Westmeath
Ireland

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

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

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

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

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

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

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

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

Bristol-Myers Squibb and Gilead
Sciences Limited
Unit 13
Stillorgan Industrial Park
Blackrock
Co. Dublin
Ireland

C 24/12

EN

Official Journal of the European Union

30.1.2009

Date of the
decision

Name of the
medicinal
product

22.12.2008

Revlimid

22.12.2008

Enbrel

22.12.2008

Truvada

22.12.2008

Evra

22.12.2008

Aptivus

Holder of the marketing authorization

Number of the entry in the
Community Register

Date of
notification

Celgene Europe Limited
Riverside House
Riverside Walk
Windsor
Berkshire SL4 1NA
United Kingdom

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

Gilead Sciences
International Limited
Cambridge CB21 6GT
United Kingdom

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

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

EU/1/07/391/001-004

24.12.2008

EU/1/99/126/001-018

24.12.2008

EU/1/04/305/001-002

24.12.2008

EU/1/02/223/001-003

24.12.2008

EU/1/05/315/001

29.12.2008

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

Date of the
decision

Name of the
medicinal
product

8.12.2008

Xeristar

8.12.2008

Cymbalta

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

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

EU/1/04/297/001-008

10.12.2008

EU/1/04/296/001-009

10.12.2008

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

Date of the
decision

Name of the
medicinal
product

5.12.2008

Parareg

5.12.2008

Neupopeg

5.12.2008

Nespo

Holder of the marketing authorization

Number of the entry in the
Community Register

Date of
notification

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

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

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

EU/1/04/293/001-012

9.12.2008

EU/1/02/228/001-003

9.12.2008

EU/1/01/184/001-073

9.12.2008

— 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

9.12.2008

Acticam

Meloxicam

16.12.2008

Onsior

Robenacoxib

Omnipharm Ltd
The Spire
Egypt Road
Nottingham NG7 7GD
United Kingdom

Novartis Animal Health UK Ltd
Frimley Business Park
Frimley/Camberley
Surrey GU16 7SR
United Kingdom

EU/2/08/088/001-003

Oral suspension

QM01AC06

11.12.2008

EU/2/08/088/004

Solution for injection

EU/2/08/089/001-019

Tablet

QM01AH91

18.12.2008

EU/2/08/089/020

Solution for injection

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

Accepted

Date of the
decision

Name of the
medicinal
product

5.12.2008

Locatim

9.12.2008

Flexicam

16.12.2008

Equilis StrepE

Holder of the marketing authorization

Number of the entry in the
Community Register

Date of
notification

Biokema Anstalt
Aeulestraße 38
FL-9490 Vaduz,
Fürstentum Liechtenstein

Omnipharm Ltd
The Spire
Egypt Road
Nottingham NG7 7GD
United Kingdom

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

EU/2/99/011/001

10.12.2008

EU/2/06/058/004

11.12.2008

EU/2/04/043/001

18.12.2008

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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