Summary of Community decisions on marketing authorizations in respect of medicinal products from 1 October 2008 to 31 October 2008 (Published pursuant to Article 13 or Article 38 of Regulation (EC) No 726/2004 of the European Parliament and of the Council )
Date: 2008-11-28
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 October 2008 to 31 October 2008

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

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

(2008/C 305/04)

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

1.10.2008

Tadalafil Lilly

Tadalafil

6.10.2008

EVICEL

Human fibrinogen/ human
thrombin

6.10.2008

Fluticasone
furoate GSK

Fluticasone furoate

7.10.2008

Olanzapine
Mylan

Olanzapine

7.10.2008

Ceplene

Histamine dihydrochloride

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

OMRIX biopharmaceuticals S.A./N.V.
200 Chaussée de Waterloo/Waterloo-
sesteenweg 200
B-1640 Rhode-St-Genèse/Sint-Gene-
sius-Rode

Glaxo Group Ltd
Greenford
Middlesex UB6 ONN
United Kingdom

Generics [UK] Limited
Station Close
Potters Bar
Hertfordshire EN6 1TL
United Kingdom

EpiCept GmbH
Goethestraße 4
D-80336 München

8.10.2008

Duloxetine Boeh-
ringer Ingelheim

Duloxetine

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

EU/1/08/476/001-004

Film-coated tablet

G04B E08

3.10.2008

EU/1/08/473/001-003

Solutions for sealant

B02BC

9.10.2008

EU/1/08/474/001-003

Nasal spray suspension

R01AD12

8.10.2008

EU/1/08/475/001-034

Film-coated tablet

N05AH03

9.10.2008

EU/1/08/477/001

Solution for injection

L03AX14

9.10.2008

EU/1/08/471/001-012

Gastro-resistant capsule

N06AX21

10.10.2008

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

.

2
8
1
1
2
0
0
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

C

3
0
5
/
3

C 305/4

EN

Official Journal of the European Union

28.11.2008

— 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

1.10.2008

Karvezide

1.10.2008

CoAprovel

8.10.2008

Simulect

9.10.2008

Tasmar

13.10.2008

Yondelis

13.10.2008

HBVAXPRO

13.10.2008

Galvus

14.10.2008

DepoCyte

20.10.2008

Onsenal

20.10.2008

Thalidomide
Pharmion

EU/1/98/085/001-034

3.10.2008

EU/1/98/086/001-034

3.10.2008

EU/1/98/084/001-002

10.10.2008

EU/1/97/044/001-008

14.10.2008

EU/1/07/417/001-002

15.10.2008

EU/1/01/183/030-032

15.10.2008

EU/1/07/414/018

15.10.2008

EU/1/01/187/001

16.10.2008

EU/1/03/259/001-006

22.10.2008

EU/1/08/443/001

22.10.2008

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

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

Valeant Pharmaceuticals Limited
Cedarwood
Chineham Business Park
Crockford lane
Basingstoke RG24 8WD
United Kingdom

Pharma Mar, S.A.
Avda. de los Reyes 1
Polígono Industrial La Mina
E-28770 Colmenar Viejo (Madrid)

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

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

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

Pfizer Limited
Ramsgate Road
Sandwich
Kent CT13 9NJ
United Kingdom

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

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

28.11.2008

EN

Official Journal of the European Union

C 305/5

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

21.10.2008

Telzir

21.10.2008

Aptivus

22.10.2008

Abseamed

23.10.2008

NeoRecormon

23.10.2008

Cellcept

24.10.2008

Prezista

24.10.2008

Vectibix

27.10.2008

Myocet

27.10.2008

Revlimid

27.10.2008

REYATAZ

27.10.2008

Lucentis

28.10.2008

Nespo

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

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

Medice Arzneimittel Pütter GmbH &
Co KG
Kuhloweg 37
D-58638 Iserlohn

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

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

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

Cephalon Europe
5, Rue Charles Martigny
F-94700 Maisons Alfort

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

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

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

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

EU/1/04/282/001-002

23.10.2008

EU/1/05/315/001

23.10.2008

EU/1/07/412/001-020

24.10.2008

EU/1/97/031/019-046

27.10.2008

EU/1/96/005/001-006

27.10.2008

EU/1/06/380/001

28.10.2008

EU/1/07/423/001-003

28.10.2008

EU/1/00/141/001

29.10.2008

EU/1/07/391/001-004

29.10.2008

EU/1/03/267/001-010

29.10.2008

EU/1/06/374/001

29.10.2008

EU/1/01/184/001-073

30.10.2008

C 305/6

EN

Official Journal of the European Union

28.11.2008

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

28.10.2008

RotaTeq

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

EU/1/06/348/001-002

30.10.2008

28.10.2008

CELSENTRI

28.10.2008

Valtropin

28.10.2008

Revatio

28.10.2008

Zavesca

28.10.2008

Advagraf

28.10.2008

Agenerase

28.10.2008

Ketek

Pfizer Limited
Ramsgate Road
Sandwich
Kent CT13 9NJ
United Kingdom

BioPartners GmbH
Eisenstraße 3
D-65428 Rüsselsheim

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

Actelion Registration Ltd
BSI Building
13th Floor
389 Chiswick High Road
London W4 4AL
United Kingdom

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

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

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

EU/1/07/418/001-010

30.10.2008

EU/1/06/335/001

5.11.2008

EU/1/05/318/001

30.10.2008

EU/1/02/238/001

30.10.2008

EU/1/07/387/001-010

30.10.2008

EU/1/00/148/001-004

30.10.2008

EU/1/01/191/001-005

30.10.2008

28.10.2008

Aranesp

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

EU/1/01/185/001-022
EU/1/01/185/031-073

30.10.2008

29.10.2008

Parareg

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

EU/1/04/293/001-012

31.10.2008

29.10.2008

Mimpara

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

EU/1/04/292/001-012

31.10.2008

29.10.2008

Binocrit

29.10.2008

Betaferon

Sandoz GmbH
Biochemiestrasse 10
A-Kundl 6250

Bayer Schering Pharma AG
Müllerstraße 170-178
D-13342 Berlin

EU/1/07/410/001-020

31.10.2008

EU/1/95/003/003-008

31.10.2008

28.11.2008

EN

Official Journal of the European Union

C 305/7

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

29.10.2008

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

31.10.2008

29.10.2008

Epoetin alfa
Hexal

HEXAL Biotech Forschungs GmbH
Industriestraße 25
D-83607 Holzkirchen

EU/1/07/411/001-020

31.10.2008

30.10.2008

Rapamune

30.10.2008

Kaletra

30.10.2008

Tysabri

30.10.2008

Tygacil

30.10.2008

Eucreas

30.10.2008

PEGASYS

30.10.2008

Infanrix Penta

30.10.2008

Hycamtin

30.10.2008

Myozyme

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

Abbott Laboratories Ltd
Queenborough
Kent ME11 5EL
United Kingdom

Elan Pharma International Ltd
Monksland
Athlone
County Westmeath
Ireland

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

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

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

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

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

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

EU/1/01/171/001
EU/1/01/171/007-010

4.11.2008

EU/1/01/172/001-006

4.11.2008

EU/1/06/346/001

4.11.2008

EU/1/06/336/001

4.11.2008

EU/1/07/425/001-018

4.11.2008

EU/1/02/221/001-010

4.11.2008

EU/1/00/153/001-010

4.11.2008

EU/1/96/027/001
EU/1/96/027/003-007

4.11.2008

EU/1/06/333/001-003

4.11.2008

C 305/8

EN

Official Journal of the European Union

28.11.2008

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

30.10.2008

SUTENT

31.10.2008

Sebivo

31.10.2008

Gardasil

31.10.2008

Silgard

31.10.2008

Tamiflu

31.10.2008

Invirase

31.10.2008

CELSENTRI

31.10.2008

Xeloda

31.10.2008

Rebetol

31.10.2008

Galvus

31.10.2008

Infanrix hexa

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

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

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

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

Pfizer Limited
Ramsgate Road
Sandwich
Kent CT13 9NJ
United Kingdom

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

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

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

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

EU/1/06/347/001-006

4.11.2008

EU/1/07/388/001-002

4.11.2008

EU/1/06/357/001-021

4.11.2008

EU/1/06/358/001-021

4.11.2008

EU/1/02/222/001-004

4.11.2008

EU/1/96/026/001-002

4.11.2008

EU/1/07/418/001-010

4.11.2008

EU/1/00/163/001-002

4.11.2008

EU/1/99/107/001-005

4.11.2008

EU/1/07/414/001-010
EU/1/07/414/018

4.11.2008

EU/1/00/152/001-018

4.11.2008

31.10.2008

Insulin human
Winthrop

Sanofi-Aventis Deutschland GmbH
D-65926 Frankfurt am Main

EU/1/06/368/088-142

4.11.2008

28.11.2008

EN

Official Journal of the European Union

C 305/9

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

31.10.2008

ViraferonPeg

31.10.2008

PegIntron

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

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

EU/1/00/132/001-050

4.11.2008

EU/1/00/131/001-050

4.11.2008

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

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

13.10.2008

Viraferon

29.10.2008

Forcaltonin

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

Unigene UK Limited
191 Sparrows Herne
Bushey Heath
Hertfordshire WD23 1AJ
United Kingdom

EU/1/99/128/001-037

15.10.2008

EU/1/98/093/002

3.11.2008

— 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

9.10.2008

SevoFlo

13.10.2008

Vaxxitek HVT
+ IBD

17.10.2008

Previcox

20.10.2008

Aivlosin

21.10.2008

Convenia

Abbott Laboratories Ltd
Queenborough
Kent ME11 5EL
United Kingdom

Merial
29, Avenue Tony Garnier
F-69007 Lyon

Merial
29, Avenue Tony Garnier
F-69007 Lyon

ECO Animal Health Ltd
78 Coombe Road
New Malden
Surrey KT3 4QS
United Kingdom

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

EU/2/02/035/007

14.10.2008

EU/2/02/032/001

15.10.2008

EU/2/04/045/001-006

21.10.2008

EU/2/04/044/001-002

22.10.2008

EU/2/06/059/001

23.10.2008

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