Summary of Community decisions on marketing authorizations in respect of medicinal products from 1 September 2006 to 30 September 2006 (Published pursuant to Article 13 or Article 38 of Regulation (EC) No 726/2004 of the European Parliament and of the Council )
Date: 2006-10-27
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 September 2006 to 30 September 2006

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

(2006/C 259/04)

— 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

20.9.2006

Gardasil

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

Human Papillomavirus Vaccine
[Types 6, 11, 16, 18] (Recom-
binant, adsorbed)

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

EU/1/06/357/001-017

Suspension for injection

J07BM1

22.9.2006

20.9.2006

Silgard

Human Papillomavirus Vaccine
[Types 6, 11, 16, 18] (Recom-
binant, adsorbed)

20.9.2006

Luminity

Perflutren

26.9.2006

Suboxone

buprenorphine/ naloxone

26.9.2006

Champix

varenicline tartrate

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

Bristol-Myers Squibb Pharma
Belgium Sprl
Chaussée de la Hulpe 185
B-1170 Brussels

Schering Plough Europ
Rue de Stalle, 73
B-1180 Bruxelles/
Stallestraat, 73
B-180 Brussel

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

EU/1/06/358/001-017

Suspension for injection

J07BM1

22.9.2006

EU/1/06/361/001

Solution for dispersion for injec-
tion or infusion

V08D A04

22.9.2006

EU/1/06/359/001-004

Sublingual tablet

N07B C51

28.9.2006

EU/1/06/360/001-010

Film-coated tablet

N07BA03

28.9.2006

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(1) OJ L 136 of 30 April 2004, page 1.

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27.10.2006

EN

Official Journal of the European Union

C 259/7

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

pean Parliament and of the Council): Rejected

Date of the
decision

Name of the
medicinal
product

5.9.2006

Alpheon

Holder of the marketing authorization

Number of the entry in the
Community Register

Date of
notification

BioPartners GmbH
Eisenstrasse 3
D-65428 Rüsselsheim

Non applicable

7.9.2006

— 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

1.9.2006

Aldara

1.9.2006

Angiox

1.9.2006

Rebif

1.9.2006

Iscover

1.9.2006

Fasturtec

1.9.2006

Neoclarityn

1.9.2006

Replagal

1.9.2006

Liprolog

1.9.2006

Fabrazyme

1.9.2006

Azomyr

Holder of the marketing authorization

Number of the entry in the
Community Register

Date of
notification

Laboratoires 3M Santé
Boulevard de l'Oise
F-95029 Cergy Pontoise Cedex

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

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

EU/1/98/080/001

5.9.2006

EU/1/04/289/001-002

7.9.2006

EU/1/98/063/001-007

7.9.2006

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

EU/1/98/070/001a-001b
EU/1/98/070/002a-002b
EU/1/98/070/003a-003b
EU/1/98/070/004a-004b

11.9.2006

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

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

TKT Europe AB
Rinkebyvägen 11B
S-182 36 Danderyd

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

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

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

EU/1/00/170/001-002

7.9.2006

EU/1/00/161/001-034

7.9.2006

EU/1/01/189/001-006

7.9.2006

EU/1/01/195/003
EU/1/01/195/006
EU/1/01/195/011
EU/1/01/195/014

7.9.2006

EU/1/01/188/001-006

7.9.2006

EU/1/00/157/001-034

7.9.2006

C 259/8

EN

Official Journal of the European Union

27.10.2006

Date of the
decision

Name of the
medicinal
product

1.9.2006

Aerius

1.9.2006

Remicade

Holder of the marketing authorization

Number of the entry in the
Community Register

Date of
notification

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

Centocor B.V.
Einsteinweg 101
2333 CB Leiden
Nederland

EU/1/00/160/001-035

6.9.2006

EU/1/99/116/001-003

6.9.2006

1.9.2006

Plavix

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

EU/1/98/069/001a-001b
EU/1/98/069/002a-002b
EU/1/98/069/003a-003b
EU/1/98/069/004a-004b

6.9.2006

1.9.2006

Lantus

Sanofi-Aventis Deutschland GmbH
D-65926 Frankfurt am Main

EU/1/00/134/030-037

6.9.2006

1.9.2006

Viramune

1.9.2006

Sustiva

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

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

EU/1/97/055/001-003

6.9.2006

EU/1/99/110/001-009

6.9.2006

1.9.2006

Betaferon

Schering Aktiengesellschaft
D-13342 Berlin

EU/1/95/003/003-006

6.9.2006

1.9.2006

Viread

1.9.2006

Stocrin

1.9.2006

Rebetol

1.9.2006

Humalog

Gilead Sciences International
Limited
Cambridge CB1 6GT
United Kingdom

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

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

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

EU/1/01/200/001

7.9.2006

EU/1/99/111/001-009

6.9.2006

EU/1/99/107/001-005

7.9.2006

EU/1/96/007/005
EU/1/96/007/008
EU/1/96/007/016
EU/1/96/007/024
EU/1/96/007/027

7.9.2006

1.9.2006

Apidra

Sanofi-Aventis Deutschland GmbH
Brueningstrasse 50
D-65926 Frankfurt am Main

EU/1/04/285/001-036

7.9.2006

1.9.2006

ViraferonPeg

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

EU/1/00/132/001-050

7.9.2006

27.10.2006

EN

Official Journal of the European Union

C 259/9

Date of the
decision

Name of the
medicinal
product

1.9.2006

IntronA

1.9.2006

Viraferon

1.9.2006

PegIntron

1.9.2006

Invanz

7.9.2006

Abilify

7.9.2006

Lyrica

7.9.2006

Rapamune

7.9.2006

Avonex

7.9.2006

Levviax

7.9.2006

Ketek

Holder of the marketing authorization

Number of the entry in the
Community Register

Date of
notification

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

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

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

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

Otsuka Pharmaceutical Europe Ltd
Hunton House
Highbridge Business Park
Oxford Road
Uxbridge
Middlesex UB8 1HU
United Kingdom

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

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

Biogen Idec Ltd
5 Roxborough Way
Foundation Park, Maidenhead
Berkshire SL6 3UD
United Kindgom

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

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

EU/1/99/127/001-044

8.9.2006

EU/1/99/128/001-037

8.9.2006

EU/1/00/131/001-050

8.9.2006

EU/1/02/216/001-002

8.9.2006

EU/1/04/276/001-035

12.9.2006

EU/1/04/279/001-035

12.9.2006

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

12.9.2006

EU/1/97/033/001-003

12.9.2006

EU/1/01/192/001-005

12.9.2006

EU/1/01/191/001-005

12.9.2006

EU/1/04/307/001-010

12.9.2006

7.9.2006

Zonegran

Eisai Limited
3, Shortlands
London W6 8EE
United Kingdom

C 259/10

EN

Official Journal of the European Union

27.10.2006

Date of the
decision

Name of the
medicinal
product

12.9.2006

Arixtra

12.9.2006

ProQuad

12.9.2006

Tamiflu

12.9.2006

Quixidar

12.9.2006

Zyprexa
Velotab

12.9.2006

Zyprexa

13.9.2006

Zyprexa
Velotab

13.9.2006

Zyprexa

14.9.2006

Glivec

14.9.2006

Prialt

Holder of the marketing authorization

Number of the entry in the
Community Register

Date of
notification

Glaxo Group Ltd
Greenford
Middlesex UB6 0NN
United Kingdom

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

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

Glaxo Group Ltd
Greenford
Middlesex UB6 0NN
United Kingdom

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

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

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

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

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

Elan Pharma International Ltd
WIL House
Shannon Business Park
Shannon
County Clare
Ireland

Eisai Limited
3, Shortlands
London W6 8EE
United Kingdom

EU/1/02/206/018-020

15.9.2006

EU/1/05/323/001-013

14.9.2006

EU/1/02/222/001-002

14.9.2006

EU/1/02/207/018-020

15.9.2006

EU/1/99/125/001-008

14.9.2006

14.9.2006

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/1/96/022/019-022

EU/1/99/125/001-008

15.9.2006

15.9.2006

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/1/96/022/019-022

EU/1/01/198/001-013

18.9.2006

EU/1/04/302/001-004

18.9.2006

18.9.2006

27.10.2006

EN

Official Journal of the European Union

C 259/11

Date of the
decision

Name of the
medicinal
product

18.9.2006

DaTSCAN

21.9.2006

Fuzeon

21.9.2006

Glivec

26.9.2006

Aclasta

26.9.2006

Enbrel

29.9.2006

Cancidas

Holder of the marketing authorization

Number of the entry in the
Community Register

Date of
notification

GE Healthcare Limited
Little Chalfont
Bucks HP7 9NA
United Kingdom

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

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

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

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

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

EU/1/00/135/001-002

20.9.2006

EU/1/03/252/001-003

25.9.2006

EU/1/01/198/001-013

25.9.2006

EU/1/05/308/001-002

28.9.2006

EU/1/99/126/013-018

28.9.2006

EU/1/01/196/001-003

3.10.2006

— 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

1.9.2006

Name of the
medicinal
product

Poulvac
FluFend
H5N3 RG

1.9.2006

Nobilis Influ-
enza H5N2

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

avian
Inactivated recombinant
influenza virus of H5N3 subtype
(strain rg-A/ck/VN/C58/04) 256
— 4046 HA Units

Fort Dodge Animal Health Ltd
Flanders Road
Hedge End
Southampton SO30 4QH
United Kingdom

Inactivated whole avian influ-
enza virus antigen of H5N2
subtype (strain A/duck/Potsdam/
1402/86), inducing an HI titre of
≥ 6.0 log2 as tested according to
the potency test.

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

EU/2/06/060/001-002

Emulsion for injection

QI01AA23

7.9.2006

EU/2/06/061/001-004

Emulsion for injection

QI01AA23

7.9.2006

29.9.2006

Cerenia

Maropitant

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

EU/2/06/062/001-004

Tablet

QA04AD90

3.10.2006

EU/2/06/062/005

Solution for injection

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

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