Summary of Community decisions on marketing authorizations in respect of medicinal products from 1 September 2007 to 30 September 2007 (Published pursuant to Article 13 or Article 38 of Regulation (EC) No 726/2004 of the European Parliament and of the Council )
Date: 2007-10-26
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 September 2007 to 30 September 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 251/09)

— 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

7.9.2007

Gliolan

5-aminolevulinic
chloride

acid hydro-

17.9.2007

Yondelis

Trabectedin

18.9.2007

CELSENTRI

Maraviroc

20.9.2007

ECALTA

Anidulafungin

Medac Gesellschaft für klinische
Spezialpräparate mbH
Fehlandtstraße 3
D-20354 Hamburg

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

Pfizer Limited
Ramsgate Road
Sandwich
Kent CT13 9NJ
United Kingdom

Pfizer Limited
Ramsgate Road
Sandwich
Kent CT13 9NJ
United Kingdom

EU/1/07/413/001-003

Powder for oral solution

L01XD04

12.9.2007

EU/1/07/417/001-002

for
Powder
solution for infusion

concentrate

for

L01CX01

20.9.2007

EU/1/07/418/001-010

Film — coated tablet

J05AX09

20.9.2007

EU/1/07/416/001

Powder and solvent for concen-
trate for solution for infusion

JO2AX06

24.9.2007

20.9.2007

Cervarix

Human
Papilloma Virus-16
and Human Papilloma Virus
18 L1 proteins

GlaxoSmithKline Biologicals S.A.
rue de l'Institut 89
B-1330 Rixensart

EU/1/07/419/001-009

Suspension for injection

J07BM02

24.9.2007

26.9.2007

Galvus

Vildagliptin

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

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

EU/1/07/414/001-017

Tablet

A10BH02

28.9.2007

C

2
5
1
/
1
0

E
N

O

f
f
i
c
i
a
l

J
o
u
r
n
a
l

o
f

t
h
e

E
u
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p
e
a
n
U
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o
n

i

.

2
6
1
0
2
0
0
7

.

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

27.9.2007

Zalasta

Olanzapine

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

EU/1/07/415/001-031

Tablet

N05AH03

1.10.2007

EU/1/07/415/032-056

Orodispersible tablet

.

2
6
1
0
2
0
0
7

.

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

2
5
1
/
1
1

C 251/12

EN

Official Journal of the European Union

26.10.2007

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

Accepted

Date of the
decision

Name of the
medicinal
product

3.9.2007

Arixtra

3.9.2007

Quixidar

3.9.2007

TRIZIVIR

3.9.2007

Combivir

3.9.2007

Mabthera

3.9.2007

Novoseven

7.9.2007

RotaTeq

7.9.2007

Evra

7.9.2007

Zavesca

7.9.2007

Ambirix

13.9.2007

Tamiflu

13.9.2007

Telzir

Holder of the marketing authorization

Number of the entry in the
Community Register

Date of
notification

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

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

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

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

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

Novo Nordisk A/S
Novo Allé
DK-2880 Bagsværd

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

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

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

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

Glaxo Group Limited
Berkeley Avenue
Greenford
Middlesex UB6 0NN
United Kingdom

EU/1/02/206/001-020

5.9.2007

EU/1/02/207/001-020

5.9.2007

EU/1/00/156/002-003

5.9.2007

EU/1/98/058/001-002

5.9.2007

EU/1/98/067/001-002

6.9.2007

EU/1/96/006/001-003

6.9.2007

EU/1/06/348/001-002

11.9.2007

EU/1/02/223/001-003

11.9.2007

EU/1/02/238/001

11.9.2007

EU/1/02/224/001-005

11.9.2007

EU/1/02/222/001-002

18.9.2007

EU/1/04/282/001-002

18.9.2007

26.10.2007

EN

Official Journal of the European Union

C 251/13

Date of the
decision

Name of the
medicinal
product

17.9.2007

Cerezyme

17.9.2007

Exelon

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

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

EU/1/97/053/001-005

20.9.2007

EU/1/98/066/019-026

20.9.2007

17.9.2007

Mirapexin

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

EU/1/97/051/001-012

20.9.2007

17.9.2007

Cialis

18.9.2007

Actraphane

18.9.2007

Protaphane

18.9.2007

Insulatard

18.9.2007

Xyrem

Lilly ICOS Limited
St Bride's House
10 Salisbury Square
London EC4Y 8EH
United Kingdom

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

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

EU/1/02/237/001-008

28.9.2007

EU/1/02/229/001-033

20.9.2007

EU/1/02/234/001-017

20.9.2007

EU/1/02/233/001-015

20.9.2007

EU/1/05/312/001

20.9.2007

18.9.2007

TOVIAZ

Schwarz Pharma AG
Alfred-Nobel Straße 10
D-40789 Monheim

EU/1/07/386/001-010

20.9.2007

Pfizer Limited
Ramsgate Road
Sandwich
Kent CT13 9NJ
United Kingdom

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

18.9.2007

Velosulin

18.9.2007

Actrapid

18.9.2007

Mixtard

20.9.2007

EU/1/02/232/001-003

20.9.2007

EU/1/02/230/001-017

20.9.2007

EU/1/02/231/001-037

20.9.2007

C 251/14

EN

Official Journal of the European Union

26.10.2007

Date of the
decision

Name of the
medicinal
product

19.9.2007

Omnitrope

19.9.2007

Tamiflu

20.9.2007

Somavert

25.9.2007

NeuroBloc

25.9.2007

Prometax

Holder of the marketing authorization

Number of the entry in the
Community Register

Date of
notification

Sandoz GmbH
Biochemiestraße 10
A-6250 Kundl

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

Solstice Neurosciences Ltd
Fitzwilton House
Wilton Place
Dublin 2
Ireland

Eisai Limited
3, Shortlands
London W6 8EE
United Kingdom

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

EU/1/06/332/007-009

21.9.2007

EU/1/02/222/003-004

21.9.2007

EU/1/02/240/001-004

24.9.2007

EU/1/00/166/001-003

27.9.2007

27.9.2007

EU/1/98/092/019-026

27.9.2007

25.9.2007

Sifrol

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

EU/1/97/050/001-012

27.9.2007

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

Accepted

Date of the
decision

Name of the
medicinal
product

3.9.2007

Oxyblobin

Holder of the marketing authorization

Number of the entry in the
Community Register

Date of
notification

Biopure Netherlands B.V.
Parnassustoren
Locatellikade 1
1076 AZ Amsterdam
Nederland

EU/2/99/015/001

5.9.2007

4.9.2007

Econor

Novartis Animal Health Austria
GmbH
Biochemiestraße 10
A-6250 Kundl

EU/2/98/010/004-006
EU/2/98/010/017-018
EU/2/98/010/021-024

6.9.2007

7.9.2007

Cortavance

VIRBAC S.A.
1ère Avenue 2065 m L.I.D.
F-06516 Carros

EU/2/06/069/001

11.9.2007

26.10.2007

EN

Official Journal of the European Union

C 251/15

Date of the
decision

Name of the
medicinal
product

7.9.2007

Meloxidyl

25.9.2007

Nobivac Bb

Holder of the marketing authorization

Number of the entry in the
Community Register

Date of
notification

CEVA SANTE ANIMALE
Z.I. la Ballastière
F-33500 Libourne

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

EU/2/06/070/001-003

11.9.2007

EU/2/02/034/001

27.9.2007

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