Summary of Community decisions on marketing authorizations in respect of medicinal products from 1 February 2009 to 28 February 2009 (Published pursuant to Article 13 or Article 38 of Regulation (EC) No 726/2004 of the European Parliament and of the Council )
Date: 2009-03-27
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 February 2009 to 28 February 2009

(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

(2009/C 73/03)

Date of the
decision

Name of the
medicinal product

INN
(International
Non-Proprietary
Name)

4.2.2009

Nplate

Romiplostim

6.2.2009

Zarzio

Filgrastim

6.2.2009

Filgrastim Hexal

Filgrastim

17.2.2009

FIRMAGON

Degarelix (as
acetate)

19.2.2009

Thymanax

Agomelatine

19.2.2009

Opgenra

Eptotermin alfa

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

Holder of the marketing authorization

Number of the entry in the
Community Register

Pharmaceutical form

ATC code
(Anatomical
Therapeutic Chemical
Code)

Date of
notification

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

Sandoz GmbH
Biochemiestraße 10
6250 Kundl
ÖSTERREICH

HEXAL AG
Industriestraße 25
83607 Holzkirchen
DEUTSCHLAND

Ferring Pharmaceuticals A/S
Kay Fiskers Plads 11
Copenhagen S 2300
DANMARK

Servier (Ireland) Industries Limited
Gorey Road
Arklow
Co. Wicklow
IRELAND

Howmedica International S. de R. L.
Raheen Business Park
Limerick
IRELAND

EU/1/08/497/001-002

Powder for solution for injection

B02BX04

6.2.2009

EU/1/08/495/001-008

Solution for injection or infusion

L03AA02

10.2.2009

EU/1/08/496/001-008

Solution for injection or infusion

L03AA02

10.2.2009

EU/1/08/504/001-002

Powder and solvent for solution
for injection

L02BX02

19.2.2009

EU/1/08/498/001-008

Film-coated tablet

NO6AX22

23.2.2009

EU/1/08/489/001

Powders
implantation

for

suspension

for

M05BC02

23.2.2009

.

.

2
7
3
2
0
0
9

E
N

O

f
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J
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/
5

Date of the
decision

Name of the
medicinal product

INN
(International
Non-Proprietary
Name)

19.2.2009

Valdoxan

Agomelatine

24.2.2009

FABLYN

Lasofoxifene

24.2.2009

INTANZA

24.2.2009

IDflu

Influenza Vaccine
(split virion, inacti-
vated)

Influenza Vaccine
(split virion, inacti-
vated)

25.2.2009

Efient

Prasugrel

Holder of the marketing authorization

Number of the entry in the
Community Register

Pharmaceutical form

ATC code
(Anatomical
Therapeutic Chemical
Code)

Date of
notification

Laboratoires Servier
22 rue Garnier
92200 Neuilly-sur-Seine
FRANCE

Pfizer Limited
Ramsgate Road
Sandwich
Kent CT13 9NJ
UNITED KINGDOM

Sanofi Pasteur MSD SNC
8 rue Jonas Salk
69007 Lyon
FRANCE

Sanofi Pasteur MSD SNC
8 rue Jonas Salk
69007 Lyon
FRANCE

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

EU/1/08/499/001-008

Film-coated tablet

NO6AX22

23.2.2009

EU/1/08/500/001-004

Film-coated tablet

Non applicable

26.2.2009

EU/1/08/505/001-006

Suspension for injection

J07BB02

26.2.2009

EU/1/08/507/001-006

Suspension for injection

J07BB02

26.2.2009

EU/1/08/503/001-014

Film-coated tablet

Non applicable

27.2.2009

C

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6

E
N

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0
0
9

27.3.2009

EN

Official Journal of the European Union

C 73/7

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

Accepted

Date of the
decision

Name of the
medicinal
product

2.2.2009

Vfend

2.2.2009

Gardasil

2.2.2009

Silgard

2.2.2009

Vimpat

2.2.2009

DuoTrav

4.2.2009

Elaprase

6.2.2009

REYATAZ

6.2.2009

Extavia

10.2.2009

Pradaxa

10.2.2009

SUTENT

Holder of the marketing authorization

Number of the entry in the
Community Register

Date of
notification

Pfizer Ltd
Ramsgate Road
Sandwich
Kent CT 13 9NJ
UNITED KINGDOM

Sanofi Pasteur MSD SNC
8 rue Jonas Salk
69007 Lyon
FRANCE

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

UCB Pharma S.A.
Allée de la Recherche 60
1070 Bruxelles
BELGIQUE

Alcon Laboratories (UK) Ltd
Pentagon Park
Boundary Way
Hemel Hempstead
Herts HP2 7UD
UNITED KINGDOM

Shire Human Genetic Therapies AB
Svardvagen 11D
182 33 Danderyd
SVERIGE

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

Boehringer Ingelheim
International GmbH
Binger Straße 173
55216 Ingelheim am Rhein
DEUTSCHLAND

Pfizer Ltd
Ramsgate Road
Sandwich
Kent CT 13 9NJ
UNITED KINGDOM

EU/1/02/212/001-026

5.2.2009

EU/1/06/357/001-021

4.2.2009

EU/1/06/358/001-021

4.2.2009

EU/1/08/470/001-016

4.2.2009

EU/1/06/338/001-003

4.2.2009

EU/1/06/365/001-003

6.2.2009

EU/1/03/267/001-010

10.2.2009

EU/1/08/454/001-004

10.2.2009

EU/1/08/442/001-008

12.2.2009

EU/1/06/347/001-006

12.2.2009

10.2.2009

Baraclude

Bristol-Myers Squibb Pharma EEIG
Uxbridge Business Park
Sanderson Road
Uxbridge UB8 1DH
UNITED KINGDOM

EU/1/06/343/001-007

12.2.2009

C 73/8

EN

Official Journal of the European Union

27.3.2009

Holder of the marketing authorization

Number of the entry in the
Community Register

Date of
notification

Date of the
decision

Name of the
medicinal
product

10.2.2009

Sprycel

10.2.2009

Xolair

10.2.2009

TachoSil

10.2.2009

Abraxane

10.2.2009

Arava

10.2.2009

IVEMEND

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

Nycomed Austria GmbH
St.-Peter-Straße 25
4020 Linz
ÖSTERREICH

Abraxis BioSciences Limited
2nd floor Titan Court 3
Bishops Sq
Hatfield AL 10 9NA
UNITED KINGDOM

Sanofi-Aventis Deutschland GmbH
65926 Frankfurt am Main
DEUTSCHLAND

Merck Sharp & Dohme Limited
Hertford Road
Hoddesdon
Hertfordshire EN11 9BU
UNITED KINGDOM

11.2.2009

Zonegran

Eisai Limited
3 Shortlands
London W6 8EE
UNITED KINGDOM

13.2.2009

Clopidogrel
Winthrop

Sanofi Pharma Bristol-Myers Squibb
SNC
174 Avenue de France
75013 Paris
FRANCE

13.2.2009

Clopidogrel
BMS

Bristol-Myers Squibb Pharma EEIG
Uxbridge Business Park
Sanderson Road
Uxbridge UB8 1DH
UNITED KINGDOM

13.2.2009

Dafiro

13.2.2009

Lyrica

Novartis Europharm Limited
Wimblehurst Road
Horsham
West Sussex RH12 5AB
UNITED KINGDOM

Pfizer Ltd
Ramsgate Road
Sandwich
Kent CT 13 9NJ
UNITED KINGDOM

EU/1/06/363/001-011

12.2.2009

EU/1/05/319/005- 010

12.2.2009

EU/1/04/277/001-004

12.2.2009

EU/1/07/428/001

13.2.2009

EU/1/99/118/001-010

12.2.2009

EU/1/07/437/001-002

12.2.2009

EU/1/04/307/001-013

13.2.2009

17.2.2009

17.2.2009

EU/1/08/465/001
EU/1/08/465/003
EU/1/08/465/005
EU/1/08/465/007
EU/1/08/465/009
EU/1/08/465/011
EU/1/08/465/013
EU/1/08/465/018-019

EU/1/08/464/001
EU/1/08/464/003
EU/1/08/464/005
EU/1/08/464/007
EU/1/08/464/009
EU/1/08/464/011
EU/1/08/464/013
EU/1/08/464/018-019

EU/1/06/371/001-036

17.2.2009

EU/1/04/279/001-043

17.2.2009

27.3.2009

EN

Official Journal of the European Union

C 73/9

Holder of the marketing authorization

Number of the entry in the
Community Register

Date of
notification

Date of the
decision

Name of the
medicinal
product

13.2.2009

Copalia

13.2.2009

Exforge

13.2.2009

Tasmar

13.2.2009

Imprida

17.2.2009

Temodal

Novartis Europharm Limited
Wimblehurst Road
Horsham
West Sussex RH12 5AB
UNITED KINGDOM

Novartis Europharm Limited
Wimblehurst Road
Horsham
West Sussex RH12 5AB
UNITED KINGDOM

Meda Actiebolag
Pipers väg 2A
Box 906
170 09 Solna
SVERIGE

Valeant Pharmaceuticals Limited
Cedarwood
Chineham Business Park
Crockford Lane
Basingstoke RG24 8WD
UNITED KINGDOM

Novartis Europharm Limited
Wimblehurst Road
Horsham
West Sussex RH12 5AB
UNITED KINGDOM

Schering Plough Europe
Rue de Stalle, 73/Stallestraat, 73
1180 Bruxelles/1180 Brussel
BELGIQUE/BELGIË

19.2.2009

Zerene

Meda AB
Pipers väg 2A
170 09 Solna
SVERIGE

EU/1/06/372/001-036

17.2.2009

EU/1/06/370/001-036

17.2.2009

EU/1/97/044/001-008

18.2.2009

EU/1/06/373/001-036

17.2.2009

EU/1/98/096/001-022

19.2.2009

EU/1/99/099/001-006

23.2.2009

19.2.2009

Insuman

Sanofi-Aventis Deutschland GmbH
65926 Frankfurt am Main
DEUTSCHLAND

EU/1/97/030/170-189

23.2.2009

19.2.2009

Sonata

Meda AB
Pipers väg 2A
170 09 Solna
SVERIGE

EU/1/99/102/001-006

23.2.2009

19.2.2009

Insulin Human
Winthrop

Sanofi-Aventis Deutschland GmbH
65926 Frankfurt am Main
DEUTSCHLAND

EU/1/06/368/143-162

23.2.2009

20.2.2009

Myozyme

20.2.2009

Evoltra

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

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

EU/1/06/333/001-003

24.2.2009

EU/1/06/334/001-004

24.2.2009

C 73/10

EN

Official Journal of the European Union

27.3.2009

Date of the
decision

Name of the
medicinal
product

20.2.2009

Luminity

20.2.2009

Bondenza

23.2.2009

Myozyme

23.2.2009

BeneFIX

23.2.2009

Bonviva

23.2.2009

Mabthera

24.2.2009

Thalidomide
Celgene

24.2.2009

Irbesartan HCT
BMS

24.2.2009

Viracept

24.2.2009

Revlimid

Holder of the marketing authorization

Number of the entry in the
Community Register

Date of
notification

Bristol-Myers Squibb Pharma Belgium
Sprl
Chaussée de la Hulpe, 185/Terhulpses-
teenweg 185
1170 Bruxelles/1180 Brussel
BELGIQUE/BELGIË

Roche Registration Limited
6 Falcon Way
Shire Park
Welwyn Garden City AL7 1TW
UNITED KINGDOM

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

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

Celgene Europe Limited
Riverside House
Riverside Walk
Windsor SL4 1NA
UNITED KINGDOM

Bristol-Myers Squibb Pharma EEIG
Uxbridge Business Park
Sanderson Road
Uxbridge UB8 1DH
UNITED KINGDOM

Roche Registration Limited
6 Falcon Way
Shire Park
Welwyn Garden City AL7 1TW
UNITED KINGDOM

Celgene Europe Limited
Riverside House
Riverside Walk
Windsor
Berkshire SL4 1NA
UNITED KINGDOM

EU/1/06/361/001-002

24.2.2009

EU/1/03/266/003-006

24.2.2009

EU/1/06/333/001-003

25.2.2009

EU/1/97/047/001-007

25.2.2009

EU/1/03/265/003-006

25.2.2009

EU/1/98/067/001-002

25.2.2009

EU/1/08/443/001

26.2.2009

EU/1/06/369/001-028

26.2.2009

EU/1/97/054/004-005

26.2.2009

EU/1/07/391/001-004

26.2.2009

27.3.2009

EN

Official Journal of the European Union

C 73/11

Date of the
decision

Name of the
medicinal
product

24.2.2009

Abilify

25.2.2009

ORENCIA

25.2.2009

Dynastat

25.2.2009

Levitra

25.2.2009

Forsteo

25.2.2009

Zerit

25.2.2009

Irbesartan
Winthrop

25.2.2009

HUMIRA

25.2.2009

Vivanza

25.2.2009

Advagraf

25.2.2009

Ranexa

Holder of the marketing authorization

Number of the entry in the
Community Register

Date of
notification

EU/1/04/276/001-020
EU/1/04/276/024-036

26.2.2009

EU/1/07/389/001-003

27.2.2009

EU/1/02/209/001-008

27.2.2009

EU/1/03/248/001-012

27.2.2009

EU/1/03/247/001-002

27.2.2009

EU/1/96/009/001-009

27.2.2009

EU/1/06/376/001-033

27.2.2009

EU/1/03/256/001-010

27.2.2009

EU/1/03/249/001-012

27.2.2009

EU/1/07/387/001-010

27.2.2009

EU/1/08/462/001-012

27.2.2009

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

Bristol-Myers Squibb Pharma EEIG
Uxbridge Business Park
Sanderson Road
Uxbridge UB8 1DH
UNITED KINGDOM

Pfizer Ltd
Ramsgate Road
Sandwich
Kent CT 13 9NJ
UNITED KINGDOM

Bayer AG
51368 Leverkusen
DEUTSCHLAND

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

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
75013 Paris
FRANCE

Abbott Laboratories Ltd
Queenborough
Kent ME11 5EL
UNITED KINGDOM

Bayer AG
51368 Leverkusen
DEUTSCHLAND

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

Menarini International Operations
Luxembourg S.A.
1, Avenue de la Gare
L-1611 Luxembourg
Luxembourg

CV Therapeutics Europe Limited
15 Meadway Court
Rutherford Close
Stevenage
Hertfordshire SG1 2EF
UNITED KINGDOM

C 73/12

EN

Official Journal of the European Union

27.3.2009

Date of the
decision

Name of the
medicinal
product

26.2.2009

Advate

26.2.2009

ReFacto AF

26.2.2009

Myfenax

26.2.2009

Fasturtec

26.2.2009

Mycophenolate
mofetil Teva

26.2.2009

Pradaxa

26.2.2009

Protopic

26.2.2009

Volibris

26.2.2009

Telzir

26.2.2009

Xeristar

26.2.2009

Karvezide

26.2.2009

Karvea

Holder of the marketing authorization

Number of the entry in the
Community Register

Date of
notification

Baxter AG
Industriesstraße 67
1220 Vienna
ÖSTERREICH

Wyeth Europa Ltd
Huntercombe Lane
South Taplow
Maidenhead
Berkshire SL6 0PH
UNITED KINGDOM

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

Sanofi-Aventis
174 avenue de France
75013 Paris
FRANCE

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

Boehringer Ingelheim
International GmbH
Binger Straße 173
55216 Ingelheim am Rhein
DEUTSCHLAND

Astellas Pharma GmbH
Neumarkter Str. 61
81673 München
DEUTSCHLAND

Glaxo Group Ltd
Greenford
Middlesex UB6 0NN
UNITED KINGDOM

Glaxo Group Ltd
Greenford Road
Greenford
Middlesex UB6 0NN
UNITED KINGDOM

Boehringer Ingelheim
International GmbH
Binger Straße 173
55216 Ingelheim am Rhein
DEUTSCHLAND

Bristol-Myers Squibb Pharma EEIG
Uxbridge Business Park
Sanderson Road
Uxbridge UB8 1DH
UNITED KINGDOM

Bristol-Myers Squibb Pharma EEIG
Uxbridge Business Park
Sanderson Road
Uxbridge UB8 1DH
UNITED KINGDOM

EU/1/03/271/001-006

2.3.2009

EU/1/99/103/001-004

2.3.2009

EU/1/07/438/001-004

2.3.2009

EU/1/00/170/001-002

2.3.2009

EU/1/07/439/001-004

2.3.2009

EU/1/08/442/001-008

2.3.2009

EU/1/02/201/001-006

4.3.2009

EU/1/08/451/001-004

2.3.2009

EU/1/04/282/001-002

2.3.2009

EU/1/04/297/001-008

2.3.2009

EU/1/98/085/001-034

2.3.2009

EU/1/97/049/001-039

2.3.2009

27.3.2009

EN

Official Journal of the European Union

C 73/13

Date of the
decision

Name of the
medicinal
product

26.2.2009

CoAprovel

26.2.2009

Oprymea

26.2.2009

Aprovel

26.2.2009

Tasigna

26.2.2009

Baraclude

26.2.2009

REYATAZ

26.2.2009

Sprycel

26.2.2009

Tyverb

26.2.2009

Xagrid

27.2.2009

Ariclaim

Holder of the marketing authorization

Number of the entry in the
Community Register

Date of
notification

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

KRKA, d. d.
Novo mesto
Šmarješka cesta 6
SI-8501 Novo mesto
SLOVENIJA

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

Novartis Europharm Limited
Wimblehurst Road
Horsham
West Sussex RH12 5AB
UNITED KINGDOM

Bristol-Myers Squibb Pharma EEIG
Uxbridge Business Park
Sanderson Road
Uxbridge UB8 1DH
UNITED KINGDOM

Bristol-Myers Squibb Pharma EEIG
Uxbridge Business Park
Sanderson Road
Uxbridge UB8 1DH
UNITED KINGDOM

Bristol-Myers Squibb Pharma EEIG
Uxbridge Business Park
Sanderson Road
Uxbridge UB8 1DH
UNITED KINGDOM

Glaxo Group Limited
Berkeley Avenue
Greenford
Middlesex UB6 0NN
UNITED KINGDOM

Shire Pharmaceutical Contracts Ltd
Hampshire International Business Park
Chineham
Basingstoke
Hampshire RG24 8EP
UNITED KINGDOM

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

EU/1/98/086/001-034

2.3.2009

EU/1/08/469/001-025

2.3.2009

EU/1/97/046/001-039

2.3.2009

EU/1/07/422/001-004

3.3.2009

EU/1/06/343/001-007

3.3.2009

EU/1/03/267/001-010

3.3.2009

EU/1/06/363/001-011

3.3.2009

EU/1/07/440/001-002

3.3.2009

EU/1/04/295/001

3.3.2009

EU/1/04/283/001-012

3.3.2009

— 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

EU/2/08/090/001-005
EU/2/08/090/006-008

Oral Suspension
Solution for Injection

ATC code
(Anatomical
Therapeutic
Chemical Code)

Date of
notification

QM01AC06

12.2.2009

10.2.2009

Loxicom

Meloxicam

11.2.2009

STARTVAC

Escherichia coli J5: > 50 RED60

Staph. Aureus (CP8): > 50 RED80

Norbrook Laboratories Limited
Station Works
Newry
Co. Down BT35 6JP
UNITED KINDGOM

Laboratorios Hipra, S.A.
Avda. La Selva, 135
17170 Amer (Girona)
ESPAÑA

EU/2/08/092/001-007

Emulsion for injection

QI02 AB

13.2.2009

C

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3
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1
4

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27.3.2009

EN

Official Journal of the European Union

C 73/15

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

Accepted

Date of the
decision

Name of the
medicinal
product

12.2.2009

Purevax RCCh

13.2.2009

Purevax RCP
FeLV

13.2.2009

Purevax RCPCh
FeLV

Holder of the marketing authorization

Number of the entry in the
Community Register

Date of
notification

Merial
29 Avenue Tony Garnier
69007 Lyon
FRANCE

Merial
29 Avenue Tony Garnier
69007 Lyon
FRANCE

Merial
29 Avenue Tony Garnier
69007 Lyon
FRANCE

EU/2/04/049/001-002

16.2.2009

EU/2/04/048/001-002

17.2.2009

EU/2/04/047/001-002

17.2.2009

17.2.2009

Purevax RCPCh Merial

EU/2/04/050/001-002

19.2.2009

17.2.2009

ProMeris Duo

17.2.2009

Purevax RC

17.2.2009

Purevax RCP

29 Avenue Tony Garnier
69007 Lyon
FRANCE

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

Merial
29 Avenue Tony Garnier
69007 Lyon
FRANCE

Merial
29 Avenue Tony Garnier
69007 Lyon
FRANCE

EU/2/06/065/001-010

19.2.2009

EU/2/04/051/001-002

20.2.2009

EU/2/04/052/001-002

19.2.2009

— Suspension of a marketing authorization (Article 45 of Regulation (EC) No 726/2004)

Date of the
decision

Name of the
medicinal
product

20.2.2009

Porcilis Pesti

Holder of the marketing authorization

Number of the entry in the
Community Register

Date of
notification

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

EU/2/99/016/001-006

24.2.2009

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