Summary of Community decisions on marketing authorizations in respect of medicinal products from  1 July 2008 to 31 July 2008 (Published pursuant to Article 13 or Article 38 of Regulation (EC) No 726/2004 of the European Parliament and of the Council )
Date: 2008-08-29
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 July 2008 to 31 July 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 220/03)

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

2.7.2008

RELISTOR

Methylnaltrexone bromide Wyeth Europa Limited

EU/1/08/463/001-003

Solution for injection

(Non applicable)

4.7.2008

Huntercombe Lane South
Taplow
Maidenhead
Berkshire SL6 0PH
United Kingdom

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

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

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

CV Therapeutics Europe Limited
15 Meadway Court
Rutherford Close
Stevenage
Hertfordshire SG1 2EF
United Kingdom

3.7.2008

Trevaclyn

Nicotinic acid/laropiprant

3.7.2008

Pelzont

Nicotinic acid/laropiprant

3.7.2008

Tredaptive

Nicotinic acid/laropiprant

9.7.2008

Latixa

Ranolazine

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

EU/1/08/458/001-011 Modified-release tablet

C10AD52

7.7.2008

EU/1/08/460/001-011 Modified-release tablet

C10AD52

7.7.2008

EU/1/08/459/001-011 Modified-release tablet

C10AD52

7.7.2008

EU/1/08/462/001-006

Prolonged release tablet

C01EB18

14.7.2008

.

.

2
9
8
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

2
2
0
/
5

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

C

2
2
0
/
6

11.7.2008

Firazyr

Icatibant

16.7.2008

Clopidogrel BMS

Clopidogrel

16.7.2008

Clopidogrel Winthrop

Clopidogrel

16.7.2008

Janumet

Sitagliptin/metformin
hydrochloride

16.7.2008

Efficib

Sitagliptin/metformin
hydrochloride

16.7.2008

Velmetia

Sitagliptin/metformin
hydrochloride

25.7.2008

Bridion

Sugammadex

25.7.2008

Doribax

Doripenem

Jerini AG
Invalidenstr. 130
D-10115 Berlin

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

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

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

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

N.V. Organon
Kloosterstraat 6
5349 AB Oss
Nederland

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

EU/1/08/461/001

Solution for injection

(Non applicable)

15.7.2008

EU/1/08/464/001-017

Film-coated tablet

B01AC04

18.7.2008

E
N

EU/1/08/465/001-017

Film-coated tablet

B01AC04

18.7.2008

EU/1/08/455/001-014

Film-coated tablet

A10BD07

18.7.2008

EU/1/08/457/001-014

Film-coated tablet

A10BD07

18.7.2008

EU/1/08/456/001-014

Film-coated tablet

A10BD07

18.7.2008

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

EU/1/08/466/001-002

Solution for injection

V03AB35

29.7.2008

EU/1/08/467/001

Powder for solution for
infusion

J01DH04

29.7.2008

.

.

2
9
8
2
0
0
8

29.8.2008

EN

Official Journal of the European Union

C 220/7

— 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

2.7.2008

PritorPlus

2.7.2008

Epivir

2.7.2008

Pritor

2.7.2008

INCRELEX

Bayer HealthCare AG
D-51368 Leverkusen

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

Bayer HealthCare AG
D-51368 Leverkusen

Tercica Europe Limited
Riverside One
Sir John Rogerson's Quay
Dublin 2
Ireland

EU/1/02/215/001-021

7.7.2008

EU/1/96/015/001-005

4.7.2008

EU/1/98/089/001-022

4.7.2008

EU/1/07/402/001

4.7.2008

3.7.2008

Kinzalkomb

Bayer HealthCare AG
D-51368 Leverkusen

EU/1/02/214/001-015

7.7.2008

3.7.2008

Micardis

3.7.2008

Aranesp

3.7.2008

Nespo

4.7.2008

Mabthera

4.7.2008

Rotarix

4.7.2008

MabCampath

4.7.2008

Prezista

4.7.2008

MicardisPlus

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

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

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

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

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

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

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

EU/1/98/090/001-020

7.7.2008

EU/1/01/185/001-073

7.7.2008

EU/1/01/184/001-073

7.7.2008

EU/1/98/067/001-002

8.7.2008

EU/1/05/330/001-004

8.7.2008

EU/1/01/193/001-002

8.7.2008

EU/1/06/380/001

8.7.2008

EU/1/02/213/001-023

8.7.2008

4.7.2008

Kinzalmono

Bayer HealthCare AG
D-51368 Leverkusen

EU/1/98/091/001-014

8.7.2008

C 220/8

EN

Official Journal of the European Union

29.8.2008

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

4.7.2008

Zometa

7.7.2008

TOVIAZ

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

Pfizer Limited
Ramsgate Road
Sandwich
Kent CT13 9NJ
United Kingdom

EU/1/01/176/001-006

8.7.2008

EU/1/07/386/001-012

9.7.2008

7.7.2008

Vasovist

Bayer Schering Pharma AG
D-13342 Berlin

EU/1/05/313/001-009

9.7.2008

7.7.2008

Kepivance

7.7.2008

Telzir

7.7.2008

Invirase

7.7.2008

Tamiflu

7.7.2008

Siklos

7.7.2008

Enbrel

7.7.2008

Aldara

7.7.2008

Aptivus

8.7.2008

Zalasta

8.7.2008

Binocrit

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

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

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

Addmedica
84, rue d'Amsterdam
F-75009 Paris

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

Meda AB
Pipers väg 2A
S-170 73 Solna

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

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

Sandoz GmbH
Biochemiestraße 10
A-6250 Kundl

EU/1/05/314/001

9.7.2008

EU/1/04/282/001-002

9.7.2008

EU/1/96/026/001-002

9.7.2008

EU/1/02/222/001-004

9.7.2008

EU/1/07/397/001

9.7.2008

EU/1/99/126/001-018

9.7.2008

EU/1/98/080/001

9.7.2008

EU/1/05/315/001

9.7.2008

EU/1/07/415/001-056

10.7.2008

EU/1/07/410/001-020

10.7.2008

29.8.2008

EN

Official Journal of the European Union

C 220/9

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

8.7.2008

Fuzeon

8.7.2008

Epoetin alfa
Hexal

8.7.2008

Busilvex

9.7.2008

Rasilez

9.7.2008

Exubera

9.7.2008

Cholestagel

9.7.2008

Circadin

9.7.2008

Pedea

9.7.2008

Sprimeo

9.7.2008

Enviage

9.7.2008

Tekturna

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

HEXAL Biotech Forschungs
GmbH
Industriestraße 25
D-83607 Holzkirchen

Pierre Fabre Médicament
45, Place Abel Gance
F-92654 Boulogne Billancourt
Cedex

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

Pfizer Ltd
Ramsgate Road
Sandwich
Kent CT13 9NJ
United Kingdom

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

RAD Neurim Pharmaceuticals
EEC Limited
6 Fortuna Court
Calleva Park
Aldermaston
Berkshire RG7 8UB
United Kingdom

Orphan Europe SARL
Immeuble Le Wilson
70, avenue du Général de Gaulle
F-92800 Puteaux

Novartis Europharm Limited
Wimblehurst Road
Horsham
West Sussex RH12 5AB
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

EU/1/03/252/001-003

10.7.2008

EU/1/07/411/001-020

10.7.2008

EU/1/03/254/002

10.7.2008

EU/1/07/405/001-020

11.7.2008

EU/1/05/327/001-018

11.7.2008

EU/1/03/268/001-003

11.7.2008

EU/1/07/392/001-002

11.7.2008

EU/1/04/284/001

11.7.2008

EU/1/07/407/001-020

11.7.2008

EU/1/07/406/001-020

11.7.2008

EU/1/07/408/001-020

11.7.2008

C 220/10

EN

Official Journal of the European Union

29.8.2008

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

9.7.2008

Riprazo

10.7.2008

Bonviva

10.7.2008

Bondenza

10.7.2008

Optaflu

10.7.2008

ViraferonPeg

10.7.2008

Remicade

10.7.2008

Silgard

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

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

Novartis Vaccines and Diagnostics
GmbH & Co. KG
Emil-von-Behring-Straße 76
D-35041 Marburg

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

Centocor B.V.
Einsteinweg 101
2333 CB Leiden
Nederland

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

EU/1/07/409/001-020

11.7.2008

EU/1/03/265/003-004

14.7.2008

EU/1/03/266/003-004

14.7.2008

EU/1/07/394/001-009

14.7.2008

EU/1/00/132/001-050

14.7.2008

EU/1/99/116/001-003

14.7.2008

EU/1/06/358/001-021

14.7.2008

10.7.2008

PegIntron

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

EU/1/00/131/001-050

14.7.2008

10.7.2008

Gardasil

11.7.2008

Sustiva

11.7.2008

Stocrin

11.7.2008

Liprolog

17.7.2008

Zimulti

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

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

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

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

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

EU/1/06/357/001-021

15.7.2008

EU/1/99/110/001-009

15.7.2008

EU/1/99/111/001-011

15.7.2008

EU/1/01/195/022-027

15.7.2008

EU/1/06/345/001-011

23.7.2008

29.8.2008

EN

Official Journal of the European Union

C 220/11

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

17.7.2008

Humira

17.7.2008

Erbitux

17.7.2008

ACOMPLIA

22.7.2008

Silapo

22.7.2008

Sprycel

22.7.2008

CUBICIN

Abbott Laboratories Ltd
Queenborough
Kent ME11 5EL
United Kingdom

Merck KGaA
Frankfurter Straße 250
D-64271 Darmstadt

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

STADA Arzneimittel AG
Stadastraße 2-18
D-61118 Bad Vilbel

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

23.7.2008

Prandin

Novo Nordisk A/S
Novo Allé
DK-2880 Bagsværd

23.7.2008

Exjade

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

23.7.2008

NovoNorm

Novo Nordisk A/S
Novo Allé
DK-2880 Bagsværd

23.7.2008

Quadramet

CIS bio international
Boîte Postale 32
F-91192 Gif-sur-Yvette

24.7.2008

Keppra

25.7.2008

Keppra

UCB Pharma S.A.
Allée de la Recherche, 60/
Researchdreef, 60
B-1070 Bruxelles/B-1070 Brussel

UCB Pharma S.A.
Allée de la Recherche, 60/
Researchdreef, 60
B-1070 Bruxelles/B-1070 Brussel

EU/1/03/256/001-010

23.7.2008

EU/1/04/281/001-005

23.7.2008

EU/1/06/344/001-011

23.7.2008

EU/1/07/432/001-022

24.7.2008

EU/1/06/363/001-009

24.7.2008

EU/1/05/328/001-002

24.7.2008

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

25.7.2008

EU/1/06/356/001-006

25.7.2008

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

25.7.2008

EU/1/97/057/001

25.7.2008

EU/1/00/146/030

28.7.2008

EU/1/00/146/001-030

29.7.2008

C 220/12

EN

Official Journal of the European Union

29.8.2008

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

25.7.2008

REYATAZ

25.7.2008

Trisenox

25.7.2008

Myfenax

25.7.2008

Valtropin

25.7.2008

Zeffix

25.7.2008

Mycophenolate
mofetil Teva

28.7.2008

Cymbalta

28.7.2008

Zyprexa

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

Cephalon Europe
5, rue Charles Martigny
F-94700 Maisons Alfort Cedex

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

BioPartners GmbH
Eisenstraße 3
D-65428 Rüsselsheim

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

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

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

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

EU/1/03/267/001-009

29.7.2008

EU/1/02/204/001

29.7.2008

EU/1/07/438/001-004

29.7.2008

EU/1/06/335/001

—

EU/1/99/114/001-003

29.7.2008

EU/1/07/439/001-004

29.7.2008

EU/1/04/296/001-009

30.7.2008

30.7.2008

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/1/96/022/019-034

28.7.2008

NovoMix

Novo Nordisk A/S
Novo Allé
DK-2880 Bagsværd

EU/1/00/142/004-005
EU/1/00/142/009-022

30.7.2008

28.7.2008

Xeristar

28.7.2008

Zostavax

28.7.2008

Zyprexa Velotab

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

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

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

EU/1/04/297/001-008

30.7.2008

EU/1/06/341/001-013

30.7.2008

EU/1/99/125/001-016

30.7.2008

29.8.2008

EN

Official Journal of the European Union

C 220/13

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

28.7.2008

Prezista

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

EU/1/06/380/001

30.7.2008

28.7.2008

Vivanza

28.7.2008

Levitra

28.7.2008

Ventavis

28.7.2008

Viracept

29.7.2008

Tracleer

29.7.2008

Remicade

29.7.2008

Velcade

29.7.2008

Angiox

29.7.2008

INCRELEX

29.7.2008

Naglazyme

29.7.2008

Circadin

EU/1/03/249/001-012

30.7.2008

EU/1/03/248/001-012

30.7.2008

EU/1/03/255/001-006

30.7.2008

EU/1/97/054/001
EU/1/97/054/004-005

30.7.2008

EU/1/02/220/001-005

31.7.2008

EU/1/99/116/001-003

31.7.2008

EU/1/04/274/001-002

31.7.2008

EU/1/04/289/001-002

31.7.2008

EU/1/07/402/001

31.7.2008

EU/1/05/324/001-002

31.7.2008

EU/1/07/392/001-002

31.7.2008

Bayer AG
D-51368 Leverkusen

Bayer AG
D-51368 Leverkusen

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

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

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

Centocor B.V.
Einsteinweg 101
2333 CB Leiden
Nederland

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

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

Tercica Europe Limited
Riverside One
Sir John Rogerson's Quay
Dublin 2
Ireland

BioMarin Europe Limited
Axtell House
23-24 Warwick Street
London W1B 5NQ
United Kingdom

RAD Neurim Pharmaceuticals
EEC Limited
6 Fortuna Court
Calleva Park
Aldermaston
Berkshire RG7 8UB
United Kingdom

C 220/14

EN

Official Journal of the European Union

29.8.2008

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

29.7.2008

Telzir

29.7.2008

Pylobactell

31.7.2008

Revlimid

31.7.2008

DuoTrav

31.7.2008

ADROVANCE

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

Torbet Laboratories Limited
Unit 14D
Wendover Road
Rackheath Industrial Estate
Norwich
Norfolk NR13 6LH
United Kingdom

Celgene Europe Limited
Morgan House
Madeira Walk
Windsor
Berkshire SL4 1EP
United Kingdom

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

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

EU/1/04/282/001-002

31.7.2008

EU/1/98/064/001

1.8.2008

EU/1/07/391/001-004

5.8.2008

EU/1/06/338/001-003

5.8.2008

EU/1/06/364/001-009

5.8.2008

— 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

8.7.2008

Reconcile

Fluoxétine

24.7.2008

ZACTRAN

Gamithromycine

Eli Lilly and Company Ltd
Priestley Road
Basingstoke
Hampshire RG24 9NL
United Kingdom

MERIAL
29, avenue Tony Garnier
F-69007 Lyon

EU/2/08/080/001-004

Chewable tablets

QN06AB03

16.7.2008

EU/2/08/082/001-003

Solution for injection

QJ01FA95

28.7.2008

.

.

2
9
8
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

2
2
0
/
1
5

C 220/16

EN

Official Journal of the European Union

29.8.2008

— 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

11.7.2008

Equilis Te

11.7.2008

Equilis
Prequenza Te

11.7.2008

ProMeris

31.7.2008

Poulvac FluFend
H5N3 RG

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

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

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

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

EU/2/05/055/001-002

15.7.2008

EU/2/05/057/001-004

15.7.2008

EU/2/06/064/001-004

15.7.2008

EU/2/06/060/001-002

5.8.2008

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