25.2.2011   

SL

Uradni list Evropske unije

C 61/1

Povzetek sklepov Evropske unije o dovoljenjih za promet z zdravili od 1. novembra 2010 do 31. decembra 2010

(Objavljeno v skladu s členom 13 ali členom 38 Uredbe (ES) št. 726/2004 Evropskega parlamenta in Sveta  (1) )

2011/C 61/01

—   Izdaja dovoljenja za promet (člen 13 Uredbe (ES) št. 726/2004 Evropskega parlamenta in Sveta): Odobrena

Datum sprejetja sklepa

Ime zdravila

INN (mednarodno nelastniško ime)

Imetnik dovoljenja za promet

Registracijska številka v registru Skupnosti

Farmacevtska oblika

ATC (anatomsko terapevtska kemijska oznaka)

Datum obvestila

29.11.2010

Aflunov

Prepandemično cepivo proti gripi (H5N1) (s površinskim antigenom, inaktivirano, z adjuvansom)

Novartis Vaccines and Diagnostics S.r.l.

Via Fiorentina, 1,

53100 Siena,

Italia

EU/1/10/658/001-002

Suspenzija za injiciranje

J07BB02

3.12.2010

29.11.2010

Leflunomide ratiopharm

Leflunomid

ratiopharm GmbH

Graf-Arco-Straße 3,

D-89079 Ulm,

Deutschland

EU/1/10/654/001-004

Filmsko obložene tablete

L04AA13

6.12.2010

29.11.2010

Prepandemic Influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted) Novartis Vaccines and Diagnostic

Prepandemično cepivo proti gripi (H5N1) (s površinskim antigenom, inaktivirano, z adjuvansom)

Novartis Vaccines and Diagnostics S.r.l.

Via Fiorentina, 1,

53100 Siena,

Italia

EU/1/10/657/001-002

Suspenzija za injiciranje

J07BB02

3.12.2010

3.12.2010

Brilique

tikagrelor

AstraZeneca AB

Södertälje S 151 85,

Sverige

EU/1/10/655/001-006

Filmsko obložene tablete

B01AC24

7.12.2010

3.12.2010

Possia

tikagrelor

AstraZeneca AB

Södertälje S 151 85,

Sverige

EU/1/10/656/001-006

Filmsko obložene tablete

B01AC24

7.12.2010


—   Sprememba dovoljenja za promet (člen 13 Uredbe (ES) št. 726/2004 Evropskega parlamenta in Sveta): Odobrena

Datum sprejetja sklepa

Ime zdravila

Imetnik dovoljenja za promet

Registracijska številka v registru Skupnosti

Datum obvestila

3.11.2010

Actraphane

Novo Nordisk A/S

Novo Allé, DK-2880 Bagsvaerd,

Danmark

EU/1/02/229/001-037

8.11.2010

3.11.2010

Adcirca

Eli Lilly Nederland B.V.

Grootslag 1-5, NL-3991 RA,

Houten,

Nederland

EU/1/08/476/005-006

9.11.2010

3.11.2010

Bridion

N.V. Organon

Kloosterstraat 6, 5349 AB Oss,

Nederland

EU/1/08/466/001-002

9.11.2010

3.11.2010

Combivir

ViiV Healthcare UK Ltd

980 Great West Road, Brentford,

Middlesex, TW8 9GS,

United Kingdom

EU/1/98/058/001-002

9.11.2010

3.11.2010

Doribax

Janssen-Cilag International NV

Turnhoutseweg, 30 - 2340 Beerse - België

EU/1/08/467/001-002

9.11.2010

3.11.2010

Effentora

Cephalon Europe

5 Rue Charles Martigny,

Maisons-Alfort 94700,

France

EU/1/08/441/001-010

9.11.2010

3.11.2010

Efficib

Merck Sharp & Dohme Ltd.

Hertford Road, Hoddesdon,

Hertfordshire EN11 9BU,

United Kingdom

EU/1/08/457/001-016

5.11.2010

3.11.2010

Enyglid

KRKA, d. d., Novo mesto

Šmarješka cesta 6,

8501 Novo mesto,

Slovenija

EU/1/09/580/001-021

9.11.2010

3.11.2010

Filgrastim Hexal

HEXAL AG

Industriestrasse 25,

D-83607 Holzkirchen,

Deutschland

EU/1/08/496/001-016

9.11.2010

3.11.2010

Janumet

Merck Sharp & Dohme Ltd.

Hertford Road, Hoddesdon,

Hertfordshire EN11 9BU,

United Kingdom

EU/1/08/455/001-016

5.11.2010

3.11.2010

Januvia

Merck Sharp & Dohme Ltd

Hertford Road, Hoddesdon,

Hertfordshire EN11 9BU,

United Kingdom

EU/1/07/383/001-018

8.11.2010

3.11.2010

Norvir

Abbott Laboratories Ltd

Abbott House, Vanwall Business Park, Vanwall Road,

Maidenhead,

Berkshire SL6 4XE,

United Kingdom

EU/1/96/016/001

EU/1/96/016/003-007

8.11.2010

3.11.2010

Olanzapine Mylan

Generics [UK] Limited

Station Close, Potters Bar,

Hertfordshire, EN6 1TL,

United Kingdom

EU/1/08/475/001-034

9.11.2010

3.11.2010

Rasilez

Novartis Europharm Limited

Wimblehurst Road,

Horsham,

West Sussex RH12 5AB,

United Kingdom

EU/1/07/405/001-040

9.11.2010

3.11.2010

Rasilez HCT

Novartis Europharm Limited

Wimblehurst Road,

Horsham,

West Sussex RH12 5AB,

United Kingdom

EU/1/08/491/001-080

5.11.2010

3.11.2010

Riprazo

Novartis Europharm Limited

Wimblehurst Road,

Horsham,

West Sussex RH12 5AB,

United Kingdom

EU/1/07/409/001-020

9.11.2010

3.11.2010

Ristaben

Merck Sharp & Dohme Ltd.

Hertford Road,

Hoddesdon,

Hertfordshire EN11 9BU,

United Kingdom

EU/1/10/621/001-018

9.11.2010

3.11.2010

Ristfor

Merck Sharp & Dohme Ltd.

Hertford Road,

Hoddesdon,

Hertfordshire EN11 9BU,

United Kingdom

EU/1/10/620/001-016

9.11.2010

3.11.2010

Rotarix

GlaxoSmithKline Biologicals S.A.

rue de l'Institut 89,

Rixensart,

B-1330 Belgique

EU/1/05/330/001-011

8.11.2010

3.11.2010

Stocrin

Merck Sharp & Dohme Ltd

Hertford Road,

Hoddesdon,

Hertfordshire EN11 9BU,

United Kingdom

EU/1/99/111/001-005

EU/1/99/111/008-011

9.11.2010

3.11.2010

Sustiva

Bristol-Myers Squibb Pharma EEIG

Uxbridge Business Park,

Sanderson Road,

Uxbridge UB8 1DH,

United Kingdom

EU/1/99/110/001-005

EU/1/99/110/008-010

9.11.2010

3.11.2010

Tesavel

Merck Sharp & Dohme Ltd

Hertford Road,

Hoddesdon,

Hertfordshire EN11 9BU,

United Kingdom

EU/1/07/435/001-018

8.11.2010

3.11.2010

Velmetia

Merck Sharp & Dohme Ltd.

Hertford Road,

Hoddesdon,

Hertfordshire EN11 9BU,

United Kingdom

EU/1/08/456/001-016

9.11.2010

3.11.2010

Xelevia

Merck Sharp & Dohme Ltd

Hertford Road,

Hoddesdon,

Hertfordshire EN11 9BU,

United Kingdom

EU/1/07/382/001-018

8.11.2010

3.11.2010

Zarzio

Sandoz GmbH

Biochemiestrasse 10,

A-6250 Kundl,

Österreich

EU/1/08/495/001-016

9.11.2010

5.11.2010

Abilify

Otsuka Pharmaceutical Europe Ltd

Hunton House, Highbridge Business Park,

Oxford Road, Uxbridge,

Middlesex UB8 1HU,

United Kingdom

EU/1/04/276/001-020

EU/1/04/276/024-036

9.11.2010

5.11.2010

Diacomit

Biocodex

7 avenue Gallieni,

94250 Gentilly,

France

EU/1/06/367/001-012

9.11.2010

5.11.2010

Erbitux

Merck KGaA

Frankfurter Straße 250,

64271 Darmstadt,

Deutschland

EU/1/04/281/001-005

9.11.2010

5.11.2010

Irbesartan Winthrop

SANOFI PHARMA BRISTOL MYERS SQUIBB SNC

174 avenue de France,

F- 75013 Paris,

France

EU/1/06/376/001-033

9.11.2010

5.11.2010

Torisel

Wyeth Europa Ltd

Huntercombe Lane South, Taplow,

Maidenhead,

Berkshire SL6 0PH,

United Kingdom

EU/1/07/424/001

9.11.2010

5.11.2010

Twinrix Paediatric

GlaxoSmithKline Biologicals S.A.

rue de l'Institut 89,

Rixensart,

B-1330 Belgique

EU/1/97/029/001-010

9.11.2010

12.11.2010

Kentera

Nicobrand Limited

189 Castleroe Road,

Coleraine,

Northern Ireland BT51 3 RP

EU/1/03/270/001-003

16.11.2010

12.11.2010

Xolair

Novartis Europharm Limited

Wimblehurst Road,

Horsham,

West Sussex RH12 5AB,

United Kingdom

EU/1/05/319/001-010

16.11.2010

19.11.2010

Qutenza

Astellas Pharma Europe B.V.

Elisabethhof 19,

2353 EW Leiderdorp,

Nederland

EU/1/09/524/001-002

23.11.2010

26.11.2010

Ambirix

GlaxoSmithKline Biologicals S.A.

rue de l'Institut 89,

Rixensart,

B-1330 Belgique

EU/1/02/224/001-005

1.12.2010

26.11.2010

Avastin

Roche Registration Limited

6 Falcon Way,

Shire Park,

Welwyn Garden City, AL7 1TW,

United Kingdom

EU/1/04/300/001-002

1.12.2010

26.11.2010

Cancidas

Merck Sharp & Dohme Ltd

Hertford Road,

Hoddesdon,

Hertfordshire EN11 9BU,

United Kingdom

EU/1/01/196/001

EU/1/01/196/003

1.12.2010

26.11.2010

Circadin

RAD Neurim Pharmaceuticals EEC Limited

One Forbury Square, The Forbury,

Reading,

Berkshire RG1 3EB,

United Kingdom

EU/1/07/392/001-002

2.12.2010

26.11.2010

Efficib

Merck Sharp & Dohme Ltd.

Hertford Road,

Hoddesdon,

Hertfordshire EN11 9BU,

United Kingdom

EU/1/08/457/001-016

1.12.2010

26.11.2010

Enbrel

Wyeth Europa Limited

Huntercombe Lane South, Taplow,

Maidenhead,

Berkshire, SL6 0PH,

United Kingdom

EU/1/99/126/001-021

1.12.2010

26.11.2010

Iressa

AstraZeneca AB

Sodertalje S 151 85,

Sverige

EU/1/09/526/001-002

1.12.2010

26.11.2010

Janumet

Merck Sharp & Dohme Ltd.

Hertford Road,

Hoddesdon,

Hertfordshire EN11 9BU,

United Kingdom

EU/1/08/455/001-016

1.12.2010

26.11.2010

Januvia

Merck Sharp & Dohme Ltd

Hertford Road,

Hoddesdon,

Hertfordshire EN11 9BU,

United Kingdom

EU/1/07/383/001-018

1.12.2010

26.11.2010

Livensa

Warner Chilcott Deutschland Gmbh

Dr.-Otto-Röhm-Strasse 2-4,

Weiterstadt 64331,

Deutschland

EU/1/06/351/001-003

1.12.2010

26.11.2010

Nexavar

Bayer Schering Pharma AG

13342 Berlin,

Deutschland

EU/1/06/342/001

1.12.2010

26.11.2010

Nplate

Amgen Europe B.V.

Minervum 7061,

4817 ZK Breda,

Nederland

EU/1/08/497/001-008

1.12.2010

26.11.2010

Prevenar 13

Wyeth Lederle Vaccines S.A.

Rue du Bosquet, 15,

B-1348 Louvain-la-Neuve,

Belgium

EU/1/09/590/001-006

1.12.2010

26.11.2010

Ristaben

Merck Sharp & Dohme Ltd.

Hertford Road,

Hoddesdon,

Hertfordshire EN11 9BU,

United Kingdom

EU/1/10/621/001-018

1.12.2010

26.11.2010

Ristfor

Merck Sharp & Dohme Ltd.

Hertford Road,

Hoddesdon,

Hertfordshire EN11 9BU,

United Kingdom

EU/1/10/620/001-016

1.12.2010

26.11.2010

Tamiflu

Roche Registration Limited

6 Falcon Way,

Shire Park,

Welwyn Garden City, AL7 1TW,

United Kingdom

EU/1/02/222/001-004

1.12.2010

26.11.2010

Temozolomide Teva

Teva Pharma B.V.

Computerweg 10,

DR Utrecht 3542,

Nederland

EU/1/09/606/001-012

1.12.2010

26.11.2010

Thalidomide Celgene

Celgene Europe Limited

Riverside House, Riverside Walk,

Windsor SL4 1NA,

United Kingdom

EU/1/08/443/001

1.12.2010

26.11.2010

Truvada

Gilead Sciences International Limited

Cambridge CB21 6GT

United Kingdom

EU/1/04/305/001-002

1.12.2010

26.11.2010

Velmetia

Merck Sharp & Dohme Ltd.

Hertford Road,

Hoddesdon,

Hertfordshire EN11 9BU,

United Kingdom

EU/1/08/456/001-016

1.12.2010

26.11.2010

Xagrid

Shire Pharmaceutical Contracts Ltd

Hampshire International Business Park, Chineham,

Basingstoke,

Hampshire RG24 8EP,

United Kingdom

EU/1/04/295/001

1.12.2010

26.11.2010

Xelevia

Merck Sharp & Dohme Ltd

Hertford Road,

Hoddesdon,

Hertfordshire EN11 9BU,

United Kingdom

EU/1/07/382/001-018

1.12.2010

26.11.2010

Zeffix

Glaxo Group Ltd.

Greenford Road,

Greenford,

Middlesex UB6 0NN,

United Kingdom

EU/1/99/114/001-003

1.12.2010

29.11.2010

Adrovance

Merck Sharp & Dohme Ltd

Hertford Road,

Hoddesdon,

Hertfordshire EN11 9BU,

United Kingdom

EU/1/06/364/001-009

6.12.2010

29.11.2010

alli

Glaxo Group Limited

Berkeley Avenue,

Greenford,

Middlesex UB6 0NN,

United Kingdom

EU/1/07/401/007-015

3.12.2010

29.11.2010

Atriance

Glaxo Group Limited

Berkeley Avenue,

Greenford,

Middlesex UB6 0NN,

United Kingdom

EU/1/07/403/001

3.12.2010

29.11.2010

Cimzia

UCB Pharma SA.

Allée de la Recherche 60,

1070 Bruxelles,

Belgique/Researchdreef, 60,

Brussel 1070,

België

EU/1/09/544/001-002

2.12.2010

29.11.2010

Corlentor

Les Laboratoires Servier

22, rue Garnier,

92200 Neuilly-sur-Seine,

France

EU/1/05/317/001-014

2.12.2010

29.11.2010

Cubicin

Novartis Europharm Limited

Wimblehurst Road,

Horsham,

West Sussex RH12 5AB,

United Kingdom

EU/1/05/328/001-004

6.12.2010

29.11.2010

DepoCyte

Pacira Limited

3 Glory Park Avenue, Wooburn Green,

High Wycombe,

Buckinghamshire, HP10 0DF,

United Kingdom

EU/1/01/187/001

18.1.2011

29.11.2010

Exalief

BIAL - Portela & Ca, SA

A Av. da Siderurgia Nacional

4745-457 S. Mamede do Coronado - Portugal

EU/1/09/520/001-020

2.12.2010

29.11.2010

Fertavid

SP Europe

Rue de Stalle, 73,

1180 Bruxelles,

Belgique - Stallestraat,

73 - 1180 Brussel,

België

EU/1/09/510/001-019

6.12.2010

29.11.2010

Fosavance

Merck Sharp & Dohme Ltd

Hertford Road,

Hoddesdon,

Hertfordshire EN11 9BU,

United Kingdom

EU/1/05/310/001-009

1.12.2010

29.11.2010

Intelence

Janssen-Cilag International NV

Turnhoutseweg, 30 - 2340 Beerse - België

EU/1/08/468/001

2.12.2010

29.11.2010

Intelence

Janssen-Cilag International NV

Turnhoutseweg, 30 - 2340 Beerse - België

EU/1/08/468/001

2.12.2010

29.11.2010

Neupro

Schwarz Pharma Ltd

Shannon, Industrial Estate,

Co.Clare,

Ireland

EU/1/05/331/001-055

2.12.2010

29.11.2010

NeuroBloc

Eisai Limited

European Knowledge Centre, Mosquito Way,

Hatfield,

Hertfordshire, AL10 9SN,

United Kingdom

EU/1/00/166/001-003

2.12.2010

29.11.2010

PREZISTA

Janssen-Cilag International NV

Turnhoutseweg, 30 - 2340 Beerse - België

EU/1/06/380/001-005

2.12.2010

29.11.2010

Procoralan

Les Laboratoires Servier

22, rue Garnier,

92200 Neuilly-sur-Seine,

France

EU/1/05/316/001-014

2.12.2010

29.11.2010

Puregon

Organon N.V.

Kloosterstraat 6, Postbus 20,

5340 BH Oss,

Nederland

EU/1/96/008/001-041

6.12.2010

29.11.2010

Remicade

Centocor B.V.

Einsteinweg 101,

2333 CB Leiden,

Nederland

EU/1/99/116/001-005

6.12.2010

29.11.2010

Sebivo

Novartis Europharm Limited

Wimblehurst Road,

Horsham,

West Sussex RH12 5AB,

United Kingdom

EU/1/07/388/001-003

6.12.2010

29.11.2010

Sildenafil Teva

Teva Pharma B.V.

Computerweg 10,

3542 DR Utrecht,

Nederland

EU/1/09/584/001-018

2.12.2010

29.11.2010

Sutent

Pfizer Ltd

Ramsgate Road,

Sandwich,

Kent CT 13 0NJ,

United Kingdom

EU/1/06/347/001-008

3.12.2010

29.11.2010

Travatan

Alcon Laboratories (UK) Ltd.

Boundary Way,

Hemel Hempstead,

Herts HP2 7UD,

United Kingdom

EU/1/01/199/001-002

2.12.2010

29.11.2010

Trizivir

ViiV Healthcare UK Limited

980 Great West Road,

Brentford,

Middlesex, TW8 9GS,

United Kingdom

EU/1/00/156/002-004

2.12.2010

29.11.2010

Tysabri

Elan Pharma International Ltd.

Monksland,

Athlone,

County Westmeath,

Ireland

EU/1/06/346/001

2.12.2010

29.11.2010

Vantavo

Merck Sharp & Dohme Ltd.

Hertford Road,

Hoddesdon,

Hertfordshire EN11 9BU,

United Kingdom

EU/1/09/572/001-009

2.12.2010

29.11.2010

Vfend

Pfizer Ltd

Ramsgate Road,

Sandwich,

Kent CT 13 0NJ,

United Kingdom

EU/1/02/212/001-026

6.12.2010

29.11.2010

Zebinix

BIAL - Portela & Ca, SA

A Av. da Siderurgia Nacional

4745-457 S. Mamede do Coronado - Portugal

EU/1/09/514/001-020

2.12.2010

3.12.2010

Aranesp

Amgen Europe B.V.

Minervum 7061,

NL-4817 ZK Breda,

Nederland

EU/1/01/185/001-022

EU/1/01/185/031-099

7.12.2010

3.12.2010

Orencia

Bristol-Myers Squibb Pharma EEIG

Uxbridge Business Park,

Sanderson Road,

Uxbridge UB8 1DH,

United Kingdom

EU/1/07/389/001-003

7.12.2010

3.12.2010

Tesavel

Merck Sharp & Dohme Ltd

Hertford Road,

Hoddesdon,

Hertfordshire EN11 9BU,

United Kingdom

EU/1/07/435/001-018

7.12.2010

3.12.2010

Zerit

Bristol-Myers Squibb Pharma EEIG

Uxbridge Business Park,

Sanderson Road,

Uxbridge UB8 1DH,

United Kingdom

EU/1/96/009/001-009

7.12.2010

6.12.2010

Ilaris

Novartis Europharm Limited

Wimblehurst Road,

Horsham,

West Sussex RH12 5AB,

United Kingdom

EU/1/09/564/001-002

8.12.2010

6.12.2010

Kiovig

Baxter AG

Industriestraße 67,

A - 1221 Wien,

Österreich

EU/1/05/329/001-006

9.12.2010

6.12.2010

Sprycel

Bristol-Myers Squibb Pharma EEIG

Uxbridge Business Park,

Sanderson Road,

Uxbridge UB8 1DH,

United Kingdom

EU/1/06/363/001-015

8.12.2010

13.12.2010

Diacomit

Biocodex

7 avenue Gallieni,

94250 Gentilly,

France

EU/1/06/367/001-012

15.12.2010

13.12.2010

Flebogamma DIF

Instituto Grifols, S.A.

Can Guasch, 2 - Parets del Vallès,

08150 Barcelona - Espaňa

EU/1/07/404/001-008

15.12.2010

13.12.2010

Invega

Janssen-Cilag International NV

Turnhoutseweg, 30 - 2340 Beerse - België

EU/1/07/395/001-095

15.12.2010

13.12.2010

Kaletra

Abbott Laboratories

Abbott House, Vanwall Business Park, Vanwall Road,

SL6 4XE Maidenhead,

Berks,

United Kingdom

EU/1/01/172/001-008

15.12.2010

13.12.2010

Revlimid

Celgene Europe Limited

Riverside House, Riverside Walk,

Windsor, Berkshire SL4 1NA,

United Kingdom

EU/1/07/391/001-004

15.12.2010

13.12.2010

Sifrol

Boehringer Ingelheim International GmbH

Binger Strasse 173,

D-55216 Ingelheim am Rhein,

Deutschland

EU/1/97/050/001-006

EU/1/97/050/009-033

15.12.2010

13.12.2010

Vectibix

Amgen Europe B.V.

Minervum 7061,

NL-4817 ZK Breda,

Nederland

EU/1/07/423/001-003

15.12.2010

13.12.2010

Velcade

Janssen-Cilag International NV

Turnhoutseweg 30,

B-2340 Beerse,

België

EU/1/04/274/001-002

15.12.2010

17.12.2010

Revlimid

Celgene Europe Limited

Riverside House, Riverside Walk,

Windsor,

Berkshire SL4 1NA,

United Kingdom

EU/1/07/391/001-004

22.12.2010

20.12.2010

Aloxi

Helsinn Birex Pharmaceuticals Ltd

Damastown,

Mulhuddart, Dublin 15,

Republic of Ireland

EU/1/04/306/001-003

4.1.2011

20.12.2010

Aranesp

Amgen Europe B.V.

Minervum 7061,

NL-4817 ZK Breda,

Nederland

EU/1/01/185/001-022

EU/1/01/185/031-099

23.12.2010

20.12.2010

Atripla

Bristol-Myers Squibb and Gilead Sciences Limited

IDA Business & Technology Park,

Carrigtohill, Co. Cork,

Ireland

EU/1/07/430/001-002

23.12.2010

20.12.2010

Avastin

Roche Registration Limited

6 Falcon Way,

Shire Park,

Welwyn Garden City, AL7 1TW,

United Kingdom

EU/1/04/300/001-002

23.12.2010

20.12.2010

Celsentri

ViiV Healthcare UK Ltd

980 Great West Road,

Brentford,

Middlesex, TW8 9GS,

United Kingdom

EU/1/07/418/001-010

23.12.2010

20.12.2010

Champix

Pfizer Ltd

Ramsgate Road,

Sandwich,

Kent CT 13 0NJ,

United Kingdom

EU/1/06/360/001-013

23.12.2010

20.12.2010

Conbriza

Wyeth Europa Limited

Huntercombe Lane South, Taplow,

Maidenhead,

Berkshire, SL6 0PH,

United Kingdom

EU/1/09/511/001-004

23.12.2010

20.12.2010

DuoCover

Bristol-Myers Squibb Pharma EEIG

Uxbridge Business Park, Sanderson Road,

Uxbridge UB8 1DH,

United Kingdom

EU/1/10/623/001-015

23.12.2010

20.12.2010

DuoPlavin

Sanofi Pharma Bristol-Myers Squibb SNC

174 Avenue de France,

F-75013 Paris,

France

EU/1/10/619/001-015

23.12.2010

20.12.2010

Emselex

Novartis Europharm Limited

Wimblehurst Road,

Horsham,

West Sussex RH12 5AB,

United Kingdom

EU/1/04/294/001-028

23.12.2010

20.12.2010

Exjade

Novartis Europharm Limited

Wimblehurst Road,

Horsham,

West Sussex RH12 5AB,

United Kingdom

EU/1/06/356/001-009

23.12.2010

20.12.2010

Glivec

Novartis Europharm Limited

Wimblehurst Road,

Horsham,

West Sussex RH12 5AB,

United Kingdom

EU/1/01/198/001-013

23.12.2010

20.12.2010

Helixate NexGen

Bayer Schering Pharma AG

13342 Berlin,

Deutschland

EU/1/00/144/001-005

23.12.2010

20.12.2010

Javlor

Pierre Fabre Médicament

45, place Abel Gance,

F-92100 Boulogne,

France

EU/1/09/550/001-012

23.12.2010

20.12.2010

Kogenate Bayer

Bayer Schering Pharma AG

13342 Berlin,

Deutschland

EU/1/00/143/004-013

23.12.2010

20.12.2010

Mabthera

Roche Registration Limited

6 Falcon Way,

Shire Park,

Welwyn Garden City, AL7 1TW,

United Kingdom

EU/1/98/067/001-002

23.12.2010

20.12.2010

Macugen

Pfizer Ltd

Ramsgate Road,

Sandwich,

Kent CT 13 0NJ,

United Kingdom

EU/1/05/325/002

23.12.2010

20.12.2010

Mirapexin

Boehringer Ingelheim International GmbH

Binger Strasse 173-

D - 55216 Ingelheim am Rhein,

Deutschland

EU/1/97/051/001-006

EU/1/97/051/009-033

23.12.2010

20.12.2010

Mycamine

Astellas Pharma Europe B.V.

Elisabethhof 19,

2353 EW Leiderdorp,

Nederland

EU/1/08/448/001-002

23.12.2010

20.12.2010

Naglazyme

BioMarin Europe Ltd

164 Shaftesbury Avenue,

London WC2H 8HL,

United Kingdom

EU/1/05/324/001-002

22.12.2010

20.12.2010

Optison

GE Healthcare AS

Nycoveien 1-2, P.O.Box 4220 Nydalen,

N-0401 OSLO,

Norway

EU/1/98/065/001-002

22.12.2010

20.12.2010

Pelzont

Merck Sharp & Dohme Ltd

Hertford Road,

Hoddesdon,

Hertfordshire EN11 9BU,

United Kingdom

EU/1/08/460/001-014

23.12.2010

20.12.2010

Pradaxa

Boehringer Ingelheim International GmbH

Binger Strasse 173,

D-55216 Ingelheim am Rhein,

Deutschland

EU/1/08/442/001-008

23.12.2010

20.12.2010

RoActemra

Roche Registration Limited

6 Falcon Way,

Shire Park,

Welwyn Garden City, AL7 1TW,

United Kingdom

EU/1/08/492/001-006

23.12.2010

20.12.2010

Stelara

Janssen-Cilag International NV

Turnhoutseweg, 30 - 2340 Beerse - België

EU/1/08/494/001-004

23.12.2010

20.12.2010

Sutent

Pfizer Ltd

Ramsgate Road,

Sandwich,

Kent CT 13 0NJ,

United Kingdom

EU/1/06/347/001-008

23.12.2010

20.12.2010

Tamiflu

Roche Registration Limited

6 Falcon Way,

Shire Park,

Welwyn Garden City, AL7 1TW,

United Kingdom

EU/1/02/222/001-004

23.12.2010

20.12.2010

Tasigna

Novartis Europharm Limited

Wimblehurst Road,

Horsham,

West Sussex RH12 5AB,

United Kingdom

EU/1/07/422/001-006

23.12.2010

20.12.2010

Tasigna

Novartis Europharm Limited

Wimblehurst Road,

Horsham,

West Sussex RH12 5AB,

United Kingdom

EU/1/07/422/001-006

23.12.2010

20.12.2010

Thalidomide Celgene

Celgene Europe Limited

Riverside House, Riverside Walk,

Windsor SL4 1NA,

United Kingdom

EU/1/08/443/001

23.12.2010

20.12.2010

Tredaptive

Merck Sharp & Dohme Ltd

Hertford Road,

Hoddesdon,

Hertfordshire EN11 9BU,

United Kingdom

EU/1/08/459/001-014

23.12.2010

20.12.2010

Trevaclyn

Merck Sharp & Dohme Ltd

Hertford Road,

Hoddesdon,

Hertfordshire EN11 9BU,

United Kingdom

EU/1/08/458/001-014

23.12.2010

20.12.2010

Ventavis

Bayer Schering Pharma AG

Müllerstrasse 170-178,

D - 13342 Berlin,

Deutschland

EU/1/03/255/001-008

23.12.2010

20.12.2010

Vfend

Pfizer Ltd

Ramsgate Road,

Sandwich,

Kent CT 13 0NJ,

United Kingdom

EU/1/02/212/001-026

23.12.2010

20.12.2010

Victoza

Novo Nordisk A/S

Novo Allé,

DK-2880 Bagsvaerd,

Danmark

EU/1/09/529/001-005

27.12.2010

20.12.2010

Zostavax

Sanofi Pasteur MSD, SNC

8, rue Jonas Salk,

69007 Lyon,

France

EU/1/06/341/001-013

22.12.2010

20.12.2010

Zyprexa

Eli Lilly Nederland B.V.

Grootslag 1-5,

3991 RA Houten,

Nederland

EU/1/96/022/002

EU/1/96/022/004

EU/1/96/022/006

EU/1/96/022/009-012

EU/1/96/022/014

EU/1/96/022/016-017

EU/1/96/022/019-040

23.12.2010

20.12.2010

Zyprexa Velotab

Eli Lilly Nederland B.V.

Grootslag 1-5,

3991 RA Houten,

Nederland

EU/1/99/125/017-020

23.12.2010


—   Ukinitev dovoljenja za promet (člen 13 Uredbe (ES) št. 726/2004 Evropskega parlamenta in Sveta)

Datum sprejetja sklepa

Ime zdravila

Imetnik dovoljenja za promet

Registracijska številka v registru Skupnosti

Datum obvestila

13.12.2010

Arepanrix

GlaxoSmithKline Biologicals S.A.

rue de l'Institut 89,

1330 Rixensart,

Belgique

EU/1/10/624/001

15.12.2010


—   Umik dovoljenja za promet (člen 20 Uredbe (ES) št. 726/2004 Evropskega parlamenta in Sveta)

Datum sprejetja sklepa

Ime zdravila

Imetnik dovoljenja za promet

Registracijska številka v registru Skupnosti

Datum obvestila

3.12.2010

Avaglim

SmithKline Beecham Ltd.

980 Great West Road,

Brentford,

Middlesex, TW8 9GS

United Kingdom

EU/1/06/349/001-010

7.12.2010

3.12.2010

Avandamet

SmithKline Beecham Ltd.

980 Great West Road,

Brentford,

Middlesex, TW8 9GS

United Kingdom

EU/1/03/258/001-022

7.12.2010

3.12.2010

Avandia

SmithKline Beecham Ltd.

980 Great West Road,

Brentford,

Middlesex, TW8 9GS

United Kingdom

EU/1/00/137/002-018

7.12.2010


—   Izdaja dovoljenja za promet (člen 38 Uredbe (ES) št. 726/2004 Evropskega parlamenta in Sveta  (2) ): Odobrena

Datum sprejetja sklepa

Ime zdravila

INN (mednarodno nelastniško ime)

Imetnik dovoljenja za promet

Registracijska številka v registru Skupnosti

Farmacevtska oblika

ATC (anatomsko terapevtska kemijska oznaka)

Datum obvestila

5.11.2010

BTVPUR AlSap 2-4

Virus modrega jezika, serotip 2, antigen - Virus modrega jezika, serotip 4, antigen

MERIAL

29 avenue Tony Garnier,

69007 LYON,

France

EU/2/10/108/001-005

Suspenzija za injiciranje

QI02AA08

QI04AA02

9.11.2010

19.11.2010

Meloxoral

Meloksikam

Le Vet B.V.

Wilgenweg 7,

3421 TV Oudewater,

Nederland

EU/2/10/111/001-004

Oralna suspenzija

QM01AC06

23.11.2010

17.12.2010

BTVPUR AlSap 1

Virus modrega jezika, serotip 1, antigen

MERIAL

29 avenue Tony Garnier,

69007 LYON,

France

EU/2/10/112/001-005

Suspenzija za injiciranje

QI02AA08

QI04AA02

22.12.2010

17.12.2010

BTVPUR AlSap 1-8

Virus modrega jezika, serotip 1, antigen - Virus modrega jezika, serotip 8, antigen

MERIAL

29 avenue Tony Garnier,

69007 LYON,

France

EU/2/10/113/001-005

Suspenzija za injiciranje

QI02AA08

QI04AA02

22.12.2010


—   Sprememba dovoljenja za promet (člen 38 Uredbe (ES) št. 726/2004 Evropskega parlamenta in Sveta): Odobrena

Datum sprejetja sklepa

Ime zdravila

Imetnik dovoljenja za promet

Registracijska številka v registru Skupnosti

Datum obvestila

3.11.2010

Melovem

Dopharma Research B.V.

Zalmweg 24,

4941 VX Raamsdonksveer,

Nederland

EU/2/09/098/001

8.11.2010

26.11.2010

ProMeris

Fort Dodge Animal Health Holland

C.J. van Houtenlaan 36,

1381 CP Weesp,

Nederland

EU/2/06/064/001-004

3.12.2010

26.11.2010

ProMeris Duo

Fort Dodge Animal Health Holland

C.J. van Houtenlaan 36,

1381 CP Weesp,

Nederland

EU/2/06/065/001-010

3.12.2010

29.11.2010

Circovac

Merial

29 Avenue Tony Garnier,

69007 Lyon,

France

EU/2/07/075/001-004

3.12.2010

3.12.2010

Masivet

AB Science S.A.

3 avenue George V,

75008 Paris,

France

EU/2/08/087/001-002

7.12.2010

13.12.2010

Poulvac FluFend H5N3 RG

Fort Dodge Animal Health Ltd

Flanders Road, Hedge End,

Southampton SO30 4QH,

United Kingdom

EU/2/06/060/001-002

15.12.2010

20.12.2010

Improvac

Pfizer Limited

Ramsgate Road,

Sandwich,

Kent CT13 9NJ,

United Kingdom

EU/2/09/095/001-006

23.12.2010

20.12.2010

Metacam

Boehringer Ingelheim Vetmedica GmbH

55216 Ingelheim am Rhein,

Deutschland

EU/2/97/004/001

EU/2/97/004/003-048

23.12.2010

Kdor želi dobiti vpogled v javno poročilo o oceni zadevnih zdravil ter o zadevnih odločbah/sklepih o zdravilih, se lahko obrne na naslov:

The European Medicines Agency

7, Westferry Circus,

Canary Wharf

UK - LONDON E14 4H

(1)  UL L 136, 30.4.2004, str. 1.

(2)  UL L 136, 30.4.2004, str. 1.