25.7.2008   

SL

Uradni list Evropske unije

C 188/6

Povzetek odločb Skupnosti o dovoljenjih za promet z zdravili od 1. junija 2008 do 30. junija 2008

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

(2008/C 188/04)

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

Datum sprejetja odločbe

Ime zdravila

INN

(mednarodno nelastniško ime)

Imetnik dovoljenja za promet

Registracijska številka v registru Skupnosti

Farmacevtska oblika

Oznaka ATC

(anatomsko terapevtsko kemijska oznaka)

Datum obvestila

10.6.2008

Tyverb

Lapatinib

Glaxo Group Limited

Berkeley Avenue

Greenford

Middlesex UB6 0NN

United Kingdom

EU/1/07/440/001-002

Filmsko obložena tableta

L01XE07

12.6.2008

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

Datum sprejetja odločbe

Ime zdravila

Imetnik dovoljenja za promet

Registracijska številka v registru Skupnosti

Datum obvestila

2.6.2008

Xyrem

UCB Pharma Ltd

208 Bath Road

Slough

Berkshire SL1 3WE

United Kingdom

EU/1/05/312/001

4.6.2008

2.6.2008

Dafiro

Novartis Europharm Limited

Wimblehurst Road

Horsham

West Sussex RH12 5AB

United Kingdom

EU/1/06/371/001-033

4.6.2008

2.6.2008

Copalia

Novartis Europharm Limited

Wimblehurst Road

Horsham

West Sussex RH12 5AB

United Kingdom

EU/1/06/372/001-033

4.6.2008

3.6.2008

Exforge

Novartis Europharm Limited

Wimblehurst Road

Horsham

West Sussex RH12 5AB

United Kingdom

EU/1/06/370/001-033

5.6.2008

3.6.2008

Imprida

Novartis Europharm Limited

Wimblehurst Road

Horsham

West Sussex RH12 5AB

United Kingdom

EU/1/06/373/001-003

5.6.2008

4.6.2008

Evoltra

Bioenvision Limited

Bassett House

5 Southwell Park Road

Camberley

Surrey GU15 3PU

United Kingdom

EU/1/06/334/001-004

6.6.2008

Genzyme Europe BV

Gooimeer 10

1411 DD Naarden

Nederland

6.6.2008

Vaniqa

Shire Pharmaceutical Contracts Ltd

Hampshire International Business Park

Chineham

Basingstoke

Hampshire RG24 8EP

United Kingdom

EU/1/01/173/001-003

10.6.2008

Laboratorios Almirall S.A.

Ronda General Mitre, no 151

E-08022 Barcelona

11.6.2008

10.6.2008

Olanzapine Neopharma

Neopharma Limited

57 High Street

Odiham

Hampshire RG29 1LF

United Kingdom

EU/1/07/426/001-011

12.6.2008

10.6.2008

Imprida

Novartis Europharm Limited

Wimblehurst Road

Horsham

West Sussex RH12 5AB

United Kingdom

EU/1/06/373/001-033

12.6.2008

10.6.2008

Irbesartan BMS

Bristol-Myers Squibb Pharma EEIG

Uxbridge Business Park

Sanderson Road

Uxbridge UB8 1DH

United Kingdom

EU/1/06/375/001-033

12.6.2008

10.6.2008

Exforge

Novartis Europharm Limited

Wimblehurst Road

Horsham

West Sussex RH12 5AB

United Kingdom

EU/1/06/370/001-033

12.6.2008

10.6.2008

Copalia

Novartis Europharm Limited

Wimblehurst Road

Horsham

West Sussex RH12 5AB

United Kingdom

EU/1/06/372/001-033

12.6.2008

10.6.2008

Aprovel

Sanofi Pharma Bristol-Myers Squibb SNC

174, avenue de France

F-75013 Paris

EU/1/97/046/001-039

12.6.2008

10.6.2008

Olanzapine Teva

Teva Pharma B.V.

Computerweg 10

DR Utrecht 3542

Nederland

EU/1/07/427/001-057

12.6.2008

10.6.2008

Karvea

Bristol-Myers Squibb Pharma EEIG

Uxbridge Business Park

Sanderson Road

Uxbridge UB8 1DH

United Kingdom

EU/1/97/049/001-039

12.6.2008

10.6.2008

Karvezide

Bristol-Myers Squibb Pharma EEIG

Uxbridge Business Park

Sanderson Road

Uxbridge UB8 1DH

United Kingdom

EU/1/98/085/001-034

12.6.2008

10.6.2008

CoAprovel

Sanofi Pharma Bristol-Myers Squibb SNC

174, avenue de France

F-75013 Paris

EU/1/98/086/001-034

12.6.2008

10.6.2008

Irbesartan HCT BMS

Bristol-Myers Squibb Pharma EEIG

Uxbridge Business Park

Sanderson Road

Uxbridge UB8 1DH

United Kingdom

EU/1/06/369/001-028

12.6.2008

10.6.2008

Irbesartan HCT Winthrop

Sanofi Pharma Bristol-Myers Squibb SNC

174, avenue de France

F-75013 Paris

EU/1/06/377/001-028

12.6.2008

10.6.2008

Dafiro

Novartis Europharm Limited

Wimblehurst Road

Horsham

West Sussex RH12 5AB

United Kingdom

EU/1/06/371/001-033

12.6.2008

11.6.2008

Irbesartan Winthrop

Sanofi Pharma Bristol-Myers Squibb SNC

174, avenue de France

F-75013 Paris

EU/1/06/376/001-033

13.6.2008

12.6.2008

Optison

GE Healthcare AS

Nycoveien 1-2

P.O.Box 4220 Nydalen

N-0401 Oslo

EU/1/98/065/001-002

16.6.2008

17.6.2008

Xenical

Roche Registration Limited

6 Falcon Way

Shire Park

Welwyn Garden City AL7 1TW

United Kingdom

EU/1/98/071/001-006

19.6.2008

18.6.2008

Insuman -

Sanofi-Aventis Deutschland GmbH

D-65926 Frankfurt am Main

EU/1/97/030/028-139

20.6.2008

18.6.2008

Novomix

Novo Nordisk A/S

Novo Allé

DK-2880 Bagsværd

EU/1/00/142/004-005

EU/1/00/142/009-022

20.6.2008

18.6.2008

Insulin Human Winthrop

Sanofi-Aventis Deutschland GmbH

D-65926 Frankfurt am Main

EU/1/06/368/001-057

20.6.2008

18.6.2008

Norvir

Abbott Laboratories Ltd

Queenborough

Kent ME11 5EL

United Kingdom

EU/1/96/016/001

EU/1/96/016/003-004

20.6.2008

18.6.2008

Remicade

Centocor B.V.

Einsteinweg 101

2333 CB Leiden

Nederland

EU/1/99/116/001-003

20.6.2008

18.6.2008

Atripla

Bristol-Myers Squibb and Gilead Sciences Limited

Unit 13

Stillorgan Industrial Park

Blackrock Co.

Dublin

Ireland

EU/1/07/430/001

23.6.2008

18.6.2008

Tamiflu

Roche Registration Limited

6 Falcon Way

Shire Park

Welwyn Garden City AL7 1TW

United Kingdom

EU/1/02/222/001-004

20.6.2008

18.6.2008

Parareg

Dompé Biotec S.p.A.

Via San Martino, 12

I-20122 Milano

EU/1/04/293/001-012

20.6.2008

18.6.2008

Agenerase

Glaxo Group Ltd

Greenford Road

Greenford

Middlesex UB6 0NN

United Kingdom

EU/1/00/148/001-004

20.6.2008

18.6.2008

Renagel

Genzyme Europe B.V.

Gooimeer 10

1411 DD Naarden

Nederland

EU/1/99/123/005-012

20.6.2008

19.6.2008

Twinrix Paediatric

GlaxoSmithKline Biologicals s.a.

rue de l'Institut 89

B-1330 Rixensart

EU/1/97/029/001-010

23.6.2008

19.6.2008

Rotarix

GlaxoSmithKline Biologicals s.a.

rue de l'Institut 89

B-1330 Rixensart

EU/1/05/330/001-004

23.6.2008

19.6.2008

Cholestagel

Genzyme Europe B.V.

Gooimeer 10

1411 DD Naarden

Nederland

EU/1/03/268/001-004

23.6.2008

19.6.2008

Plavix

Sanofi Pharma Bristol-Myers Squibb SNC

174, avenue de France

F-75013 Paris

EU/1/98/069/001a-007b, 008-010

23.6.2008

19.6.2008

Iscover

Bristol-Myers Squibb Pharma EEIG

Uxbridge Business Park

Sanderson Road

Uxbridge UB8 1DH

United Kingdom

EU/1/98/070/001a-007b, 008-010

23.6.2008

19.6.2008

InductOs

Wyeth Europa Ltd

Huntercombe Lane South

Taplow

Maidenhead

Berkshire SL6 0PH

United Kingdom

EU/1/02/226/001

23.6.2008

19.6.2008

Paxene

Norton Healthcare Limited

Albert Basin

Royal Docks

London E16 2QJ

United Kingdom

EU/1/99/113/001-004

24.6.2008

19.6.2008

Mimpara

Amgen Europe B.V.

Minervum 7061

4817 ZK Breda

Nederland

EU/1/04/292/001-012

23.6.2008

19.6.2008

Twinrix Adult

GlaxoSmithKline Biologicals s.a.

rue de l'Institut 89

B-1330 Rixensart

EU/1/96/020/001-009

23.6.2008

20.6.2008

PEGASYS

Roche Registration Limited

6 Falcon Way

Shire Park

Welwyn Garden City AL7 1TW

United Kingdom

EU/1/02/221/001-010

24.6.2008

20.6.2008

Viracept

Roche Registration Limited

6 Falcon Way

Shire Park

Welwyn Garden City AL7 1TW

United Kingdom

EU/1/97/054/001

EU/1/97/054/004-005

24.6.2008

20.6.2008

Azopt

Alcon Laboratories (UK) Ltd

Pentagon Park

Boundary Way

Hemel Hempstead

Herts HP2 7UD

United Kingdom

EU/1/00/129/001-003

24.6.2008

20.6.2008

Tysabri

Elan Pharma International Ltd

Monksland

Athlone

County Westmeath

Ireland

EU/1/06/346/001

26.6.2008

20.6.2008

REYATAZ

Bristol-Myers Squibb Pharma EEIG

Uxbridge Business Park

Sanderson Road

Uxbridge UB8 1DH

United Kingdom

EU/1/03/267/001-009

24.6.2008

20.6.2008

Evra

Janssen-Cilag International NV

Turnhoutseweg 30

B-2340 Beerse

EU/1/02/223/001-003

24.6.2008

20.6.2008

Crixivan

Merck Sharp & Dohme Ltd

Hertford Road

Hoddesdon

Hertfordshire EN11 9BU

United Kingdom

EU/1/96/024/001-005

EU/1/96/024/007-08

EU/1/96/024/010

24.6.2008

20.6.2008

Apidra

Sanofi-Aventis Deutschland GmbH

Brueningstrasse, 50

D-65926 Frankfurt am Main

EU/1/04/285/001-036

24.6.2008

20.6.2008

Prezista

Janssen-Cilag International NV

Turnhoutseweg 30

B-2340 Beerse

EU/1/06/380/001

24.6.2008

20.6.2008

ProQuad

Sanofi Pasteur MSD, SNC

8, rue Jonas Salk

F-69007 Lyon

EU/1/05/323/001-013

24.6.2008

20.6.2008

Abilify

Otsuka Pharmaceutical Europe Ltd

Hunton House

Highbridge Business Park

Oxford Road

Uxbridge

Middlesex UB8 1HU

United Kingdom

EU/1/04/276/036

24.6.2008

20.6.2008

M-M-RVAXPRO

Sanofi Pasteur MSD, SNC

8, rue Jonas Salk

F-69007 Lyon

EU/1/06/337/001-013

24.6.2008

20.6.2008

Puregon

Organon N.V.

Kloosterstraat 6

Postbus 20

5340 BH Oss

Nederland

EU/1/96/008/001-041

24.6.2008

20.6.2008

Kaletra

Abbott Laboratories Ltd

Queenborough

Kent ME11 5EL

United Kingdom

EU/1/01/172/001-006

24.6.2008

20.6.2008

Vistide

Pfizer Enterprises SARL

51, Avenue Kennedy-Rond Point du Kirchberg

L-1855 Luxembourg

EU/1/97/037/001-

24.6.2008

20.6.2008

Raptiva

Serono Europe Limited

56, Marsh Wall

London E14 9TP

United Kingdom

EU/1/04/291/001-002

24.6.2008

20.6.2008

Prevenar

Wyeth-Lederle Vaccines S.A.

Rue du Bosquet 15

B-1348 Louvain-La-Neuve

EU/1/00/167/001-008

24.6.2008

20.6.2008

Rapilysin

Roche Registration Limited

6 Falcon Way

Shire Park

Welwyn Garden City AL7 1TW

United Kingdom

EU/1/97/033/002

24.6.2008

Actavis Group PTC ehf.

Reykjavikurvegi 76-78

IS-220 Hafnarfjordur

24.6.2008

20.6.2008

Avonex

Biogen Idec Ltd

5 Roxborough Way

Foundation Park

Maidenhead

Berkshire SL6 3UD

United Kindgom

EU/1/97/033/002-004

24.6.2008

20.6.2008

Vfend

Pfizer Ltd

Ramsgate Road

Sandwich

Kent CT 13 9NJ

United Kingdom

EU/1/02/212/001-026

24.6.2008

20.6.2008

Telzir

Glaxo Group Ltd

Greenford Road

Greenford

Middlesex UB6 0NN

United Kingdom

EU/1/04/282/001-002

24.6.2008

23.6.2008

Humira

Abbott Laboratories Ltd

Queenborough

Kent ME11 5EL

United Kingdom

EU/1/03/256/001-010

25.6.2008

25.6.2008

Optisulin

Sanofi-Aventis Deutschland GmbH

D-65926 Frankfurt am Main

EU/1/00/133/001-007

27.6.2008

25.6.2008

Baraclude

Bristol-Myers Squibb Pharma EEIG

Uxbridge Business Park

Sanderson Road

Uxbridge UB8 1DH

United Kingdom

EU/1/06/343/001-007

27.6.2008

25.6.2008

Lantus

Sanofi-Aventis Deutschland GmbH

D-65926 Frankfurt am Main

EU/1/00/134/001-037

27.6.2008

25.6.2008

Temodal

Schering Plough Europe

Rue de Stalle 73/Stallestraat 73

B-1180 Bruxelles/B-1180 Brussel

EU/1/98/096/001-012

27.6.2008

25.6.2008

Elaprase

Shire Human Genetic Therapies AB

Rinkebyvägen 11B

S-182 36 Danderyd

EU/1/06/365/001-003

27.6.2008

27.6.2008

Abseamed

Medice Arzneimittel Pütter GmbH & Co KG

Kuhloweg 37

D-58638 Iserlohn

EU/1/07/412/001-020

1.7.2008

30.6.2008

Sprycel

Bristol-Myers Squibb Pharma EEIG

Uxbridge Business Park

Sanderson Road

Uxbridge UB8 1DH

United Kingdom

EU/1/06/363/001-009

2.7.2008

—   Sprememba dovoljenja za promet (člen 13 Uredbe (ES) št. 726/2004): Zavrnjena

Datum sprejetja odločbe

Ime zdravila

Imetnik dovoljenja za promet

Registracijska številka v registru Skupnosti

Datum obvestila

25.6.2008

Tygacil

Wyeth Europa Ltd

Huntercombe Lane South

Taplow

Maidenhead

Berkshire SL6 0PH

United Kingdom

EU/1/06/336/001

27.6.2008

—   Umik dovoljenja za promet (člen 13 Uredbe (ES) št. 726/2004)(velja od 1. januarja 2009)

Datum sprejetja odločbe

Ime zdravila

Imetnik dovoljenja za promet

Registracijska številka v registru Skupnosti

Datum obvestila

10.6.2008

Zenapax

Roche Registration Limited

6 Falcon Way

Shire Park

Welwyn Garden City AL7 1TW

United Kingdom

EU/1/99/098/001-002

12.6.2008

—   Izdaja dovoljenja za promet (člen 38 Uredbe (ES) št. 726/2004): Odobrena

Datum sprejetja odločbe

Ime zdravila

INN

(mednarodno nelastniško ime)

Imetnik dovoljenja za promet

Registracijska številka v registru Skupnosti

Farmacevtska oblika

Oznaka ATC

(anatomsko terapevtsko kemijska oznaka)

Datum obvestila

23.6.2008

Posatex

Orbifloksacin, Mometazon furoat, Posakonazol

S-P Veterinary

Shire Park

Welwyn Garden City

Hertfordshire AL7 1TW

United Kingdom

EU/2/08/081/001-003

Kapljice za uho, suspenzija

QS02CA91

25.6.2008

25.6.2008

EQUIOXX

Firokoksib

MERIAL

29, avenue Tony Garnier

F-69007 Lyon

EU/2/08/083/001

Peroralna pasta

QM01AH90

27.6.2008

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

Datum sprejetja odločbe

Ime zdravila

Imetnik dovoljenja za promet

Registracijska številka v registru Skupnosti

Datum obvestila

3.6.2008

Convenia

Pfizer Ltd

Ramsgate Road

Sandwich

Kent CT 13 9NJ

United Kingdom

EU/2/06/059/001

5.6.2008

4.6.2008

Aivlosin

ECO Animal Health Ltd

78 Coombe Road

New Malden

Surrey KT3 4QS

United Kingdom

EU/2/04/044/007

6.6.2008

13.6.2008

Gonazon

Intervet International B.V.

Wim de Körverstraat 35

5831 AN Boxmeer

Nederland

EU/2/03/040/001-002

17.6.2008

20.6.2008

DRAXXIN

Pfizer Ltd

Ramsgate Road

Sandwich

Kent CT 13 9NJ

United Kingdom

EU/2/03/041/001-005

24.6.2008

23.6.2008

Nobilis Influenza H7N1

Intervet International B.V.

Wim de Körverstraat 35

5831 AN Boxmeer

Nederland

EU/2/07/073/001-004

25.6.2008

Kdor želi dobiti vpogled v javno poročilo o oceni zadevnih zdravil ter o zadevnih odločb zdravil, se lahko obrne na naslov:

The European Medicines Agency

7, Westferry Circus

Canary Wharf

London E14 4HB

United Kingdom

(1)  UL L 136, 30.4.2004, str. 1.