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Document 52008XC0926(02)

Kopsavilkums par Kopienas lēmumiem attiecībā uz zāļu tirdzniecības atļaujām no 1.8.2008. līdz 31.8.2008. (Publicēts atbilstīgi 13. pantam vai 38. pantam Eiropas Parlamenta un Padomes Regulā (EK) Nr. 726/2004 )

OJ C 245, 26.9.2008, p. 15–20 (BG, ES, CS, DA, DE, ET, EL, EN, FR, IT, LV, LT, HU, MT, NL, PL, PT, RO, SK, SL, FI, SV)

26.9.2008   

LV

Eiropas Savienības Oficiālais Vēstnesis

C 245/15


Kopsavilkums par Kopienas lēmumiem attiecībā uz zāļu tirdzniecības atļaujām no 1.8.2008. līdz 31.8.2008.

(Publicēts atbilstīgi 13. pantam vai 38. pantam Eiropas Parlamenta un Padomes Regulā (EK) Nr. 726/2004  (1) )

(2008/C 245/03)

—   Tirdzniecības atļaujas izsniegšana (13. pants Regulā (EK) Nr. 726/2004): Pieņemts

Lēmuma datums

Zāļu nosaukums

SNN

(Starptautiskais nepatentētais nosaukums)

Tirdzniecības atļaujas turētājs

Ieraksta numurs Kopienas reģistrā

Farmaceitiskā forma

ATĶ kods

(Anatomiski terapeitiski ķīmiskais kods)

Paziņojuma datums

28.8.2008.

INTELENCE

etravirinum

Janssen-Cilag International NV

Turnhoutseweg, 30

B-2340 Beerse

EU/1/08/468/001

Tabletes

(Nav piemērojams)

1.9.2008.

29.8.2008.

Vimpat

Lacosamidum

UCB S.A.

Allée de la Recherche, 60/Researchdreef, 60

B-1070 Bruxelles/B-1070 Brussel

EU/1/08/470/001-013

Apvalkotā tablete

N03AX18

2.9.2008.

EU/1/08/470/014-015

Sīrups

EU/1/08/470/016

Šķīdums infūzijām

—   Tirdzniecības atļaujas izmaiņas (13. pants Regulā (EK) Nr. 726/2004): Pieņemts

Lēmuma datums

Zāļu nosaukums

Tirdzniecības atļaujas turētājs

Ieraksta numurs Kopienas reģistrā

Paziņojuma datums

4.8.2008.

Neupro

Schwarz Pharma Ltd

Shannon

Industrial Estate

Co.Clare

Ireland

EU/1/05/331/001-037

6.8.2008.

8.8.2008.

Champix

Pfizer Ltd

Ramsgate Road

Sandwich

Kent CT 13 9NJ

United Kingdom

EU/1/06/360/001-012

12.8.2008.

8.8.2008.

Vectibix

Amgen Europe B.V.

Minervum 7061

4817 ZK Breda

Nederland

EU/1/07/423/001-003

12.8.2008.

8.8.2008.

Infanrix hexa

GlaxoSmithKline Biologicals s.a.

rue de l'Institut 89

B-1330 Rixensart

EU/1/00/152/001-018

12.8.2008.

8.8.2008.

Evista

Eli Lilly Nederland B.V.

Grootslag 1-5

3991 RA Houten

Nederland

EU/1/98/073/001-004

12.8.2008.

8.8.2008.

Avandamet

SmithKline Beecham plc

980 Great West Road

Brentford

Middlesex TW8 9GS

United Kingdom

EU/1/03/258/001-022

12.8.2008.

11.8.2008.

Optruma

Eli Lilly Nederland B.V.

Grootslag 1-5

3991 RA Houten

Nederland

EU/1/98/074/001-004

13.8.2008.

13.8.2008.

Silapo

STADA Arzneimittel AG

Stadastrasse 2-18

D-61118 Bad Vilbel

EU/1/07/432/001-022

15.8.2008.

13.8.2008.

Retacrit

HOSPIRA Enterprises B.V.

Taurusavenue 19-21b

2132 LS Hoofddorp

Nederland

EU/1/07/431/001-019

15.8.2008.

13.8.2008.

Humira

Abbott Laboratories Ltd

Queenborough

Kent ME11 5EL

United Kingdom

EU/1/03/256/001-010

15.8.2008.

13.8.2008.

Hepsera

Gilead Sciences International Limited

Cambridge CB21 6GT

United Kingdom

EU/1/03/251/001-002

15.8.2008.

13.8.2008.

Infanrix penta

GlaxoSmithKline Biologicals s.a.

rue de l'Institut 89

B-1330 Rixensart

EU/1/00/153/001-010

18.8.2008.

13.8.2008.

Cervarix

GlaxoSmithKline Biologicals s.a.

rue de l'Institut 89

B-1330 Rixensart

EU/1/07/419/001-009

18.8.2008.

22.8.2008.

Evista

DAIICHI SANKYO EUROPE GmbH

Zielstattstrasse 48

D-81379 München

EU/1/98/073/001-004

26.8.2008.

Eli Lilly Nederland B.V.

Grootslag 1-5

3991 RA Houten

Nederland

22.8.2008.

Kaletra

Abbott Laboratories Ltd

Queenborough

Kent ME11 5EL

United Kingdom

EU/1/01/172/001-006

26.8.2008.

22.8.2008.

Baraclude

Bristol-Myers Squibb Pharma EEIG

Uxbridge Business Park

Sanderson Road

Uxbridge UB8 1DH

United Kingdom

EU/1/06/343/001-007

26.8.2008.

22.8.2008.

SUTENT

Pfizer Ltd

Ramsgate Road

Sandwich

Kent CT 13 9NJ

United Kingdom

EU/1/06/347/001-006

26.8.2008.

22.8.2008.

Fosavance

Merck Sharp & Dohme Ltd

Hertford Road

Hoddesdon

Hertfordshire EN11 9BU

United Kingdom

EU/1/05/310/001-009

26.8.2008.

22.8.2008.

Zalasta

KRKA d.d.

Šmarješka cesta 6

SLO-8501 Novo mesto

EU/1/07/415/001-056

26.8.2008.

22.8.2008.

Arixtra

Glaxo Group Ltd

Greenford Road

Greenford

Middlesex UB6 0NN

United Kingdom

EU/1/02/206/001-035

26.8.2008.

22.8.2008.

Revlimid

Celgene Europe Limited

Morgan House

Madeira Walk

Windsor

Berkshire SL4 1EP

United Kingdom

EU/1/07/391/001-004

26.8.2008.

25.8.2008.

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

27.8.2008.

25.8.2008.

TARGRETIN

Eisai Limited

3 Shortlands

London W6 8EE

United Kingdom

EU/1/01/178/001

27.8.2008.

25.8.2008.

Emselex

Novartis Europharm Limited

Wimblehurst Road

Horsham

West Sussex RH12 5AB

United Kingdom

EU/1/04/294/001-028

27.8.2008.

25.8.2008.

Sifrol

Boehringer Ingelheim International GmbH

Binger Straße 173

D-55216 Ingelheim am Rhein

EU/1/97/050/001-006

EU/1/97/050/009-012

27.8.2008.

25.8.2008.

Humira

Abbott Laboratories Ltd

Queenborough

Kent ME11 5EL

United Kingdom

EU/1/03/256/001-010

27.8.2008.

25.8.2008.

Revatio

Pfizer Limited

Sandwich

Kent CT13 9NJ

United Kingdom

EU/1/05/318/001

27.8.2008.

25.8.2008.

Prialt

Eisai Limited

3 Shortlands

London W6 8EE

United Kingdom

EU/1/04/302/001-004

27.8.2008.

25.8.2008.

NovoSeven

Novo Nordisk A/S

Novo Allé

DK-2880 Bagsværd

EU/1/96/006/001-006

27.8.2008.

26.8.2008.

Viagra

Pfizer Limited

Sandwich

Kent CT13 9NJ

United Kingdom

EU/1/98/077/002-004

EU/1/98/077/006-008

EU/1/98/077/010-019

28.8.2008.

28.8.2008.

Rasilez

Novartis Europharm Limited

Wimblehurst Road

Horsham

West Sussex RH12 5AB

United Kingdom

EU/1/07/405/001-020

1.9.2008.

28.8.2008.

Tekturna

Novartis Europharm Limited

Wimblehurst Road

Horsham

West Sussex RH12 5AB

United Kingdom

EU/1/07/408/001-020

1.9.2008.

28.8.2008.

Raptiva

Serono Europe Limited

56 Marsh Wall

London E14 9TP

United Kingdom

EU/1/04/291/001-003

1.9.2008.

28.8.2008.

ISENTRESS

Merck Sharp & Dohme Limited

Hertford Road

Hoddesdon

Hertfordshire EN11 9BU

United Kingdom

EU/1/07/436/001-002

1.9.2008.

28.8.2008.

Enviage

Novartis Europharm Limited

Wimblehurst Road

Horsham

West Sussex RH12 5AB

United Kingdom

EU/1/07/406/001-020

1.9.2008.

28.8.2008.

Sprimeo

Novartis Europharm Limited

Wimblehurst Road

Horsham

West Sussex RH12 5AB

United Kingdom

EU/1/07/407/001-020

1.9.2008.

28.8.2008.

Riprazo

Novartis Europharm Limited

Wimblehurst Road

Horsham

West Sussex RH12 5AB

United Kingdom

EU/1/07/409/001-020

1.9.2008.

29.8.2008.

Avastin

Roche Registration Limited

6 Falcon Way

Shire Park

Welwyn Garden City AL7 1TW

United Kingdom

EU/1/04/300/001-002

2.9.2008.

29.8.2008.

Nespo

Dompé Biotec S.p.A.

Via San Martino, 12

I-20122 Milano

EU/1/01/184/001-073

2.9.2008.

29.8.2008.

Enbrel

Wyeth Europa Limited

Huntercombe Lane

South Taplow

Maidenhead

Berkshire SL6 0PH

United Kingdom

EU/1/99/126/001-018

1.9.2008.

29.8.2008.

Velcade

Janssen-Cilag International NV

Turnhoutseweg, 30

B-2340 Beerse

EU/1/04/274/001-002

2.9.2009.

29.8.2008.

Humira

Abbott Laboratories Ltd

Queenborough

Kent ME11 5EL

United Kingdom

EU/1/03/256/001-010

2.9.2009.

29.8.2008.

Prezista

Janssen-Cilag International NV

Turnhoutseweg, 30

B-2340 Beerse

EU/1/06/380/001

2.9.2009.

29.8.2008.

Truvada

Gilead Sciences International Limited

Cambridge CB21 6GT

United Kingdom

EU/1/04/305/001-002

2.9.2009.

29.8.2008.

Neupro

Schwarz Pharma Ltd

Shannon Industrial Estate

Co.Clare

Ireland

EU/1/05/331/038-055

2.9.2009.

29.8.2008.

Neupro

Schwarz Pharma Ltd

Shannon Industrial Estate

Co.Clare

Ireland

EU/1/05/331/001-055

2.9.2009.

—   Tirdzniecības atļaujas anulēšana (13. pants Regulā (EK) Nr. 726/2004)

Lēmuma datums

Zāļu nosaukums

Tirdzniecības atļaujas turētājs

Ieraksta numurs Kopienas reģistrā

Paziņojuma datums

22.8.2008.

Protopy

Astellas Pharma GmbH

Neumarkter Str. 61

D-81673 München

EU/1/02/202/001-006

26.8.2008.

28.8.2008.

Quintanrix

GlaxoSmithKline Biologicals s.a.

rue de l'Institut 89

B-1330 Rixensart

EU/1/04/301/001-005

1.9.2008.

—   Tirdzniecības atļaujas izmaiņas (38. pants Regulā (EK) Nr. 726/2004): Pieņemts

Lēmuma datums

Zāļu nosaukums

Tirdzniecības atļaujas turētājs

Ieraksta numurs Kopienas reģistrā

Paziņojuma datums

13.8.2008.

Dexdomitor

Orion Corporation

Orionintie 1

FI-02200 Espoo

EU/2/02/033/001-002

15.8.2008.

22.8.2008.

Suvaxyn Aujeszky

Fort Dodge Animal Health Holland

C.J. van Houtenlaan 36

1381 CP Weesp

Nederland

EU/2/98/009/001-006

26.8.2008.

25.8.2008.

Zubrin

Schering-Plough Limited

Schering-Plough House

Shire Park

Welwyn Garden City

Hertfordshire AL7 1TW

United Kingdom

EU/2/00/028/002-008

27.8.2008.

25.8.2008.

Circovac

Merial

29, Avenue Tony Garnier

F-69007 Lyon

EU/2/07/075/001-004

27.8.2008.

25.8.2008.

Profender

Bayer HealthCare AG

D-51368 Leverkusen

EU/2/05/054/018-031

27.8.2008.

Ja vēlaties apskatīt publisko novērtējuma ziņojumu par attiecīgajām zālēm un ar tām saistītos lēmumus, lūdzam sazināties ar

The European Medicines Agency

7 Westferry Circus

Canary Wharf

London E14 4HB

United Kingdom


(1)  OV L 136, 30.4.2004., 1. lpp.


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