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Document 52008XC0926(02)

Bendrijos sprendimų dėl leidimų prekiauti vaistais sąrašas nuo 2008 m. rugpjūčio 1 d. iki 2008 m. rugpjūčio 31 d. (Paskelbtas pagal Europos Parlamento ir Tarybos reglamento (EB) Nr. 726/2004 13 arba 38 straipsnį)

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   

LT

Europos Sąjungos oficialusis leidinys

C 245/15

Bendrijos sprendimų dėl leidimų prekiauti vaistais sąrašas nuo 2008 m. rugpjūčio 1 d. iki 2008 m. rugpjūčio 31 d.

(Paskelbtas pagal Europos Parlamento ir Tarybos reglamento (EB) Nr. 726/2004  (1) 13 arba 38 straipsnį)

(2008/C 245/03)

—   Leidimas prekiauti (pagal Reglamento (EB) Nr. 726/2004 13 straipsnį): išduotas

Sprendimo data

Vaisto pavadinimas

INN

(Tarptautinis nepatentuotas pavadinimas)

Leidimo prekiauti turėtojas

Įrašo Bendrijos registre numeris

Vaisto forma

ATC kodas

(Anatominis terapinis cheminis kodas)

Pranešimo data

2008 8 28

INTELENCE

etravirinas

Janssen-Cilag International NV

Turnhoutseweg, 30

B-2340 Beerse

EU/1/08/468/001

Tabletės

(Netaikoma)

2008 9 1

2008 8 29

Vimpat

Lakozamidas

UCB S.A.

Allée de la Recherche, 60/Researchdreef, 60

B-1070 Bruxelles/B-1070 Brussel

EU/1/08/470/001-013

Plėvele dengta tabletė

N03AX18

2008 9 2

EU/1/08/470/014-015

Sirupas

EU/1/08/470/016

Infuzinis tirpalas

—   Leidimas prekiauti (pagal Reglamento (EB) Nr. 726/2004 13 straipsnį): pakeistas

Sprendimo data

Vaisto pavadinimas

Leidimo prekiauti turėtojas

Įrašo Bendrijos registre numeris

Pranešimo data

2008 8 4

Neupro

Schwarz Pharma Ltd

Shannon

Industrial Estate

Co.Clare

Ireland

EU/1/05/331/001-037

2008 8 6

2008 8 8

Champix

Pfizer Ltd

Ramsgate Road

Sandwich

Kent CT 13 9NJ

United Kingdom

EU/1/06/360/001-012

2008 8 12

2008 8 8

Vectibix

Amgen Europe B.V.

Minervum 7061

4817 ZK Breda

Nederland

EU/1/07/423/001-003

2008 8 12

2008 8 8

Infanrix hexa

GlaxoSmithKline Biologicals s.a.

rue de l'Institut 89

B-1330 Rixensart

EU/1/00/152/001-018

2008 8 12

2008 8 8

Evista

Eli Lilly Nederland B.V.

Grootslag 1-5

3991 RA Houten

Nederland

EU/1/98/073/001-004

2008 8 12

2008 8 8

Avandamet

SmithKline Beecham plc

980 Great West Road

Brentford

Middlesex TW8 9GS

United Kingdom

EU/1/03/258/001-022

2008 8 12

2008 8 11

Optruma

Eli Lilly Nederland B.V.

Grootslag 1-5

3991 RA Houten

Nederland

EU/1/98/074/001-004

2008 8 13

2008 8 13

Silapo

STADA Arzneimittel AG

Stadastrasse 2-18

D-61118 Bad Vilbel

EU/1/07/432/001-022

2008 8 15

2008 8 13

Retacrit

HOSPIRA Enterprises B.V.

Taurusavenue 19-21b

2132 LS Hoofddorp

Nederland

EU/1/07/431/001-019

2008 8 15

2008 8 13

Humira

Abbott Laboratories Ltd

Queenborough

Kent ME11 5EL

United Kingdom

EU/1/03/256/001-010

2008 8 15

2008 8 13

Hepsera

Gilead Sciences International Limited

Cambridge CB21 6GT

United Kingdom

EU/1/03/251/001-002

2008 8 15

2008 8 13

Infanrix penta

GlaxoSmithKline Biologicals s.a.

rue de l'Institut 89

B-1330 Rixensart

EU/1/00/153/001-010

2008 8 18

2008 8 13

Cervarix

GlaxoSmithKline Biologicals s.a.

rue de l'Institut 89

B-1330 Rixensart

EU/1/07/419/001-009

2008 8 18

2008 8 22

Evista

DAIICHI SANKYO EUROPE GmbH

Zielstattstrasse 48

D-81379 München

EU/1/98/073/001-004

2008 8 26

Eli Lilly Nederland B.V.

Grootslag 1-5

3991 RA Houten

Nederland

2008 8 22

Kaletra

Abbott Laboratories Ltd

Queenborough

Kent ME11 5EL

United Kingdom

EU/1/01/172/001-006

2008 8 26

2008 8 22

Baraclude

Bristol-Myers Squibb Pharma EEIG

Uxbridge Business Park

Sanderson Road

Uxbridge UB8 1DH

United Kingdom

EU/1/06/343/001-007

2008 8 26

2008 8 22

SUTENT

Pfizer Ltd

Ramsgate Road

Sandwich

Kent CT 13 9NJ

United Kingdom

EU/1/06/347/001-006

2008 8 26

2008 8 22

Fosavance

Merck Sharp & Dohme Ltd

Hertford Road

Hoddesdon

Hertfordshire EN11 9BU

United Kingdom

EU/1/05/310/001-009

2008 8 26

2008 8 22

Zalasta

KRKA d.d.

Šmarješka cesta 6

SLO-8501 Novo mesto

EU/1/07/415/001-056

2008 8 26

2008 8 22

Arixtra

Glaxo Group Ltd

Greenford Road

Greenford

Middlesex UB6 0NN

United Kingdom

EU/1/02/206/001-035

2008 8 26

2008 8 22

Revlimid

Celgene Europe Limited

Morgan House

Madeira Walk

Windsor

Berkshire SL4 1EP

United Kingdom

EU/1/07/391/001-004

2008 8 26

2008 8 25

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

2008 8 27

2008 8 25

TARGRETIN

Eisai Limited

3 Shortlands

London W6 8EE

United Kingdom

EU/1/01/178/001

2008 8 27

2008 8 25

Emselex

Novartis Europharm Limited

Wimblehurst Road

Horsham

West Sussex RH12 5AB

United Kingdom

EU/1/04/294/001-028

2008 8 27

2008 8 25

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

2008 8 27

2008 8 25

Humira

Abbott Laboratories Ltd

Queenborough

Kent ME11 5EL

United Kingdom

EU/1/03/256/001-010

2008 8 27

2008 8 25

Revatio

Pfizer Limited

Sandwich

Kent CT13 9NJ

United Kingdom

EU/1/05/318/001

2008 8 27

2008 8 25

Prialt

Eisai Limited

3 Shortlands

London W6 8EE

United Kingdom

EU/1/04/302/001-004

2008 8 27

2008 8 25

NovoSeven

Novo Nordisk A/S

Novo Allé

DK-2880 Bagsværd

EU/1/96/006/001-006

2008 8 27

2008 8 26

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

2008 8 28

2008 8 28

Rasilez

Novartis Europharm Limited

Wimblehurst Road

Horsham

West Sussex RH12 5AB

United Kingdom

EU/1/07/405/001-020

2008 9 1

2008 8 28

Tekturna

Novartis Europharm Limited

Wimblehurst Road

Horsham

West Sussex RH12 5AB

United Kingdom

EU/1/07/408/001-020

2008 9 1

2008 8 28

Raptiva

Serono Europe Limited

56 Marsh Wall

London E14 9TP

United Kingdom

EU/1/04/291/001-003

2008 9 1

2008 8 28

ISENTRESS

Merck Sharp & Dohme Limited

Hertford Road

Hoddesdon

Hertfordshire EN11 9BU

United Kingdom

EU/1/07/436/001-002

2008 9 1

2008 8 28

Enviage

Novartis Europharm Limited

Wimblehurst Road

Horsham

West Sussex RH12 5AB

United Kingdom

EU/1/07/406/001-020

2008 9 1

2008 8 28

Sprimeo

Novartis Europharm Limited

Wimblehurst Road

Horsham

West Sussex RH12 5AB

United Kingdom

EU/1/07/407/001-020

2008 9 1

2008 8 28

Riprazo

Novartis Europharm Limited

Wimblehurst Road

Horsham

West Sussex RH12 5AB

United Kingdom

EU/1/07/409/001-020

2008 9 1

2008 8 29

Avastin

Roche Registration Limited

6 Falcon Way

Shire Park

Welwyn Garden City AL7 1TW

United Kingdom

EU/1/04/300/001-002

2008 9 2

2008 8 29

Nespo

Dompé Biotec S.p.A.

Via San Martino, 12

I-20122 Milano

EU/1/01/184/001-073

2008 9 2

2008 8 29

Enbrel

Wyeth Europa Limited

Huntercombe Lane

South Taplow

Maidenhead

Berkshire SL6 0PH

United Kingdom

EU/1/99/126/001-018

2008 9 1

2008 8 29

Velcade

Janssen-Cilag International NV

Turnhoutseweg, 30

B-2340 Beerse

EU/1/04/274/001-002

2009 9 2

2008 8 29

Humira

Abbott Laboratories Ltd

Queenborough

Kent ME11 5EL

United Kingdom

EU/1/03/256/001-010

2009 9 2

2008 8 29

Prezista

Janssen-Cilag International NV

Turnhoutseweg, 30

B-2340 Beerse

EU/1/06/380/001

2009 9 2

2008 8 29

Truvada

Gilead Sciences International Limited

Cambridge CB21 6GT

United Kingdom

EU/1/04/305/001-002

2009 9 2

2008 8 29

Neupro

Schwarz Pharma Ltd

Shannon Industrial Estate

Co.Clare

Ireland

EU/1/05/331/038-055

2009 9 2

2008 8 29

Neupro

Schwarz Pharma Ltd

Shannon Industrial Estate

Co.Clare

Ireland

EU/1/05/331/001-055

2009 9 2

—   Leidimas prekiauti (pagal Reglamento (EB) Nr. 726/2004 13 straipsnį): panaikintas

Sprendimo data

Vaisto pavadinimas

Leidimo prekiauti turėtojas

Įrašo Bendrijos registre numeris

Pranešimo data

2008 8 22

Protopy

Astellas Pharma GmbH

Neumarkter Str. 61

D-81673 München

EU/1/02/202/001-006

2008 8 26

2008 8 28

Quintanrix

GlaxoSmithKline Biologicals s.a.

rue de l'Institut 89

B-1330 Rixensart

EU/1/04/301/001-005

2008 9 1

—   Leidimas prekiauti (pagal Reglamento (EB) Nr. 726/2004 38 straipsnį): pakeistas

Sprendimo data

Vaisto pavadinimas

Leidimo prekiauti turėtojas

Įrašo Bendrijos registre numeris

Pranešimo data

2008 8 13

Dexdomitor

Orion Corporation

Orionintie 1

FI-02200 Espoo

EU/2/02/033/001-002

2008 8 15

2008 8 22

Suvaxyn Aujeszky

Fort Dodge Animal Health Holland

C.J. van Houtenlaan 36

1381 CP Weesp

Nederland

EU/2/98/009/001-006

2008 8 26

2008 8 25

Zubrin

Schering-Plough Limited

Schering-Plough House

Shire Park

Welwyn Garden City

Hertfordshire AL7 1TW

United Kingdom

EU/2/00/028/002-008

2008 8 27

2008 8 25

Circovac

Merial

29, Avenue Tony Garnier

F-69007 Lyon

EU/2/07/075/001-004

2008 8 27

2008 8 25

Profender

Bayer HealthCare AG

D-51368 Leverkusen

EU/2/05/054/018-031

2008 8 27

Pageidaujantys susipažinti su konkrečių vaistų viešo įvertinimo ataskaita ir su sprendimais dėl jų gali kreiptis į Europos vaistų agentūrą:

The European Medicines Agency

7 Westferry Circus

Canary Wharf

London E14 4HB

United Kingdom

(1)  OL L 136, 2004 4 30, p. 1.

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