52006XC1229(03)

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Document 52006XC1229(03)

Bendrijos sprendimų dėl leidimų prekiauti vaistais sąrašas nuo 2006 11 1 iki 2006 11 30 (Paskelbtas pagal Europos Parlamento ir Tarybos reglamento (EB) Nr. 726/2004 13 arba 38 straipsnį)

OJ C 321, 29.12.2006, p. 13–18 (ES, CS, DA, DE, ET, EL, EN, FR, IT, LV, LT, HU, NL, PL, PT, SK, SL, FI, SV)

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29.12.2006

Europos Sąjungos oficialusis leidinys

C 321/13

Bendrijos sprendimų dėl leidimų prekiauti vaistais sąrašas nuo 2006 11 1 iki 2006 11 30

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

(2006/C 321/06)

— Leidimas prekiauti (pagal Europos Parlamento ir Tarybos 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

2006 11 20

BYETTA

Eksenatidas

Eli Lilly Nederland B.V.

Grootslag 1-5

3991 RA Houten

Nederland

EU/1/06/362/001-004

Injekcinis tirpalas

A10BX04

2006 11 22

2006 11 20

Sprycel

Dasatinibas

Bristol-Myers Squibb Pharma EEIG

Uxbridge Business Park

Sanderson Road

Uxbridge UD8 1DH

United Kingdom

EU/1/06/363/001-009

Plėvele dengta tabletė

L01XX

2006 11 22

— Leidimas prekiauti (pagal Europos Parlamento ir Tarybos Reglamento (EB) Nr. 726/2004 13 straipsnį): Pakeistas

Sprendimo data

Vaisto pavadinimas

Leidimo prekiauti turėtojas

Įrašo Bendrijos registre numeris

Pranešimo data

2006 11 7

Exubera

PFIZER Ltd

Ramsgate Road

Sandwich Kent CT 13 9NJ

United Kingdom

EU/1/05/327/001-018

2006 11 9

2006 11 7

Humira

Abbott Laboratories Ltd.

Queenborough

Kent ME11 5EL

United Kingdom

EU/1/03/256/001-010

2006 11 9

2006 11 7

Trudexa

Abbott Laboratories Ltd.

Queenborough Kent ME11 5EL

United Kingdom

EU/1/03/257/001-010

2006 11 9

2006 11 14

Humalog

Eli Lilly Nederland B.V.

Grootslag 1-5

3991 RA Houten

Nederland

EU/1/96/007/015-017

EU/1/96/007/026-028

2006 11 16

2006 11 14

Zevalin

Schering AG

Müllerstrasse 170-178

D-13342 Berlin

EU/1/03/264/001

2006 11 16

2006 11 20

Crixivan

Merck Sharp & Dohme Ltd.

Hertford Road

Hoddesdon

Hertfordshire EN11 9BU

United-Kingdom

EU/1/96/024/001-005

EU/1/96/024/007-008

EU/1/96/024/010

2006 11 22

2006 11 20

Hycamtin

SmithKline Beecham plc

980 Great West Road

Brentford Middlesex TW8 9GS

United Kingdom

EU/1/96/027/001

EU/1/96/027/003-005

2006 11 22

2006 11 20

Yttriga

QSA Global GmbH

Gieselweg 1

D-38110 Braunschweig

EU/1/05/322/001

2006 11 22

2006 11 20

Liprolog

Eli Lilly Nederland BV

Grootslag 1-5

3991 RA Houten

Nederland

EU/1/01/195/005-007

EU/1/01/195/013-015

2006 11 22

2006 11 20

Protopic

Astellas Pharma GmbH

Neumarkter Str. 61

D-81673 München

EU/1/02/201/001-006

2006 11 22

2006 11 20

Protopy

Astellas Pharma GmbH

Neumarkter Str. 61

D-81673 München

EU/1/02/202/001-006

2006 11 22

2006 11 20

Norvir

Abbott laboratories Ltd

Queenborough

Kent ME11 5EL

United-Kingdom

EU/1/96/016/001

EU/1/96/016/003

2006 11 22

TRIZIVIR

Glaxo Group Ltd

Greenford

Middlesex UB6 0NN

United Kingdom

EU/1/00/156/002-003

2006 11 24

2006 11 22

Evista

Eli Lilly Nederland BV

Grootslag 1-5

3991 RA Houten

Nederland

EU/1/98/073/001-004

2006 11 24

2006 11 22

Optruma

Eli Lilly Nederland BV

Grootslag 1-5

3991 RA Houten

Nederland

EU/1/98/074/001-004

2006 11 24

2006 11 22

PEGASYS

Roche Registration Limited

6 Falcon Way

Shire Park

Welwyn Garden City, AL7 1TW

United Kingdom

EU/1/02/221/01-010

2006 11 24

2006 11 22

Tarceva

Roche Registration Limited

6 Falcon Way

Shire Park

Welwyn Garden City AL7 1TW

United Kingdom

EU/1/05/311/001-003

2006 11 24

2006 11 22

Invirase

Roche Registration Limited

6 Falcon Way

Shire Park

Welwyn Garden City AL7 1TW

United Kingdom

EU/1/96/026/001-002

2006 11 24

2006 11 22

Hycamtin

SmithKline Beecham plc

980 Great West Road

Brentford

Middlesex TW8 9GS

United Kingdom

EU/1/96/027/001

EU/1/96/027/003-005

2006 11 24

2006 11 22

Avandamet

SmithKline Beecham plc

980 Great West Road

Brentford

Middlesex TW8 9GS

United Kingdom

EU/1/03/258/001-022

2006 11 24

2006 11 22

AVANDIA

SmithKline Beecham plc

980 Great West Road

Brentford

Middlesex TW8 9GS

United Kingdom

EU/1/00/137/002-018

2006 11 24

Ariclaim

Eli Lilly Nederland B.V.

Grootslag 1-5

3991 RA Houten

Nederland

EU/1/04/283/001-007

2006 11 28

2006 11 24

Avaglim

SmithKline Beecham plc

980 Great West Road

Brentford

Middlesex TW8 9GS

United Kingdom

EU/1/06/349/001-008

2006 11 28

2006 11 24

Stocrin

Merck Sharp & Dohme Ltd

Hertford Road

Hoddesdon

Hertfordshire EN11 9BU

United Kingdom

EU/1/99/111/010-011

2006 11 28

2006 11 24

Pedea

Orphan Europe SARL

Immeuble „Le Guillaumet“

F-92046 Paris-La-Défense

EU/1/04/284/001

2006 11 28

2006 11 24

Aptivus

Boehringer Ingelheim International GmbH

Binger Strasse 173

D-55216 Ingelheim am Rhein

EU/1/05/315/001

2006 11 28

2006 11 24

Replagal

Shire Human Genetic Therapies AB

Rinkebyvägen 11B

S-182 36 Danderyd

EU/1/01/189/001-006

2006 11 28

2006 11 24

Levitra

Bayer AG

D-51368 Leverkusen,

EU/1/03/248/001-012

2006 11 28

2006 11 24

Vivanza

Bayer AG

D-51368 Leverkusen

EU/1/03/249/001-012

2006 11 28

2006 11 24

Xeristar

Boehringer Ingelheim International GmbH

Binger Strasse 173

D-55216 Ingelheim am Rhein

EU/1/04/297/001-008

2006 11 28

2006 11 24

Cymbalta

Eli Lilly Nederland BV

Grootslag 1-5

3991 RA Houten

Nederland

EU/1/04/296/001-008

2006 11 28

Ziagen

Glaxo Group Ltd, Greenford

Middlesex UB6 0NN

United Kingdom

EU/1/99/112/001-002

2006 12 1

2006 11 28

Glivec

Novartis Europharm Limited

Wimblehurst Road

Horsham

West Sussex RH12 5AB

United Kingdom

EU/1/01/198/001-013

2006 12 1

2006 11 28

Tysabri

Elan Pharma International Ltd.

Monksland

Athlone

County Westmeath

Ireland

EU/1/06/346/001

2006 12 4

2006 11 28

Ebixa

H. Lundbeck A/S, Ottiliavej 9

DK-2500 Valby

EU/1/02/219/001-015

2006 12 1

2006 11 28

Axura

Merz Pharmaceuticals GmbH

Eckenheimer Landstr. 100-104

D-60318 Frankfurt/Main

EU/1/02/218/001-011

2006 12 1

2006 11 28

Kepivance

Amgen Europe B.V.

Minervum 7061

4817 ZK Breda

Nederland

EU/1/05/314/001

2006 12 1

2006 11 28

Nespo

Dompé Biotec S.p.A.

Via San Martino 12

I-20122 Milano

EU/1/01/184/001-068

2006 12 1

2006 11 28

Kivexa

Glaxo Group Ltd

Berkeley Avenue

Greenford

Middlesex UB6 0NN

United Kingdom

EU/1/04/298/001-002

2006 12 1

2006 11 28

YENTREVE

Eli Lilly Nederland B.V.

Grootslag 1-5

3991 RA Houten

Nederland

EU/1/04/280/001-008

2006 12 1

2006 11 28

Abilify

Otsuka Pharmaceutical Europe Ltd

Hunton House

Highbridge Business Park

Oxford Road

Uxbridge

Middlesex UB8 1HU

United Kingdom

EU/1/04/276/001-036

2006 12 1

2006 11 29

Enbrel

Wyeth Europa Limited

Huntercombe Lane South

Taplow

Maidenhead,

Berkshire, SL6 0PH

United Kingdom

EU/1/99/126/001-018

2006 12 1

2006 11 29

Aldara

Laboratoires 3M Santé

Boulevard de l'Oise

F-95029 Cergy Pontoise Cedex

EU/1/98/080/001

2006 12 1

2006 11 29

Foscan

Biolitec pharma Ltd

United Drug House

Magna Drive

Dublin 24

Ireland

EU/1/01/197/001-002

2006 12 1

2006 11 29

Emselex

Novartis Europharm Limited

Wimblehurst Road

Horsham

West Sussex RH12 5AB

United Kingdom

EU/1/04/294/001-028

2006 12 1

2006 11 29

Aranesp

Amgen Europe B.V.

Minervum 7061

4817 ZK Breda

Nederland

EU/1/01/185/001-068

2006 12 1

— Leidimas prekiauti (pagal Europos Parlamento ir Tarybos Reglamento (EB) Nr. 726/2004 13 straipsnį): Panaikintas

Sprendimo data

Vaisto pavadinimas

Leidimo prekiauti turėtojas

Įrašo Bendrijos registre numeris

Pranešimo data

2006 11 14

Monotard

Novo Nordisk A/S

Novo Allé

DK-2880 Bagsværd

EU/1/02/235/001-004

2006 11 16

2006 11 14

Ultratard

Novo Nordisk A/S

Novo Allé

DK-2880 Bagsværd

EU/1/02/236/001-004

2006 11 16

— Leidimas prekiauti (pagal Europos Parlamento ir Tarybos reglamento (EB) Nr. 726/2004 38 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

2006 11 14

Yarvitan

Mitratapide

Janssen Animal Health B.V.B.A.

Turnhoutseweg, 30

B-2340 Beerse

EU/2/06/063/001-003

Geriamasis tirpalas

QA08AB90

2006 11 16

— Leidimas prekiauti (pagal Europos Parlamento ir Tarybos reglamento (EB) Nr. 726/2004 38 straipsnį): Pakeistas

Sprendimo data

Vaisto pavadinimas

Leidimo prekiauti turėtojas

Įrašo Bendrijos registre numeris

Pranešimo data

2006 11 20

Virbagen Omega

VIRBAC S.A.

1ere Avenue 2065 m L.I.D.

F-06516 Carros

EU/2/01/030/001-004

2006 11 22

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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