28.4.2006   

LT

Europos Sąjungos oficialusis leidinys

C 102/2

Bendrijos sprendimų dėl leidimų prekiauti vaistais sąrašas nuo 2006 m. kovo 1 d. iki 2006 m. kovo 31 d.

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

(2006/C 102/02)

—   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 3 29

Myozyme

algliukozidazė alfa

Genzyme Europe B.V.

Gooimeer 10

1411 DD Naarden

Nederland

EU/1/06/333/001-003

Milteliai koncentratui infuziniam tirpalui ruošti

A16AB07

2006 3 31

—   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 3 2

Prometax

Novartis Europharm Limited

Wimblehurst Road

Horsham

West Sussex RH12 5AB

United Kingdom

EU/1/98/092/001-018

2006 3 6

2006 3 8

Litak

Lipomed GmbH

Schönaugasse 11

D-79713 Bad Säckingen

EU/1/04/275/001-002

2006 3 10

2006 3 9

Kentera

Nicobrand Limited

189 Casteroe Road

Coleraine

Northern Ireland BT51 3 RP

EU/1/03/270/001-003

2006 3 13

2006 3 13

Cellcept

Roche Registration Limited

6 Falcon Way

Shire Park

Welwyn Garden City

AL7 1TW

United Kingdom

EU/1/96/005/001-006

2006 3 15

2006 3 13

Enbrel

Wyeth Europa Limited

Huntercombe Lane South

Taplow

Maidenhead

Berkshire

SL6 0PH

United Kingdom

EU/1/99/126/001-011

2006 3 15

2006 3 15

Angiox

The Medicines Company UK Ltd

Suite B

Park House

11 Milton Park

Abingdon

Oxfordshire OX14 4RS

United Kingdom

EU/1/04/289/001-002

2006 3 17

2006 3 20

CoAprovel

Sanofi Pharma Bristol-Myers Squibb SNC

174, avenue de France

F-75013 Paris

EU/1/98/086/001-022

2006 3 22

2006 3 20

Karvezide

Bristol-Myers Squibb Pharma EEIG

141-149 Staines Road

Hounslow TW3 3JA

United Kingdom

EU/1/98/085/001-022

2006 3 22

2006 3 20

Glivec

Novartis Europharm Limited

Wimblehurst Road

Horsham

West Sussex RH12 5AB

United Kingdom

EU/1/01/198/001-013

2006 3 22

2006 3 20

Zyprexa

Eli Lilly Nederland B.V.

Grootslag 1-5

3991 RA Houten

Nederland

EU/1/96/022/016-017

2006 3 22

2006 3 20

Prialt

Elan Pharma International Ltd

WIL House

Shannon Business Park

Shannon

County Clare

Ireland

EU/1/04/302/004

2006 3 22

2006 3 20

Lyrica

PFIZER Ltd

Ramsgate Road

Sandwich

Kent CT 13 9NJ

United Kingdom

EU/1/04/279/001-032

2006 3 22

2006 3 20

Mabthera

Roche Registration Limited

6 Falcon Way

Shire Park

Welwyn Garden City

AL7 1TW

United Kingdom

EU/1/98/067/001-002

2006 3 22

2006 3 21

NutropinAq

IPSEN Limited

190 Bath Road

Slough

Berkshire

SLI 3XE

United Kingdom

EU/1/00/164/003-005

2006 3 23

2006 3 21

Exubera

PFIZER Ltd

Ramsgate Road

Sandwich

Kent CT 13 9NJ

United Kingdom

Aventis/Pfizer EEIG

Ramsgate Road

Sandwich

Kent CT13 9NJ

United Kingdom

EU/1/05/327/001-017

2006 3 23

2006 3 22

Kinzalmono

Bayer HealthCare AG

D-51368 Leverkusen

Bayer AG

D-51368 Leverkusen

EU/1/98/091/001-014

2006 3 24

2006 3 22

NeoSpect

CIS bio international

Route Nationale 306

Saclay

Boite Postale 32

F-91192 Gifsur-Yvette

Amersham Health AS

Nycoveien 1-2

P.O. Box 4220 Nydalen

N-0401 Oslo

EU/1/00/154/001-002

2006 3 24

2006 3 22

Tarceva

Roche Registration Limited

6 Falcon Way

Shire Park

Welwyn Garden City

AL7 1TW

United Kingdom

EU/1/05/311/001-003

2006 3 24

2006 3 22

Kinzalkomb

Bayer HealthCare AG

D-51368 Leverkusen

Bayer AG

D-51368 Leverkusen

EU/1/02/214/001-010

2006 3 24

2006 3 22

Pritor

Bayer HealthCare AG

D-51368 Leverkusen

Glaxo Group Ltd

Greenford

Middlesex UB6 0NN

United Kingdom

EU/1/98/089/001-019

2006 3 24

2006 3 22

PritorPlus

Bayer HealthCare AG

D-51368 Leverkusen

Glaxo Group Ltd

Greenford Road

Greenford

Middlesex UB6 0NN

United Kingdom

EU/1/02/215/001-012

2006 3 24

2006 3 22

Levviax

Aventis Pharma S.A.

20, Avenue Raymond Aron

F-92160 Antony

EU/1/01/192/001-005

2006 3 24

2006 3 22

Ketek

Aventis Pharma S.A.

20, Avenue Raymond Aron

F-92160 Antony

EU/1/01/191/001-005

2006 3 24

2006 3 22

Avonex

Biogen Idec Ltd

5 Roxborough Way

Foundation Park

Maidenhead

Berkshire

SL6 3UD

United Kingdom

EU/1/97/033/001-003

2006 3 24

2006 3 23

Cancidas

Merck Sharp & Dohme Ltd

Hertford Road

Hoddesdon

Hertfordshire EN11 9BU

United Kingdom

EU/1/01/196/001-003

2006 3 28

2006 3 29

Actos

Takeda Europe R&D Centre Ltd

Arundel Great Court

2 Arundel Street

London WC2R 3DA

United Kingdom

EU/1/00/150/001-024

2006 3 31

2006 3 29

IntronA

Schering Plough Europe

Rue de Stalle, 73/Stallestraat, 73

B-1180 Bruxelles/Brussel

EU/1/99/127/001-044

2006 3 31

2006 3 29

Parareg

Dompé Biotec S.p.A.

Via San Martino, 12

I-20122 Milano

EU/1/04/293/001-012

2006 3 31

2006 3 29

Mimpara

Amgen Europe B.V.

Minervum 7061

4817 ZK Breda

Nederland

EU/1/04/292/001-012

2006 3 31

2006 3 29

Viraferon

Schering Plough Europe

Rue de Stalle, 73/Stallestraat, 73

B-1180 Bruxelles/Brussel

EU/1/99/128/001-037

2006 3 31

2006 3 29

Glustin

Takeda Europe R&D Centre Ltd

Arundel Great Court

2 Arundel Street

London WC2R 3DA

United Kingdom

EU/1/00/151/001-022

2006 3 31

2006 3 29

Ariclaim

Boehringer Ingelheim International GmbH

Binger Straße 173

D-55216 Ingelheim am Rhein

EU/1/04/283/001-007

2006 3 31

2006 3 29

Raptiva

Serono Europe Limited

56, Marsh Wall

London E14 9TP

United Kingdom

EU/1/04/291/001-002

2006 4 5

2006 3 29

Hepsera

Gilead Sciences International Limited

Cambridge CB1 6GT

United Kingdom

EU/1/03/251/001

2006 3 31

2006 3 29

Erbitux

Merck KGaA

Frankfurter Straße 250

D-64293 Darmstadt

EU/1/04/281/001

2006 3 31

2006 3 29

Keppra

UCB S.A.

Allée de la recherche, 60/Researchdreef, 60

B-1070 Bruxelles/Brussel

EU/1/00/146/030

2006 3 31

2006 3 29

Rebetol

Schering Plough Europe

Rue de Stalle, 73/Stallestraat, 73

B-1180 Bruxelles/Brussel

EU/1/99/107/001-005

2006 3 30

2006 3 29

Protopy

Astellas Pharma GmbH

Neumarkter Str. 61

D-81673 München

EU/1/02/202/001-006

2006 3 31

2006 3 29

Protopic

Astellas Pharma GmbH

Neumarkter Str. 61

D-81673 München

EU/1/02/201/001-006

2006 3 31

2006 3 29

Aptivus

Boehringer Ingelheim International GmbH

Binger Straße 173

D-55216 Ingelheim am Rhein

EU/1/05/315/001

2006 3 31

2006 3 29

Bondenza

Roche Registration Limited

6 Falcon Way Shire Park

Welwyn Garden City

Hertfordshire AL7 1TW

United Kingdom

EU/1/03/266/005-006

2006 3 31

2006 3 29

Xeristar

Boehringer Ingelheim International GmbH

Binger Straße 173

D-55216 Ingelheim am Rhein

EU/1/04/297/001-007

2006 3 31

2006 3 29

YENTREVE

Eli Lilly Nederland B.V.

Grootslag 1-5

3991 RA Houten

Nederland

EU/1/04/280/001-007

2006 3 31

2006 3 29

Prialt

Elan Pharma International Ltd

WIL House

Shannon Business Park

Shannon

County Clare

Ireland

EU/1/04/302/001-004

2006 4 3

2006 3 29

NovoMix

Novo Nordisk A/S

Novo Allé

DK-2880 Bagsværd

EU/1/00/142/004-005

EU/1/00/142/009-022

2006 3 31

2006 3 29

Cymbalta

Eli Lilly Nederland B.V.

Grootslag 1-5

3991 RA Houten

Nederland

EU/1/04/296/001-007

2006 3 31

2006 3 29

Pedea

Orphan Europe

Immeuble «Le Guillaumet»

F-92046 Paris La Défense

EU/1/04/284/001

2006 3 31

2006 3 29

Bonviva

Roche Registration Limited

6 Falcon Way Shire Park

Welwyn Garden City

Hertfordshire AL7 1TW

United Kingdom

EU/1/03/265/005-006

2006 3 31

2006 3 29

NovoRapid

Novo Nordisk A/S

Novo Allé

DK-2880 Bagsværd

EU/1/99/119/001

EU/1/99/119/003

EU/1/99/119/005-014

2006 3 31

2006 3 29

InductOs

Wyeth Europa Ltd.

Huntercombe Lane South

Taplow

Maidenhead

Berkshire

SL6 0PH

United Kingdom

EU/1/02/226/001

2006 3 31

2006 3 29

Truvada

Gilead Sciences International Limited

Granta Park

Abington Cambridge CB1 6GT

United Kingdom

EU/1/04/305/001

2006 3 31

—   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 3 15

Zubrin

Schering Plough Limited

Schering Plough House

Shire Park

Welwyn Garden City

Hertfordshire

AL7 1TW

United Kingdom

EU/2/00/028/002-008

2006 3 17

2006 3 21

Porcilis Pesti

Intervet International B.V.

Wim de Körverstraat 35

5831 AN Boxmeer

Nederland

EU/2/99/016/001-006

2006 3 23

2006 3 23

METACAM

Boehringer Ingelheim Vetmedica GmbH

D-55216 Ingelheim am Rhein

EU/2/97/004/016-023

2006 3 28

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