31.3.2006   

LT

Europos Sąjungos oficialusis leidinys

C 78/15

Bendrijos sprendimų dėl leidimų prekiauti vaistais sąrašas nuo 2006 vasario 1 d. iki 2006 vasario 28 d.

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

(2006/C 78/03)

—   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 2 15

Neupro

Rotigotinas

Schwarz Pharma Ltd

Shannon

Industrial Estate

Co.Clare

Ireland

EU/1/05/331/001-013

Transderminis pleistras

N04BC09

2006 2 17

2006 2 21

Rotarix

Gyva rotaviruso vakcina

GlaxoSmithKline Biologicals SA

rue de l'Institut 89

B-1330 Rixensart

EU/1/05/330/001-004

Milteliai ir tirpiklis geriamajai suspensijai

J07BH01

2006 2 23

—   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 2 2

Fareston

Orion Corporation

Orionintie 1

FIN-02200 Espoo

EU/1/96/004/001-002

2006 2 6

2006 2 9

NovoSeven

Novo Nordisk A/S

Novo Allé

DK-2880 Bagsværd

EU/1/96/006/001-003

2006 2 13

2006 2 9

Aerius

Schering Plough Europe

Rue de Stalle, 73, Stallestraat, 73

B-1180 Brussel/Bruxelles

EU/1/00/160/001-034

2006 2 13

2006 2 9

Neoclarityn

Schering Plough Europe

Rue de Stalle, 73, Stallestraat, 73

B-1180 Brussel/Bruxelles

EU/1/00/161/001-034

2006 2 13

2006 2 9

Azomyr

Schering Plough Europe

Rue de Stalle, 73, Stallestraat, 73

B-1180 Brussel/Bruxelles

EU/1/00/157/001-034

2006 2 13

2006 2 9

Humalog

Eli Lilly Nederland BV

Grootslag 1-5

3991 RA Houten

Nederland

EU/1/96/007/002

EU/1/96/007/004-006

EU/1/96/007/008

EU/1/96/007/010-011

EU/1/96/007/015-021

EU/1/96/007/023-028

2006 2 13

2006 2 9

Xeloda

Roche Registration Limited

40 Broadwater Road

Welwyn Garden City

Hertfordshire AL7 3AY

United Kingdom

EU/1/00/163/001-002

2006 2 13

2006 2 9

Replagal

TKT Europe AB

Rinkebyvägen 11B

S-182 36 Danderyd

EU/1/01/189/001-006

2006 2 13

2006 2 9

Fasturtec

Sanofi-Aventis

174, avenue de France

F-75013 Paris

EU/1/00/170/001-002

2006 2 13

2006 2 9

Kepivance

Amgen Europe BV

Minervum 7061

4817 ZK Breda

Nederland

EU/1/05/314/001

2006 2 13

2006 2 13

Metalyse

Boehringer Ingelheim International GmbH

Binger Straße 173

D-55216 Ingelheim am Rhein

EU/1/00/169/004-006

2006 2 15

2006 2 13

Fabrazyme

Genzyme Europe BV

Gooimeer 10

Naarden 1411 DD

Nederland

EU/1/01/188/001-006

2006 2 15

2006 2 13

Liprolog

Eli Lilly Nederland BV

Grootslag 1-5

3991 RA Houten

Nederland

EU/1/01/195/001-015

2006 2 15

2006 2 13

InductOs

Wyeth Europa Ltd

Huntercombe Lane South

Taplow

Maidenhead

Berkshire

SL6 0PH

United Kingdom

EU/1/02/226/001

2006 2 15

2006 2 13

HBVAXPRO

Sanofi Pasteur MSD, SNC

8, rue Jonas Salk

F-69007 Lyon

EU/1/01/183/020-029

2006 2 16

2006 2 14

Insuman

Aventis Pharma Deutschland GmbH

Brueningstraße 50

D-65926 Frankfurt am Main

EU/1/97/030/030

EU/1/97/030/035

EU/1/97/030/040

EU/1/97/030/045

EU/1/97/030/050

EU/1/97/030/055-084

2006 2 16

2006 2 14

Tasmar

Valeant Pharmaceuticals Limited

Cedarwood

Chineham Business Park

Crockford lane

Basingstoke RG24 8WD

United Kingdom

EU/1/97/044/001-008

2006 2 16

2006 2 17

Pritor

Glaxo Group Ltd

Greenford

Middlesex UB6 0NN

United Kingdom

EU/1/98/089/011-014

EU/1/98/089/017-019

2006 2 21

2006 2 28

Viracept

Roche Registration Limited

6 Falcon Way

Shire Park

Welwyn Garden City

AL7 1TW

United Kingdom

EU/1/97/054/001

EU/1/97/054/003-006

2006 3 2

2006 2 28

Parareg

Dompé Biotec SpA

Via San Martino, 12

I-20122 Milano

EU/1/04/293/001-012

2006 3 2

2006 2 28

Truvada

Gilead Sciences International Limited

Granta Park Abington Cambridge

CB1 6GT

United Kingdom

EU/1/04/305/001

2006 3 2

2006 2 28

TachoSil

Nycomed Austria GmbH

St.-Peter-Straße 25

A-4020 Linz

EU/1/04/277/001-004

2006 3 2

2006 2 28

BeneFIX

Wyeth Europa Ltd.

Huntercombe Lane South

Taplow

Maidenhead

Berkshire

SL6 0PH

United Kingdom

EU/1/97/047/001-003

2006 3 2

2006 2 28

Aranesp

Amgen Europe BV

Minervum 7061

4817 ZK Breda

Nederland

EU/1/01/185/001-056

2006 3 2

2006 2 28

Lysodren

Laboratoire HRA Pharma

19 rue Frédérick Lemaître

F-75020 Paris

EU/1/04/273/001

2006 3 6

2006 2 28

Glivec

Novartis Europharm Limited

Wimblehurst Road

Horsham

West Sussex RH12 5AB

United Kingdom

EU/1/01/198/001-013

2006 3 2

2006 2 28

Xagrid

Shire Pharmaceutical Contracts Ltd

Hampshire International Business Park

Chineham

Basingstoke

Hampshire RG24 8EP

United Kingdom

EU/1/04/295/001

2006 3 2

2006 2 28

Exelon

Novartis Europharm Limited

Wimblehurst Road

Horsham

West Sussex RH12 5AB

United Kingdom

EU/1/98/066/001-018

2006 3 2

2006 2 28

Viread

Gilead Sciences International Limited

Cambridge CB1 6GT

United Kingdom

EU/1/01/200/001

2006 3 2

2006 2 28

Telzir

Glaxo Group Ltd

Greenford Road, Greenford

Middlesex UB6 0NN

United Kingdom

EU/1/04/282/001-002

2006 3 2

2006 2 28

Nespo

Dompé Biotec SpA

Via San Martino, 12

I-20122 Milano

EU/1/01/184/001-056

2006 3 2

2006 2 28

Rapamune

Wyeth Europa Limited

Huntercombe Lane South

Taplow

Maidenhead, Berkshire

SL6 0PH

United Kingdom

EU/1/01/171/001-012

2006 3 2

2006 2 28

Mimpara

Amgen Europe BV

Minervum 7061

4817 ZK Breda

Nederland

EU/1/04/292/001-012

2006 3 2

2006 2 28

Remicade

Centocor BV

Einsteinweg 101

2333 CB Leiden

Nederland

EU/1/99/116/001-003

2006 3 2

—   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 2 2

Theryttrex

MDS Nordion SA

Zoning Industriel

B-6220 Fleurus

EU/1/02/245/001

2006 2 6

2006 2 2

Daquiran

Dr. Karl Thomae GmbH

Birkendorfferstr. 65

D-88397 Biberach/Riss

EU/1/97/052/001-006

EU/1/97/052/009-010

2006 2 6

—   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 2 2

Aivlosin

ECO Animal Health Ltd

78 Coombe Road New Malden Surrey KT3 4QS

United Kingdom

EU/2/04/044/001-005

2006 2 6

2006 2 3

Econor

Novartis Animal Health Austria GmbH

Biochemiestraße 10

A-6250 Kundl

EU/2/98/010/004-006

EU/2/98/010/017-018

EU/2/98/010/023-024

2006 2 7

2006 2 8

Porcilis AR-T DF

Intervet International BV

Wim de Körverstraat 35

5831 AN Boxmeer

Nederland

EU/2/00/026/001-004

2006 2 10

2006 2 8

Pirsue

PFIZER Ltd

Ramsgate Road

Sandwich

Kent CT 13 9NJ

United Kingdom

EU/2/00/027/001-003

2006 2 10

2006 2 13

ProteqFlu Te

Merial

29 Avenue Tony Garnier

F-69007 Lyon

EU/2/03/038/005

2006 2 16

2006 2 13

Advasure

PFIZER Ltd

Ramsgate Road

Sandwich

Kent CT 13 9NJ

United Kingdom

EU/2/00/025/001-004

2006 2 15

2006 2 13

ProteqFlu

Merial

29 avenue Tony Garnier

F-69007 Lyon

EU/2/03/037/005

2006 2 16

2006 2 28

Stronghold

PFIZER Ltd

Ramsgate Road

Sandwich

Kent CT 13 9NJ

United Kingdom

EU/2/99/014/001-012

2006 3 2

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.