30.9.2006   

LT

Europos Sąjungos oficialusis leidinys

C 236/2

Bendrijos sprendimų dėl leidimų prekiauti vaistais sąrašas nuo 2006 m. rugsėjo 1 d. iki 200 m. rugsėjo 31 d.

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

(2006/C 236/02)

—   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 8 10

Thelin

Natrio sitaksentanas

Encysive (UK) Limited

Alder Castle House

10 Noble Street

London EC2V 7QJ

United Kingdom

EU/1/06/353/001-005

Tabletė padengta apvalkalu

Netaikoma

2006 8 11

2006 8 28

Exjade

deferasiroksas

Novartis Europharm Limited

Wimblehurst Road

Horsham

West Sussex RH12 5AB

United Kingdom

EU/1/06/356/001-006

Disperguojamoji tabletė

V03AC03

2006 8 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 8 4

Taxotere

Aventis Pharma S.A.

20 avenue Raymond Aron

F-92165 Antony Cedex

EU/1/95/002/001-002

2006 8 8

2006 8 4

NovoSeven

Novo Nordisk A/S

Novo Allé

DK-2880 Bagsværd

EU/1/96/006/001-003

2006 8 8

2006 8 4

Hepsera

Gilead Sciences International Limited

Cambridge CB1 6GT

United Kingdom

EU/1/03/251/001

2006 8 8

2006 8 4

HBVAXPRO

Sanofi Pasteur MSD, SNC

8, rue Jonas Salk

F-69007 Lyon

EU/1/01/183/001

EU/1/01/183/004-005

EU/1/01/183/007-008

EU/1/01/183/011

EU/1/01/183/013

EU/1/01/183/015

EU/1/01/183/018-029

2006 8 8

2006 8 4

HBVAXPRO

Sanofi Pasteur MSD, SNC

8, rue Jonas Salk

F-69007 Lyon

EU/1/01/183/001

EU/1/01/183/004-005

EU/1/01/183/007-008

EU/1/01/183/011

EU/1/01/183/013

EU/1/01/183/015

EU/1/01/183/018-029

2006 8 8

2006 8 4

Tasmar

Valeant Pharmaceuticals Limited

Cedarwood

Chineham Business Park

Crockford lane

Basingstoke RG24 8WD

United Kingdom

EU/1/97/044/001-008

2006 8 8

2006 8 4

Enbrel

Wyeth Europa Limited

Huntercombe Lane South

Taplow

Maidenhead

Berkshire SL6 0PH

United Kingdom

EU/1/99/126/012

2006 8 8

2006 8 4

Mirapexin

Boehringer Ingelheim International GmbH

Binger Strasse 173

D-55216 Ingelheim am Rhein

EU/1/97/051/001-006

EU/1/97/051009-012

2006 8 8

2006 8 4

InductOs

Wyeth Europa Ltd

Huntercombe Lane South

Taplow

Maidenhead

Berkshire SL6 0PH

United Kingdom

EU/1/02/226/001

2006 8 8

2006 8 7

Levviax

Aventis Pharma S.A.

20, Avenue Raymond Aron

F-92160 Antony

EU/1/01/192/001-005

2006 8 9

2006 8 7

Ketek

Aventis Pharma S.A.

20, Avenue Raymond Aron

F-92160 Antony

EU/1/01/191/001-005

2006 8 9

2006 8 7

Lantus

Sanofi-Aventis Deutschland GmbH

D-65926 Frankfurt am Main

EU/1/00/134/001-029

2006 8 9

2006 8 7

Optisulin

Sanofi-Aventis Deutschland GmbH

D-65926 Frankfurt am Main

EU/1/00/133/001-008

2006 8 9

2006 8 7

Keppra

UCB S.A.

Allée de la recherche, 60

B-1070 Bruxelles

Researchdreef 60

B-1070 Brussel

EU/1/00/146/001-030

2006 8 9

2006 8 7

Fasturtec

Sanofi-Aventis

174, avenue de France

F-75013 Paris

EU/1/00/170/001-002

2006 8 9

2006 8 7

Zenapax

Roche Registration Limited

6 Falcon Way

Shire Park

Welwyn Garden City AL7 1TW

United Kingdom

EU/1/99/098/001-002

2006 8 9

2006 8 7

KOGENATE Bayer

Bayer HealthCare AG

D-51368 Leverkusen

EU/1/00/143/001-009

2006 8 9

2006 8 7

Xagrid

Shire Pharmaceutical Contracts Ltd

Hampshire International Business Park

Chineham

Basingstoke

Hampshire RG24 8EP

United Kingdom

EU/1/04/295/001

2006 8 9

2006 8 7

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

2006 8 9

2006 8 7

Optison

Amersham Health AS

Nycoveien 1-2

P.O.Box 4220 Nydalen

N-0401 Oslo

EU/1/98/065/001-002

2006 8 9

2006 8 10

Tracleer

Actelion Registration Ltd

BSI Building 13th Floor

389 Chiswick High Road

London W4 4AL

United Kingdom

EU/1/02/220/001-005

2006 8 14

2006 8 10

Rapilysin

Roche Registration Limited

6 Falcon Way

Shire Park

Welwyn Garden City AL7 1TW

United Kingdom

EU/1/96/018/001

2006 8 14

2006 8 21

HBVAXPRO

Sanofi Pasteur MSD, SNC

8, rue Jonas Salk

F-69007 Lyon

EU/1/01/183/001

EU/1/01/183/004-005

EU/1/01/183/007-008

EU/1/01/183/011

EU/1/01/183/013

EU/1/01/183/015

EU/1/01/183/018-029

2006 8 23

2006 8 21

Ziagen

Glaxo Group Ltd

Greenford

Middlesex UB6 0NN

United Kingdom

EU/1/99/112/001-002

2006 8 23

2006 8 21

NovoSeven

Novo Nordisk A/S

Novo Allé

DK-2880 Bagsværd

EU/1/96/006/001-003

2006 8 23

2006 8 28

Bonviva

Roche Registration Limited

6 Falcon Way Shire Park

Welwyn Garden City

Hertfordshire AL7 1TW

United Kingdom

EU/1/03/265/001-006

2006 8 31

2006 8 28

Aptivus

Boehringer Ingelheim International GmbH

Binger Strasse 173

D-55216 Ingelheim am Rhein

EU/1/05/315/001

2006 8 31

2006 8 28

Twinrix Paediatric

GlaxoSmithKline Biologicals S.A.

rue de l'Institut 89

B-1330 Rixensart

EU/1/97/029/001-010

2006 8 31

2006 8 28

Twinrix Adult

GlaxoSmithKline Biologicals S.A.

rue de l'Institut 89

B-1330 Rixensart

EU/1/96/020/001-009

2006 8 31

2006 8 28

Bondenza

Roche Registration Limited

6 Falcon Way Shire Park

Welwyn Garden City

Hertfordshire AL7 1TW

United Kingdom

EU/1/03/266/001-006

2006 8 31

2006 8 28

Truvada

Gilead Sciences International Limited

Granta Park Abington

Cambridge CB1 6GT

United Kingdom

EU/1/04/305/001

2006 8 31

2006 8 28

Vfend

Pfizer Limited

Sandwich

Kent CT13 9NJ

United Kingdom

EU/1/02/212/001-026

2006 8 31

2006 8 28

Inductos

Wyeth Europa Ltd.

Huntercombe Lane South

Taplow

Maidenhead

Berkshire SL6 0PH

United Kingdom

EU/1/02/226/001

2006 8 31

2006 8 28

Hepsera

Gilead Sciences International Limited

Cambridge CB1 6GT

United Kingdom

EU/1/03/251/001

2006 8 31

2006 8 28

Orfadin

Swedish Orphan International AB

Drottninggatan 98

S-111 60 Stockholm

EU/1/04/303/001-003

2006 8 31

2006 8 28

Karvezide

Bristol-Myers Squibb Pharma EEIG

Uxbridge Business Park

Sanderson Road

Uxbridge UD8 1DH

United Kingdom

EU/1/98/085/023-028

2006 8 31

2006 8 28

Revatio

Pfizer Ltd

Ramsgate Road

Sandwich

Kent CT 13 9NJ

United Kingdom

EU/1/05/318/001

2006 9 1

2006 8 28

CoAprovel

Sanofi Pharma Bristol-Myers Squibb SNC

174, avenue de France

F-75013 Paris

EU/1/98/086/023-028

2006 8 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 8 10

Equilis Prequenza

Intervet International B.V.

Wim de Körverstraat 35

5831 AN Boxmeer

Nederland

EU/2/05/056/003-004

2006 8 14

2006 8 10

Equilis Prequenza te

Intervet International B.V.

Wim de Körverstraat 35

5831 AN Boxmeer

Nederland

EU/2/05/057/003-004

2006 8 14

2006 8 21

Vaxxitek HVT+ IBD

Merial

29, avenue Tony Garnier

F-69007 Lyon

EU/2/02/032/001

2006 8 23

2006 8 21

Naxcel

Pfizer Limited

Sandwich

Kent CT13 9NJ

United Kingdom

EU/2/05/053/002

2006 8 23

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.