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Document 52006XC0930(01)

    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 13 arba 38 straipsnį)

    OL C 236, 2006 9 30, p. 2–6 (ES, CS, DA, DE, ET, EL, EN, FR, IT, LV, LT, HU, NL, PL, PT, SK, SL, FI, SV)

    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.


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