Access to European Union law
<a href="https://eur-lex.europa.eu/content/help/eurlex-content/experimental-features.html" target="_blank">More about the experimental features corner</a>
Choose the experimental features you want to try
EUR-Lex
Access to European Union law

This document is an excerpt from the EUR-Lex website

You are here
Use quotation marks to search for an "exact phrase". Append an asterisk (*) to a search term to find variations of it (transp*, 32019R*). Use a question mark (?) instead of a single character in your search term to find variations of it (ca?e finds case, cane, care).
Search tips
Need more search options? Use the Advanced search

Document 52008XC0926(02)

    Bendrijos sprendimų dėl leidimų prekiauti vaistais sąrašas nuo 2008 m. rugpjūčio 1 d. iki 2008 m. rugpjūčio 31 d. (Paskelbtas pagal Europos Parlamento ir Tarybos reglamento (EB) Nr. 726/2004 13 arba 38 straipsnį)

    OL C 245, 2008 9 26, p. 15–20 (BG, ES, CS, DA, DE, ET, EL, EN, FR, IT, LV, LT, HU, MT, NL, PL, PT, RO, SK, SL, FI, SV)

    26.9.2008   

    LT

    Europos Sąjungos oficialusis leidinys

    C 245/15

    Bendrijos sprendimų dėl leidimų prekiauti vaistais sąrašas nuo 2008 m. rugpjūčio 1 d. iki 2008 m. rugpjūčio 31 d.

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

    (2008/C 245/03)

    —   Leidimas prekiauti (pagal 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

    2008 8 28

    INTELENCE

    etravirinas

    Janssen-Cilag International NV

    Turnhoutseweg, 30

    B-2340 Beerse

    EU/1/08/468/001

    Tabletės

    (Netaikoma)

    2008 9 1

    2008 8 29

    Vimpat

    Lakozamidas

    UCB S.A.

    Allée de la Recherche, 60/Researchdreef, 60

    B-1070 Bruxelles/B-1070 Brussel

    EU/1/08/470/001-013

    Plėvele dengta tabletė

    N03AX18

    2008 9 2

    EU/1/08/470/014-015

    Sirupas

    EU/1/08/470/016

    Infuzinis tirpalas

    —   Leidimas prekiauti (pagal Reglamento (EB) Nr. 726/2004 13 straipsnį): pakeistas

    Sprendimo data

    Vaisto pavadinimas

    Leidimo prekiauti turėtojas

    Įrašo Bendrijos registre numeris

    Pranešimo data

    2008 8 4

    Neupro

    Schwarz Pharma Ltd

    Shannon

    Industrial Estate

    Co.Clare

    Ireland

    EU/1/05/331/001-037

    2008 8 6

    2008 8 8

    Champix

    Pfizer Ltd

    Ramsgate Road

    Sandwich

    Kent CT 13 9NJ

    United Kingdom

    EU/1/06/360/001-012

    2008 8 12

    2008 8 8

    Vectibix

    Amgen Europe B.V.

    Minervum 7061

    4817 ZK Breda

    Nederland

    EU/1/07/423/001-003

    2008 8 12

    2008 8 8

    Infanrix hexa

    GlaxoSmithKline Biologicals s.a.

    rue de l'Institut 89

    B-1330 Rixensart

    EU/1/00/152/001-018

    2008 8 12

    2008 8 8

    Evista

    Eli Lilly Nederland B.V.

    Grootslag 1-5

    3991 RA Houten

    Nederland

    EU/1/98/073/001-004

    2008 8 12

    2008 8 8

    Avandamet

    SmithKline Beecham plc

    980 Great West Road

    Brentford

    Middlesex TW8 9GS

    United Kingdom

    EU/1/03/258/001-022

    2008 8 12

    2008 8 11

    Optruma

    Eli Lilly Nederland B.V.

    Grootslag 1-5

    3991 RA Houten

    Nederland

    EU/1/98/074/001-004

    2008 8 13

    2008 8 13

    Silapo

    STADA Arzneimittel AG

    Stadastrasse 2-18

    D-61118 Bad Vilbel

    EU/1/07/432/001-022

    2008 8 15

    2008 8 13

    Retacrit

    HOSPIRA Enterprises B.V.

    Taurusavenue 19-21b

    2132 LS Hoofddorp

    Nederland

    EU/1/07/431/001-019

    2008 8 15

    2008 8 13

    Humira

    Abbott Laboratories Ltd

    Queenborough

    Kent ME11 5EL

    United Kingdom

    EU/1/03/256/001-010

    2008 8 15

    2008 8 13

    Hepsera

    Gilead Sciences International Limited

    Cambridge CB21 6GT

    United Kingdom

    EU/1/03/251/001-002

    2008 8 15

    2008 8 13

    Infanrix penta

    GlaxoSmithKline Biologicals s.a.

    rue de l'Institut 89

    B-1330 Rixensart

    EU/1/00/153/001-010

    2008 8 18

    2008 8 13

    Cervarix

    GlaxoSmithKline Biologicals s.a.

    rue de l'Institut 89

    B-1330 Rixensart

    EU/1/07/419/001-009

    2008 8 18

    2008 8 22

    Evista

    DAIICHI SANKYO EUROPE GmbH

    Zielstattstrasse 48

    D-81379 München

    EU/1/98/073/001-004

    2008 8 26

    Eli Lilly Nederland B.V.

    Grootslag 1-5

    3991 RA Houten

    Nederland

    2008 8 22

    Kaletra

    Abbott Laboratories Ltd

    Queenborough

    Kent ME11 5EL

    United Kingdom

    EU/1/01/172/001-006

    2008 8 26

    2008 8 22

    Baraclude

    Bristol-Myers Squibb Pharma EEIG

    Uxbridge Business Park

    Sanderson Road

    Uxbridge UB8 1DH

    United Kingdom

    EU/1/06/343/001-007

    2008 8 26

    2008 8 22

    SUTENT

    Pfizer Ltd

    Ramsgate Road

    Sandwich

    Kent CT 13 9NJ

    United Kingdom

    EU/1/06/347/001-006

    2008 8 26

    2008 8 22

    Fosavance

    Merck Sharp & Dohme Ltd

    Hertford Road

    Hoddesdon

    Hertfordshire EN11 9BU

    United Kingdom

    EU/1/05/310/001-009

    2008 8 26

    2008 8 22

    Zalasta

    KRKA d.d.

    Šmarješka cesta 6

    SLO-8501 Novo mesto

    EU/1/07/415/001-056

    2008 8 26

    2008 8 22

    Arixtra

    Glaxo Group Ltd

    Greenford Road

    Greenford

    Middlesex UB6 0NN

    United Kingdom

    EU/1/02/206/001-035

    2008 8 26

    2008 8 22

    Revlimid

    Celgene Europe Limited

    Morgan House

    Madeira Walk

    Windsor

    Berkshire SL4 1EP

    United Kingdom

    EU/1/07/391/001-004

    2008 8 26

    2008 8 25

    Abilify

    Otsuka Pharmaceutical Europe Ltd

    Hunton House

    Highbridge Business Park

    Oxford Road

    Uxbridge

    Middlesex UB8 1HU

    United Kingdom

    EU/1/04/276/001-020

    EU/1/04/276/024-036

    2008 8 27

    2008 8 25

    TARGRETIN

    Eisai Limited

    3 Shortlands

    London W6 8EE

    United Kingdom

    EU/1/01/178/001

    2008 8 27

    2008 8 25

    Emselex

    Novartis Europharm Limited

    Wimblehurst Road

    Horsham

    West Sussex RH12 5AB

    United Kingdom

    EU/1/04/294/001-028

    2008 8 27

    2008 8 25

    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

    2008 8 27

    2008 8 25

    Humira

    Abbott Laboratories Ltd

    Queenborough

    Kent ME11 5EL

    United Kingdom

    EU/1/03/256/001-010

    2008 8 27

    2008 8 25

    Revatio

    Pfizer Limited

    Sandwich

    Kent CT13 9NJ

    United Kingdom

    EU/1/05/318/001

    2008 8 27

    2008 8 25

    Prialt

    Eisai Limited

    3 Shortlands

    London W6 8EE

    United Kingdom

    EU/1/04/302/001-004

    2008 8 27

    2008 8 25

    NovoSeven

    Novo Nordisk A/S

    Novo Allé

    DK-2880 Bagsværd

    EU/1/96/006/001-006

    2008 8 27

    2008 8 26

    Viagra

    Pfizer Limited

    Sandwich

    Kent CT13 9NJ

    United Kingdom

    EU/1/98/077/002-004

    EU/1/98/077/006-008

    EU/1/98/077/010-019

    2008 8 28

    2008 8 28

    Rasilez

    Novartis Europharm Limited

    Wimblehurst Road

    Horsham

    West Sussex RH12 5AB

    United Kingdom

    EU/1/07/405/001-020

    2008 9 1

    2008 8 28

    Tekturna

    Novartis Europharm Limited

    Wimblehurst Road

    Horsham

    West Sussex RH12 5AB

    United Kingdom

    EU/1/07/408/001-020

    2008 9 1

    2008 8 28

    Raptiva

    Serono Europe Limited

    56 Marsh Wall

    London E14 9TP

    United Kingdom

    EU/1/04/291/001-003

    2008 9 1

    2008 8 28

    ISENTRESS

    Merck Sharp & Dohme Limited

    Hertford Road

    Hoddesdon

    Hertfordshire EN11 9BU

    United Kingdom

    EU/1/07/436/001-002

    2008 9 1

    2008 8 28

    Enviage

    Novartis Europharm Limited

    Wimblehurst Road

    Horsham

    West Sussex RH12 5AB

    United Kingdom

    EU/1/07/406/001-020

    2008 9 1

    2008 8 28

    Sprimeo

    Novartis Europharm Limited

    Wimblehurst Road

    Horsham

    West Sussex RH12 5AB

    United Kingdom

    EU/1/07/407/001-020

    2008 9 1

    2008 8 28

    Riprazo

    Novartis Europharm Limited

    Wimblehurst Road

    Horsham

    West Sussex RH12 5AB

    United Kingdom

    EU/1/07/409/001-020

    2008 9 1

    2008 8 29

    Avastin

    Roche Registration Limited

    6 Falcon Way

    Shire Park

    Welwyn Garden City AL7 1TW

    United Kingdom

    EU/1/04/300/001-002

    2008 9 2

    2008 8 29

    Nespo

    Dompé Biotec S.p.A.

    Via San Martino, 12

    I-20122 Milano

    EU/1/01/184/001-073

    2008 9 2

    2008 8 29

    Enbrel

    Wyeth Europa Limited

    Huntercombe Lane

    South Taplow

    Maidenhead

    Berkshire SL6 0PH

    United Kingdom

    EU/1/99/126/001-018

    2008 9 1

    2008 8 29

    Velcade

    Janssen-Cilag International NV

    Turnhoutseweg, 30

    B-2340 Beerse

    EU/1/04/274/001-002

    2009 9 2

    2008 8 29

    Humira

    Abbott Laboratories Ltd

    Queenborough

    Kent ME11 5EL

    United Kingdom

    EU/1/03/256/001-010

    2009 9 2

    2008 8 29

    Prezista

    Janssen-Cilag International NV

    Turnhoutseweg, 30

    B-2340 Beerse

    EU/1/06/380/001

    2009 9 2

    2008 8 29

    Truvada

    Gilead Sciences International Limited

    Cambridge CB21 6GT

    United Kingdom

    EU/1/04/305/001-002

    2009 9 2

    2008 8 29

    Neupro

    Schwarz Pharma Ltd

    Shannon Industrial Estate

    Co.Clare

    Ireland

    EU/1/05/331/038-055

    2009 9 2

    2008 8 29

    Neupro

    Schwarz Pharma Ltd

    Shannon Industrial Estate

    Co.Clare

    Ireland

    EU/1/05/331/001-055

    2009 9 2

    —   Leidimas prekiauti (pagal Reglamento (EB) Nr. 726/2004 13 straipsnį): panaikintas

    Sprendimo data

    Vaisto pavadinimas

    Leidimo prekiauti turėtojas

    Įrašo Bendrijos registre numeris

    Pranešimo data

    2008 8 22

    Protopy

    Astellas Pharma GmbH

    Neumarkter Str. 61

    D-81673 München

    EU/1/02/202/001-006

    2008 8 26

    2008 8 28

    Quintanrix

    GlaxoSmithKline Biologicals s.a.

    rue de l'Institut 89

    B-1330 Rixensart

    EU/1/04/301/001-005

    2008 9 1

    —   Leidimas prekiauti (pagal Reglamento (EB) Nr. 726/2004 38 straipsnį): pakeistas

    Sprendimo data

    Vaisto pavadinimas

    Leidimo prekiauti turėtojas

    Įrašo Bendrijos registre numeris

    Pranešimo data

    2008 8 13

    Dexdomitor

    Orion Corporation

    Orionintie 1

    FI-02200 Espoo

    EU/2/02/033/001-002

    2008 8 15

    2008 8 22

    Suvaxyn Aujeszky

    Fort Dodge Animal Health Holland

    C.J. van Houtenlaan 36

    1381 CP Weesp

    Nederland

    EU/2/98/009/001-006

    2008 8 26

    2008 8 25

    Zubrin

    Schering-Plough Limited

    Schering-Plough House

    Shire Park

    Welwyn Garden City

    Hertfordshire AL7 1TW

    United Kingdom

    EU/2/00/028/002-008

    2008 8 27

    2008 8 25

    Circovac

    Merial

    29, Avenue Tony Garnier

    F-69007 Lyon

    EU/2/07/075/001-004

    2008 8 27

    2008 8 25

    Profender

    Bayer HealthCare AG

    D-51368 Leverkusen

    EU/2/05/054/018-031

    2008 8 27

    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.

    Top