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)

    Kopsavilkums par Kopienas lēmumiem attiecībā uz zāļu tirdzniecības atļaujām no 1.8.2008. līdz 31.8.2008. (Publicēts atbilstīgi 13. pantam vai 38. pantam Eiropas Parlamenta un Padomes Regulā (EK) Nr. 726/2004 )

    OV C 245, 26.9.2008, 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   

    LV

    Eiropas Savienības Oficiālais Vēstnesis

    C 245/15

    Kopsavilkums par Kopienas lēmumiem attiecībā uz zāļu tirdzniecības atļaujām no 1.8.2008. līdz 31.8.2008.

    (Publicēts atbilstīgi 13. pantam vai 38. pantam Eiropas Parlamenta un Padomes Regulā (EK) Nr. 726/2004  (1) )

    (2008/C 245/03)

    —   Tirdzniecības atļaujas izsniegšana (13. pants Regulā (EK) Nr. 726/2004): Pieņemts

    Lēmuma datums

    Zāļu nosaukums

    SNN

    (Starptautiskais nepatentētais nosaukums)

    Tirdzniecības atļaujas turētājs

    Ieraksta numurs Kopienas reģistrā

    Farmaceitiskā forma

    ATĶ kods

    (Anatomiski terapeitiski ķīmiskais kods)

    Paziņojuma datums

    28.8.2008.

    INTELENCE

    etravirinum

    Janssen-Cilag International NV

    Turnhoutseweg, 30

    B-2340 Beerse

    EU/1/08/468/001

    Tabletes

    (Nav piemērojams)

    1.9.2008.

    29.8.2008.

    Vimpat

    Lacosamidum

    UCB S.A.

    Allée de la Recherche, 60/Researchdreef, 60

    B-1070 Bruxelles/B-1070 Brussel

    EU/1/08/470/001-013

    Apvalkotā tablete

    N03AX18

    2.9.2008.

    EU/1/08/470/014-015

    Sīrups

    EU/1/08/470/016

    Šķīdums infūzijām

    —   Tirdzniecības atļaujas izmaiņas (13. pants Regulā (EK) Nr. 726/2004): Pieņemts

    Lēmuma datums

    Zāļu nosaukums

    Tirdzniecības atļaujas turētājs

    Ieraksta numurs Kopienas reģistrā

    Paziņojuma datums

    4.8.2008.

    Neupro

    Schwarz Pharma Ltd

    Shannon

    Industrial Estate

    Co.Clare

    Ireland

    EU/1/05/331/001-037

    6.8.2008.

    8.8.2008.

    Champix

    Pfizer Ltd

    Ramsgate Road

    Sandwich

    Kent CT 13 9NJ

    United Kingdom

    EU/1/06/360/001-012

    12.8.2008.

    8.8.2008.

    Vectibix

    Amgen Europe B.V.

    Minervum 7061

    4817 ZK Breda

    Nederland

    EU/1/07/423/001-003

    12.8.2008.

    8.8.2008.

    Infanrix hexa

    GlaxoSmithKline Biologicals s.a.

    rue de l'Institut 89

    B-1330 Rixensart

    EU/1/00/152/001-018

    12.8.2008.

    8.8.2008.

    Evista

    Eli Lilly Nederland B.V.

    Grootslag 1-5

    3991 RA Houten

    Nederland

    EU/1/98/073/001-004

    12.8.2008.

    8.8.2008.

    Avandamet

    SmithKline Beecham plc

    980 Great West Road

    Brentford

    Middlesex TW8 9GS

    United Kingdom

    EU/1/03/258/001-022

    12.8.2008.

    11.8.2008.

    Optruma

    Eli Lilly Nederland B.V.

    Grootslag 1-5

    3991 RA Houten

    Nederland

    EU/1/98/074/001-004

    13.8.2008.

    13.8.2008.

    Silapo

    STADA Arzneimittel AG

    Stadastrasse 2-18

    D-61118 Bad Vilbel

    EU/1/07/432/001-022

    15.8.2008.

    13.8.2008.

    Retacrit

    HOSPIRA Enterprises B.V.

    Taurusavenue 19-21b

    2132 LS Hoofddorp

    Nederland

    EU/1/07/431/001-019

    15.8.2008.

    13.8.2008.

    Humira

    Abbott Laboratories Ltd

    Queenborough

    Kent ME11 5EL

    United Kingdom

    EU/1/03/256/001-010

    15.8.2008.

    13.8.2008.

    Hepsera

    Gilead Sciences International Limited

    Cambridge CB21 6GT

    United Kingdom

    EU/1/03/251/001-002

    15.8.2008.

    13.8.2008.

    Infanrix penta

    GlaxoSmithKline Biologicals s.a.

    rue de l'Institut 89

    B-1330 Rixensart

    EU/1/00/153/001-010

    18.8.2008.

    13.8.2008.

    Cervarix

    GlaxoSmithKline Biologicals s.a.

    rue de l'Institut 89

    B-1330 Rixensart

    EU/1/07/419/001-009

    18.8.2008.

    22.8.2008.

    Evista

    DAIICHI SANKYO EUROPE GmbH

    Zielstattstrasse 48

    D-81379 München

    EU/1/98/073/001-004

    26.8.2008.

    Eli Lilly Nederland B.V.

    Grootslag 1-5

    3991 RA Houten

    Nederland

    22.8.2008.

    Kaletra

    Abbott Laboratories Ltd

    Queenborough

    Kent ME11 5EL

    United Kingdom

    EU/1/01/172/001-006

    26.8.2008.

    22.8.2008.

    Baraclude

    Bristol-Myers Squibb Pharma EEIG

    Uxbridge Business Park

    Sanderson Road

    Uxbridge UB8 1DH

    United Kingdom

    EU/1/06/343/001-007

    26.8.2008.

    22.8.2008.

    SUTENT

    Pfizer Ltd

    Ramsgate Road

    Sandwich

    Kent CT 13 9NJ

    United Kingdom

    EU/1/06/347/001-006

    26.8.2008.

    22.8.2008.

    Fosavance

    Merck Sharp & Dohme Ltd

    Hertford Road

    Hoddesdon

    Hertfordshire EN11 9BU

    United Kingdom

    EU/1/05/310/001-009

    26.8.2008.

    22.8.2008.

    Zalasta

    KRKA d.d.

    Šmarješka cesta 6

    SLO-8501 Novo mesto

    EU/1/07/415/001-056

    26.8.2008.

    22.8.2008.

    Arixtra

    Glaxo Group Ltd

    Greenford Road

    Greenford

    Middlesex UB6 0NN

    United Kingdom

    EU/1/02/206/001-035

    26.8.2008.

    22.8.2008.

    Revlimid

    Celgene Europe Limited

    Morgan House

    Madeira Walk

    Windsor

    Berkshire SL4 1EP

    United Kingdom

    EU/1/07/391/001-004

    26.8.2008.

    25.8.2008.

    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

    27.8.2008.

    25.8.2008.

    TARGRETIN

    Eisai Limited

    3 Shortlands

    London W6 8EE

    United Kingdom

    EU/1/01/178/001

    27.8.2008.

    25.8.2008.

    Emselex

    Novartis Europharm Limited

    Wimblehurst Road

    Horsham

    West Sussex RH12 5AB

    United Kingdom

    EU/1/04/294/001-028

    27.8.2008.

    25.8.2008.

    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

    27.8.2008.

    25.8.2008.

    Humira

    Abbott Laboratories Ltd

    Queenborough

    Kent ME11 5EL

    United Kingdom

    EU/1/03/256/001-010

    27.8.2008.

    25.8.2008.

    Revatio

    Pfizer Limited

    Sandwich

    Kent CT13 9NJ

    United Kingdom

    EU/1/05/318/001

    27.8.2008.

    25.8.2008.

    Prialt

    Eisai Limited

    3 Shortlands

    London W6 8EE

    United Kingdom

    EU/1/04/302/001-004

    27.8.2008.

    25.8.2008.

    NovoSeven

    Novo Nordisk A/S

    Novo Allé

    DK-2880 Bagsværd

    EU/1/96/006/001-006

    27.8.2008.

    26.8.2008.

    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

    28.8.2008.

    28.8.2008.

    Rasilez

    Novartis Europharm Limited

    Wimblehurst Road

    Horsham

    West Sussex RH12 5AB

    United Kingdom

    EU/1/07/405/001-020

    1.9.2008.

    28.8.2008.

    Tekturna

    Novartis Europharm Limited

    Wimblehurst Road

    Horsham

    West Sussex RH12 5AB

    United Kingdom

    EU/1/07/408/001-020

    1.9.2008.

    28.8.2008.

    Raptiva

    Serono Europe Limited

    56 Marsh Wall

    London E14 9TP

    United Kingdom

    EU/1/04/291/001-003

    1.9.2008.

    28.8.2008.

    ISENTRESS

    Merck Sharp & Dohme Limited

    Hertford Road

    Hoddesdon

    Hertfordshire EN11 9BU

    United Kingdom

    EU/1/07/436/001-002

    1.9.2008.

    28.8.2008.

    Enviage

    Novartis Europharm Limited

    Wimblehurst Road

    Horsham

    West Sussex RH12 5AB

    United Kingdom

    EU/1/07/406/001-020

    1.9.2008.

    28.8.2008.

    Sprimeo

    Novartis Europharm Limited

    Wimblehurst Road

    Horsham

    West Sussex RH12 5AB

    United Kingdom

    EU/1/07/407/001-020

    1.9.2008.

    28.8.2008.

    Riprazo

    Novartis Europharm Limited

    Wimblehurst Road

    Horsham

    West Sussex RH12 5AB

    United Kingdom

    EU/1/07/409/001-020

    1.9.2008.

    29.8.2008.

    Avastin

    Roche Registration Limited

    6 Falcon Way

    Shire Park

    Welwyn Garden City AL7 1TW

    United Kingdom

    EU/1/04/300/001-002

    2.9.2008.

    29.8.2008.

    Nespo

    Dompé Biotec S.p.A.

    Via San Martino, 12

    I-20122 Milano

    EU/1/01/184/001-073

    2.9.2008.

    29.8.2008.

    Enbrel

    Wyeth Europa Limited

    Huntercombe Lane

    South Taplow

    Maidenhead

    Berkshire SL6 0PH

    United Kingdom

    EU/1/99/126/001-018

    1.9.2008.

    29.8.2008.

    Velcade

    Janssen-Cilag International NV

    Turnhoutseweg, 30

    B-2340 Beerse

    EU/1/04/274/001-002

    2.9.2009.

    29.8.2008.

    Humira

    Abbott Laboratories Ltd

    Queenborough

    Kent ME11 5EL

    United Kingdom

    EU/1/03/256/001-010

    2.9.2009.

    29.8.2008.

    Prezista

    Janssen-Cilag International NV

    Turnhoutseweg, 30

    B-2340 Beerse

    EU/1/06/380/001

    2.9.2009.

    29.8.2008.

    Truvada

    Gilead Sciences International Limited

    Cambridge CB21 6GT

    United Kingdom

    EU/1/04/305/001-002

    2.9.2009.

    29.8.2008.

    Neupro

    Schwarz Pharma Ltd

    Shannon Industrial Estate

    Co.Clare

    Ireland

    EU/1/05/331/038-055

    2.9.2009.

    29.8.2008.

    Neupro

    Schwarz Pharma Ltd

    Shannon Industrial Estate

    Co.Clare

    Ireland

    EU/1/05/331/001-055

    2.9.2009.

    —   Tirdzniecības atļaujas anulēšana (13. pants Regulā (EK) Nr. 726/2004)

    Lēmuma datums

    Zāļu nosaukums

    Tirdzniecības atļaujas turētājs

    Ieraksta numurs Kopienas reģistrā

    Paziņojuma datums

    22.8.2008.

    Protopy

    Astellas Pharma GmbH

    Neumarkter Str. 61

    D-81673 München

    EU/1/02/202/001-006

    26.8.2008.

    28.8.2008.

    Quintanrix

    GlaxoSmithKline Biologicals s.a.

    rue de l'Institut 89

    B-1330 Rixensart

    EU/1/04/301/001-005

    1.9.2008.

    —   Tirdzniecības atļaujas izmaiņas (38. pants Regulā (EK) Nr. 726/2004): Pieņemts

    Lēmuma datums

    Zāļu nosaukums

    Tirdzniecības atļaujas turētājs

    Ieraksta numurs Kopienas reģistrā

    Paziņojuma datums

    13.8.2008.

    Dexdomitor

    Orion Corporation

    Orionintie 1

    FI-02200 Espoo

    EU/2/02/033/001-002

    15.8.2008.

    22.8.2008.

    Suvaxyn Aujeszky

    Fort Dodge Animal Health Holland

    C.J. van Houtenlaan 36

    1381 CP Weesp

    Nederland

    EU/2/98/009/001-006

    26.8.2008.

    25.8.2008.

    Zubrin

    Schering-Plough Limited

    Schering-Plough House

    Shire Park

    Welwyn Garden City

    Hertfordshire AL7 1TW

    United Kingdom

    EU/2/00/028/002-008

    27.8.2008.

    25.8.2008.

    Circovac

    Merial

    29, Avenue Tony Garnier

    F-69007 Lyon

    EU/2/07/075/001-004

    27.8.2008.

    25.8.2008.

    Profender

    Bayer HealthCare AG

    D-51368 Leverkusen

    EU/2/05/054/018-031

    27.8.2008.

    Ja vēlaties apskatīt publisko novērtējuma ziņojumu par attiecīgajām zālēm un ar tām saistītos lēmumus, lūdzam sazināties ar

    The European Medicines Agency

    7 Westferry Circus

    Canary Wharf

    London E14 4HB

    United Kingdom

    (1)  OV L 136, 30.4.2004., 1. lpp.

    Top