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Document 52006XC1124(02)

    Summary of Community decisions on marketing authorizations in respect of medicinal products from 1.10.2006 to 31.10.2006 (Published pursuant to Article 13 or Article 38 of Regulation (EC) No 726/2004 of the European Parliament and of the Council)

    OJ C 287, 24.11.2006, p. 7–11 (ES, CS, DA, DE, ET, EL, EN, FR, IT, LV, LT, HU, NL, PL, PT, SK, SL, FI, SV)

    24.11.2006   

    EN

    Official Journal of the European Union

    C 287/7

    Summary of Community decisions on marketing authorizations in respect of medicinal products from 1.10.2006 to 31.10.2006

    (Published pursuant to Article 13 or Article 38 of Regulation (EC) No 726/2004 of the European Parliament and of the Council (1))

    (2006/C 287/03)

    —   Modification of a marketing authorization (Article 13 of Regulation (EC) No 726/2004 of the European Parliament and of the Council): Accepted

    Date of the decision

    Name of the medicinal product

    Holder of the marketing authorization

    Number of the entry in the Community Register

    Date of notification

    4.10.2006

    Abilify

    Otsuka Pharmaceutical Europe Ltd

    Hunton House

    Highbridge Business Park

    Oxford Road

    Uxbridge

    Middlesex UB8 1HU

    United Kingdom

    EU/1/04/276/036

    6.10.2006

    4.10.2006

    Abilify

    Otsuka Pharmaceutical Europe Ltd

    Hunton House

    Highbridge Business Park

    Oxford Road

    Uxbridge

    Middlesex UB8 1HU

    United Kingdom

    EU/1/04/276/036

    6.10.2006

    6.10.2006

    Travatan

    Alcon Laboratories (UK) Ltd.

    Boundary Way

    Hemel Hempstead

    Herts HP2 7UD

    United Kingdom

    EU/1/01/199/001-002

    10.10.2006

    11.10.2006

    Invirase

    Roche Registration Limited

    6 Falcon Way

    Shire Park

    Welwyn Garden City AL7 1TW

    United Kingdom

    EU/1/96/026/001-002

    13.10.2006

    17.10.2006

    Cetrotide

    Serono Europe Ltd.

    56, Marsh Wall

    London E14 9TP

    United Kingdom

    EU/1/99/100/001-003

    19.10.2006

    19.10.2006

    Zometa

    Novartis Europharm Limited

    Wimblehurst Road

    Horsham

    West Sussex RH12 5AB

    United Kingdom

    EU/1/01/176/001-006

    23.10.2006

    19.10.2006

    Zevalin

    Schering AG

    Müllerstrasse 170-178

    D-13342 Berlin

    EU/1/03/264/001

    23.10.2006

    20.10.2006

    Herceptin

    Roche Registration Limited

    6 Falcon Way

    Shire Park

    Welwyn Garden City AL7 1TW

    United Kingdom

    EU/1/00/145/001

    24.10.2006

    20.10.2006

    PritorPlus

    Bayer HealthCare AG

    D-51368 Leverkusen

    EU/1/02/215/001-012

    24.10.2006

    20.10.2006

    Enbrel

    Wyeth Europa Limited

    Huntercombe Lane South

    Taplow

    Maidenhead

    Berkshire, SL6 0PH

    United Kingdom

    EU/1/99/126/001-018

    24.10.2006

    20.10.2006

    Caelyx

    Schering Plough Europe

    Rue de Stalle 73

    B-1180 Bruxelles

    Stallestraat 73

    B-1180 Brussel

    EU/1/96/011/001-004

    24.10.2006

    20.10.2006

    Avonex

    Biogen Idec Ltd

    5 Roxborough Way

    Foundation Park

    Maidenhead

    Berkshire SL6 3UD

    United Kingdom

    EU/1/97/033/001-003

    24.10.2006

    20.10.2006

    Faslodex

    AstraZeneca UK Limited

    Alderley Park

    Macclesfield

    Cheshire SK10 4TG

    United Kingdom

    EU/1/03/269/001

    24.10.2006

    20.10.2006

    ViraferonPeg

    Schering Plough Europe

    Rue de Stalle, 73

    B-1180 Bruxelles

    Stallestraat 73

    B-1180 Brussel

    EU/1/00/132/001-050

    24.10.2006

    23.10.2006

    Taxotere

    Aventis Pharma S.A., 20 Avenue Raymond Aron, Antony Cedex 92165, France

    EU/1/95/002/001-002

    25.10.2006

    23.10.2006

    PhotoBarr

    Axcan Pharma International BV

    Engelenkampstraat 72

    6131 JJ Sittard

    Nederland

    EU/1/04/272/001-002

    25.10.2006

    23.10.2006

    Dynepo

    Shire Pharmaceutical Contracts Ltd

    Hampshire International Business Park

    Chineham

    Basingstoke

    Hampshire RG24 8EP

    United Kingdom

    EU/1/02/211/001-005

    26.10.2006

    24.10.2006

    PegIntron

    Schering Plough Europe

    Rue de Stalle, 73

    B-1180 Bruxelles

    Stallestraat 73

    B-1180 Brussel

    EU/1/00/131/001-050

    25.10.2006

    24.10.2006

    AVANDIA

    SmithKline Beecham plc

    980 Great West Road

    Brentford

    Middlesex TW8 9GS

    United Kingdom

    EU/1/00/137/002-018

    26.10.2006

    24.10.2006

    Aclasta

    Novartis Europharm Limited

    Wimblehurst Road

    Horsham West

    Sussex RH12 5AB

    United Kingdom

    EU/1/05/308/001-002

    26.10.2006

    24.10.2006

    Prometax

    Novartis Europharm Limited

    Wimblehurst Road

    Horsham West

    Sussex RH12 5AB

    United Kingdom

    EU/1/98/092/001-018

    26.10.2006

    24.10.2006

    Invanz

    Merck Sharp & Dohme Ltd

    Hertford Road

    Hoddesdon

    Hertfordshire EN11 9BU

    United Kingdom

    EU/1/02/216/001-002

    26.10.2006

    24.10.2006

    Apidra

    Sanofi-Aventis Deutschland GmbH

    Brueningstrasse, 50

    D-65926 Frankfurt am Main

    EU/1/04/285/013-020

    26.10.2006

    24.10.2006

    Fuzeon

    Roche Registration Limited

    6 Falcon Way

    Shire Park

    Welwyn Garden City AL7 1TW

    United Kingdom

    EU/1/03/252/001-003

    26.10.2006

    24.10.2006

    Avandamet

    SmithKline Beecham plc

    980 Great West Road

    Brentford

    Middlesex TW8 9GS

    United Kingdom

    EU/1/03/258/001-022

    26.10.2006

    26.10.2006

    Ketek

    Aventis Pharma S.A.

    20 Avenue Raymond Aron

    F-92160 Antony

    EU/1/01/191/001-005

    30.10.2006

    26.10.2006

    Levviax

    Aventis Pharma S.A.

    20 Avenue Raymond Aron

    F-92160 Antony

    EU/1/01/192/001-005

    30.10.2006

    26.10.2006

    Actos

    Takeda Global Research and Development Centre (Europe) Ltd, Arundel Great Court

    2 Arundel Street

    London WC2R 3DA

    United Kingdom

    EU/1/00/150/001-024

    30.10.2006

    26.10.2006

    Glustin

    Takeda Global Research and Development Centre (Europe) Ltd

    Arundel Great Court

    2 Arundel Street

    London WC2R 3DA

    United Kingdom

    EU/1/00/151/001-022

    30.10.2006

    26.10.2006

    Sustiva

    Bristol-Myers Squibb Pharma EEIG

    Uxbridge Business Park

    Sanderson Road

    Uxbridge UD8 1DH

    United Kingdom

    EU/1/99/110/001-009

    30.10.2006

    26.10.2006

    Stocrin

    Merck Sharp & Dohme Ltd

    Hertford Road

    Hoddesdon

    Hertfordshire EN11 9BU

    United Kingdom

    EU/1/99/111/001-009

    30.10.2006

    26.10.2006

    Exelon

    Novartis Europharm Limited

    Wimblehurst Road

    Horsham West

    Sussex RH12 5AB

    United Kingdom

    EU/1/98/066/001-018

    30.10.2006

    26.10.2006

    Helixate NexGen

    Bayer AG

    D-51368 Leverkusen,

    EU/1/00/144/001-003

    30.10.2006

    26.10.2006

    Vfend

    Pfizer Limited, Sandwich

    Kent CT13 9NJ

    United Kingdom

    EU/1/02/212/001-026

    30.10.2006

    27.10.2006

    Pritor

    Bayer HealthCare AG

    D-51368 Leverkusen

    EU/1/98/089/001-019

    31.10.2006

    27.10.2006

    Ariclaim

    Eli Lilly Nederland B.V.

    Grootslag 1-5

    3991 RA Houten

    Nederland

    Boehringer Ingelheim International GmbH

    Binger Strasse 173

    D-55216 Ingelheim am Rhein

    EU/1/04/283/001-007

    31.10.2006

    27.10.2006

    Rebetol

    Schering Plough Europe

    Rue de Stalle 73

    B-1180 Bruxelles

    Stallestraat, 73

    B-1180 Brussel

    EU/1/99/107/001-005

    31.10.2006

    27.10.2006

    Remicade

    Centocor B.V.

    Einsteinweg 101

    2333 CB Leiden

    Nederland

    EU/1/99/116/001-003

    31.10.2006

    27.10.2006

    Avaglim

    SmithKline Beecham plc

    980 Great West Road

    Brentford

    Middlesex TW8 9GS

    United Kingdom

    EU/1/06/349/001-008

    31.10.2006

    27.10.2006

    Viramune

    Boehringer Ingelheim International GmbH

    Binger Strasse 173

    D-55216 Ingelheim am Rhein

    EU/1/97/055/001-003

    31.10.2006

    27.10.2006

    Invirase

    Roche Registration Limited

    6 Falcon Way

    Shire Park

    Welwyn Garden City AL7 1TW

    United Kingdom

    EU/1/96/026/001-002

    31.10.2006

    27.10.2006

    Tracleer

    Actelion Registration Ltd

    BSI Building 13th Floor

    389 Chiswick High Road

    London W4 4AL

    United Kingdom

    EU/1/02/220/001-005

    31.10.2006

    30.10.2006

    FOSAVANCE

    Merck Sharp & Dohme Ltd

    Hertford Road

    Hoddesdon

    Hertfordshire EN11 9BU

    United Kingdom

    EU/1/05/310/001-005

    1.11.2006

    30.10.2006

    Lyrica

    PFIZER Ltd, Ramsgate Road

    Sandwich

    Kent CT 13 9NJ

    United Kingdom

    EU/1/04/279/001-035

    1.11.2006

    30.10.2006

    NutropinAq

    IPSEN Limited, 190 Bath Road

    Slough, Berkshire SLI 3XE

    United Kingdom

    EU/1/00/164/003-005

    1.11.2006

    30.10.2006

    Keppra

    UCB S.A.

    Allée de la recherche 60

    B-Bruxelles 1070

    Researchdreef, 60

    B-Brussel 1070

    EU/1/00/146/001-030

    3.11.2006

    30.10.2006

    Noxafil

    SP Europe

    Rue de Stalle, 73

    B-1180 Bruxelles

    Stallestraat 73

    B-1180 Brussel

    EU/1/05/320/001

    2.11.2006

    30.10.2006

    Posaconazole SP

    SP Europe

    Rue de Stalle 73

    B-1180 Bruxelles

    Stallestraat 73 — B-1180 Brussel

    EU/1/05/321/001

    2.11.2006

    30.10.2006

    Nespo

    Dompé Biotec S.p.A.

    Via San Martino 12

    I-20122 Milano

    EU/1/01/184/001-068

    2.11.2006

    30.10.2006

    Aranesp

    Amgen Europe B.V.

    Minervum 7061

    4817 ZK Breda

    Nederland

    EU/1/01/185/001-068

    1.11.2006

    31.10.2006

    Lantus

    Sanofi-Aventis Deutschland GmbH

    D-65926 Frankfurt am Main

    EU/1/00/134/001-037

    14.11.2006

    31.10.2006

    Insuman

    Aventis Pharma Deutschland GmbH

    Brueningstrasse 50

    D-65926 Frankfurt am Main

    EU/1/97/030/065-084

    6.11.2006

    31.10.2006

    Optruma

    Eli Lilly Nederland BV

    Grootslag 1-5

    3991 RA Houten

    Nederland

    EU/1/98/074/001-004

    6.11.2006

    31.10.2006

    Evista

    Eli Lilly Nederland BV

    Grootslag 1-5

    3991 RA Houten

    Nederland

    EU/1/98/073/001-004

    6.11.2006

    31.10.2006

    Telzir

    Glaxo Group Ltd.

    Greenford Road

    Greenford

    Middlesex UB6 0NN

    United Kingdom

    EU/1/04/282/001-002

    7.11.2006

    Anyone wishing to consult the public assessment report on the medicinal products in question and the decisions relating thereto is invited to contact:

    The European Medicines Agency

    7, Westferry Circus, Canary Wharf

    London E14 4HB

    United Kingdom

    (1)  OJ L 136 of 30 April 2004, page 1

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