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Document 52004XC0625(01)

    Summary of Community decisions on marketing authorizations in respect of medicinal products from 15/05/2004 to 15/06/2004 (Published pursuant to Article 12 or Article 34 of Council Regulation (EEC) No 2309/93)

    IO C 166, 25.6.2004, p. 2–4 (ES, CS, DA, DE, ET, EL, EN, FR, IT, LV, LT, HU, NL, PL, PT, SK, SL, FI, SV)

    25.6.2004   

    EN

    Official Journal of the European Union

    C 166/2

    Summary of Community decisions on marketing authorizations in respect of medicinal products from 15/05/2004 to 15/06/2004

    (Published pursuant to Article 12 or Article 34 of Council Regulation (EEC) No 2309/93)

    (2004/C 166/02)

    Issuing of a marketing authorization (Article 12 of Council Regulation (EEC) No 2309/93) 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

    01.06.2004

    Levemir

    Novo Nordisk A/S,

    Novo Allé,

    DK-2880 Bagsvaerd,

    EU/01/04/278/001-009

    04.06.2004

    04.06.2004

    Abilifly

    Otsuka Pharmaceutical Europe Ltd,

    Common-wealth House,

    2 Chalkhill Road,

    Hammersmith,

    London W6 8DW,

    United Kingdom

    EU/1/04/276/001-020

    08.06.2004

    08.06.2004

    TachoSil

    Nycomed Austria GMBH,

    St.-Peter-Strasse 25,

    A-4020 Linz,

    EU/1/04/277/001-004

    11.06.2004

    15.06.2004

    Oxybutynin

    Nicobrand Limited,

    189 Casteroe Road,

    Coleraine,

    Northerne Ireland

    EU/1/03/270/001-002

    18.06.2004

    Modification of a marketing authorization (Article 12 of Council Regulation (EEC) No 2309/93) 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

    19.05.2004

    Protopic

    Fujisawa GmbH,

    Neumarkter Str. 61,

    D-81673 München,

    EU/1/02/201/001-006

    25.05.2004

    25.05.2004

    Hepsera

    Gilead Sciences International Limited,

    Cambridge CB1 6GT

    United Kingdom

    EU/1/03/251/001

    27.05.2004

    26.05.2004

    Viagra

    Pfizer Limited,

    Sandwich,

    Kent CT13 9NJ,

    United Kingdom

    EU/1/98/077/001-012

    01.06.2004

    26.05.2004

    Combivir

    Glaxo Group Ltd.,

    Greenford Road,

    Greenford,

    Middlesex UB6 0NN

    United Kingdom

    EU/1/98/058/001-002

    01.06.2004

    26.05.2004

    Ziagen

    Glaxo Group Ltd,

    Greenford,

    Middlesex UB6 0NN,

    United Kingdom

    EU/1/99/112/001-002

    01.06.2004

    26.05.2004

    Taxotere

    Aventis Pharma S.A.,

    20 avenue Raymond Aron,

    92165 Antony Cedex, France

    EU/1/95/002/001-002

    01.06.2004

    26.05.2004

    TRIZIVIR

    Glaxo Group Ltd,

    Greenford,

    Middlesex UB6 0NN,

    United Kingdom

    EU/1/00/156/001-003

    01.06.2004

    01.06.2004

    Vivanza

    Bayer AG,

    D-51368 Leverkusen,

    EU/1/03/249/001-012

    07.06.2004

    01.06.2004

    Levitra

    Bayer AG,

    D-51368 Leverkusen,

    EU/1/03/248/001-012

    07.06.2004

    01.06.2004

    Epivir

    Glaxo Group Ltd.,

    Greenford Road,

    Greenford,

    Middlesex UB6 0NN,

    United Kingdom

    EU/1/96/015/001-005

    07.06.2004

    08.06.2004

    Remicade

    Centocor B.V.,

    Einsteinweg 101,

    2333 CB Leiden,

    Nederland

    EU/1/99/116/001-003

    10.06.2004

    08.06.2004

    Remicade

    Centocor B.V.,

    Einsteinweg 101,

    2333 CB Leiden,

    Nederland

    EU/1/99/116/001-003

    10.06.2004

    08.06.2004

    Fuzeon

    Roche Registration Limited,

    40 Broadwater Road,

    Welwyn Garden City,

    Hertfordshire AL7 3AY,

    United Kingdom

    EU/1/03/252/001-003

    10.06.2004

    08.06.2004

    Arava

    Aventis Pharma Deutschland GmbH,

    D-65926 Frankfurt am Main,

    EU/1/99/118/001-010/

    18.06.2004

    08.06.2004

    Vfend

    Pfizer Limited,

    Sandwich,

    Kent CT13 9NJ,

    United Kingdom

    EU/1/02/212/001-026

    10.06.2004

    09.06.2004

    Vfend

    Pfizer Limited,

    Sandwich,

    Kent CT13 9NJ,

    United Kingdom

    EU/1/02/212/001-026

    11.06.2004

    10.06.2004

    Arava

    Aventis Pharma Deutschland GmbH,

    D-65926 Frankfurt am Main,

    EU/1/99/118/001-010/

    16.06.2004

    10.06.2004

    Viread

    Gilead Sciences International Limited,

    Cambridge CB1 6GT

    United Kingdom

    EU/1/01/200/001

    14.06.2004

    10.06.2004

    Viread

    Gilead Sciences International Limited,

    Cambridge CB1 6GT

    United Kingdom

    EU/1/01/200/001

    15.06.2004

    10.06.2004

    Herceptin

    Roche Registration Limited,

    40 Broadwater Road,

    Welwyn Garden City,

    Hertfordshire AL7 3AY,

    United Kingdom

    EU/1/00/145/001

    14.06.2004

    10.06.2004

    Humira

    Abbott Laboratories Ltd.,

    Queenborough,

    Kent ME11 5EL,

    United Kingdom

    EU/1/03/256/001-006

    14.06.2004

    10.06.2004

    Trudexa

    Abbott Laboratories Ltd.,

    Queenborough,

    Kent ME11 5EL,

    United Kingdom

    EU/1/03/257/001-006

    14.06.2004

    15.06.2004

    Xigris

    Eli Lilly Nederland B.V.,

    Grootslag 1-5,

    3991 RA Houten,

    Nederland

    EU/1/02/225/001-002

    17.06.2004
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