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Document 52004XC0625(01)

    Kopsavilkums par Kopienas lēmumiem attiecībā uz zāļu tirdzniecības atļaujām no 15.05.2004. līdz 15.06.2004. (Publicēts atbilstīgi 12. vai 34. pantam Padomes Regulā (EEK) Nr. 2309/93 )

    OV 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   

    LV

    Eiropas Savienības Oficiālais Vēstnesis

    C 166/2


    Kopsavilkums par Kopienas lēmumiem attiecībā uz zāļu tirdzniecības atļaujām no 15.05.2004. līdz 15.06.2004.

    (Publicēts atbilstīgi 12. vai 34. pantam Padomes Regulā (EEK) Nr. 2309/93 (1) )

    (2004/C 166/02)

    Tirdzniecības atļaujas izsniegšana (12. pants Padomes Regulā (EEK) Nr. 2309/93) Pieņemts

    Lēmuma datums

    Zāļu nosaukums

    Tirdzniecības atļaujas turētājs

    Ieraksta numurs Kopienas reģistrā

    Paziņojuma datums

    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

    Tirdzniecības atļaujas izmaiņas (12. pants Padomes Regulā (EEK) Nr. 2309/93) Pieņemts

    Lēmuma datums

    Zāļu nosaukums

    Tirdzniecības atļaujas turētājs

    Ieraksta numurs Kopienas reģistrā

    Paziņojuma datums

    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,

    Deutschland

    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


    (1)  OV L 214, 24.8.1993., 1. lpp.


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