Mylotarg
Country: European Union
Language: Spanish
Source: EMA (European Medicines Agency)
Public Assessment Report
(PAR)
24-01-2008
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Active ingredient:
gemtuzumab ozogamicina
Available from:
Wyeth Europa Ltd
ATC code:
L01XC05
INN (International Name):
gemtuzumab ozogamicin
Therapeutic group:
Agentes antineoplásicos
Therapeutic area:
Leucemia, mieloide, aguda
Therapeutic indications:
re-tratamiento de inducción de CD33-LMA positiva pacientes adultos en primera recaída que no son candidatos para otros intensivo de re-inducción regímenes de quimioterapia (e. altas dosis de Ara-C) y cumplir con al menos uno de los siguientes criterios: duración de la primera remisión de 60 años.
Authorization status:
Rehusó
