Mylotarg
Country: European Union
Language: Maltese
Source: EMA (European Medicines Agency)
Public Assessment Report
(PAR)
24-01-2008
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Active ingredient:
gemtuzumab ozogamicin
Available from:
Wyeth Europa Ltd
ATC code:
L01XC05
INN (International Name):
gemtuzumab ozogamicin
Therapeutic group:
Aġenti antineoplastiċi
Therapeutic area:
Lewkimja, Mijelojda, Akuta
Therapeutic indications:
mill-ġdid tal-kura ta 'induzzjoni ta CD33-pożittivi AML f'pazjenti adulti fl-ewwel rikaduta li mhumiex kandidati għall-oħra intensiv mill-ġdid l-induzzjoni ta' kimoterapija (e. doża għolja Ara-C) u tissodisfax mill-inqas wieħed mill-kriterji li ġejjin: t-tul ta'l-ewwel remissjoni 60 sena.
Authorization status:
Miċħuda
