Mylotarg
Country: European Union
Language: English
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:
Antineoplastic agents
Therapeutic area:
Leukemia, Myeloid, Acute
Therapeutic indications:
re-induction treatment of CD33-positive AML adult patients in first relapse who are not candidates for other intensive re-induction chemotherapy regimens (e.g. high-dose Ara-C) and meet at least one of the following criteria: duration of first remission 60 years.
Authorization status:
Refused
