MYLOTARG (Pfizer Australia Pty Ltd)
Product name
MYLOTARG
Sponsor
Date registered
Evaluation commenced
Decision date
Approval time
175 working days (255)
Active ingredients
gemtuzumab ozogamicin
Registration type
NCE/NBE
Indication
MYLOTARG (powder for injection) is indicated for combination therapy with standard anthracycline and cytarabine (AraC) for the treatment of patients age 15 years and above with previously untreated, de novo CD33-positive acute myeloid leukaemia (AML), except acute promyelocytic leukaemia (APL) (see Section 4.4 Special warnings and precautions for use, and Section 5.1 Pharmacodynamic properties).