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ARSENIC TRIOXIDE-AFT (AFT Pharmaceuticals Pty Ltd)
Product name
ARSENIC TRIOXIDE-AFT
Sponsor
Date registered
Evaluation commenced
Decision date
Approval time
145 (175 working days)
Active ingredients
arsenic trioxide
Registration type
New generic medicine
Indication
ARSENIC TRIOXIDE-AFT (concentrated injection) is indicated for the induction of remission and consolidation in patients with acute promyelocytic leukaemia (APL) who are refractory to, or have relapsed from, retinoid and anthracycline chemotherapy, and whose APL is characterised by the presence of the t(15:17) translocation or PML/RAR-alpha gene expression.
For the induction of remission and consolidation in patients with previously untreated acute promyelocytic leukaemia (APL) in combination with all-trans retinoic acid (ATRA) and/or chemotherapy and whose APL is characterised by the presence of the t(15:17) translocation or PML/RAR-alpha gene expression.