DASATINIB APOTEX, APO-DASATINIB (Apotex Pty Ltd)
Product name
DASATINIB APOTEX, APO-DASATINIB
Sponsor
Date registered
Evaluation commenced
Decision date
Approval time
245 working days (255)
Active ingredients
Dasatinib
Registration type
New generic medicine
Indication
DASATINIB APOTEX, APO-DASATINIB (tablets) is indicated for the treatment of adults aged 18 years or over with:
- newly diagnosed Philadelphia chromosome positive (Ph+) chronic myeloid leukaemia in the chronic phase.
- chronic, accelerated or myeloid or lymphoid blast phase chronic myeloid leukaemia with resistance or intolerance to prior therapy including imatinib.
- Philadelphia chromosome positive acute lymphoblastic leukaemia with resistance or intolerance to prior therapy.