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DASATINIB-TEVA, TE-DASATINIB (Teva Pharma Australia Pty Ltd)
Product name
DASATINIB-TEVA, TE-DASATINIB
Sponsor
Date registered
Evaluation commenced
Decision date
Approval time
163 (175 working days)
Active ingredients
dasatinib
Registration type
New generic medicine
Indication
DASATINIB-TEVA, TE-DASATINI (tablet) 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.
- newly diagnosed Philadelphia chromosome positive acute lymphoblastic leukaemia integrated with chemotherapy.
- Philadelphia chromosome positive acute lymphoblastic leukaemia with resistance or intolerance to prior therapy.
Dasatinib is indicated for the treatment of paediatric patients with:
- Ph+ CML in the chronic phase.
- newly diagnosed Ph+ ALL in combination with chemotherapy.