DASATINIB RBX, DASATINIB SUN, DASATINIB RAN (Sun Pharma ANZ Pty Ltd)
Product name
DASATINIB RBX, DASATINIB SUN, DASATINIB RAN
Sponsor
Date registered
Evaluation commenced
Decision date
Approval time
130 (255 working days)
Active ingredients
Dasatinib
Registration type
New generic medicine
Indication
DASATINIB RBX, DASATINIB SUN, DASATINIB RAN 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 RBX, DASATINIB SUN, DASATINIB RAN is indicated for the treatment of paediatric patients with:
- Ph+ CML in the chronic phase.
- newly diagnosed Ph+ ALL in combination with chemotherapy.