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RYDAPT (Novartis Pharmaceuticals Australia Pty Ltd)
Product name
RYDAPT
Date registered
Evaluation commenced
Decision date
Approval time
213 working days (255)
Active ingredients
midostaurin
Registration type
NCE/NBE
Indication
RYDAPT (capsules) is indicated for:
- adult patients with newly diagnosed acute myeloid leukemia (AML) who are FLT3 mutation-positive, in combination with standard anthracycline and cytarabine induction and cytarabine consolidation chemotherapy, followed in patients in complete response by single agent maintenance therapy; and,
- the treatment of adult patients with aggressive systemic mastocytosis (ASM), systemic mastocytosis with associated haematological neoplasms (SMAHB) or mast cell leukaemia (MCL)
Registration process
Orphan drug
Sponsors receive a fee waiver to help bring medicines for a small population to market.