Rydapt
What Rydapt is used for
Rydapt is indicated: in combination with standard daunorubicin and cytarabine induction and high dose cytarabine consolidation chemotherapy, and for patients in complete response followed by Rydapt single agent maintenance therapy, for adult patients with newly diagnosed acute myeloid leukaemia (AML) who are FLT3 mutation positive (see section 4.2); as monotherapy for the treatment of adult patients with aggressive systemic mastocytosis (ASM), systemic mastocytosis with associated haematological neoplasm (SM AHN), or mast cell leukaemia (MCL).
Approved use, as published by the European Medicines Agency.
What the labels mean
- Orphan medicine: for a rare disease (affecting no more than 5 in 10,000 people in the EU).
Key facts
- Brand
- Rydapt
- Active substance
- midostaurin
- Disease area
- Leukemia, Myeloid, Acute; Mastocytosis
- Medicine group
- Antineoplastic agents
- ATC code
- L01XE
- Marketing authorisation holder
- Novartis Europharm Ltd
- Authorised in the EU since
- 2017
Official information
Specialist medicine: started and supervised by a specialist doctor or hospital. This page is a plain-language summary of public official information, not medical advice; follow your doctor and the official product information.
Common questions
What is Rydapt used for?
Rydapt is indicated: in combination with standard daunorubicin and cytarabine induction and high dose cytarabine consolidation chemotherapy, and for patients in complete response followed by Rydapt single agent maintenance therapy, for adult patients with newly diagnosed acute myeloid leukaemia (AML) who are FLT3 mutation positive (see section 4.2); as monotherapy for the treatment of adult patients with aggressive systemic mastocytosis (ASM), systemic mastocytosis with associated haematological neoplasm (SM AHN), or mast cell leukaemia (MCL).
What is the active substance in Rydapt?
Rydapt contains midostaurin.
Who makes Rydapt?
The EU marketing authorisation holder is Novartis Europharm Ltd.
Is Rydapt an orphan medicine?
Yes. Rydapt is designated an orphan medicine in the EU, for a rare disease (Leukemia, Myeloid, Acute; Mastocytosis).
Source: European Medicines Agency medicines data (ema.europa.eu), reproduced with acknowledgement of the source. Page made 5 November 2026 by Satya Babu.
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