This is a summary of the European public assessment report (EPAR) for Rydapt. It explains how the Agency assessed the medicine to recommend its authorisation in the EU and its conditions of use. It is not intended to provide practical advice on how to use Rydapt. For practical information about using Rydapt, patients should read the package leaflet or contact their doctor or pharmacist.
Therapeutic Indication
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).
Therapeutic Area (MeSH)
ATC Code
L01XE
ATC Item
N/A
Pharmacotherapeutic Group
Antineoplastic agents
Active Substance (Summary)
INN / Common Names
EMA Name
Rydapt
Medicine Name
Rydapt
Aliases
N/ANo risk management plan link.
