Basic Information
Rydapt
Regulatory Information
EMEA/H/C/004095
September 18, 2017
June 22, 2017
13
December 12, 2024
Company Information
United Kingdom
Frimley Business Park Camberley GU16 7SR
Novartis Europharm Ltd.
Drug Classification
Active Substances Detail
EMA Resources
Detailed Information
Therapeutic Indication
### 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).
Overview Summary
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.