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.
Rydapt : EPAR - Summary for the public (PDF/78.59 KB)
First published: 25/10/2017
Last updated: 25/10/2017
Rydapt - EPAR - Risk-management plan summary (PDF/73.91 KB)
First published: 12/10/2020
Last updated: 01/02/2021
|Agency product number||
|International non-proprietary name (INN) or common name||
|Therapeutic area (MeSH)||
|Anatomical therapeutic chemical (ATC) code||
Novartis Europharm Ltd
|Date of issue of marketing authorisation valid throughout the European Union||
Frimley Business Park
Camberley GU16 7SR
22/01/2021 Rydapt - EMEA/H/C/004095 - II/0014
- Annex I - Summary of product characteristics
- Annex IIA - Manufacturing-authorisation holder responsible for batch release
- Annex IIB - Conditions of the marketing authorisation
- Annex IIIA - Labelling
- Annex IIIB - Package leaflet
Please note that the size of the above document can exceed 50 pages.
You are therefore advised to be selective about which sections or pages you wish to print.
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).