Rydapt
midostaurin
Table of contents
Overview
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.
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List item
Rydapt : EPAR - Summary for the public (PDF/78.59 KB)
First published: 25/10/2017
Last updated: 25/10/2017
EMA/471783/2017 -
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List item
Rydapt - EPAR - Risk-management plan summary (PDF/73.91 KB) (updated)
First published: 12/10/2020
Last updated: 01/02/2021
Authorisation details
Product details | |
---|---|
Name |
Rydapt
|
Agency product number |
EMEA/H/C/004095
|
Active substance |
Midostaurin
|
International non-proprietary name (INN) or common name |
midostaurin
|
Therapeutic area (MeSH) |
|
Anatomical therapeutic chemical (ATC) code |
L01XE
|
Additional monitoring |
This medicine is under additional monitoring, meaning that it is monitored even more intensively than other medicines. For more information, see Medicines under additional monitoring. |
Orphan |
This medicine was designated an orphan medicine. This means that it was developed for use against a rare, life-threatening or chronically debilitating condition or, for economic reasons, it would be unlikely to have been developed without incentives. For more information, see Orphan designation. |
Publication details | |
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Marketing-authorisation holder |
Novartis Europharm Ltd
|
Revision |
4
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Date of issue of marketing authorisation valid throughout the European Union |
18/09/2017
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Contact address |
Product information
22/01/2021 Rydapt - EMEA/H/C/004095 - II/0014
Contents
- 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.
Pharmacotherapeutic group
Antineoplastic agents
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).