Rydapt

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midostaurin

Authorised
This medicine is authorised for use in the European Union.

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.

This EPAR was last updated on 24/05/2018

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)
  • Leukemia, Myeloid, Acute
  • Mastocytosis
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
Marketing-authorisation holder
Novartis Europharm Ltd
Revision
2
Date of issue of marketing authorisation valid throughout the European Union
18/09/2017
Contact address
Frimley Business Park
Camberley GU16 7SR
United Kigdom

Product information

30/04/2018 Rydapt - EMEA/H/C/004095 - T/0003

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).

Assessment history

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