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 23/09/2022

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
OrphanOrphan

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
9
Date of issue of marketing authorisation valid throughout the European Union
18/09/2017
Contact address

Frimley Business Park
Camberley GU16 7SR
United Kingdom

Product information

15/09/2022 Rydapt - EMEA/H/C/004095 - II/0024

Other EU languages available icon This medicine’s product information is available in all official EU languages.
Select ‘available languages’ to access the language you need.

 

Product information documents contain:

You can find product information documents for centrally authorised human medicines on this website. For centrally authorised veterinary medicines authorised or updated from February 2022, see the Veterinary Medicines Information website.

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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