Is Midostaurin registered with the SFDA?

The SFDA human drug list (edition 4-2026, as published by the Council of Health Insurance) lists 1 valid registration of Midostaurin, including Rydapt 25mg Soft Capsules (25 mg, Capsule, soft, SAR 58587.25).

Is Midostaurin approved by the US FDA?

Drugs@FDA lists 4 application product lines for Midostaurin, including RYDAPT (Prescription); MIDOSTAURIN (Prescription); MIDOSTAURIN (Prescription); MIDOSTAURIN (Discontinued).

Is Midostaurin authorised in the European Union?

EMA lists 1 centrally authorised medicine containing Midostaurin: Rydapt.

Are there safety signals or safety updates for Midostaurin?

US FDA: 1 entry (latest 2023-05-22).

Active substance

Midostaurin

SFDA 1
US FDA 4
EMA 1
Health Canada 1
Safety 1

Open in the medicines table

SFDA Saudi Arabia — SFDA human drug list

Trade name	Strength	Form · route	Pack	Public price	Type	Company	Status
Rydapt 25mg Soft Capsules	25 mg	Capsule, soft · Oral use	112 Blister	SAR 58587.25	NCE · Prescription	Novartis Europharm Limited	Valid

Indications — CHI Daman Drug Formulary

ADULT ACUTE MYELOID LEUKAEMIA (AML)

US FDA United States — FDA approvals (Drugs@FDA)

Product	Strength	Form · route	Applicant	Status	First approved
RYDAPT	25MG	capsule · oral	NOVARTIS	Prescription	28 Apr 2017
MIDOSTAURIN	25MG	capsule · oral	LUPIN	Prescription	10 May 2024
MIDOSTAURIN	25MG	capsule · oral	DR REDDYS	Prescription	28 Jun 2024
MIDOSTAURIN	25MG	capsule · oral	TEVA PHARMS	Discontinued	29 Apr 2024

EMA European Union — centrally authorised medicines

Rydapt Novartis Europharm Ltd · Authorised · authorised 18 Sep 2017 · ATC L01XE

Therapeutic indication (EMA)

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).

Canada Canada — marketed products (Health Canada)

Brand	DIN	Strength	Form · route	Company
RYDAPT	02466236	25 MG	CAPSULE · ORAL	NOVARTIS PHARMACEUTICALS CANADA INC

Safety signals and safety-related labeling changes

US FDA 22 May 2023 RYDAPT — safety-related labeling change
Labeling sections changed: Warnings and Precautions; Adverse Reactions; Drug Interactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide

All safety entries for midostaurin →

Values as published by each source: SFDA human drug list (4-2026, as published by the Council of Health Insurance; indications from the CHI Daman Drug Formulary), Drugs@FDA, EMA medicines data, Health Canada Drug Product Database (Open Government Licence – Canada), CMS NADAC, NHS Drug Tariff Part VIIIA (NHSBSA Copyright, Open Government Licence v3.0), WHO Model List of Essential Medicines (CC BY 3.0 IGO; regrouped by active substance, not created by WHO), EMA PRAC, US FDA safety-related labeling changes and MHRA Drug Safety Update (Open Government Licence v3.0). Sources and reuse. Not a substitute for the official registers or the product information.