Is Ivosidenib 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 Ivosidenib, including TIBSOVO (250 mg, Film-coated tablet, SAR 78081.35).

Is Ivosidenib approved by the US FDA?

Drugs@FDA lists 1 application product line for Ivosidenib, including TIBSOVO (Prescription).

Is Ivosidenib authorised in the European Union?

EMA lists 1 centrally authorised medicine containing Ivosidenib: Tibsovo.

Are there safety signals or safety updates for Ivosidenib?

US FDA: 1 entry (latest 2023-10-24).

Active substance

Ivosidenib

SFDA 1
US FDA 1
EMA 3
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
TIBSOVO	250 mg	Film-coated tablet · Oral use	60 Bottle	SAR 78081.35	NCE · Prescription	LES LABORATOIRES SERVIER	Valid

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

Product	Strength	Form · route	Applicant	Status	First approved
TIBSOVO	250MG	tablet · oral	SERVIER	Prescription	20 Jul 2018

EMA European Union — centrally authorised medicines

Tibsovo Les Laboratoires Servier · Authorised · authorised 4 May 2023 · ATC L01XM02

Therapeutic indication (EMA)

Tibsovo in combination with azacitidine is indicated for the treatment of adult patients with newly diagnosed acute myeloid leukaemia (AML) with an isocitrate dehydrogenase-1 (IDH1) R132 mutation who are not eligible to receive standard induction chemotherapy (see section 5.1). Tibsovo monotherapy is indicated for the treatment of adult patients with locally advanced or metastatic cholangiocarcinoma with an IDH1 R132 mutation who were previously treated by at least one prior line of systemic therapy.

Tibsovo Agios Netherlands B.V. · Application withdrawn · ATC L01XX62

Therapeutic indication (EMA)

Treatment of adult patients with newly diagnosed acute myeloid leukaemia (AML) and locally advanced or metastatic cholangiocarcinoma

Tidhesco Les Laboratoires Servier · Application withdrawn · ATC L01XX62

Therapeutic indication (EMA)

Treatment of newly diagnosed acute myeloid leukaemia

Canada Canada — marketed products (Health Canada)

Brand	DIN	Strength	Form · route	Company
TIBSOVO	02549980	250 MG	TABLET (IMMEDIATE-RELEASE) · ORAL	SERVIER CANADA INC

Safety signals and safety-related labeling changes

US FDA 24 Oct 2023 TIBSOVO — safety-related labeling change
Labeling sections changed: Warnings and Precautions; Adverse Reactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide

All safety entries for ivosidenib →

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.