Is Fedratinib approved by the US FDA?

Drugs@FDA lists 1 application product line for Fedratinib, including INREBIC (Prescription).

Is Fedratinib authorised in the European Union?

EMA lists 1 centrally authorised medicine containing Fedratinib: Inrebic.

Are there safety signals or safety updates for Fedratinib?

US FDA: 1 entry (latest 2026-07-20).

Active substance

Fedratinib

US FDA 1
EMA 1
Health Canada 1
Safety 1

Open in the medicines table

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

Product	Strength	Form · route	Applicant	Status	First approved
INREBIC	EQ 100MG BASE	capsule · oral	BRISTOL-MYERS	Prescription	16 Aug 2019

EMA European Union — centrally authorised medicines

Inrebic Bristol Myers Squibb Pharma EEIG · Authorised · authorised 8 Feb 2021 · ATC L01EJ02

Therapeutic indication (EMA)

Inrebic is indicated for the treatment of disease-related splenomegaly or symptoms in adult patients with primary myelofibrosis, post polycythaemia vera myelofibrosis or post essential thrombocythaemia myelofibrosis who are Janus Associated Kinase (JAK) inhibitor naïve or have been treated with ruxolitinib.

Canada Canada — marketed products (Health Canada)

Brand	DIN	Strength	Form · route	Company
INREBIC	02502445	100 MG	CAPSULE · ORAL	BRISTOL-MYERS SQUIBB CANADA

Safety signals and safety-related labeling changes

US FDA 20 Jul 2026 INREBIC — safety-related labeling change
Labeling sections changed: Boxed Warning; Warnings and Precautions; Adverse Reactions; Drug Interactions; Patient Counseling Information / Patient Information / Medication Guide

All safety entries for fedratinib →

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.