Is Migalastat approved by the US FDA?

Drugs@FDA lists 1 application product line for Migalastat, including GALAFOLD (Prescription).

Is Migalastat authorised in the European Union?

EMA lists 1 centrally authorised medicine containing Migalastat: Galafold.

Are there safety signals or safety updates for Migalastat?

US FDA: 1 entry (latest 2025-03-19).

Active substance

Migalastat

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
GALAFOLD	EQ 123MG BASE	capsule · oral	AMICUS THERAP US	Prescription	10 Aug 2018

EMA European Union — centrally authorised medicines

Galafold Amicus Therapeutics Europe Limited · Authorised · authorised 25 May 2016 · ATC A16AX

Therapeutic indication (EMA)

Galafold is indicated for long-term treatment of adults and adolescents aged 12 years and older with a confirmed diagnosis of Fabry disease (α-galactosidase A deficiency) and who have an amenable mutation (see the tables in section 5.1).

Canada Canada — marketed products (Health Canada)

Brand	DIN	Strength	Form · route	Company
GALAFOLD	02468042	123 MG	CAPSULE · ORAL	AMICUS THERAPEUTICS CANADA INC.

Safety signals and safety-related labeling changes

US FDA 19 Mar 2025 GALAFOLD — safety-related labeling change
Labeling sections changed: Adverse Reactions; Drug Interactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide

All safety entries for migalastat →

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.