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🇪🇺EU · EMAAuthorisedATC: A16AXOrphan Medicine

Galafold(migalastat hydrochloride)

Fabry Disease

Marketing Authorisation Holder: Amicus Therapeutics Europe Limited

EMA Authorisation: 25/05/2016

INN: migalastat

Indication

Galafold is indicated for long-term treatment of adults and adolescents aged 16 years and older with a confirmed diagnosis of Fabry disease (?-galactosidase A deficiency) and who have an amenable mutation.

Official EMA Resources

View on EMA (ema.europa.eu)

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Medical disclaimer: This information is intended for qualified healthcare professionals. Always verify with the official EMA Summary of Product Characteristics (SmPC) before clinical use.