EMA Authorised: Galafold (migalastat hydrochloride) — Amicus Therapeutics Europe Limited

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Summary

The EMA authorised Galafold (migalastat hydrochloride) by Amicus Therapeutics Europe Limited for Fabry disease, with orphan medicine designation.

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Diseases / indications

• Fabry Disease

Drugs mentioned

• GALAFOLD (MIGALASTAT HYDROCHLORIDE)

Snippet

Status: Authorised. Therapeutic area: Fabry Disease. MAH: Amicus Therapeutics Europe Limited. Decision date: 22/08/2025. Orphan medicine