Galafold
What Galafold is used for
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).
Approved use, as published by the European Medicines Agency.
Key facts
- Brand
- Galafold
- Active substance
- migalastat
- Disease area
- Fabry Disease
- Medicine group
- migalastat
- ATC code
- A16AX
- Marketing authorisation holder
- Amicus Therapeutics Europe Limited
- Authorised in the EU since
- 2016
Official information
Specialist medicine: started and supervised by a specialist doctor or hospital. This page is a plain-language summary of public official information, not medical advice; follow your doctor and the official product information.
Common questions
What is Galafold used for?
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).
What is the active substance in Galafold?
Galafold contains migalastat.
Who makes Galafold?
The EU marketing authorisation holder is Amicus Therapeutics Europe Limited.
Source: European Medicines Agency medicines data (ema.europa.eu), reproduced with acknowledgement of the source. Page made 5 November 2026 by Satya Babu.
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