Galafold (migalastat)
- Region
- 🇪🇺 EU
- Active substance
- migalastat
- Company
- Amicus Therapeutics Europe Limited
- Status
- Authorised
- Therapeutic area
- Fabry Disease
- CHMP opinion
- Wed 30 Mar 2016
- EU approval
- Wed 25 May 2016
- Application
- EMEA/H/C/004059
- ATC
- A16AX
- Official record
- www.ema.europa.eu
Indication
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).
Regulatory milestones
No milestones recorded in the last year.
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Information from official EMA, FDA, Federal Register and SEC records. Dates marked company-announced come from the company's own SEC filing; dates marked estimate are calculated, not official. Not investment or medical advice; always confirm on the source.