Galafold
·
- Prescription status not stated
- Digestion, stomach, diabetes and nutrition
- Active substance
- Migalastat
- Made by
- Amicus Therapeutics Europe Limited
- Source
- Official label
Quoted from the official source. Not yet reviewed by Mediclarum — the leaflet in your pack is authoritative.
What it is 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).
From the official label · 2026-09-30 · European Medicines Agency
Same active substance, strength and form in other countries
Matched on active substance, strength and kind of form only. This is not a statement that the products are equivalent or interchangeable: other ingredients, release and approved uses can differ — ask a pharmacist before swapping.
Medicine passport: one printable page to show a pharmacist abroad
United StatesNo exact match for this strength and form
SpainNo exact match for this strength and form
Details
| Made by | Amicus Therapeutics Europe Limited |
|---|---|
| Active substance | Migalastat |
| Used in | Digestion, stomach, diabetes and nutrition |
| Classification | A16AX · Digestion, stomach, diabetes and nutrition |
| Additional monitoring ▼ | Yes — under additional monitoring (black triangle). Report suspected side effects. |
| Authorised on | 2016-05-25 |
| Last updated by the regulator | 2025-08-25 |
| EMA product number | EMEA/H/C/004059 |
Source: European Medicines Agency — medicine data · 2026-09-30 · not reviewed by a clinician
Source: European Medicines Agency (EMA). Product information as published by EMA. Reuse terms: EMA legal notice (reproduction authorised).