Migalastat
Various Alimentary Tract and Metabolism Products
Sold as GALAFOLD
- Drug class
- Various Alimentary Tract and Metabolism Products
- Availability
- See label
- Routes
- Oral
- Markets covered
- 3
- Products on record
- 3
Overview
Migalastat is an active pharmaceutical ingredient in the Various Alimentary Tract and Metabolism Products group (A16AX). The information below is compiled per regulator from the product labels on record, with direct links to the original documents.
Regulatory status by market
| Market | Regulator | Products | Last revision |
|---|---|---|---|
| GB United Kingdom | MHRA | 1 | May 15, 2026 |
| CA Canada | Health Canada | 1 | April 15, 2026 |
| EU European Union | EMA | 1 | August 25, 2025 |
GBUnited Kingdom· MHRA
1 product
Uses
1).
How to take
CACanada· Health Canada
1 product
Uses
1 Mechanism of Action - Table 5). 1 Pediatrics 12 to < 18 years of age: Based on the data submitted and reviewed by Health Canada, the safety and efficacy of GALAFOLD in pediatric patients 12 to < 18 years and weighing ≥ 45 kg have been established.
2 Study Results, Pediatric Population). < 12 years of age: GALAFOLD has not been authorized for use in pediatric patients less than 12 years of age. 2 Geriatrics > 65 years of age: Evidence from clinical studies and experience suggests that use in the geriatric population is not associated with differences in safety or effectiveness.
How to take
EUEuropean Union· EMA
1 product
Uses
1).
How to take
Drug interactions
Known interactions involving Migalastat. Select one for details. This list is informational and not a complete interaction checker.
Interaction data compiled from DDInter (academic, CC-BY). Severity classification only - this is not a complete interaction checker and not medical advice.
Sources & citations
- [1]MHRA (UK) · PLGB258230002 · revised May 15, 2026
- [2]Health Canada (DPD) · 02468042 · revised April 15, 2026
- [3]European Medicines Agency · EMEA/H/C/004059 · revised August 25, 2025
Information on this page is compiled from public regulatory records. Drugvu is not affiliated with any regulator or pharmaceutical manufacturer. This is not medical advice. Always consult a qualified healthcare professional.