Miglustat
Various Alimentary Tract and Metabolism Products
Sold as Zavesca · Yargesa · Opfolda
- Drug class
- Various Alimentary Tract and Metabolism Products
- Availability
- See label
- Routes
- Oral
- Markets covered
- 3
- Products on record
- 14
Overview
Miglustat 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 | 6 | May 1, 2026 |
| EU European Union | EMA | 5 | January 28, 2026 |
| CA Canada | Health Canada | 3 | December 16, 2025 |
GBUnited Kingdom· MHRA
6 products
Uses
Opfolda (miglustat) is an enzyme stabiliser of cipaglucosidase alfa long-term enzyme replacement therapy in adults with late-onset Pompe disease (acid α-glucosidase [GAA] deficiency).
How to take
EUEuropean Union· EMA
5 products
Uses
Zavesca is indicated for the oral treatment of adult patients with mild to moderate type 1 Gaucher disease. 1). 1).
How to take
CACanada· Health Canada
3 products
Uses
ZAVESCA® (miglustat) is indicated for: the treatment of adult patients with mild to moderate Type 1 Gaucher disease for whom enzyme replacement therapy is not a therapeutic option. slowing the progression of some of the neurological manifestations in adult and pediatric (4- 17 years of age) patients with Niemann-Pick Type C disease.
1 Pediatrics There is no experience with the use of ZAVESCA® in patients with type 1 Gaucher disease under the age of 18; therefore, Health Canada has not authorized this indication for pediatric use. Based on the data submitted and reviewed by Health Canada, the safety and efficacy of ZAVESCA® in pediatric patients aged 4 to 18 years with Niemann-Pick Type C disease has been established.
However, patients below 4 years of age were not enrolled in the prospective study of ZAVESCA® in Niemann-Pick Type C disease. Therefore, Health Canada has authorized this indication for use in pediatric patients aged 4 to 18 only. 2 Geriatrics No data are available to Health Canada; therefore, Health Canada has not authorized an indication for geriatric use.
Drug interactions
Known interactions involving Miglustat. 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) · PLGB258230004 · revised March 20, 2026
- [2]European Medicines Agency · EMEA/H/C/000435 · revised January 28, 2026
- [3]Health Canada (DPD) · 02250519 · revised March 22, 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.