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
Miglustat Capsules are indicated for the oral treatment of adult patients with mild to moderate type 1 Gaucher disease. 1). 1).
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
OPFOLDA (miglustat capsules) is an enzyme stabilizer indicated in combination with POMBILITI (cipaglucosidase alfa) for the treatment of adult patients with late-onset Pompe disease (acid α-glucosidase [GAA] deficiency) weighing ≥40 kg.
OPFOLDA must be used in combination with cipaglucosidase alfa. Consult the Product Monograph of POMBILITI (cipaglucosidase alfa) for detailed information. 1 Pediatrics Pediatrics (<18 years of age): No data are available to Health Canada; therefore, Health Canada has not authorized an indication for pediatric use.
3 Pharmacokinetics).
How to take
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) · PL200751246 · revised May 1, 2026
- [2]European Medicines Agency · EMEA/H/C/000435 · revised January 28, 2026
- [3]Health Canada (DPD) · 02556812 · revised December 16, 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.