Is Miglustat registered with the SFDA?

The SFDA human drug list (edition 4-2026, as published by the Council of Health Insurance) lists 1 valid registration of Miglustat, including Miglustat Gen Orph (100 mg, Capsule, hard, SAR 27630.75).

Is Miglustat approved by the US FDA?

Drugs@FDA lists 6 application product lines for Miglustat, including ZAVESCA (Prescription); MIGLUSTAT (Prescription); YARGESA (Prescription); OPFOLDA (Prescription); MIGLUSTAT (Prescription).

Is Miglustat authorised in the European Union?

EMA lists 5 centrally authorised medicines containing Miglustat: Zavesca, Yargesa, Miglustat Gen.Orph, Miglustat Dipharma, Opfolda.

Are there safety signals or safety updates for Miglustat?

US FDA: 2 entries (latest 2024-07-25).

Active substance

Miglustat

SFDA 1
US FDA 6
EMA 5
Health Canada 3
Safety 2

Open in the medicines table

SFDA Saudi Arabia — SFDA human drug list

Trade name	Strength	Form · route	Pack	Public price	Type	Company	Status
Miglustat Gen Orph	100 mg	Capsule, hard · Oral use	84 Blister	SAR 27630.75	Generic · Prescription	Gen.Orph	Valid

US FDA United States — FDA approvals (Drugs@FDA)

Product	Strength	Form · route	Applicant	Status	First approved
ZAVESCA	100MG	capsule · oral	ACTELION	Prescription	31 Jul 2003
MIGLUSTAT	100MG	capsule · oral	ANI PHARMS	Prescription	17 Apr 2018
YARGESA	100MG	capsule · oral	EDENBRIDGE PHARMS	Prescription	6 Aug 2020
OPFOLDA	65MG	capsule · oral	AMICUS THERAP US	Prescription	28 Sep 2023
MIGLUSTAT	100MG	capsule · oral	NAVINTA LLC	Prescription	14 Mar 2025
MIGLUSTAT	100MG	capsule · oral	CHARTWELL RX	Discontinued	3 Feb 2022

EMA European Union — centrally authorised medicines

Zavesca Advanz Pharma Limited · Authorised · authorised 20 Nov 2002 · ATC A16AX06

Therapeutic indication (EMA)

Zavesca is indicated for the oral treatment of adult patients with mild to moderate type-1 Gaucher disease. Zavesca may be used only in the treatment of patients for whom enzyme replacement therapy is unsuitable. Zavesca is indicated for the treatment of progressive neurological manifestations in adult patients and paediatric patients with Niemann-Pick type-C disease.

Yargesa Piramal Critical Care B.V. · Authorised · authorised 22 Mar 2017 · ATC A16AX06

Therapeutic indication (EMA)

Yargesa is indicated for the oral treatment of adult patients with mild to moderate type 1 Gaucher disease. Yargesa may be used only in the treatment of patients for whom enzyme replacement therapy is unsuitable. Yargesa is indicated for the treatment of progressive neurological manifestations in adult patients and paediatric patients with Niemann-Pick type C disease.

Miglustat Gen.Orph Gen.Orph · Authorised · authorised 9 Nov 2017 · ATC A16AX06

Therapeutic indication (EMA)

Miglustat Gen.Orph is indicated for the oral treatment of adult patients with mild to moderate type 1 Gaucher disease. Miglustat Gen.Orph may be used only in the treatment of patients for whom enzyme replacement therapy is unsuitable. Miglustat Gen.Orph is indicated for the treatment of progressive neurological manifestations in adult patients and paediatric patients with Niemann-Pick type C disease.

Miglustat Dipharma Dipharma Arzneimittel GmbH · Authorised · authorised 18 Feb 2019 · ATC A16AX06

Therapeutic indication (EMA)

Miglustat Dipharma is indicated for the oral treatment of adult patients with mild to moderate type 1 Gaucher disease. Miglustat Dipharma may be used only in the treatment of patients for whom enzyme replacement therapy is unsuitable. Miglustat Dipharma is indicated for the treatment of progressive neurological manifestations in adult patients and paediatric patients with Niemann-Pick type C disease.

Opfolda Amicus Therapeutics Europe Limited · Authorised · authorised 26 Jun 2023 · ATC A16AX06

Therapeutic indication (EMA)

Opfolda (miglustat) is an enzyme stabiliser of cipaglucosidase alfa long-term enzyme replacement therapy in adults with late-onset Pompe disease (acid ?- glucosidase [GAA] deficiency).

Canada Canada — marketed products (Health Canada)

Brand	DIN	Strength	Form · route	Company
OPFOLDA	02556812	65 MG	CAPSULE · ORAL	AMICUS THERAPEUTICS CANADA INC.
SANDOZ MIGLUSTAT	02456257	100 MG	CAPSULE · ORAL	SANDOZ CANADA INCORPORATED
ZAVESCA	02250519	100 MG	CAPSULE · ORAL	JANSSEN INC

Safety signals and safety-related labeling changes

US FDA 25 Jul 2024 OPFOLDA — safety-related labeling change
Labeling sections changed: Adverse Reactions
US FDA 8 Dec 2020 ZAVESCA — safety-related labeling change
Labeling sections changed: Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide

All safety entries for miglustat →

Values as published by each source: SFDA human drug list (4-2026, as published by the Council of Health Insurance; indications from the CHI Daman Drug Formulary), Drugs@FDA, EMA medicines data, Health Canada Drug Product Database (Open Government Licence – Canada), CMS NADAC, NHS Drug Tariff Part VIIIA (NHSBSA Copyright, Open Government Licence v3.0), WHO Model List of Essential Medicines (CC BY 3.0 IGO; regrouped by active substance, not created by WHO), EMA PRAC, US FDA safety-related labeling changes and MHRA Drug Safety Update (Open Government Licence v3.0). Sources and reuse. Not a substitute for the official registers or the product information.