Is Alglucosidase alfa 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 Alglucosidase alfa, including MYOZYME 50mg Powder For Concentrate For Solution For Infusion (5 mg/ml, Powder for concentrate for solution for infusion, SAR 2606.00).

Is Alglucosidase alfa approved by the US FDA?

Drugs@FDA lists 2 application product lines for Alglucosidase alfa, including MYOZYME (Prescription); LUMIZYME (Prescription).

Is Alglucosidase alfa authorised in the European Union?

EMA lists 1 centrally authorised medicine containing Alglucosidase alfa: Myozyme.

Are there safety signals or safety updates for Alglucosidase alfa?

US FDA: 2 entries (latest 2024-12-30).

Active substance

Alglucosidase alfa

SFDA 1
US FDA 2
EMA 1
Health Canada 1
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
MYOZYME 50mg Powder For Concentrate For Solution For Infusion	5 mg/ml	Powder for concentrate for solution for infusion · Intravenous use	1 Vial	SAR 2606.00	Biological · Prescription	Sanofi B.V	Valid

Indications — CHI Daman Drug Formulary

POMPE DISEASE (IOPD/LOPD)

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

Product	Strength	Form · route	Applicant	Status	First approved
MYOZYME	20MG/KG	injectable · iv (infusion)	GENZYME	Prescription	28 Apr 2006
LUMIZYME	5MG/ML	powder · iv (infusion)	GENZYME	Prescription	24 May 2010

EMA European Union — centrally authorised medicines

Myozyme Sanofi B.V. · Authorised · authorised 28 Mar 2006 · ATC A16AB07

Therapeutic indication (EMA)

Myozyme is indicated for long-term enzyme-replacement therapy (ERT) in patients with a confirmed diagnosis of Pompe disease (acid-?-glucosidase deficiency). In patients with late-onset Pompe disease the evidence of efficacy is limited.

Canada Canada — marketed products (Health Canada)

Brand	DIN	Strength	Form · route	Company
MYOZYME	02284863	50 MG / VIAL	POWDER FOR SOLUTION · INTRAVENOUS	SANOFI-AVENTIS CANADA INC

Safety signals and safety-related labeling changes

US FDA 30 Dec 2024 LUMIZYME — safety-related labeling change
Labeling sections changed: Boxed Warning; Warnings and Precautions; Adverse Reactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide
US FDA 18 Feb 2020 MYOZYME — safety-related labeling change
Labeling sections changed: Warnings and Precautions; Adverse Reactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide

All safety entries for alglucosidase alfa →

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.