Is Agalsidase beta registered with the SFDA?

The SFDA human drug list (edition 4-2026, as published by the Council of Health Insurance) lists 2 valid registrations of Agalsidase beta, including FABRAZYME 35 mg powder for concentrate for solution for infusion (5 mg/ml, Powder for concentrate for solution for infusion, SAR 14909.65); FABRAZYME 5 mg powder for concentrate for solution for infusion (5 mg/ml, Powder for concentrate for solution for infusion, SAR 2129.95).

Is Agalsidase beta approved by the US FDA?

Drugs@FDA lists 1 application product line for Agalsidase beta, including FABRAZYME (Prescription).

Is Agalsidase beta authorised in the European Union?

EMA lists 1 centrally authorised medicine containing Agalsidase beta: Fabrazyme.

Are there safety signals or safety updates for Agalsidase beta?

US FDA: 1 entry (latest 2024-07-10).

Active substance

Agalsidase beta

SFDA 2
US FDA 1
EMA 1
Health Canada 2
Safety 1

Open in the medicines table

SFDA Saudi Arabia — SFDA human drug list

Trade name	Strength	Form · route	Pack	Public price	Type	Company	Status
FABRAZYME 35 mg powder for concentrate for solution for infusion	5 mg/ml	Powder for concentrate for solution for infusion · Intravenous use	1 Vial	SAR 14909.65	Biological · Prescription	Sanofi B.V	Valid
FABRAZYME 5 mg powder for concentrate for solution for infusion	5 mg/ml	Powder for concentrate for solution for infusion · Intravenous use	1 Vial	SAR 2129.95	Biological · Prescription	Sanofi B.V	Valid

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

Product	Strength	Form · route	Applicant	Status	First approved
FABRAZYME	5MG/VIAL; 35MG/VIAL	vial · intravenous	GENZYME	Prescription	24 Apr 2003

EMA European Union — centrally authorised medicines

Fabrazyme Sanofi B.V. · Authorised · authorised 3 Aug 2001 · ATC A16AB04

Therapeutic indication (EMA)

Fabrazyme is indicated for long-term enzyme replacement therapy in patients with a confirmed diagnosis of Fabry disease (?-galactosidase-A deficiency).

Canada Canada — marketed products (Health Canada)

Brand	DIN	Strength	Form · route	Company
FABRAZYME	02248965	5 MG / VIAL	POWDER FOR SOLUTION · INTRAVENOUS	SANOFI-AVENTIS CANADA INC
FABRAZYME	02248966	35 MG / VIAL	POWDER FOR SOLUTION · INTRAVENOUS	SANOFI-AVENTIS CANADA INC

Safety signals and safety-related labeling changes

US FDA 10 Jul 2024 FABRAZYME — 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

All safety entries for agalsidase beta →

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.