Is Agalsidase 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 Agalsidase alfa, including REPLAGAL 1mg/ml concetrate for solution for infusion (1 mg/ml, Concentrate for solution for infusion, SAR 7509.56).

Is Agalsidase alfa authorised in the European Union?

EMA lists 1 centrally authorised medicine containing Agalsidase alfa: Replagal.

Active substance

Agalsidase alfa

SFDA 1
EMA 1
Health Canada 1

Open in the medicines table

SFDA Saudi Arabia — SFDA human drug list

Trade name	Strength	Form · route	Pack	Public price	Type	Company	Status
REPLAGAL 1mg/ml concetrate for solution for infusion	1 mg/ml	Concentrate for solution for infusion · Intravenous use	1 Vial	SAR 7509.56	NCE · Prescription	Takeda Pharmaceuticals International AG	Valid

EMA European Union — centrally authorised medicines

Replagal Takeda Pharmaceuticals International AG Ireland Branch · Authorised · authorised 3 Aug 2001 · ATC A16AB03

Therapeutic indication (EMA)

Replagal 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
REPLAGAL	02249057	1 MG / ML	SOLUTION · INTRAVENOUS	TAKEDA CANADA INC

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.