Is Olipudase 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 Olipudase alfa, including Xenpozyme (20 mg, Powder for concentrate for solution for infusion, SAR 17896.60).

Is Olipudase alfa authorised in the European Union?

EMA lists 1 centrally authorised medicine containing Olipudase alfa: Xenpozyme.

Active substance

Olipudase 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
Xenpozyme	20 mg	Powder for concentrate for solution for infusion · Intravenous use	1 Vial	SAR 17896.60	Biological · Prescription	Sanofi B.V	Valid

Indications — CHI Daman Drug Formulary

ACID SPHINGOMYELINASE DEFICIENCY

EMA European Union — centrally authorised medicines

Xenpozyme Sanofi B.V. · Authorised · authorised 24 Jun 2022 · ATC A16AB25

Therapeutic indication (EMA)

Xenpozyme is indicated as an enzyme replacement therapy for the treatment of non-Central Nervous System (CNS) manifestations of Acid Sphingomyelinase Deficiency (ASMD) in paediatric and adult patients with type A/B or type B.

Canada Canada — marketed products (Health Canada)

Brand	DIN	Strength	Form · route	Company
XENPOZYME	02545721	20 MG / VIAL	POWDER FOR SOLUTION · INTRAVENOUS	SANOFI-AVENTIS 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.