Is Idursulfase 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 Idursulfase, including ELAPRASE 2 mg/ml concentrate for solution for infusion (2 mg/ml, Concentrate for solution for infusion, SAR 10363.65).

Is Idursulfase approved by the US FDA?

Drugs@FDA lists 1 application product line for Idursulfase, including ELAPRASE (Prescription).

Is Idursulfase authorised in the European Union?

EMA lists 1 centrally authorised medicine containing Idursulfase: Elaprase.

Are there safety signals or safety updates for Idursulfase?

US FDA: 1 entry (latest 2018-11-16).

Active substance

Idursulfase

SFDA 2
US FDA 1
EMA 1
Health Canada 1
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
ELAPRASE 2 mg/ml concentrate for solution for infusion	2 mg/ml	Concentrate for solution for infusion · Intravenous use	1 Vial	SAR 10363.65	NCE · Prescription	Takeda Pharmaceuticals International AG	Valid
ELAPRASE 2 mg/ml concentrate for solution for infusion	2 mg/ml	Concentrate for solution for infusion · Intravenous use	1 Vial	SAR 13681.55	NCE · Prescription	SHIRE HUMAN GENETICS THERAPIES	Withdrawn by MAH · Not Marketed

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

Product	Strength	Form · route	Applicant	Status	First approved
ELAPRASE	6MG/3ML	injectable · iv (infusion)	SHIRE	Prescription	24 Jul 2006

EMA European Union — centrally authorised medicines

Elaprase Takeda Pharmaceuticals International AG Ireland Branch · Authorised · authorised 8 Jan 2007 · ATC A16AB09

Therapeutic indication (EMA)

Elaprase is indicated for the long-term treatment of patients with Hunter syndrome (mucopolysaccharidosis II, MPS II). Heterozygous females were not studied in the clinical trials.

Canada Canada — marketed products (Health Canada)

Brand	DIN	Strength	Form · route	Company
ELAPRASE	02296314	2 MG / ML	SOLUTION · INTRAVENOUS	TAKEDA CANADA INC

Safety signals and safety-related labeling changes

US FDA 16 Nov 2018 ELAPRASE — safety-related labeling change
Labeling sections changed: Use in Specific Populations

All safety entries for idursulfase →

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.