Is Asfotase alfa registered with the SFDA?

The SFDA human drug list (edition 4-2026, as published by the Council of Health Insurance) lists 4 valid registrations of Asfotase alfa, including STRENSIQ (40 mg/ml, Solution for injection, SAR 93298.50); STRENSIQ (100 mg/ml, Solution for injection, SAR 266570.10).

Is Asfotase alfa approved by the US FDA?

Drugs@FDA lists 1 application product line for Asfotase alfa, including STRENSIQ (Prescription).

Is Asfotase alfa authorised in the European Union?

EMA lists 1 centrally authorised medicine containing Asfotase alfa: Strensiq.

Are there safety signals or safety updates for Asfotase alfa?

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

Active substance

Asfotase alfa

SFDA 4
US FDA 1
EMA 1
Health Canada 4
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
STRENSIQ	40 mg/ml	Solution for injection · Subcutaneous use	12 Vial	SAR 93298.50	Biological · Prescription	Alexion Europe SAS	Valid
STRENSIQ	40 mg/ml	Solution for injection · Subcutaneous use	12 Vial	SAR 59977.20	Biological · Prescription	Alexion Europe SAS	Valid
STRENSIQ	40 mg/ml	Solution for injection · Subcutaneous use	12 Vial	SAR 133285.10	Biological · Prescription	Alexion Europe SAS	Valid
STRENSIQ	100 mg/ml	Solution for injection · Subcutaneous use	12 Vial	SAR 266570.10	Biological · Prescription	Alexion Europe SAS	Valid

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

Product	Strength	Form · route	Applicant	Status	First approved
STRENSIQ	18MG/0.45ML; 28MG/0.7ML; 40MG/ML; 80MG/0.8ML	solution · injection	ALEXION PHARM	Prescription	23 Oct 2015

EMA European Union — centrally authorised medicines

Strensiq Alexion Europe SAS · Authorised · authorised 28 Aug 2015 · ATC A16AB

Therapeutic indication (EMA)

Strensiq is indicated for long-term enzyme replacement therapy in patients with paediatric-onset hypophosphatasia to treat the bone manifestations of the disease.

Canada Canada — marketed products (Health Canada)

Brand	DIN	Strength	Form · route	Company
STRENSIQ	02444615	40 MG / ML	SOLUTION · SUBCUTANEOUS	ALEXION PHARMA GMBH
STRENSIQ	02444623	40 MG / ML	SOLUTION · SUBCUTANEOUS	ALEXION PHARMA GMBH
STRENSIQ	02444631	40 MG / ML	SOLUTION · SUBCUTANEOUS	ALEXION PHARMA GMBH
STRENSIQ	02444658	100 MG / ML	SOLUTION · SUBCUTANEOUS	ALEXION PHARMA GMBH

Safety signals and safety-related labeling changes

US FDA 10 Jul 2024 STRENSIQ — safety-related labeling change
Labeling sections changed: Boxed Warning; Warnings and Precautions; Adverse Reactions; Drug Interactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide

All safety entries for asfotase 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.