Is Vosoritide registered with the SFDA?

The SFDA human drug list (edition 4-2026, as published by the Council of Health Insurance) lists 3 valid registrations of Vosoritide, including Voxzogo (0.56 mg, Powder and solvent for solution for injection, SAR 32624.60); Voxzogo (0.4 mg, Powder and solvent for solution for injection, SAR 32624.60); Voxzogo (1.2 mg, Powder and solvent for solution for injection, SAR 32624.60).

Is Vosoritide approved by the US FDA?

Drugs@FDA lists 1 application product line for Vosoritide, including VOXZOGO (Prescription).

Is Vosoritide authorised in the European Union?

EMA lists 1 centrally authorised medicine containing Vosoritide: Voxzogo.

Are there safety signals or safety updates for Vosoritide?

US FDA: 1 entry (latest 2024-11-04).

Active substance

Vosoritide

SFDA 3
US FDA 1
EMA 1
Health Canada 3
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
Voxzogo	0.56 mg	Powder and solvent for solution for injection · Subcutaneous use	10 Vial	SAR 32624.60	Biological · Prescription	BioMarin International Limited	Valid
Voxzogo	0.4 mg	Powder and solvent for solution for injection · Subcutaneous use	10 Vial	SAR 32624.60	Biological · Prescription	BioMarin International Limited	Valid
Voxzogo	1.2 mg	Powder and solvent for solution for injection · Subcutaneous use	10 Vial	SAR 32624.60	Biological · Prescription	BioMarin International Limited	Valid

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

Product	Strength	Form · route	Applicant	Status	First approved
VOXZOGO	0.4MG/VIAL; 0.56MG/VIAL; 1.2MG/VIAL	powder · subcutaneous	BIOMARIN PHARM	Prescription	19 Nov 2021

EMA European Union — centrally authorised medicines

Voxzogo BioMarin International Limited · Authorised · authorised 26 Aug 2021 · ATC M05BX

Therapeutic indication (EMA)

Voxzogo is indicated for the treatment of achondroplasia in patients 4 months of age and older whose epiphyses are not closed. The diagnosis of achondroplasia should be confirmed by appropriate genetic testing.

Canada Canada — marketed products (Health Canada)

Brand	DIN	Strength	Form · route	Company
VOXZOGO	02564653	0.4 MG / VIAL	POWDER FOR SOLUTION · SUBCUTANEOUS	BIOMARIN INTERNATIONAL LIMITED
VOXZOGO	02564661	0.56 MG / VIAL	POWDER FOR SOLUTION · SUBCUTANEOUS	BIOMARIN INTERNATIONAL LIMITED
VOXZOGO	02564688	1.2 MG / VIAL	POWDER FOR SOLUTION · SUBCUTANEOUS	BIOMARIN INTERNATIONAL LIMITED

Safety signals and safety-related labeling changes

US FDA 4 Nov 2024 VOXZOGO — safety-related labeling change
Labeling sections changed: Adverse Reactions

All safety entries for vosoritide →

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.