Is Burosumab 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 Burosumab, including CRYSVITA (10 mg/ml, Solution for injection, SAR 13256.95); CRYSVITA (20 mg/ml, Solution for injection, SAR 26513.90); CRYSVITA (30 mg/ml, Solution for injection, SAR 39770.75).

Is Burosumab approved by the US FDA?

Drugs@FDA lists 1 application product line for Burosumab, including CRYSVITA (Prescription).

Is Burosumab authorised in the European Union?

EMA lists 1 centrally authorised medicine containing Burosumab: Crysvita.

Are there safety signals or safety updates for Burosumab?

US FDA: 1 entry (latest 2020-06-18).

Active substance

Burosumab

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
CRYSVITA	10 mg/ml	Solution for injection · Subcutaneous use	1 Vial	SAR 13256.95	Biological · Prescription	Kyowa Kirin Holdings B.V.	Valid
CRYSVITA	20 mg/ml	Solution for injection · Subcutaneous use	1 Vial	SAR 26513.90	Biological · Prescription	Kyowa Kirin Holdings B.V.	Valid
CRYSVITA	30 mg/ml	Solution for injection · Subcutaneous use	1 Vial	SAR 39770.75	Biological · Prescription	Kyowa Kirin Holdings B.V.	Valid

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

Product	Strength	Form · route	Applicant	Status	First approved
CRYSVITA	10MG/ML	injectable · injection	KYOWA KIRIN	Prescription	17 Apr 2018

EMA European Union — centrally authorised medicines

Crysvita Kyowa Kirin Holdings B.V. · Authorised · authorised 19 Feb 2018 · ATC M05BX05

Therapeutic indication (EMA)

Crysvita is indicated for the treatment of X-linked hypophosphataemia, in children and adolescents aged 1 to 17 years with radiographic evidence of bone disease, and in adults. Crysvita is indicated for the treatment of FGF23-related hypophosphataemia in tumour-induced osteomalacia associated with phosphaturic mesenchymal tumours that cannot be curatively resected or localised in children and adolescents aged 1 to 17 years and in adults.

Canada Canada — marketed products (Health Canada)

Brand	DIN	Strength	Form · route	Company
CRYSVITA	02483629	10 MG / ML	SOLUTION · SUBCUTANEOUS	KYOWA KIRIN, INC.
CRYSVITA	02483637	20 MG / ML	SOLUTION · SUBCUTANEOUS	KYOWA KIRIN, INC.
CRYSVITA	02483645	30 MG / ML	SOLUTION · SUBCUTANEOUS	KYOWA KIRIN, INC.

Safety signals and safety-related labeling changes

US FDA 18 Jun 2020 CRYSVITA — safety-related labeling change
Labeling sections changed: Contraindications; Warnings and Precautions; Adverse Reactions; Drug Interactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide

All safety entries for burosumab →

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.