Is Radium ra 223 dichloride 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 Radium ra 223 dichloride, including XOFIGO 1100 kBq/ml Solution for Injection (1100 kBq/ml, Solution for injection, SAR 22054.20).

Is Radium ra 223 dichloride approved by the US FDA?

Drugs@FDA lists 1 application product line for Radium ra 223 dichloride, including XOFIGO (Prescription).

Are there safety signals or safety updates for Radium ra 223 dichloride?

US FDA: 1 entry (latest 2019-12-10).

Active substance

Radium ra 223 dichloride

SFDA 2
US FDA 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
XOFIGO 1100 kBq/ml Solution for Injection	1100 kBq/ml	Solution for injection · Intravenous use	1 Vial	SAR 22054.20	Radiopharmaceutical · Prescription	BAYER AG	Valid
XOFIGO 1100 kBq/ml Solution for Injection	1100 kBq/ml	Solution for injection · Intravenous use	1 Vial	SAR 22054.20	Radiopharmaceutical · Prescription	BAYER PHARMA AG	Withdrawn by MAH · Not Marketed

Indications — CHI Daman Drug Formulary

PROSTATE CANCER

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

Product	Strength	Form · route	Applicant	Status	First approved
XOFIGO	162mCi/6ML (27mCi/ML)	solution · intravenous	BAYER HLTHCARE	Prescription	15 May 2013

Safety signals and safety-related labeling changes

US FDA 10 Dec 2019 XOFIGO — safety-related labeling change
Labeling sections changed: Contraindications; Warnings and Precautions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide

All safety entries for radium ra 223 dichloride →

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.