Is Luspatercept registered with the SFDA?

The SFDA human drug list (edition 4-2026, as published by the Council of Health Insurance) lists 2 valid registrations of Luspatercept, including Reblozyl (75 mg, powder for solution for injection, SAR 21912.20); Reblozyl (25 mg, powder for solution for injection, SAR 7303.00).

Is Luspatercept approved by the US FDA?

Drugs@FDA lists 1 application product line for Luspatercept, including REBLOZYL (Prescription).

Is Luspatercept authorised in the European Union?

EMA lists 1 centrally authorised medicine containing Luspatercept: Reblozyl.

Are there safety signals or safety updates for Luspatercept?

EMA PRAC: 1 entry; US FDA: 1 entry (latest 2026-06-11).

Active substance

Luspatercept

SFDA 2
US FDA 1
EMA 1
Health Canada 2
Safety 2

Open in the medicines table

SFDA Saudi Arabia — SFDA human drug list

Trade name	Strength	Form · route	Pack	Public price	Type	Company	Status
Reblozyl	75 mg	powder for solution for injection · Subcutaneous use	1 Vial	SAR 21912.20	Biological · Prescription	Bristol Myers Squibb Pharma EEIG	Valid
Reblozyl	25 mg	powder for solution for injection · Subcutaneous use	1 Vial	SAR 7303.00	Biological · Prescription	Bristol Myers Squibb Pharma EEIG	Valid

Indications — CHI Daman Drug Formulary

ANEMIA DUE TO BETA-THALASSEMIA AND ANEMIA DUE TO MDS; MYELODYSPLASTIC SYNDROMES- ANEMIA; THALASSEMIA

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

Product	Strength	Form · route	Applicant	Status	First approved
REBLOZYL	25MG/VIAL; 75MG/VIAL	powder · subcutaneous	CELGENE CORP	Prescription	8 Nov 2019

EMA European Union — centrally authorised medicines

Reblozyl Bristol Myers Squibb Pharma EEIG · Authorised · authorised 25 Jun 2020 · ATC B03XA06

Therapeutic indication (EMA)

Reblozyl is indicated in adults for the treatment of transfusion-dependent anaemia due to very low, low and intermediate-risk myelodysplastic syndromes (MDS).Reblozyl is indicated in adults for the treatment of anaemia associated with transfusion dependent and non transfusion dependent beta thalassaemia. Reblozyl is indicated in adults for the treatment of transfusion-dependent anaemia due to very low, low and intermediate-risk myelodysplastic syndromes (MDS).Reblozyl is indicated in adults for the treatment of anaemia associated with transfusion dependent and non transfusion dependent beta thalassaemia.

Canada Canada — marketed products (Health Canada)

Brand	DIN	Strength	Form · route	Company
REBLOZYL	02505541	25 MG / VIAL	POWDER FOR SOLUTION · SUBCUTANEOUS	BRISTOL-MYERS SQUIBB CANADA
REBLOZYL	02505568	75 MG / VIAL	POWDER FOR SOLUTION · SUBCUTANEOUS	BRISTOL-MYERS SQUIBB CANADA

Safety signals and safety-related labeling changes

EMA PRAC 11 Jun 2026 PRAC signal: Ventilation perfusion mismatch
Action for MAH: update of the product information: No
US FDA 27 Feb 2026 REBLOZYL — safety-related labeling change
Labeling sections changed: Warnings and Precautions; Adverse Reactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide

All safety entries for luspatercept →

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.