Is Sotatercept 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 Sotatercept, including Winrevair (45 mg, Powder and solvent for solution for injection, SAR 36247.20); Winrevair (60 mg, Powder and solvent for solution for injection, SAR 90750.00).

Is Sotatercept approved by the US FDA?

Drugs@FDA lists 1 application product line for Sotatercept, including WINREVAIR (Prescription).

Is Sotatercept authorised in the European Union?

EMA lists 1 centrally authorised medicine containing Sotatercept: Winrevair.

Are there safety signals or safety updates for Sotatercept?

US FDA: 1 entry (latest 2026-09-21).

Active substance

Sotatercept

SFDA 4
US FDA 1
EMA 1
Health Canada 2
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
Winrevair	45 mg	Powder and solvent for solution for injection · Subcutaneous use	1 Vial	SAR 36247.20	Biological · Prescription	MERCK SHARP & DOHME	Valid
Winrevair	45 mg	Powder and solvent for solution for injection · Subcutaneous use	2 Vial	SAR 72494.40	Biological · Prescription	MERCK SHARP & DOHME	Valid
Winrevair	60 mg	Powder and solvent for solution for injection · Subcutaneous use	2 Vial	SAR 90750.00	Biological · Prescription	Merck Sharp & Dohme B.V	Valid
Winrevair	60 mg	Powder and solvent for solution for injection · Subcutaneous use	1 Vial	SAR 45375.00	Biological · Prescription	Merck Sharp & Dohme B.V	Valid

Indications — CHI Daman Drug Formulary

PULMONARY ARTERIAL HYPERTENSION

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

Product	Strength	Form · route	Applicant	Status	First approved
WINREVAIR	45MG; 60MG	injectable · injection	MERCK SHARP DOHME	Prescription	26 Mar 2024

EMA European Union — centrally authorised medicines

Winrevair Merck Sharp & Dohme B.V. · Authorised · authorised 22 Aug 2024 · ATC C02KX06

Therapeutic indication (EMA)

Winrevair, in combination with other pulmonary arterial hypertension (PAH) therapies, is indicated for the treatment of PAH in adult patients with WHO Functional Class (FC) II, III and IV.

Canada Canada — marketed products (Health Canada)

Brand	DIN	Strength	Form · route	Company
WINREVAIR	02551306	45 MG / VIAL	KIT; POWDER FOR SOLUTION · SUBCUTANEOUS	MERCK CANADA INC
WINREVAIR	02551314	60 MG / VIAL	KIT; POWDER FOR SOLUTION · SUBCUTANEOUS	MERCK CANADA INC

Safety signals and safety-related labeling changes

US FDA 21 Sep 2026 WINREVAIR — safety-related labeling change
Labeling sections changed: Contraindications; Warnings and Precautions; Adverse Reactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide

All safety entries for sotatercept →

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.