Is Narsoplimab approved by the US FDA?

Drugs@FDA lists 1 application product line for Narsoplimab, including YARTEMLEA (Prescription).

Is Narsoplimab authorised in the European Union?

EMA lists 0 centrally authorised medicines containing Narsoplimab.

Active substance

Narsoplimab

US FDA 1
EMA 1

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

Product	Strength	Form · route	Applicant	Status	First approved
YARTEMLEA		injection	OMEROS CORP	Prescription	23 Dec 2025

EMA European Union — centrally authorised medicines

Yartemlea Omeros Ireland Limited · Opinion under re-examination · ATC L01FX

Therapeutic indication (EMA)

Treatment of patients with haemopoietic stem cell transplant-associated thrombotic microangiopathy

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.