Is Clesrovimab approved by the US FDA?

Drugs@FDA lists 1 application product line for Clesrovimab, including ENFLONSIA (Prescription).

Is Clesrovimab authorised in the European Union?

EMA lists 1 centrally authorised medicine containing Clesrovimab: Enflonsia.

Active substance

Clesrovimab

US FDA 1
EMA 1

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

Product	Strength	Form · route	Applicant	Status	First approved
ENFLONSIA	105MG/0.7ML	injection · solution	MERCK SHARP DOHME	Prescription	9 Jun 2025

EMA European Union — centrally authorised medicines

Enflonsia Merck Sharp Dohme Limited · Authorised · authorised 15 Apr 2026 · ATC J06BD10

Therapeutic indication (EMA)

Enflonsia is indicated for the prevention of respiratory syncytial virus (RSV) lower respiratory tract disease in neonates and infants during their first RSV season.Enflonsia should be used in accordance with official recommendations.

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.