Is Besilesomab authorised in the European Union?

EMA lists 1 centrally authorised medicine containing Besilesomab: Scintimun.

Is Besilesomab authorised in the United Kingdom?

The MHRA category lists of UK marketing authorisations include 1 product containing Besilesomab, including SCINTIMUN 1 MG KIT FOR RADIOPHARMACEUTICAL PREPARATION.

Active substance

Besilesomab

EMA 2
UK MHRA 1

Open in the medicines table

EMA European Union — centrally authorised medicines

Scintimun Telix Innovations · Authorised · authorised 11 Jan 2010 · ATC V09HA03

Therapeutic indication (EMA)

This medicinal product is for diagnostic use only and the approved indication is scintigraphic imaging, in conjunction with other appropriate imaging modalities, for determining the location of inflammation/infection in peripheral bone in adults with suspected osteomyelitis. Scintimun should not be used for the diagnosis of diabetic foot infection.

Scintimun CIS bio international · Application withdrawn

UK MHRA United Kingdom — marketing authorisations

Product	Authorisation	Holder	Legal status
SCINTIMUN 1 MG KIT FOR RADIOPHARMACEUTICAL PREPARATION	PL 57676/0002	TELIX PHARMACEUTICALS (UK) LIMITED	POM

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), MHRA category lists of UK marketing authorisations (Open Government Licence v3.0), 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.