Is Lutetium oxodotreotide authorised in the European Union?

EMA lists 1 centrally authorised medicine containing Lutetium oxodotreotide: Lutathera.

Is Lutetium oxodotreotide authorised in the United Kingdom?

The MHRA category lists of UK marketing authorisations include 1 product containing Lutetium oxodotreotide, including LUTATHERA 370 MBQ/ML SOLUTION FOR INFUSION.

Active substance

Lutetium oxodotreotide

EMA 1
UK MHRA 1

Open in the medicines table

EMA European Union — centrally authorised medicines

Lutathera Novartis Europharm Limited · Authorised · authorised 26 Sep 2017 · ATC V10XX04

Therapeutic indication (EMA)

Lutathera is indicated for the treatment of unresectable or metastatic, progressive, well differentiated (G1 and G2), somatostatin receptor positive gastroenteropancreatic neuroendocrine tumours (GEP?NETs) in adults.

UK MHRA United Kingdom — marketing authorisations

Product	Authorisation	Holder	Legal status
LUTATHERA 370 MBQ/ML SOLUTION FOR INFUSION	PLGB 00101/1230	NOVARTIS 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.