Regulatory PathRegulatory requirements compared

Active substance

Lutetium

Open in the medicines table

EMA European Union — centrally authorised medicines

EndolucinBeta ITM Medical Isotopes GmbH · Authorised · authorised 6 Jul 2016 · ATC V10X

Therapeutic indication (EMA)

EndolucinBeta is a radiopharmaceutical precursor, and it is not intended for direct use in patients. It is to be used only for the radiolabelling of carrier molecules that have been specifically developed and authorised for radiolabelling with Lutetium (177Lu) chloride.

Lutetium (177Lu) chloride Billev (previously Illuzyce) Billev Pharma Aps · Authorised · authorised 15 Sep 2022 · ATC V10X

Therapeutic indication (EMA)

Lutetium (177Lu) chloride Billev is a radiopharmaceutical precursor, and it is not intended for direct use in patients. It is to be used only for the radiolabelling of carrier molecules that have been specifically developed and authorised for radiolabelling with lutetium (177Lu) chloride.

Theralugand Eckert & Ziegler Radiopharma GmbH · Authorised · authorised 22 Nov 2024 · ATC V10X

Therapeutic indication (EMA)

Theralugand is a radiopharmaceutical precursor, and it is not intended for direct use in patients. It is to be used only for the radiolabelling of carrier molecules that have been specifically developed and authorised for radiolabelling with lutetium (177Lu) chloride.

Ilumira Shine Europe B.V. · Authorised · authorised 26 Mar 2026 · ATC V10X

Therapeutic indication (EMA)

Ilumira is a radiopharmaceutical precursor, and it is not intended for direct use in patients. It is to be used only for the radiolabelling of carrier molecules that have been specifically developed and authorised for radiolabelling with lutetium (177Lu) chloride.

Lumark I.D.B. Radiopharmacy B.V. · Withdrawn · authorised 18 Jun 2015 · ATC V10

Therapeutic indication (EMA)

Lumark is a radiopharmaceutical precursor. It is not intended for direct use in patients. This medicinal must be used only for the radiolabelling of carrier molecules, which have been specifically developed and authorised for radiolabelling with this radionuclide.

UK MHRA United Kingdom — marketing authorisations

ProductAuthorisationHolderLegal status
ENDOLUCINBETA 40 GBQ/ML RADIOPHARMACEUTICAL PRECURSOR, SOLUTIONPLGB 45370/0001ITM MEDICAL ISOTOPES GMBHPOM
ENDOLUCINBETA 40 GBQ/ML RADIOPHARMACEUTICAL PRECURSOR, SOLUTIONPLGB 45370/0002ITM MEDICAL ISOTOPES GMBHPOM
PLUVICTO 1,000 MBQ/ML SOLUTION FOR INJECTION/INFUSIONPLGB 00101/1233NOVARTIS PHARMACEUTICALS UK LIMITEDPOM

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.