Regulatory PathRegulatory requirements compared

Active substance

L

Open in the medicines table

EMA European Union — centrally authorised medicines

LysaKare Novartis Europharm Limited · Authorised · authorised 25 Jul 2019 · ATC V03AF11

Therapeutic indication (EMA)

LysaKare is indicated for reduction of renal radiation exposure during Peptide-Receptor Radionuclide Therapy (PRRT) with lutetium (177Lu) oxodotreotide in adults.

UK MHRA United Kingdom — marketing authorisations

ProductAuthorisationHolderLegal status
LYSAKARE 25 G/25 G SOLUTION FOR INFUSIONPLGB 00101/1224NOVARTIS 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.