EMA European Union — centrally authorised medicines
GalliaPharm Eckert & Ziegler Radiopharma GmbH · Authorised · authorised 1 Aug 2024 · ATC V09X
Therapeutic indication (EMA)
This radionuclide generator is not intended for direct use in patients. The sterile eluate (gallium (68Ga) chloride solution) from the radionuclide generator GalliaPharm is indicated for in vitro radiolabelling of various kits for radiopharmaceutical preparation developed and approved for radiolabelling with such eluate, to be used for positron emission tomography (PET) imaging.
GalenVita Curium Romania S.R.L. · Authorised · authorised 8 Jan 2026 · ATC V09X
Therapeutic indication (EMA)
This radionuclide generator is not intended for direct use in patients. The sterile eluate (gallium (68Ga) chloride solution) from the radionuclide generator GalenVita is indicated for in vitro radiolabelling of various kits for radiopharmaceutical preparation developed and approved for radiolabelling with such eluate, to be used for positron emission tomography (PET) imaging.
GeGant ITM Medical Isotopes GmbH · Application withdrawn · ATC V09X
Therapeutic indication (EMA)
Indicated for in vitro labelling of kits for radiopharmaceutical preparation.
UK MHRA United Kingdom — marketing authorisations
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.