GalenVita (germanium (68Ge) chloride;gallium (68Ga) chloride)

Region: 🇪🇺 EU
Active substance: germanium (68Ge) chloride;gallium (68Ga) chloride
Company: Curium Romania S.R.L.
Status: Authorised
Therapeutic area: Radionuclide Imaging
CHMP opinion: Thu 13 Nov 2025
EU approval: Thu 08 Jan 2026
Application: EMEA/H/C/006639
ATC: V09X
Official record: www.ema.europa.eu

Indication

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.

Regulatory milestones

Thu 08 Jan 2026🇪🇺 EU approval (EC decision)

GalenVita (germanium (68Ge) chloride;gallium (68Ga) chloride) approved in the EU

Marketing authorisation to Curium Romania S.R.L. · source

Thu 13 Nov 2025🇪🇺 CHMP positive opinion

GalenVita (germanium (68Ge) chloride;gallium (68Ga) chloride): CHMP positive opinion

Curium Romania S.R.L. · source

Same substance in other markets

🇪🇺 GeGant Application withdrawn · ITM Medical Isotopes GmbH

Follow GalenVita

Get VigiEye Daily: approvals, opinions, safety actions and PDUFA dates every morning.

Information from official EMA, FDA, Federal Register and SEC records. Dates marked company-announced come from the company's own SEC filing; dates marked estimate are calculated, not official. Not investment or medical advice; always confirm on the source.