GalliaPharm (gallium (68Ga) chloride;germanium (68Ge) chloride)
- Region
- 🇪🇺 EU
- Active substance
- gallium (68Ga) chloride;germanium (68Ge) chloride
- Company
- Eckert & Ziegler Radiopharma GmbH
- Status
- Authorised
- Therapeutic area
- Radionuclide Imaging
- CHMP opinion
- Thu 30 May 2024
- EU approval
- Thu 01 Aug 2024
- Application
- EMEA/H/C/006053
- 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 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.
Regulatory milestones
No milestones recorded in the last year.
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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.