Basic Information
GalliaPharm
Regulatory Information
EMEA/H/C/006053
August 1, 2024
May 30, 2024
August 22, 2024
Company Information
Germany
Robert-Rossle-Str. 10 D-13125 Berlin
Eckert & Ziegler Radiopharma GmbH
Active Substances Detail
EMA Resources
Detailed Information
Therapeutic Indication
### Therapeutic 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.
Overview Summary
GalliaPharm is a so-called ‘radionuclide generator’, a medicine used to obtain a solution containing gallium (68Ga) chloride, a radioactive substance. GalliaPharm and the obtained gallium (68Ga) chloride solution are not intended for direct use in patients. The gallium (68Ga) chloride solution is used for radiolabelling other medicines, which are used during the body scan known as positron-emission tomography (PET). Radiolabelling is a technique that tags molecules with a radioactive substance. GalliaPharm contains germanium (68Ge) chloride / gallium (68Ga) chloride.