The GalliaPharm® 68Ge/68Ga Radionuclide Generator from Eckert & Ziegler Radiopharma GmbH is a pharmaceutical product for obtaining the positron emitter 68Gallium, independent of a cyclotron. GalliaPharm® is a closed system consisting of pharmacopoeia grade borosilicate glass column containing a titanium dioxide bed on which 68Ge is adsorbed. 68Ga is continuously produced by decay of its radioactive parent 68Ge and is eluted with sterile ultrapure 0,1 mol/l hydrochloric acid. GalliaPharm® is available with the following activities: 0,74 GBq, 1,11 GBq, 1,48 GBq and 1,85 GBq (20 mCi, 30 mCi, 40 mCi, 50 mCi).
Shelf life
Expected shelf-life of GalliaPharm® is dependent upon several factors such as frequency of use, volume of elution and others. The useful life of the generator has been investigated in a long-term study and may vary from country to country. A shelf-life of 12 months is justified when used according to the Summary of Product Characteristics (SmPC). No additional testing for 68Ge breakthrough will be necessary.
Registration number NL
RVG 113484
Registration number BE
BE468133
