CHMP positive recommendation for GalliaPharm, a radionuclide generator.- Eckert & Ziegler Radiopharm GmbH

GalliaPharm is not intended for direct use in patients and must be used only for in vitro radiolabelling of various kits for radiopharmaceutical preparation. The applicant for this medicinal product is Eckert & Ziegler Radiopharma GmbH.

GalliaPharm will be available as a 1.11, 1.48, 1.85, 2.22, 2.59, 2.96, 3.33 and 3.70 GBq radionuclide generator. Galliapharm uses germanium (68Ge) to generate a gallium (68Ga) chloride solution for radiolabelling. This solution contains gallium (68Ga), a positron-emitting radioisotope (ATC code: V09X), that is used to label a carrier medicinal product. Gallium (68Ga)-labelled carrier molecules are applied in positron emission tomography (PET) imaging.

As shown in the medical literature, gallium (G8Ga) labelled carrier medicinal products are effective in the diagnosis of neuroendocrine tumours (NETs, primarily in gastro-enteropancreatic NETs, i.e., GEP-NETs) and prostate cancer (primary imaging, recurrence diagnostics). The safety of the radionuclide generator GalliaPharm depends on its technical features and functioning.

Increased exposure to germanium (68Ge) resulting from germanium (68Ge) breakthrough may occur if the radionuclide generator is not used and maintained adequately. This may lead to increased and prolonged radiation exposure. Unfavourable effects relating to the use of gallium (68Ga) depend on the carrier medicinal product labelled with the radionuclide. Gallium (68Ga) emits radiation that contributes to a risk of cancer or hereditary abnormalities. Information on the radiation exposure and unfavourable effects will be supplied in the summary of product characteristics (SmPC) of the kit for radiopharmaceutical preparation of these carrier medicinal products.