IRE ELiT Galli Ad® generator’s compatibility with SomaKit TOC® officialised by the EMA
Saturday 13 October 2018 — IRE ELiT today announces that the EMA (European Medicines Agency) has officially approved SomaKit TOC® reconstitution with its Galli Ad®* generator. This update will be presented, at the European Association of Nuclear Medicine congress, taking place this weekend in Düsseldorf.
Last May, IRE ELiT (a subsidiary and innovation hub of IRE) received Marketing Authorization for its Galli Ad®*, a 68Germanium/68Gallium generator, filled in 13 European countries. When accompanied by a cold vector - in this case AAA’s SomaKit TOC®, the Gallium-68 isotope (got from the generator) is used in oncology for the PET (Positron Emission Tomography) diagnosis imaging of neuroendocrine cancers, particularly difficult to detect at the early stage.
Erich Kollegger, General Manager of IRE and IRE ELiT, comments: “We have designed our generator especially for cold kits, in order to enable doing PET imaging with Ga-68 as simply as SPECT imaging with Tc-99. The approval of SomaKit TOC® reconstitution with our Galli Ad® generator is an important step to achieve this ambition, facilitating the whole procedure for the radiopharmacist”.
In parallel, the FDA (Food and Drug Administration) has also approved the NETSPOT® application with the Galli Eo®** generator for the US.
More information about IRE ELiT’s 68Ge/68Ga generator in the technical information sheet below.
SmPC of both products are available here:
Galli Ad®: http://www.ire.eu/medias/brochure/53/file/eng/SmPC.pdf
Somakit TOC®: https://www.adacap.com/wp-content/uploads/2018/10/emea-combined-h-4140-en.pdf
*Also called GalliAd, Galliad and Germanio (68Ge)cloruro/Gallio(68Ga) depending on the marketed country.
**GalliEo is the name of the generator in the US and countries without Marketing Authorization.