IRE ELiT Galli Ad® generator’s compatibility with SomaKit TOC® officialised by the EMA

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.

Technical information sheet

PDF - 498 Kb
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Bérénice Pignol

IRE - IRE ELiT

Ariane Goossens

Whyte Corporate Affairs

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About IRE and IRE ELiT

50 years dedicated to excellence in nuclear medicine

The IRE or the National Institute for Radioelements is a public utility foundation, whose main activity is the production of radioisotopes for diagnostic and therapeutic applications in the field of nuclear medicine. The IRE is the world leader in the production of molybdenum-99, the "parent" isotope of metastable technetium-99, and the most widely used in nuclear medicine for many examinations (heart, bone, lungs, thyroid, brain, kidneys, etc).


In addition to its production activities, the IRE contributes to protection and environmental monitoring through its services of measuring radioactivity in various samples, radiological characterisation of waste and contaminated elements and consultancy and technical assistance in the fields of radiology and nuclear energy.


For its part, IRE ELiT is IRE's innovation subsidiary founded in 2010 to develop radiopharmaceuticals used for imaging and treatment of certain cancers and palliative care. In 2020, the group devoted 15% of its turnover to R&D, a percentage which has been steadily increasing since the company's creation. IRE and IRE ELiT currently employ 250 people.

Contact

www.ire.eu