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

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Bérénice Pignol

IRE - IRE ELiT

Ariane Goossens

Whyte Corporate Affairs

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About IRE and IRE ELiT

Founded in 1971 and based in Fleurus, in the province of Hainaut, the National Institute of Radioelements (IRE), a Belgian foundation of public interest, is one of the very few players worldwide capable of producing and developing certain radioisotopes used in nuclear medicine.

IRE is notably the global leader in the production of Molybdenum‑99, the “parent” isotope of metastable Technetium-99m. Using a gamma camera, this isotope makes it possible to observe a patient’s internal anatomy in real time (heart, bones, lungs, thyroid, brain, kidneys, etc.) and to diagnose certain diseases at an early stage. IRE supplies around 50% of European demand for Mo-99 and 25% of global production, a share that can rise to up to 65% during periods of global supply tension.

At the same time, IRE ELiT, a subsidiary founded in 2010, is one of the two global leaders in pharmaceutical‑grade Ge-68/Ga-68 generators for human use. Gallium-68 (Ga-68) is a key isotope for high‑precision PET imaging - particularly for neuroendocrine tumours and prostate cancer - and for personalised medicine in radioligand therapy (RLT) strategies. IRE-ELiT’s Ga-68 generators are currently marketed in around 40 countries.

Beyond its production activities aimed at improving patient care and quality of life, IRE also contributes - through its IRE Lab division - to environmental protection and monitoring. The Institute offers services for radioactivity measurement in various samples, radiological characterisation of waste and contaminated materials, as well as consultancy and technical support in the radiological and nuclear fields.

Today, IRE and IRE ELiT employ 300 people, all committed to translating cutting‑edge scientific advances into diagnostic and therapeutic solutions for patients.

More information: www.ire.eu

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www.ire.eu