PRESS RELEASE -IRE Elit files marketing authorisation
IRE Elit, the IRE subsidiary specialised in the production of radiopharmaceuticals, is pleased to announce the filing of a marketing authorisation (MAA) application with the European Medicines Agency (EMA) for the Galli EoTM, a radiopharmaceutical 68Germanium/68Gallium generator that constitutes major progress in the availability and routine use of Gallium-68 by nuclear medicine centres.
This application is the culmination of a major effort made by the company to propose a new generation Gallium-68 generator which, thanks to its innovative design, facilitates the use of Gallium-68 in PET imaging, in full compliance with nuclear and pharmaceutical safety standards, for the benefit of patients and users.
This next-generation generator not only enables cost optimisation, but also innovates by providing health professionals with greater ease of use. This innovation will contribute to the development of personalised medicine.
"This innovation marks a major stage in the development of IRE Elit and the awarding of an MAA will open up new markets and excellent growth prospects for us," said Jean-Michel Vanderhofstadt, CEO – General Manager IRE – IRE ELiT
Galli EoTM is currently used in the preclinical stages in European university hospitals with which the IRE-ELiT works very closely, and also benefits from the status as a Medicine for Clinical Trials for research centres. The generator is already registered as an API outside Europe and was acclaimed by the EANM (European Association of Nuclear Medicine) Congress, held recently in Barcelona from 15 to 19 October. It will also be presented internationally during Theranostics Congress dedicated to Gallium-68, in Melbourne from 7-9 November 2016.
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