ATIR classified as "cell based" medicinal product by the EMEA
ATIR is under development to prevent acute Graft versus Host Disease (GvHD) allowing the use of a mismatched donor for bone marrow transplantations. It is a personalized cell-based treatment prepared according to a proprietary protocol using both a novel small molecule substance and a proprietary medical device. With the official classification of ATIR as a cell based medicinal product by the EMEA, it is now categorized as an Advanced Therapy, and considered to be a highly innovative treatment. The benefits are a centralized marketing authorization procedure, which harmonizes and facilitates access to the European market. In addition, it provides access to an expert Committee for Advanced Therapies within the EMEA, to address scientific, legal and regulatory issues during product development.
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