IBAs PET agent gets initial approval in EU

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IBA Molecular’s PET radiopharmaceutical product Dopacis (18F-Fluorodopa) has received a positive opinion for the mutual recognition of the initial French authorization in 12 European Union (EU) concerned member states, a final step in the application process before marketing authorizations are granted by the national health authorities of the EU concerned member states.

Dopacis is a radiopharmaceutical product that is currently approved for use in France in PET for indications in neurology and oncology, specifically the differential diagnosis of extrapyramidal symptoms linked to Parkinson’s disease, and for diagnosis of neuroendocrine tumors.

IBA Molecular expects to obtain marketing approvals in the EU concerned member states in 2011. Following this, the company will begin to supply Dopacis to medical specialists from its European network of 24 PET sites to make it available on a European scale.