IBA Molecular Receives Positive Opinion for Marketing Dopacis® Across Europe
News Dec 08, 2010
IBA Molecular, member of IBA group and global developer of next generation radiopharmaceuticals used in molecular imaging, announced that its registered radiopharmaceutical product Dopacis® (18F-Fluorodopa) received a positive opinion for the mutual recognition of the initial French authorization in 12 European Union concerned member states on November 10, 2010. This is the 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 positron emission tomography (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. PET is a non-invasive method used in molecular imaging to visualize biological processes for the early detection and real-time monitoring of diseases.
Further to this positive opinion of the European Union’s Mutual Recognition Procedure (MRP), 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. IBA Molecular’s sites in Bordeaux and Sarcelles (Paris) have already been validated in the European procedure and the company plans to extend approval to its additional European sites next.
“We are dedicated to providing solutions that address critical therapeutic areas through a more accurate and effective diagnosis and treatment of diseases, and a key element to this is proximity,” said François Labarre, vice president, Europe, IBA Molecular. “IBA Molecular’s 57 PET facilities worldwide represent the only global PET network in the industry today, and the largest one in Europe. Our goal is to provide specialists across Europe with innovative products such as Dopacis®, and the greatest access possible to them, as they must be delivered within a crucial window of time. This positive opinion brings us one step closer to doing so, and we will continue to advance other products in our pipeline – generic, proprietary and in-licensed – with this mission in mind.”
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