Radiopharmaceutical developer IBA Molecular has taken another step toward clearance to market its radiopharmaceutical product Dopacis (F-18 fluorodopa) in 12 member states of the European Union (EU).
The recently received preliminary approval is the final step in the application process before the EU's national health authorities grant marketing authorization, according to the Gif-sur-Yvette, France-based division of Ion Beam Applications (IBA).
Dopacis currently is approved for use in France for PET indications in neurology and oncology, specifically the differential diagnosis of extrapyramidal symptoms linked to Parkinson's disease, and for diagnosing neuroendocrine tumors.
In addition to French preapproval, IBA Molecular expects to obtain marketing approvals in the other EU countries in 2011, and then supply Dopacis from its European network of 24 PET radiopharmaceutical production sites.
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