January 3, 2011 – A registered radiopharmaceutical product has received a positive opinion for the mutual recognition of the initial French authorization in 12 European Union concerned member states. The opinion concens IBA’s Dopacis (18F-Fluorodopa).
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.
It is currently approved for use in France in positron emission tomography (PET) for indications in neurology and oncology. Specifically, it is used for the differential diagnosis of extrapyramidal symptoms linked to Parkinson’s disease and for diagnosing 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.
The company expects to obtain marketing approvals in the EU concerned member states in 2011.
For more information: www.iba-molecular.com