Approximately 34,000 as Orphan Medicinal Product Designation by the European Commission for the treatment of small cell lung cancer Designated Celgene International Sarl announced that amrubicin hydrochloride as an orphan medicinal product has been designated by the European Commission for the treatment of small cell lung cancer after a positive opinion of the European Medicines Agency Committee for Orphan Medicinal Products . Demand criteria for the designation of orphan medicinal products that the product for the treatment of life-threatening or serious conditions that are rare and affect not more than 5 in 10,000 persons determined in the EU -. In the European Union concerns NSCLC more than 57,000 people and about 34,000 new cases of the disease diagnosed this year.
In March 2008ves are eligibility for protocol assistance and possible exemptions or reductions for certain regulatory fees during development or at the time of application for marketing authorization. Orphan will offer amrubicin with 10 years of market exclusivity following marketing approval for the treatment of small cell lung cancer. The decision by the European Commission for amrubicin hydrochloride call orphan medicinal continue our efforts to develop innovative therapies worldwide patients in areas of unmet medical need to deliver, such as cancers with solid tumors, said Graham Burton MD, Global Regulatory Affairs and Pharmacovigilance for Celgene Corporation..From the Henry J. Implementation Issues: Emergency Room costs, consumers and SmallBusiness Websites question.
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