EpiCept Corporation
EpiCept Announces Non-Binding Opinion by European Regulatory Authority on Ceplene Marketing Application
Published in Cancer Weekly, March 11th, 2008
EpiCept Corporation (Nasdaq and OMX Nordic Exchange: EPCT) announced that the Company recently presented at the Oral Explanation meeting to the European Committee for Medicinal Products for Human Use (CHMP), the scientific committee of the European Medicines Agency (EMEA), regarding the remaining outstanding issues on the marketing authorization application (MAA) for Ceplene(R) (histamine dihydrochloride), which is intended to be indicated for the maintenance of remission and prevention of relapse of patients with Acute Myeloid Leukemia (AML) in first remission. Ceplene was designated as an orphan medicinal product in the European Union on April 11, 2005 in respect of this...
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Source: Cancer Weekly (2008-03-11)
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