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Thursday 4 July 2013
European Medicines Agency recommends granting marketing authorisation for sipuleucel-T
The European Medicines Agency Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion, recommending the granting of a marketing authorisation for the medicinal product sipuleucel-T (Provenge) to Dendreon UK Ltd. The indication recommended by the CHMP is as follows: “Provenge is indicated for the treatment of asymptomatic or minimally symptomatic metastatic (non-visceral) castrate resistant prostate cancer in male adults in whom chemotherapy is not yet clinically indicated.” Read more here.
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