A Commission approval would result in centralized Marketing Authorization with unified labeling in the EU, which followed the use of TEMODAL for the treatment of patients with newly diagnosed GBM simultaneously with radiation therapy for up to 6 cycles of temozolomide monotherapy. The new labeling will be in addition to the currently approved indications, and is the current 25 the current 25 EU member states plus Iceland and Norway, will be issued after approval by the European Commission.
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24 Feb 2017