Attachment 2. Extract from the Clinical Evaluation Report ...

This confirmed the results of Study 123, in which a 20 mg vortioxetine dose was administered. Bioequivalence was demonstrated between 4 x 5 mg vortioxetine tablets Formulation 4 and 1 x 20 mg vortioxetine tablet Formulation 4, in Study 14520A. Hence, bioequivalence is expected for the intermediate dose strengths, that is, 10 mg and 15 mg tablets. ................
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