Regulatory requirements for the authorisation of low-dose modified-release acetyl-salicylic-acid formulations in the secondary prevention of cardiovascular events - Scientific guideline
HumanScientific guidelines
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This document focuses on the requirements for approval of new low-dose oral modified release formulations of acetylic salicylic acid in the well-established indication of secondary prevention of cardiovascular events.
Keywords: Acetylic salicylic acid (ASA), modified release (MR-) formulations