Regulatory requirements for the authorisation of low-dose modified-release acetyl-salicylic-acid formulations in the secondary prevention of cardiovascular events - Scientific guideline

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

Current effective version

Position paper on the regulatory requirements for the authorisation of low-dose modified release asa formulations in the secondary prevention of cardiovascular events

AdoptedReference Number: EMEA/CPMP/EWP/282/02/Final