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

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Position paper

Reference numberCPMP/EWP/282/02
KeywordsAcetylic salicylic acid (ASA), modified release (MR-) formulations
DescriptionThis 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. 

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