Regulatory requirements for the authorisation of low-dose modified-release acetyl-salicylic-acid formulations in the secondary prevention of cardiovascular events
| Current version |
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| Reference number | CPMP/EWP/282/02 |
| Published | 25/07/2002 |
| Keywords | Acetylic salicylic acid (ASA), modified release (MR-) formulations |
| Description | 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. |
