This guideline replaces 'Points to consider on the clinical investigation of new medicinal products for the treatment of acute coronary syndrome (ACS) without persistent ST segment elevation' (CPMP/EWP/570/98) and 'Points to consider on the clinical development of fibrinolytic medicinal products in the treatment of patients with ST segment elevation acute myocardial infarction (STEMI)' (CPMP/EWP/967/01).
Keywords: Acute coronary syndrome, STE-ACS, NSTE-ACS
Current effective version
Guideline on clinical investigation of new medicinal products for the treatment of acute coronary syndrome - First version
This guideline replaces 'Points to consider on the clinical investigation of new medicinal products for the treatment of acute coronary syndrome (ACS) without persistent ST segment elevation' (CPMP/EWP/570/98).
English (EN) (443.86 KB - PDF)
Document history - First version
Guideline on clinical investigation of new medicinal products for the treatment of acute coronary syndrome - First version
This guideline replaces 'Points to consider on the clinical investigation of new medicinal products for the treatment of acute coronary syndrome (ACS) without persistent ST segment elevation' (CPMP/EWP/570/98).
English (EN) (443.86 KB - PDF)
Overview of comments received on 'Guideline on clinical investigation of new medicinal products for the treatment of acute coronary syndrome'
Overview of comments received on 'Guideline on clinical investigation of new medicinal products for the treatment
English (EN) (168.44 KB - PDF)
Draft guideline on clinical investigation of new medicinal products for the treatment of acute coronary syndrome - First version
Two CHMP guidelines have been previously developed to address clinical investigations of new medicinal products for the treatment of acute coronary syndrome (ACS).
English (EN) (231.05 KB - PDF)
Concept paper on the need for revision of the points to consider on the clinical investigation of new medicinal products for the treatment of acute coronary syndrome - First version
An update of the Committe for Medicinal Products for Human Use points to consider on new medicinal products for the treatment of acute coronary syndrome is foreseen. This document covers a number of points that are proposed to be addressed in the update.
English (EN) (106.89 KB - PDF)
Document history - Superseded document
Points to consider on clinical investigation of new medicinal products for the treatment of acute coronary syndrome (ACS) without persistent st-segment elevation - Superseded document
English (EN) (64.69 KB - PDF)
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