Clinical investigation of new medicinal products for the treatment of acute coronary syndrome - Scientific guideline
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
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Guideline on clinical investigation of new medicinal products for the treatment of acute coronary syndrome - First version (PDF/443.86 KB)
Adopted
First published: 20/09/2017
Last updated: 20/09/2017
Legal effective date: 01/03/2018
EMA/CHMP/760125/2016 -
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Overview of comments received on 'Guideline on clinical investigation of new medicinal products for the treatment of acute coronary syndrome' (PDF/168.44 KB)
First published: 26/09/2017
Last updated: 26/09/2017
EMA/CHMP/33407/2017 -
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Draft guideline on clinical investigation of new medicinal products for the treatment of acute coronary syndrome - First version (PDF/231.05 KB)
Draft: consultation closed
First published: 27/04/2016
Last updated: 27/04/2016
Consultation dates: 27/04/2016 to 31/10/2016
EMA/CHMP/207892/2015 -
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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 (PDF/106.89 KB)
Draft: consultation closed
First published: 15/10/2014
Last updated: 15/10/2014
Consultation dates: 15/10/2014 to 15/01/2015
EMA/CHMP/559636/2014