Clinical investigation of medicinal products in the treatment of chronic heart failure - Scientific guideline
Table of contents
Guidance for the clinical investigation of medicinal products in the treatment of cardiac failure.
Keywords: Heart failure, left ventricular function, mortality, morbidity, hospitalisation
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Guideline on clinical investigation of medicinal products for the treatment of chronic heart failure - Revision 2 (PDF/318.89 KB)
Adopted
First published: 20/09/2017
Last updated: 20/09/2017
Legal effective date: 01/03/2018
CPMP/EWP/235/95 Rev.2 -
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Draft guideline on clinical investigation of medicinal products for the treatment of chronic heart failure - Revision 2 (PDF/266 KB)
Draft: consultation closed
First published: 11/02/2016
Last updated: 11/02/2016
Consultation dates: 11/02/2016 to 31/08/2016
EMA/CHMP/392958/2015 -
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Overview of comments received on draft Guideline on clinical investigation of medicinal products for the treatment of chronic heart failure (CPMP/EWP/235/95, Rev.2) (PDF/299.74 KB)
First published: 26/09/2017
Last updated: 26/09/2017
EMA/547655/2017 -
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Draft concept paper on the need for revision of the addendum on acute cardiac failure of the note for guidance on clinical investigation of medicinal products for the treatment of cardiac failure (CPMP/EWP/2986/03) (PDF/113.81 KB)
Draft: consultation closed
First published: 04/06/2010
Last updated: 04/06/2010
Consultation dates: 20/05/2010 to 31/08/2010
EMA/CHMP/EWP/215701/2010 -
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Note for guidance on clinical investigation of medicinal products for the treatment of cardiac failure - Addendum on acute cardiac failure (PDF/209.08 KB)
Adopted
First published: 29/07/2004
Last updated: 29/07/2004
Legal effective date: 01/01/2005
CPMP/EWP/2986/03 -
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Concept paper on the need for revision of the note for guidance on the clinical investigation of medicinal products for the treatment of cardiac failure - Revision 1 (PDF/96.22 KB)
Draft: consultation closed
First published: 01/03/2013
Last updated: 01/03/2013
Consultation dates: 01/03/2013 to 31/05/2013
EMA/CHMP/87576/2013 -
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Note for guidance on clinical investigation of medicinal products in the treatment of cardiac failure - Revision 1 (PDF/63.39 KB)
Adopted
First published: 16/12/1999
Last updated: 16/12/1999
Legal effective date: 01/06/2000
CPMP/EWP/235/95, Rev 1