The CHMP guideline on the clinical investigations of medicinal products for the treatment of Acute Heart Failure (AHF) addresses the development issues in this specific patient population but is restricted to adults. Acute Heart Failure Syndromes (AHFS) represent a very heterogeneous group of patients. In children the diagnosis of AHF has different aetiologies, different pathophysiology and clinical presentations.

 

Download document Concept paper on the need for a paediatric addendum to the guideline on clinical investigation of medicinal products for the treatment of acute heart failure
Reference number EMA/CHMP/778582/2012
Status draft: consultation open
First published 16/01/2013
Last updated 16/01/2013
Consultation start date 15/01/2013
Consultation end date 15/04/2013
Email address for submissions cvswpsecretariat@ema.europa.eu

 

Posted on EMA website on 16 January 2013