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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

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.

 

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