Paediatric addendum on the CHMP guideline on clinical investigation of medicinal products for the treatment of acute heart failure - Scientific guideline

This document is an addendum to the guideline on clinical investigation of medicinal products in the treatment of acute heart failure. It highlights differences from adult patients with acute heart failure and points out paediatric-specific aspects.

Keywords: Paediatric, drug evaluation, drug approval guideline, heart failure, acute heart failure, clinical evaluation, efficacy criteria, safety aspects

Current effective version

Paediatric addendum on the CHMP guideline on clinical investigation of medicinal products for the treatment of acute heart failure

Adopted Reference Number: EMA/CHMP/707532/2013 Legal effective date: 01/06/2017

Document history - First version (current)

Paediatric addendum on the CHMP guideline on clinical investigation of medicinal products for the treatment of acute heart failure

Adopted Reference Number: EMA/CHMP/707532/2013 Legal effective date: 01/06/2017

Overview of comments received on ‘Paediatric addendum on the CHMP guideline on clinical investigation of medicinal products for the treatment of acute heart failure’

Reference Number: EMA/CHMP/852405/2015

Draft paediatric addendum on the CHMP guideline on clinical investigation of medicinal products for the treatment of acute heart failure

Draft: consultation closed Consultation dates: 10/06/2015 to 30/11/2015 Reference Number: EMA/CHMP/707532/2013 Summary:

This is an addendum to the 'Guideline on clinical investigation of medicinal products in the treatment of acute heart failure' (CHMP/EWP/2986/03 Rev. 1). It is not meant as a guidance document on its own but rather highlights differences from adult patients with Acute Heart Failure (AHF) and points out paediatric-specific aspects.

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

Draft: consultation closed Consultation dates: 15/01/2013 to 15/04/2013 Reference Number: EMA/CHMP/778582/2012 Summary:

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.