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

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

How useful was this page?

Add your rating