Paediatric addendum on the CHMP guideline on clinical investigation of medicinal products for the treatment of acute heart failure - Scientific guideline
HumanPaediatricsScientific guidelines
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
AdoptedReference Number: EMA/CHMP/707532/2013Legal effective date:
English (EN) (157.07 KB - PDF)
First published: Last updated:
Document history - First version (current)
Paediatric addendum on the CHMP guideline on clinical investigation of medicinal products for the treatment of acute heart failure
AdoptedReference Number: EMA/CHMP/707532/2013Legal effective date:
English (EN) (157.07 KB - PDF)
First published: Last updated:
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
English (EN) (302.28 KB - PDF)
First published: Last updated:
Draft paediatric addendum on the CHMP guideline on clinical investigation of medicinal products for the treatment of acute heart failure
Draft: consultation closedConsultation dates:
to Reference Number: EMA/CHMP/707532/2013Summary:
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.
English (EN) (136.43 KB - PDF)
First published: Last updated:
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 closedConsultation dates:
to Reference Number: EMA/CHMP/778582/2012Summary:
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.
English (EN) (83.39 KB - PDF)
First published: Last updated:
Related content
- Clinical efficacy and safety: cardiovascular system
- Scientific guidelines: paediatrics
- Ethical considerations for clinical trials on medical products conducted with the paediatric population
- Clinical investigation of medicinal products for the treatment of acute heart failure
- Clinical trials in small population
- ICH E11 Clinical investigation of medicinal products in the paediatric population
- Impact of liver immaturity when investigating medicinal products intended for neonatal use
- Impact of renal immaturity when investigating medicinal products intended for paediatric use
- Impact of brain immaturity when investigating medicinal products intended for neonatal use
- Investigation of medicinal products in the term and preterm neonate
- Pharmaceutical development of medicines for paediatric use
- Role of pharmacokinetics in the development of medicinal products in the paediatric population