Paediatric addendum to the guideline on clinical investigation of medicinal products for the treatment of pulmonary arterial hypertension - Scientific guideline

This document is a paediatric addendum to the guideline on the clinical investigation of medicinal products for the treatment of pulmonary arterial hypertension. It includes guidance on paediatric clinical medicine development, with highlights on differences from adult pulmonary arterial hypertension and points out paediatric specific issues.

Keywords: Pulmonary arterial hypertension (PAH), paediatric, persistent pulmonary hypertension of the newborn, congenital heart disease

Current effective version

Paediatric addendum to the Committee for Medicinal Products for Human Use guideline on the clinical investigations of medicinal products for the treatment of pulmonary arterial hypertension

Adopted Reference Number: EMA/CHMP/213972/2010 Legal effective date: 05/06/2012 Summary:

This is a paediatric addendum to the guideline on the “Clinical Investigations of Medicinal Products for the Treatment of Pulmonary Arterial Hypertension” for adults. It should be read in conjunction with that guideline. This addendum includes guidance on paediatric clinical medicine development, with highlights on differences from adult pulmonary arterial hypertension PAH and points out paediatric specific issues.

Concept paper on the need for revision of the Paediatric addendum to the guideline on clinical investigation of medicinal products for the treatment of pulmonary arterial hypertension

Reference Number: EMA/CHMP/264860/2023

Document history - First version (current)

Paediatric addendum to the Committee for Medicinal Products for Human Use guideline on the clinical investigations of medicinal products for the treatment of pulmonary arterial hypertension

Adopted Reference Number: EMA/CHMP/213972/2010 Legal effective date: 05/06/2012 Summary:

This is a paediatric addendum to the guideline on the “Clinical Investigations of Medicinal Products for the Treatment of Pulmonary Arterial Hypertension” for adults. It should be read in conjunction with that guideline. This addendum includes guidance on paediatric clinical medicine development, with highlights on differences from adult pulmonary arterial hypertension PAH and points out paediatric specific issues.

Draft paediatric addendum to CHMP guideline on the clinical investigations of medicinal products for the treatment of pulmonary arterial hypertension

Draft: consultation closed Consultation dates: 20/05/2010 to 30/11/2010 Reference Number: EMA/CHMP/EWP/213972/2010

Concept paper on the need for the development of a paediatric addendum to the chmp guideline on the clinical investigations of medicinal products for the treatment of pulmonary arterial hypertension

Reference Number: EMEA/CHMP/EWP/644261/2008