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

We have adopted this International Scientific Guideline - EMA/CHMP/213972/2010

Last updated

17 January 2025

About this guideline

Overseas effective date: 5 June 2012

Replaces: EMEA/CHMP/EWP/644261/2008 concept paper on this topic (provided for information 1 May 2009)

Note: This document is a paediatric addendum to the Guideline on the clinical investigations of medicinal products for the treatment of pulmonary arterial hypertension (EMEA/CHMP/EWP/356954/2008).It includes guidance on paediatric clinical medicine development, with highlights on differences from adult pulmonary arterial hypertension and points out paediatric specific issues.

Categories: Clinical efficacy and safety | Cardiovascular system | Pulmonary arterial hypertension

TGA annotations: Nil

Where EU guidelines adopted in Australia include references to EU legislation (including EC Directives and Regulations), the requirements contained in the referenced EU legislation are not applicable to the evaluation of medicines by the TGA.
All documents and other content published by the European Medicines Agency (EMA) on this website are under the copyright and other intellectual property rights ownership of the EMA. Please refer to Legal notice | European Medicines Agency for further information.

Product types