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

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Current effective version

Adopted guideline

Reference numberCHMP/EWP/213972/10
Published07/02/2012
Effective from05/06/2012
KeywordsPulmonary arterial hypertension (PAH), paediatric, persistent pulmonary hypertension of the newborn, congenital heart disease
DescriptionThis 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.


Document history

First version

Current version

Adopted guideline

 

Draft guideline

 

Concept paper

In operation: 05/06/2012–present

 

Published: 04/06/2010

 

Published: 22/01/2009


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