Clinical investigation of medicinal products for the treatment of pulmonary arterial hypertension - Scientific guideline

This document provides guidance on the evaluation of new medicinal products used in combination in the treatment of pulmonary arterial hypertension.

Keywords: Pulmonary arterial hypertension (PAH), revised WHO classification on pulmonary hypertension

 

Current effective version

Guideline on the clinical investigations of medicinal products for the treatment of pulmonary arterial hypertension

Adopted Reference Number: EMEA/CHMP/EWP/356954/2008 Legal effective date: 01/05/2010

Document history

Guideline on the clinical investigations of medicinal products for the treatment of pulmonary arterial hypertension

Adopted Reference Number: EMEA/CHMP/EWP/356954/2008 Legal effective date: 01/05/2010

Overview of comments for the guideline on the clinical investigations of medicinal products for the treatment of pulmonary arterial hypertension

Adopted Reference Number: EMEA/CHMP/EWP/582423/2009

Draft guideline on the use of bovine serum in the manufacture of human biological medicinal products

Draft: consultation closed Consultation dates: 01/10/2012 to 31/12/2012 Reference Number: EMA/CHMP/BWP/457920/2012 Rev. 1 Summary:

This guideline replaces the note for guidance on the use of bovine serum in the manufacture of human biological medicinal products (CPMP/BWP/1793/02).

Concept paper on the development of a CHMP guideline on the clinical investigation of medicinal products for the treatment of pulmonary hypertension

Reference Number: EMEA/CHMP/EWP/566954/2007