Clinical development of medicinal products for the treatment of cystic fibrosis

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Current effective version

Adopted guideline

Currently under revision - see below

Reference numberCHMP/EWP/9147/08
Published29/11/2009
Effective from30/04/2010
KeywordsAntibiotics, cystic fibrosis, exocrine pancreas insufficiency, paediatrics, pancreatic enzymes preparations (PEP), pulmonary disease, pulmonary infection, pseudomonas aeruginosa
DescriptionThis document provides guidance on the clinical development and evaluation of medicinal products for the treatment of cystic fibrosis.


Document history

Revision 1 

In progress

Concept paperPublished: 01/08/2016

First version  

Current version

Adopted guideline


Draft guideline


Concept paper

In operation: 01/11/2010–present


Published: 30/05/2008


Published: 22/03/2007


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