Clinical investigation of immunosuppressants for solid organ transplantation

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Current effective version

Adopted guideline

Reference numberCHMP/EWP/263148/06
Published24/07/2008
Effective from01/02/2009
KeywordsImmunosuppressants, solid organ transplantation
DescriptionThis document provides guidance on the conduct of clinical studies for solid organ transplantation. It definines treatment goals, study designs, outcome measures and data analysis for new immunosuppressive products developed to prevent and treat solid organ allograft rejection.


Document history

First version

Current version

Adopted guideline


Overview of comments


Draft guideline


Concept paper

In operation: 01/11/2010–present


Published: 16/07/2008


Published: 19/07/2007


Published: 24/01/2007


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