Carcinogenicity evaluation of medicinal products for the treatment of HIV infection

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Current effective version

Adopted guideline

Reference numberEMEA/194898/2006
Published13/12/2007
Effective from01/07/2008
KeywordsAnti-HIV compounds, NRTI’s, NNRTI’s, protease inhibitors, genotoxic properties, carcinogenicity timing
DescriptionThis document provides guidance on carcinogenicity studies that should be conducted during development and before marketing authorisation for any new anti-HIV medicinal product, if applicable. It also assists with describing this non-clinical information in the summary of products characteristics.


Document history

First version

Current version

Adopted guideline


Overview of comments


Draft guideline

In operation: 01/07/2008–present


Published: 26/05/2009


Published: 27/07/2006


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