Carcinogenicity evaluation of medicinal products for the treatment of HIV infection

Current effective version

PDF iconAdopted 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

PDF iconAdopted guideline


PDF iconOverview of comments


PDF iconDraft guideline

In operation: 01/07/2008–present


Published: 26/05/2009


Published: 27/07/2006


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