Carcinogenicity evaluation of medicinal products for the treatment of HIV infection

  • Email
  • Help
Current effective version

Adopted guideline

Reference numberEMEA/194898/2006
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

Related conent

How helpful is this page?

Average rating:

 Based on 15 ratings

Add your rating:

See all ratings
3 ratings
3 ratings
3 ratings
3 ratings
3 ratings

Tell us more