Non-clinical development of fixed combinations of medicinal products - Scientific guideline

This document provides guidance on the non-clinical strategies to be considered when developing a fixed combination based on the different data available. It may also apply to the development of a combination therapy not involving a fixed combination formulation.

Keywords: Fixed combination, new active substance, safety pharmacology, toxicity studies

Current effective version

Guideline on the non-clinical development of fixed combinations of medicinal products

Adopted Reference Number: CHMP/EMEA/CHMP/SWP/258498/2005 Legal effective date: 01/08/2008

Document history - First version (current)

Guideline on the non-clinical development of fixed combinations of medicinal products

Adopted Reference Number: CHMP/EMEA/CHMP/SWP/258498/2005 Legal effective date: 01/08/2008

Draft guideline on the non-clinical development of fixed combinations of medicinal products

Draft: consultation closed Consultation dates: 12/10/2005 to 30/04/2006 Reference Number: CHMP/EMEA/CHMP/SWP/258498/2005