Need for assessment of reproduction toxicity of human insulin analogues - Scientific guideline

This document gives consideration to the impact of insulin use during pregnancy. It provides guidance on the assessment of the reproductive toxicity of new insulin analogues.

Keywords: Insulin analogues, reproduction toxicity, teratogenic potential, pregnancy, glucose

Current version

Points to consider on the need for assessment of reproductive toxicity of human insulin analogues

AdoptedReference Number: CPMP/SWP/2600/01 Final