Need for assessment of reproduction toxicity of human insulin analogues

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Adopted guideline

Reference numberCPMP/SWP/2600/01
Published01/03/2001
KeywordsInsulin analogues, reproduction toxicity, teratogenic potential, pregnancy, glucose
DescriptionThis 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.


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