Risk assessment of medicinal products on human reproduction and lactation: from data to labelling - Scientific guideline
HumanScientific guidelines
This document describes how to assess the risk of an adverse reproductive/developmental effect in human based on reproductive toxicity studies in animals and human clinical data. It addresses information to be included in the summary of product characteristics on how to use the medicinal product taking into account the nature of the risk.
Keywords: Pregnancy, lactation, contraindication, non-clinical assessment, clinical assessment, risk assessment, labelling, summary of product characteristics (SmPC)
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