Draft guideline on the adventitious agent safety of urine-derived medicinal products

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Document details

Download document Draft guideline on the adventitious agent safety of urine-derived medicinal products
Reference number EMA/CHMP/BWP/126802/2012
Status draft: consultation closed
First published 2013-11-22
Last updated 2013-11-22

Summary

Human urine is used to prepare several products indicated in the field of endocrinology, such as human chorionic gonadotropin (hCG), human menopausal gonadotropin or menotropin (HMG) and follicle-stimulating hormone (FSH) and urokinase products used for thrombolysis. This document addresses specific aspects which should be taken into consideration in the evaluation of viral and TSE safety of medicinal products derived from human urine.