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 open
First published 22/11/2013
Last updated 22/11/2013
Consultation start date 22/11/2013
Consultation end date 31/05/2014
Email address for submissions alberto.ganan@ema.europa.eu

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.