Ethanol content in herbal medicinal products and traditional herbal medicinal products used in children - Scientific guideline
Table of contents
This document reflects the need for safety limits for ethanol exposure by oral herbal medicinal products intended for the paediatric population. It aims to ensure a harmonised approach in assessment work among Member States.
Keywords: Herbal medicinal products, herbal substances, herbal preparations, ethanol, paediatric use, children
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Reflection paper on ethanol content in herbal medicinal products and traditional herbal medicinal products used in children (PDF/97.05 KB)
Adopted
First published: 01/02/2010
Last updated: 01/02/2010
EMA/HMPC/85114/2008 -
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Overview of comments received on reflection paper on ethanol content in herbal medicinal products and traditional herbal medicinal products used in children (PDF/197.57 KB)
First published: 01/02/2010
Last updated: 01/02/2010
EMA/HMPC/427952/2009 -
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Draft reflection paper on ethanol content in herbal medicinal products and traditional herbal medicinal products used in children (PDF/98.89 KB)
Draft: consultation closed
First published: 06/11/2008
Last updated: 06/11/2008
Consultation dates: 06/11/2008 to 15/03/2009
EMA/HMPC/85114/2008