Ethanol content in herbal medicinal products and traditional herbal medicinal products used in children - Scientific guideline

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

Current version

Reflection paper on ethanol content in herbal medicinal products and traditional herbal medicinal products used in children

AdoptedReference Number: EMA/HMPC/85114/2008

Document history

Reflection paper on ethanol content in herbal medicinal products and traditional herbal medicinal products used in children

AdoptedReference Number: EMA/HMPC/85114/2008

Overview of comments received on reflection paper on ethanol content in herbal medicinal products and traditional herbal medicinal products used in children

Reference Number: EMA/HMPC/427952/2009

Draft reflection paper on ethanol content in herbal medicinal products and traditional herbal medicinal products used in children

Consultation dates: 06/11/2008 to 15/03/2009Draft: consultation closedReference Number: EMA/HMPC/85114/2008