Clinical assessment of fixed combinations of herbal substances/herbal preparations - Scientific guideline
Table of contents
This document explains how to structure the clinical documentation of herbal fixed-combination products. It also provides advice to assessors for an assessment of the clinical safety and efficacy.
Keywords: Herbal fixed-combination products
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Guideline on the clinical assessment of fixed combinations of herbal substances / herbal preparations (PDF/155.17 KB)
Adopted
First published: 11/01/2006
Last updated: 11/01/2006
Legal effective date: 01/07/2006
EMEA/HMPC/166326/2005 -
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Overview of comments received on guideline on the clinical assessment of fixed combinations of herbal substances / herbal preparations (PDF/178.45 KB)
First published: 11/01/2006
Last updated: 11/01/2006
EMEA/HMPC/419395/2005