Conduct of pharmacovigilance for medicines used by the paediatric population
Table of contents
This document provides guidance on the conduct of pharmacovigilance for medicines used by paediatric population. It applies to 'off-label' and unlicensed as well as licensed use.
Keywords: Pharmacovigilance, safety, paediatrics, children, neonates, adverse drug reaction (ADR), periodic safety update report (PSUR), risk management plan (RMP), signal detection, patient information leaflet
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Guideline on conduct of pharmacovigilance for medicines used by the paediatric population (PDF/203.36 KB)
First published: 25/01/2007
Last updated: 25/01/2007
Legal effective date: 26/01/2007
EMEA/CHMP/PhVWP/235910/2005 Rev.1 -
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Overview of comments received on draft guideline on conduct of pharmacovigilance for medicines used by the paediatric population (PDF/79.77 KB)
First published: 27/06/2007
Last updated: 27/06/2007
EMEA/CHMP/PhVWP/228720/2006 -
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Draft guideline on conduct of pharmacovigilance for medicines used by the paediatric population (PDF/145.97 KB)
Draft: consultation closed
First published: 27/07/2005
Last updated: 27/07/2005
EMEA/CHMP/235910/2005 -
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Concept paper on conduct of pharmacovigilance for medicines used children (PDF/130.58 KB)
First published: 17/10/2002
Last updated: 17/10/2002
CPMP/PhVWP/4838/02