Paediatric addendum to the guideline on clinical investigation on medicinal products in the treatment of hypertension
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This document is an addendum to the guideline on clinical investigation of medicinal products in the treatment of hypertension. It highlights differences from adult patients with arterial hypertension and points out paediatric-specific aspects.
Keywords: Paediatric, drug evaluation, drug approval guideline, hypertension, clinical evaluation, efficacy criteria, safety aspects
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Paediatric addendum to the note for guidance on the clinical investigation on medicinal products in the treatment of hypertension (PDF/190.51 KB)
Adopted
First published: 26/03/2015
Last updated: 26/03/2015
EMA/CHMP/206815/2013 -
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Overview of comments received on 'Paediatric addendum to the note for guidance on the clinical investigation on medicinal products in the treatment of hypertension' (PDF/134.84 KB)
First published: 26/03/2015
Last updated: 26/03/2015
EMA/CHMP/68390/2015 -
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Draft paediatric addendum to the note for guidance on the clinical investigation on medicinal products in the treatment of hypertension (PDF/195.75 KB)
Draft: consultation closed
First published: 30/09/2013
Last updated: 30/09/2013
Consultation dates: 30/09/2013 to 31/03/2014
EMA/CHMP/206815/2013 -
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Concept paper on the need for the development of a paediatric addendum to the note for guidance on the clinical investigation on medicinal products in the treatment of hypertension (PDF/97.83 KB)
First published: 18/12/2008
Last updated: 18/12/2008
EMEA/CHMP/EWP/545456/2008