Paediatric addendum on the CHMP guideline on clinical investigation of medicinal products for the treatment of acute heart failure
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This document is an addendum to the guideline on clinical investigation of medicinal products in the treatment of acute heart failure. It highlights differences from adult patients with acute heart failure and points out paediatric-specific aspects.
Keywords: Paediatric, drug evaluation, drug approval guideline, heart failure, acute heart failure, clinical evaluation, efficacy criteria, safety aspects
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Paediatric addendum on the CHMP guideline on clinical investigation of medicinal products for the treatment of acute heart failure (PDF/157.07 KB)
Adopted
First published: 18/11/2016
Last updated: 18/11/2016
Legal effective date: 01/06/2017
EMA/CHMP/707532/2013 -
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Overview of comments received on ‘Paediatric addendum on the CHMP guideline on clinical investigation of medicinal products for the treatment of acute heart failure’ (PDF/302.28 KB)
First published: 18/11/2016
Last updated: 18/11/2016
EMA/CHMP/852405/2015 -
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Draft paediatric addendum on the CHMP guideline on clinical investigation of medicinal products for the treatment of acute heart failure (PDF/136.43 KB)
Draft: consultation closed
First published: 10/06/2015
Last updated: 10/06/2015
Consultation dates: 10/06/2015 to 30/11/2015
EMA/CHMP/707532/2013 -
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Concept paper on the need for a paediatric addendum to the guideline on clinical investigation of medicinal products for the treatment of acute heart failure (PDF/83.39 KB)
Draft: consultation closed
First published: 16/01/2013
Last updated: 16/01/2013
Consultation dates: 15/01/2013 to 15/04/2013
EMA/CHMP/778582/2012