Draft addendum to the guideline on the evaluation of medicinal products indicated for treatment of bacterial infections to address paediatric-specific clinical data requirements - First version

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Download document Draft addendum to the guideline on the evaluation of medicinal products indicated for treatment of bacterial infections to address paediatric-specific clinical data requirements - First version
Reference number EMA/CHMP/187859/2017
Status draft: consultation open
First published 2018-04-06
Last updated 2018-04-06
Consultation start date 2018-04-06
Consultation end date 2018-10-30
Email address for submissions idwpsecretariat@ema.europa.eu

Summary

This document proposes the development of an addendum to the Guideline on the evaluation of medicines indicated for treatment of bacterial infections CPMP/EWP/558/95 rev 2), to provide specific guidance on paediatric clinical development programmes to support the authorisation of antibacterial agents for treating infectious diseases in children.