Addendum to the guideline on the evaluation of medicinal products indicated for treatment of bacterial infections to address paediatric-specific clinical data requirements - Scientific guideline
Table of contents
This addendum to the Guideline on the evaluation of medicines indicated for treatment of bacterial infections (CPMP/EWP/558/95 rev 3) has been developed to provide guidance on clinical development programmes that are required to support the authorisation of antibacterial agents for treatment of infectious diseases in paediatric patients.
Keywords: Antibacterial agents, paediatric population, paediatric bacterial infections, extrapolation of efficacy, paediatric study designs, timing paediatric studies
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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 (PDF/305.9 KB)
Draft: consultation closed
First published: 06/04/2018
Last updated: 06/04/2018
Consultation dates: 06/04/2018 to 30/10/2018
EMA/CHMP/187859/2017 -
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Draft concept paper on an addendum to the guideline on the evaluation of medicinal products indicated for treatment of bacterial infections (CPMP/EWP/558/95 Rev. 2) to address paediatric-specific clinical data requiremen... (PDF/92.06 KB)
Draft: consultation closed
First published: 20/04/2016
Last updated: 20/04/2016
Consultation dates: 20/04/2016 to 31/07/2016
EMA/CHMP/213862/2016