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

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Concept paper

Reference numberEMA/CHMP/213862/2016
Published20/04/2016
KeywordsAntibacterial agents, paediatric population, paediatric bacterial infections, extrapolation of efficacy, paediatric study designs, timing paediatric studies
DescriptionThis document proposes the development of an addendum to the guideline on the evaluation of medicinal products indicated for treatment of bacterial infections to address the clinical development of antibacterial medicinal products for use in the paediatric population.

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