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

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