Enabling appropriate use of antibiotics: review of European Union procedures of harmonising product information, 2007 to 2020.

ABSTRACT: IntroductionAntimicrobial resistance (AMR) is one of the most important challenges in modern clinical practice. The European regulatory network has a strategy to support prevention of AMR by applying specific referral procedures.AimThe aim of this study was to evaluate post-authorisation changes made in the product information of key antibiotics that underwent referral procedures between 2007 and 2020.MethodIn a comprehensive analysis of the changes made for antibiotics, we extracted information on changes from the European Commission community register of medicinal products and the European Medicines Agency's database for antibiotics that went through referrals. Changes made in the specific sections of the summary of product characteristics of each referral procedure were scrutinised.Resu

SUBMITTER: Opalska A 

PROVIDER: S-EPMC7667629 | biostudies-literature | 2020 Nov

REPOSITORIES: biostudies-literature