Implementation of indication restrictions made by European regulatory action for antibiotics – amoxicillin

Inconsistencies in therapeutic indications continue to pose challenges, potentially impacting the safe and effective use of antibiotics. Such discrepancies can lead to misuse or inappropriate prescribing of crucial antibiotics, contributing to the growing problem of antimicrobial resistance. Our study highlights the importance of following up on and verifying the implementation of finalized regulatory procedures at EU level. Further research is needed to understand the root causes of incomplete implementations, possibly also due to incomplete updates of the EMA Article 57 database.