12.09.2025 – European Commission final decision

With the publication of the European Commission's decision, the risk assessment procedure according to Article 31 of Directive 2001/83/ EC on medicinal products containing azithromycin has been completed. According to this decision, among other things, some indications for oral use are to be deleted and the summary of product characteristics and package leaflet for the medicinal products listed in Annex I are to be adapted in accordance with Annex III to reflect the state of scientific knowledge as set out in Annex II to the implementing decision.

European Commission final decision

23.05.2025 - CHMP opinion

Changes to the use of antibiotic azithromycin
Recommendations aim to optimise use and minimise development of antimicrobial resistance

EMA’s human medicines committee (CHMP) has recommended several changes to the way the antibiotic azithromycin is used in the EU, including the removal of certain indications. These recommendations aim to optimise the use of this common antibiotic and minimise the development of antimicrobial resistence – the ability of microorganisms to become resistant to antimicrobials.

10.11.2023 - Procedure started

EMA’s human medicines committee (CHMP) has started a review of systemic medicines (given by mouth or by injection) that contain the antibiotic azithromycin. Antimicrobial resistance (AMR) against azithromycin is increasing in the European Union (EU). Therefore, and in view of the broad use of these medicines, a re-evaluation of the benefits and risks of azithromycin in its many authorised uses is considered warranted to optimise its use and minimise the risk of AMR development.

Further information

For details on the procedure please click on the following link to the homepage of the European Medicines Agency (EMA):