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23.05.2025
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European Medicines Agency 

Changes to the use of antibiotic azithromycin

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 resistance – the ability of microorganisms to become resistant to antimicrobials. Azithromycin has been used for decades to treat a wide range of infectious diseases, both in children and adults. It is i...
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 resistance – the ability of microorganisms to become resistant to antimicrobials. Azithromycin has been used for decades to treat a wide range of infectious diseases, both in children and adults. It is included in the World Health Organization (WHO) list of essential medicines, which highlights its importance for public health. However, azithromycin is also classified by WHO as an antibiotic that carries a higher risk of antimicrobial resistance and is included in WHO’s Watch category (AWaRe classification). Data show that antimicrobial resistance against this antibiotic has increased in recent years. Medicines in WHO’s Watch category should be prioritised as key targets for prudent use and monitoring. However, consumption data indicate an increased use of azithromycin medicines in recent years. A recent EMA-commissioned study, performed by DARWIN EU, showed a broad use of this antibiotic across the EU, both in adults and children. To promote a more rational use of this antibiotic based on current evidence and preserve its effectiveness, the CHMP re-evaluated the benefits and risks of azithromycin medicines given by mouth or infusion (drip) into a vein for the various authorised...

Errors and omissions excepted. As of: 23.05.2025