27 January 2023
EMA/362787/2024 Rev.21

Shortage of amoxicillin and amoxicillin/clavulanic acid
Various presentations including paediatric formulations and presentations
What is amoxicillin

Amoxicillin, alone or in combination with clavulanic acid, is an antibiotic

used for?

used to treat a wide range of bacterial infections.

Reason for shortage

This shortage started in October 2022 and has several root causes; themain reason was a surge in respiratory infections that led to an increased
demand for antibiotics. This was compounded by manufacturing delays
and production capacity issues (lack of personnel).

Member States

The shortage affects or may affect all Member States where the medicine

affected

is marketed.
The shortage situation has improved or has been resolved in mostcountries. While some intermittent shortages of amoxicillin andamoxicillin/clavulanic acid continue to occur, alternative antibiotics areavailable in most countries.
For up-to-date information about the status of a medicine shortage in aparticular EU/EEA Member State, consult the national shortage register orcontact the national competent authority.

Monitoring ofEMA’s SPOC working party engaged with key stakeholders in the supply

shortagechain of amoxicillin and amoxicillin/clavulanic acid to agree on possible
measures to mitigate the impact of the supply shortage, such asincreasing manufacturing capacity. The SPOC working party is responsible
for monitoring and reporting events that could affect the supply ofmedicines in the EU. Summaries of the SPOC working party meetings canbe found on EMA’s website.
Furthermore, EMA, together with the European Commission’s Directorate
General for Health Emergency Preparedness and Response (DG HERA),
monitored the supply and demand of a subset of antibiotics, including
amoxicillin and amoxicillin/clavulanic acid. As a result, the Medicine
Shortages Steering Group (MSSG) issued recommendations to help
ensure the availability of key antibiotics used to treat respiratory
infections. More information about this cooperation is available on theEMA website.

This document was modified on 17 July 2023 to update the list of Member States affected and to reflect ongoing
monitoring by EMA and DG HERA; and on 2 September 2024 to reflect the fact that the situation has improved orresolved in most countries.
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Shortage of amoxicillin and amoxicillin/clavulanic acid
Various presentations including paediatric formulations and presentations
Following the actions taken, the situation has improved or has been
resolved in many EU Member States. EMA’s SPOC working party continues
to monitor the shortage situation in cooperation with the relevant
stakeholders and takes appropriate actions when necessary.
Information to•

A surge in respiratory infections during the winter of 2022/2023 led tohealthcare

an increase in the demand for antibiotics such as amoxicillin (aloneprofessionals

and in combination with clavulanic acid), especially as paediatricformulations. In addition, manufacturing delays and production
capacity issues led to supply problems in the majority of the EU
Member States.
•Although the situation has since improved, shortages are still ongoingin some countries. Where shortages are ongoing, alternative
antibiotics are available. If amoxicillin is not available, an alternative
antibiotic can be prescribed based on national guidelines. Please checkthe current availability status of alternative medicinal products withyour national competent authority.

•As for all antibiotics, amoxicillin should only be prescribed to treat
bacterial infections and not viral infections such as cold and flu, forwhich they are not effective.

Information to•

It is important not to overorder amoxicillin to prevent shortages.

•Please consult your national shortage register for further advice.

•A surge in respiratory infections during the winter of 2022/2023 led to
an increase in the demand for antibiotics such as amoxicillin (alonepatientsand in combination with clavulanic acid), especially as formulations forchildren. In addition, manufacturing delays and production capacity
issues led to supply problems in the majority of the EU MemberStates.
•Although the situation has since improved, shortages are still ongoingin some countries. If amoxicillin is not available in your country, yourdoctor will prescribe an alternative antibiotic. For children, yourpharmacist may make a preparation themselves. Ask your pharmacist
for advice on how to give this preparation to your child.

•Your doctor will only prescribe amoxicillin to treat bacterial infections
and not viral infections such as cold and flu, where antibiotics are noteffective.

•If you have any questions you should speak to your doctor orpharmacist.

•Please consult your national shortage register for further advice,including advice on alternatives, if applicable.

StatusOngoing

Shortage of Insuman (insulin human)
EMA/362787/2024

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