Veterinary medicinal products containing amoxicillin - referral

Current status

Procedure started

Overview

The European Medicines Agency (EMA) has started a review of veterinary medicines containing amoxicillin as a single active substance for use in drinking water or in feed in pigs, specifically for respiratory indications.

In the context of the Dosage Review and Adjustment of established veterinary Antibiotics (ADRA) project, the EMA’s veterinary medicines committee (CVMP) will review and refine the dosage regimen (i.e., dose, frequency and treatment duration) in the product information of the above-mentioned veterinary antibiotics, using non-experimental approaches (i.e. not necessitating the generation of new data), including pharmacokinetics/pharmacodynamics (PK/PD) integration for dose review and adjustment, PK modelling for withdrawal period adjustment, and scientific review approaches to address the safety of both target animals and the environment.

The aim of this scientific advice provided by the CVMP is to minimise the occurrence of antimicrobial resistance in the Union, and the outcome of this procedure will be considered to constitute current scientific knowledge, thus allowing the product information of the concerned products to be aligned accordingly.

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More about the procedure

The review has been self-mandated by the Committee for Veterinary Medicinal Products (CVMP) under Article 141(1)(i) of Regulation (EU) 2019/6. The review is being carried out by the CVMP, responsible for questions concerning medicines for veterinary use, and will result in a scientific advice.

Veterinary medicines containing amoxicillin - Article 141(1)(i) referral - Start of review

Reference Number: EMA/353616/2025

Key facts

About this medicine

• Approved name:
  Veterinary medicinal products containing amoxicillin
• International non-proprietary name (INN) or common name:
  amoxicillin

About this procedure

• Current status:
  Procedure started
• Reference number:
  EMA/REF/0000290626
• Type:
  Article 141(1)(i) procedures

  This type of procedure is initiated when there is a request to the Committee to provide scientific advice on the use of antimicrobials and antiparasitics in animals in order to minimise the occurrence of resistance in the Union.

• Authorisation model:
  Nationally authorised product(s)

Key dates and outcomes

• Procedure start date:
  06/11/2025

All documents

Procedure started

Veterinary medicines containing amoxicillin - Article 141(1)(i) referral - Annex I

Reference Number: EMA/105000/2022

Veterinary medicines containing amoxicillin - Article 141(1)(i) referral - CVMP List of questions to be addressed by the marketing authorisation holders

Reference Number: EMA/CVMP/322656/2025

Veterinary medicines containing amoxicillin - Article 141(1)(i) referral - Timetable for the procedure

Reference Number: EMA/CVMP/322603/2025

Veterinary medicines containing amoxicillin - Article 141(1)(i) referral - CVMP list of questions to be addressed by stakeholders

Reference Number: EMA/CVMP/324544/2025

Veterinary medicines containing amoxicillin - Article 141(1)(i) referral - Start of review

Reference Number: EMA/353616/2025

Description of documents published

Please note that some of the listed documents apply only to certain procedures.

• Overview - lay-language summary of the stage of the procedure
• Notification – a letter from a Member State, the European Commission or the marketing authorisation holder requesting the initiation of the procedure
• List of questions – questions agreed by the Committee requesting further information from the marketing authorisation holder(s) / applicant(s) to evaluate the issues identified
• Timetable for the procedure – agreed timeframe to respond to the list of questions, to assess the issues and to adopt a conclusion
• List of medicines concerned by the procedure – medicine(s) / active substance(s) concerned, and marketing authorisation holder(s) / applicant(s)
• List of questions to be addressed by the stakeholders – call for data to be submitted by stakeholders (e.g. veterinary healthcare professionals, farmers, academia) (if applicable)
• Stakeholder submission form – form to be used by stakeholders to submit data (if applicable)
• Scientific conclusions – scientific conclusions of CVMP
• Divergent positions – divergent positions of the CVMP members (if applicable)
• Changes to the summary of product characteristics, labelling and package leaflet (amended sections or fully revised version) (if applicable)
• Condition(s) to the marketing authorisation(s) – condition(s) for the safe and effective use of the medicine(s) (if applicable)
• Condition for lifting the suspension – condition to be fulfilled for the suspension of the marketing authorisation(s) to be lifted (if applicable)