Use of aminopenicillins and their beta-lactamase inhibitor combinations in animals in the European Union: development of resistance and impact on human and animal health - Scientific guideline

The objective of this document is to review available information on the use of aminopenicillins and their beta-lactamase inhibitor combinations in veterinary medicines in the EU, their effect on the emergence of antimicrobial resistance (AMR) and the potential impact of resistance on human and animal health. The document provides information for the risk profiling, as recommended by the Antimicrobial Advice ad hoc Expert Group (AMEG) of the EMA.

Keywords: aminopenicillins, beta-lactamase inhibitor combinations, antimicrobial resistance

Current version

Reflection paper on the use of aminopenicillins and their beta-lactamase inhibitor combinations in animals in the European Union: development of resistance and impact on human and animal health - First version

Adopted Reference Number: EMA/CVMP/AWP/842786/2015

Document history

Reflection paper on the use of aminopenicillins and their beta-lactamase inhibitor combinations in animals in the European Union: development of resistance and impact on human and animal health - First version

Adopted Reference Number: EMA/CVMP/AWP/842786/2015

Overview of comments received on 'Reflection paper on the use of aminopenicillins and their beta-lactamase inhibitor combinations in animals in the European Union: development of resistance and impact on human and animal health - First version'

Reference Number: EMA/CVMP/AWP/902538/2019

Draft reflection paper on the use of aminopenicillins and their beta-lactamase inhibitor combinations in animals in the European Union: development of resistance and impact on human and animal health - First version

Draft: consultation closed Consultation dates: 21/09/2018 to 21/12/2018 Reference Number: EMA/CVMP/AWP/842786/2015 Summary:

The objective of this document is to review available information on the use of aminopenicillins and their beta-lactamase inhibitor combinations in veterinary medicines in the EU, their effect on the emergence of antimicrobial resistance (AMR) and the potential impact of resistance on human and animal health. The document provides information for the risk profiling, as recommended by the Antimicrobial Advice ad hoc Expert Group (AMEG) of the EMA.

Draft concept paper for the development of a reflection paper on the use of extended-spectrum penicillins in animals in the European Union: development of resistance and impact on human and animal health - First version

Draft: consultation closed Consultation dates: 17/07/2015 to 31/10/2015 Reference Number: EMA/CVMP/AWP/37203/2015 Summary:

This concept paper will focus on authorised veterinary medicinal products containing extended- spectrum penicillins1 (aminopenicillins, including their combinations with beta-lactamase inhibitors) which are currently classified as Category 22 by EMA/AMEG3, pending risk profiling before a final decision on the category. Aspects regarding the use of these substances in veterinary medicine and their potential public health risks are discussed.