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

AdoptedReference Number: EMA/CVMP/AWP/842786/2015

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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

AdoptedReference Number: EMA/CVMP/AWP/842786/2015

English (EN) (1.22 MB - PDF)

First published:
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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

English (EN) (465.69 KB - PDF)

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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

Consultation dates: to Draft: consultation closedReference Number: EMA/CVMP/AWP/842786/2015Summary:

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.

English (EN) (980.29 KB - PDF)

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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

Consultation dates: to Draft: consultation closedReference Number: EMA/CVMP/AWP/37203/2015Summary:

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.

English (EN) (158.36 KB - PDF)

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