Off-label use of antimicrobials in veterinary medicine in the European Union
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| Keywords | off-label use, antimicrobials, antimicrobial resistance, veterinary medicines |
| Description | The reflection paper, prepared by EMA's Committee for Medicinal Products for Veterinary Use (CVMP) and its Antimicrobial Working Party (AWP), aims to define off-label use and to better understand the underlying reasons for the practice in relation to the use of antimicrobials. However, data on the off-label use of antimicrobials in veterinary medicine in the EU is currently too limited to allow a full assessment of the impact of these prescriptions on the spread of AMR and the associated risks for human and animal health. |
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Reflection paper on off-label use of antimicrobials in veterinary medicine in the European Union - First version (PDF/632.54 KB)
Adopted
First published: 21/11/2018
EMA/CVMP/AWP/237294/2017 -
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Overview of comments received on 'Reflection paper on off-label use of antimicrobials in veterinary medicine in the European Union' (EMA/CVMP/AWP/237294/2017) - First version (PDF/644.58 KB)
First published: 21/11/2018
EMA/CVMP/AWP/30098/2018 -
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Draft reflection paper on off-label use of antimicrobials in veterinary medicine in the European Union - First version (PDF/453.73 KB)
Draft: consultation closed
First published: 25/07/2017
Last updated: 25/07/2017
Consultation dates: 25/07/2017 to 31/01/2018
EMA/CVMP/AWP/237294/2017