Dose review and adjustment of established veterinary antibiotics in the context summary of product characteristic (SPC) harmonisation
The Committee for Medicinal Products for Veterinary Use (CVMP) started a pilot project on dose optimisation of established veterinary antibiotics to which AnimalhealthEurope (formerly IFAH Europe), and the European Group for Generic Veterinary Products (EGGVP) were invited to provide anonymised data. The results of this project are for consideration by the CVMP for possible future work on the subject.
Keywords: antimicrobial resistance (AMR), summary of product characteristics (SPC), Dose optimisation, pharmacokinetic/pharmacodynamic (PK/PD) modelling, target animal safety (TAS), withdrawal periods (WP) and the environmental risk assessment (ERA)
Overview of comments received on ''Reflection paper on dose optimisation of established veterinary antibiotics in the context of SPC harmonisation" (PDF/1.29 MB)Adopted
First published: 13/01/2021
Draft reflection paper on dose optimisation of established veterinary antibiotics in the context of summary of product characteristics (SPC) harmonisation - First version (PDF/2.4 MB)Draft: consultation closed
First published: 27/07/2018
Consultation dates: 27/07/2018 to 31/01/2019