Practical implication
Marketing authorization holders must prepare to submit any relevant pre-clinical and clinical data pertaining to amoxicillin's dosing regimens in pigs during the review.
The European Medicines Agency (EMA) is conducting a referral review of veterinary medicines containing amoxicillin, focusing on dosage adjustments for respiratory treatments in pigs. This review, part of the ADRA project, will utilize pharmacokinetic and pharmacodynamic data to refine dosing and address antimicrobial resistance.
What changed: A review has begun evaluating veterinary medicines containing amoxicillin, aimed at adjusting dosage regimens based on non-experimental approaches.
Why it matters: This initiative seeks to minimize antimicrobial resistance across the Union, ensuring safe use of antibiotics in veterinary medicine and impacting associated regulatory processes.
Practical implication: Marketing authorization holders must prepare to submit any relevant pre-clinical and clinical data pertaining to amoxicillin's dosing regimens in pigs during the review.
View original source
- Source: EMA - What's new
- Published at source: 2026-09-10T14:30:00.000Z
- Discovered by monitor: 2026-09-10T21:33:41.813Z
Published from the regulator source ingestion pipeline after PV impact triage.
