The Committee adopted a positive opinion for a marketing authorisation forBexatilfor the reduction of hyperglycaemia in cats with diabetes mellitus not previously treated with insulin. The Committee adopted a positive opinion for a variation forMometamax Ultrato implement the outcome of the MAH's signal management process to include ‘deafness’, ‘impaired hearing’, ‘application site inflammation’ and ‘application site pruritus’ as ‘very rare’ adverse events. The Committee adopted a positive opinion for a variation forCimalgexto implement the outcome of the MAH's signal management process to change the frequency of the adverse events ‘elevated renal parameters’ and ‘renal failure’ from ‘very rare’ to ‘rare’.
EMA - European Medicines Agency · March 30, 2023
CVMP meeting highlights, 14-16 July 2026: marketing authorisation and variation opinions
Original title: Meeting highlights from the Committee for Veterinary Medicinal Products (CVMP) 14-16 July 2026
Committee adopted positive opinions for one new veterinary medicine (Bexatil) and two variations (Mometamax Ultra, Cimalgex) updating adverse event frequencies.
Published by EMA - European Medicines Agency. HealthSignal links to the original document; the summary above is extracted from the source text.