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.

Low obligation Product class Other Regulated Products EU-wide Pharmacovigilance

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’.

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