CVMP opinions on veterinary medicinal products 

The Committee adopted a positive opinion for a marketing authorisation for Bexatil for the reduction of hyperglycaemia in cats with diabetes mellitus not previously treated with insulin.

The Committee adopted a positive opinion for a variation for Mometamax Ultra to 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 for Cimalgex to 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’.

Union referrals and related procedures

The Committee started a procedure for Vetmedin 1.5 mg/ml oral solution for dogs (pimobendan) from Boehringer Ingelheim Vetmedica GmbH,…