The Committee for Medicinal Products for Veterinary Use (CVMP) held a meeting from 8th to 10th October 2024.
The Committee adopted two positive opinions for marketing authorisations. One for Duotic (betamethasone acetate, terbinafine), a new product for the treatment of otitis externa associated with Malassezia pachydermatis in dogs and the other for Bravecto Triuno (fluralaner, moxidectin, pyrantel), a new product for the dogs with, or at risk from, mixed parasitic infestations by ticks or fleas, gastrointestinal nematodes, lungworm and/or heartworm.
The Committee adopted a positive opinion for a marketing authorisation for Vaxxon ND Clone a new vaccine for the active immunisation of chickens from the age of day one to reduce mortality and clinical signs of disease caused by infection with Newcastle Disease virus.
The Committee adopted positive opinions for a variation requiring assessment concerning quality-related changes for: Bovela, Cortavance, Easotic, Enteroporc Coli AC, Poulvac Procerta HVT-IBD and Zycortal.
The Committee adopted a positive opinion for variations requiring assessment for Bovilis Nasalgen-C to indicate in the product information that Bovilis Nasalgen-C can be used during pregnancy ; for Eluracat to implement the outcome of the MAH’s signal management process and change a warning for use of the product in cats with hypersomatotropism and for Mometamax Ultra to amend the instructions for use in the SPC and the package leaflet to indicate that the bottle must be shaken before each use.
The Committee adopted a clarification of a previous scientific advice report further to a request from the developer of a veterinary medicinal product, concerning a biological product for cattle, pigs and sheep.
The Committee adopted a draft revised guideline for the demonstration of efficacy for veterinary medicinal products containing anticoccidial substances for release for a 2nd period of public consultation.
Also, the Committee adopted the following guidelines related to limited markets after close of public consultation:
- on quality data requirements for applications for veterinary medicinal products other than biologicals intended for limited markets;
- on safety and residue data requirements for applications for non-immunological veterinary medicinal products intended for limited markets but not eligible for authorisation under the Regulation 2019/6;
- on efficacy and target animal safety data requirements for applications for non-immunological veterinary medicinal products intended for limited markets but not eligible for authorisation under the Regulation 2019/6;
- on safety and efficacy data requirements for applications for immunological veterinary medicinal products intended for limited markets but not eligible for authorisation under the Regulation 2019/6 ;
and guideline on quality data requirements for applications for biological veterinary medicinal products intended for limited markets and overview of comments.