CVMP opinions on veterinary medicinal products

The Committee adopted, by majority, a positive opinion for a marketing authorisation from Zoetis Belgium for Portela (relfovetmab), for the alleviation of pain associated with osteoarthritis in cats.

The Committee adopted, by consensus, a positive opinion for a variation requiring assessment for Divence Tetra (Bovine viral diarrhoea (subunit), bovine parainfluenza 3 virus (inactivated)) to implement the outcome of the MAH’s signal management process to add new, uncommon adverse events in the product information: milk production decrease, reduced food intake and decreased activity. Information on allowing the vaccine to reach room temperature before use was also added to the product information.

The Committee adopted, by consensus, a positive opinion for a variation requiring assessment for Bravecto TriUNO (fluralaner/ moxidectin/ pyrantel) concerning change(s) to therapeutic indication(s) – addition of a new therapeutic…