Meeting highlights from the Committee for Veterinary Medicinal Products (CVMP) 6-8 October 2026

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Announcement

Safety Classified by Officially

CVMP opinions on veterinary medicinal products

The Committee adopted a positive opinion, in exceptional circumstances, for a marketing authorisation for Bovilis Lumpyvax (lumpy skin disease vaccine (live)), for the active immunisation of cattle to reduce clinical signs and viraemia caused by lumpy skin disease virus.

The Committee adopted a positive opinion for a marketing authorisation for Stemyca (equine umbilical cord mesenchymal stem cells), for reduction of clinical signs of non-food-responsive chronic inflammatory enteropathy (CIE) in dogs.

The Committee adopted a positive opinion for a variation for Mirataz (mirtazapine) to update the product information on the basis of new target animal safety data. The SPC and package leaflet were updated to show that the administration of Mirataz at overdose was associated with some of the known adverse events (e.g. erythema and alopecia at the application site).

Re-examinations of marketing authorisations in exceptional circumstances

The Committee adopted a positive opinion on the re-examination of Vaxxitek HVT+IBD+H5, an avian influenza vaccine. The Committee recommended the extension for one year of the validity of the marketing authorisation in exceptional circumstances.

The Committee concluded the procedure for Vetmedin 1.5 mg/ml oral solution for dogs (pimobendan). Due to lack of consensus between Member States in the Veterinary Coordination Group for Mutual Recognition and Decentralised Procedures (CMDv) review procedure on grounds of efficacy, the European Commission (EC) had requested clarifications from the Committee under Article 54(8) of Regulation (EU) 2019/6 on a variation to add an indication. The CVMP, having considered the request by the EC and all available data, concluded, by majority, that the benefit-risk balance of Vetmedin 1.5 mg/ml oral solution for dogs for the proposed indication is positive. The CVMP's clarifications will be sent to the EC for its consideration.

This is an extract. The publication continues at the source.

Source: European Medicines Agency.

Read the original at the source: https://www.ema.europa.eu/en/news/meeting-highlights-committee-veterinary-medicinal-products-cvmp-6-8-october-2026

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