CVMP meeting highlights — 6–8 Oct 2026
- CVMP adopted a positive opinion in exceptional circumstances for Bovilis Lumpyvax, a live lumpy skin disease vaccine for cattle.
- The Committee gave a positive opinion for Stemyca (equine umbilical cord mesenchymal stem cells) for non‑food‑responsive chronic inflammatory enteropathy in dogs.
- The marketing authorisation for Vaxxitek HVT+IBD+H5 avian influenza vaccine was recommended for a one‑year extension under exceptional circumstances.
- CVMP concluded by majority that the benefit‑risk of Vetmedin 1.5 mg/ml (pimobendan) for the proposed indication is positive and will send clarifications to the European Commission.
CVMP opinions
The Committee adopted a positive opinion, in exceptional circumstances, for Bovilis Lumpyvax (lumpy skin disease vaccine (live)) for active immunisation of cattle to reduce clinical signs and viraemia. It also adopted a positive opinion for Stemyca (equine umbilical cord mesenchymal stem cells) for reduction of clinical signs of non‑food‑responsive chronic inflammatory enteropathy in dogs. A positive opinion was adopted for a variation to Mirataz (mirtazapine) to update product information based on new target animal safety data; the SPC and package leaflet now note that overdose administration is associated with some known adverse events, including erythema and alopecia at the application site.
Re‑examinations
The Committee recommended a one‑year extension of the marketing authorisation in exceptional circumstances for Vaxxitek HVT+IBD+H5, an avian influenza vaccine.
Union referrals
On Vetmedin 1.5 mg/ml oral solution for dogs (pimobendan), following a CMDv review lacking consensus and an EC request under Article 54(8) of Regulation (EU) 2019/6, the CVMP concluded by majority that the benefit‑risk for the proposed indication is positive and will send its clarifications to the European Commission.
Scientific advice, market classification and pharmacovigilance
The Committee adopted two scientific‑advice reports for Atlantic salmon (one pharmaceutical, one immunological). It classified one dog antiparasitic product (ATCvet: antiparasitic products, insecticides and repellents) as intended for a limited market and not eligible under Article 23 of Regulation (EU) 2019/6. The CVMP also adopted the outcomes of the monthly signal‑management process; submitted signals are listed chronologically on the IRIS public portal using the 'Signal management submission' filter.
Source: EMA