CVMP meeting highlights — 6–8 Oct 2026

Key highlights
  • 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

chemXplore Weekly

The week’s project milestones and project news from the chemical industry, free every Wednesday.

Free. One email a week. Unsubscribe any time.

Related articles

9 October 2026
EMA recommends Intervet's Bovilis Lumpyvax for lumpy skin disease

Live attenuated vaccine cuts clinical signs and viraemia from three weeks post‑vaccination and confers protection for one year; authorised under exceptional circumstances; side effects are uncommon.

1 October 2026
EMA opens first women's health multistakeholder workshop

Workshop to close gaps in research, diagnosis and treatment for women; aims to deliver a practical roadmap and public report to speed innovation and improve outcomes.

1 October 2026
EMA Management Board highlights — September 2026

Mid‑year operational results, NPL implementation progress, CTIS upgrade tied to the Biotech Act, and arrangements for the next Executive Director.

18 September 2026
Novo Nordisk’s Sogroya recommended by EMA CHMP for idiopathic short stature in children

Once-weekly somapacitan (Sogroya) receives CHMP positive opinion for children with idiopathic short stature; European Commission decision expected later this year.

18 September 2026
EMA CHMP restricts and redefines ipidacrine indications

CHMP limits ipidacrine to specific neuropathies, Alzheimer’s, intestinal atony and certain stroke/TBI recovery uses; removes several neuritis and demyelinating indications; cautions >80 mg/day.