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CVMP backs first limited-market veterinary product, Scovella, after re-examination of June opinion

🇪🇺 EMA · Fri 06 Nov 2026

The EMA committee's November meeting also produced five further positive opinions on new products, several variations, and an extension of two avian influenza vaccine authorisations.

The European Medicines Agency's Committee for Veterinary Medicinal Products (CVMP) adopted a positive opinion on Scovella (velagliflozin) at its 3-5 November 2026 meeting, following re-examination of the opinion it adopted in June 2026. The product is intended to reduce hyperinsulinaemia and the associated risk of laminitis in horses with Equine Metabolic Syndrome that do not respond to changes in husbandry and exercise.

According to EMA, Scovella is the first veterinary medicine the committee has recommended under the limited market framework since Regulation (EU) 2019/6 took effect in 2022. The framework allows authorisation on the basis of customised documentation requirements, provided the benefit-risk assessment is favourable.

The committee also recommended marketing authorisations for Credelio Quattro (lotilaner/moxidectin/pyrantel/praziquantel) for mixed parasitic infestations in dogs, and Laverdia (verdinexor) for increasing time to progression in dogs with stage II-IV lymphoma. Laverdia is classed as minor use, minor species/limited market. Streptoporc, a vaccine for sows and gilts against Streptococcus suis, and Nobivac PLUS DHPPi / Leptos, a canine vaccine, also received positive opinions.

Positive variation opinions covered Syvazul BTV 3, Hepizovac and Orbyk EHD, each to meet specific obligations on potency testing, immunity duration or stability data. Zenrelia (ilunocitinib) will have "aggression" added as a very rare adverse event, and Credelio (lotilaner) gains an indication for ear mite infestations (Otodectes cynotis) in the product information. For Vaxxinact H5 and Vaxxitek HVT+IBD+H5, the committee recommended extending authorisations granted in exceptional circumstances by one year after re-examination.

On guidance, the CVMP adopted the fifth JIACRA report on antimicrobial consumption and resistance, due for publication on 10 December. It also released the revised VGVP Module on medically important VeDDRA terms for a two-month consultation, and VICH GL49(R2) for a consultation running to the end of April 2027.

What it means for your team

  • Sponsors considering the limited market route now have a first CVMP recommendation as a reference point for what the pathway can deliver.
  • Pharmacovigilance teams should note the Zenrelia product information change and the public consultation on the Medically Important VeDDRA terms list.
  • Vaccine MAHs holding exceptional-circumstances authorisations should track the one-year extensions for the two avian influenza vaccines, and the specific-obligation variations for the bluetongue and EHD vaccines.
  • Residue and analytical teams may wish to respond to the VICH GL49(R2) consultation, open until the end of April 2027.

Official source: EMA ↗

Article written by VigiEye from the official source (EMA). AI-assisted; check the source before acting.

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