Meeting highlights from the Committee for Veterinary Medicinal Products (CVMP) 3-5 November 2026

CVMP opinions on veterinary medicinal products

Further to the re-examination of the opinion adopted by the Committee during its June 2026 meeting, the Committee adopted a positive opinion for a marketing authorisation for Scovella (velagliflozin), intended for the reduction of hyperinsulinaemia and reduction of associated risk of laminitis in horses with Equine Metabolic Syndrome not responsive to changes in husbandry and exercise regimen. Scovella is the first veterinary medicinal product recommended by the Committee under the limited market regulatory framework, since Regulation (EU) 2019/6 came into effect in 2022. This framework permits to grant authorisation based on customised requirements for documentation and a favourable benefit-risk assessment for a limited market authorisation.

The Committee adopted a positive opinion for a marketing authorisation for Credelio Quattro (lotilaner/moxidectin/pyrantel/praziquantel)for the treatment of mixed external and internal parasitic infestations/infections by ectoparasites, cestodes and nematodes in dogs. The veterinary medicinal product is only indicated when use against ectoparasites, cestodes and nematodes is indicated at the same time.

The Committee adopted a positive opinion for a marketing authorisation for Laverdia (verdinexor) for increasing time to progression in dogs with stage II, III and IV lymphoma where use in a home setting is indicated, a product classified as minor use, minor species/limited market in accordance with the applicable legal basis of this marketing authorisation application.

The Committee adopted a positive opinion for a marketing authorisation for Streptoporc, for the passive immunisation of progeny by active immunisation of pregnant sows and gilts to reduce clinical signs, mortality, bacterial load and pathological lesions in serosae, joints and organs which are associated with Streptococcus suis belonging to Ide_Ssuis genotype 1.1.

The Committee adopted a positive opinion for a marketing authorisation for Nobivac PLUS DHPPi / Leptos, for the active immunisation of dogs from 6 weeks of age onwards to prevent or reduce symptoms or lesions caused by CDV, CAV1, CAV2, CPV, CPi, Leptospira interrogans and L. kirschneri.

The Committee adopted a positive opinion for a variation for Syvazul BTV 3 (Bluetongue virus vaccine (inactivated)) to fulfil two specific obligations regarding completion of the development of the ELISA potency test for the BTV 3 antigen and to provide the study of duration of immunity in sheep.

The Committee adopted a positive opinion for a variation for Hepizovac (epizootic haemorrhagic disease vaccine (inactivated)) to fulfil a specific obligation regarding the stability studies (up to 21 months) to confirm the accepted shelf life of 18 months under the recommended storage conditions for the finished product.

The Committee adopted a positive opinion for a variation for Orbyk EHD (epizootic haemorrhagic disease vaccine (recombinant protein)) to fulfil two specific obligations: to provide the complete validation report for the potency test in the finished product and to support the in-use shelf life of 10 hours by potency data.

The Committee adopted a positive opinion for a variation for Zenrelia (ilunocitinib), to implement the outcome of the MAH’s signal management process to include “aggression” as a very rare adverse event in the product information.

The Committee adopted a positive opinion for a variation for Credelio (lotilaner) to add a new therapeutic indication or modification of an approved one: treatment of ear mite infestations (Otodectes cynotis).

Re-examinations of marketing authorisations in exceptional circumstances

The Committee adopted an opinion on the re-examination of the marketing authorization for the avian influenza vaccine Vaxxinact H5, further to the evaluation of the data submitted by the marketing authorisation holder. The Committee recommended that the validity of the marketing authorisation in exceptional circumstances for the above-mentioned veterinary medicinal product be extended for one year.

The Committee adopted an opinion on the re-examination of the marketing authorization for the avian influenza vaccine Vaxxitek HVT+IBD+H5, further to the evaluation of the data submitted by the marketing authorisation holder. The Committee recommended that the validity of the marketing authorisation in exceptional circumstances for the above-mentioned veterinary medicinal product be extended for one year.

Scientific advice

The Committee adopted one scientific advice report for a biological product for horses.

Pharmacovigilance

The Committee adopted the outcomes of the signal management process for the current month. The signals submitted by marketing authorisation holders are listed, in chronological order, in the IRIS public portal: List of signals from Veterinary Signal Management. In order to access the list, the following filter should be applied in the ‘Submission type’ category: ‘Signal management submission’.

Concept papers, guidelines

Immunologicals

The Committee adopted an administrative revision of the reflection paper on the use of heat treatment to inactivate endogenous retroviruses in live immunological veterinary medicinal products (EMA/CVMP/IWP/37924/2014). This document outlines the requirements that need to be fulfilled to demonstrate that the inactivation treatment has no negative impact on the vaccine.

Pharmacovigilance

The Committee adopted the revised VGVP Module: Medically Important (MI) VeDDRA terms list for release for a 2-month period of public consultation.

Antimicrobial resistance

The Committee adopted the ‘Fifth joint inter-agency report on integrated analysis of antimicrobial agent consumption and occurrence of antimicrobial resistance in bacteria from humans and food-producing animals in the EU/EEA’ (JIACRA V). Compared with previous reports, a stronger One Health approach is introduced by incorporating environmental data and expertise from the European Environment Agency, analysing post-COVID trends (2022-2024), and providing new long-term evidence that sustained reductions in antimicrobial use are associated with improvements in bacterial susceptibility at country level. The report will be published on 10 December on the websites of the ECDC, EFSA and EMA.

International harmonisation

The Committee adopted VICH GL49(R2) on validation of analytical methods used in residue depletion studies for release for a six-month public consultation, until the end of April 2027.

Working parties

The Committee elected Jana Pantzke as vice-chair of the 3Rs Working Party (3RsWP) for a 3-year mandate.

The Committee appointed Sarah Buckley as a member of the Scientific Advice Working Party for a 3-year mandate.

The Committee appointed Susana Casado as a member of the Novel Therapy and Technologies Working Party for a 3-year mandate.

More information about the above-mentioned medicines (including their full indications), guidelines, reflection papers, questions and answers and other documents, such as overviews on comments received during consultation, can be found below in “Related content”.