AMSTERDAM, Netherlands — October 9, 2026 — Following its plenary sessions held October 6–8, 2026, the European Medicines Agency’s (EMA) Committee for Veterinary Medicinal Products (CVMP) adopted major positive opinions across livestock biologicals, companion animal therapeutics, cardiology formulations, and pharmacovigilance safety profiles.
The regulatory milestone highlights the authorization of a novel live vaccine against Lumpy Skin Disease (LSD) in cattle, an equine umbilical-derived stem cell treatment for chronic canine enteropathy, and the resolution of an internal European Union referral concerning canine heart failure management.
1. New Marketing Authorizations & Innovative Biologics
A. Bovilis Lumpyvax (Live Lumpy Skin Disease Vaccine)
The CVMP granted a positive opinion under exceptional circumstances for a centralized marketing authorization for Bovilis Lumpyvax (Intervet International B.V.).
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Target Species: Cattle
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Indication: Active immunization of cattle to reduce clinical signs and viraemia caused by the Lumpy Skin Disease Virus (LSDV)
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Regulatory Context: Authorizations granted under “exceptional circumstances” allow crucial immunologies to reach European livestock producers where comprehensive data collection may be constrained by disease dynamics, subject to annual regulatory reassessments. This provides European herds with a critical prophylactic barrier against transboundary vector-borne poxviruses
B. Stemyca (Equine Umbilical Cord Mesenchymal Stem Cells)
Advancing regenerative veterinary medicine, the Committee issued a positive opinion for Stemyca.
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Target Species: Dogs (Canis lupus familiaris)
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Indication: Reduction of clinical signs associated with non-food-responsive chronic inflammatory enteropathy (CIE)
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Mechanism: Harnessing equine umbilical cord-derived mesenchymal stem cells (MSCs), the cell therapy provides an advanced immunomodulatory option for complex, refractory canine gastrointestinal inflammation
2. Post-Authorization Variations & Re-Examinations
A. Mirataz (Mirtazapine Transdermal Ointment)
The CVMP approved a post-approval variation updating the Summary of Product Characteristics (SPC) and package leaflet for Mirataz based on newly submitted target animal safety trial data.
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Safety Profile Revision: Updated clinical guidance reflects that mirtazapine administration at overdose levels is directly correlated with localized target-site adverse events, primarily application-site erythema and alopecia
B. Vaxxitek HVT+IBD+H5 (Avian Influenza Recombinant Vaccine)
Following a formal re-examination procedure, the Committee reaffirmed a positive opinion for Vaxxitek HVT+IBD+H5, recommending a one-year extension of its marketing authorization under exceptional circumstances. The vector vaccine protects commercial poultry against Marek’s Disease, Infectious Bursal Disease (IBD), and Avian Influenza (H5 clade).
3. Union Referrals, Aquaculture Advice & Pharmacovigilance
A. Union Referral: Vetmedin 1.5 mg/ml Oral Solution (Pimobendan)
The CVMP formally concluded a Referral Procedure under Article 54(8) of Regulation (EU) 2019/6 initiated by the European Commission (EC) due to a disagreement among EU Member States during a Mutual Recognition/Decentralised procedure (CMDv).
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Ruling: Having evaluated clinical trial efficacy data, the CVMP concluded by majority vote that the benefit-risk ratio for Vetmedin 1.5 mg/ml oral solution remains positive for the proposed expanded therapeutic indication in canine cardiac health. Clarification reports have been officially transmitted to the EC for final binding adoption.
