Summary
The EMA’s Committee for Veterinary Medicinal Products adopted positive opinions for Cirbloc, a vaccine for pigs, and AviGate S. Typhimurium, a vaccine for chickens. The committee also advanced guidance on antimicrobial use, pharmacovigilance and user safety.
The European Medicines Agency’s Committee for Veterinary Medicinal Products (CVMP) adopted positive opinions for marketing authorisations for two veterinary vaccines at its 8–10 September 2026 meeting. Cirbloc is intended for pigs, while AviGate S. Typhimurium is intended for healthy chickens.
The meeting also produced product changes covering animal species, indications, shelf life and adverse-event information, alongside new or revised guidance on antimicrobial use, pharmacovigilance and user safety.
Two vaccines receive positive opinions
Cirbloc is intended for the active immunisation of pigs from three weeks of age. According to the CVMP, vaccination is intended to reduce viraemia, virus load in the lungs and lymphoid tissues, and virus shedding caused by porcine circovirus type 2 (PCV2) infection. Viraemia refers to the presence of a virus in the bloodstream; virus shedding describes the release of virus from an infected animal.
AviGate S. Typhimurium is intended for the active immunisation of healthy chickens. Its stated purpose is to reduce faecal excretion and colonisation of internal organs with Salmonella Typhimurium. Active immunisation means using vaccination to stimulate an immune response before or during the risk of infection.
The CVMP also adopted positive opinions for several product variations. Vectormune HVT-AIV would add turkeys as a target species and increase the minimum titre per dose, meaning the minimum amount of vaccine potency specified for each dose. Firocoxib CP-Pharma would add horses as a new target species, while Innovax ND-H5 would incorporate data supporting a 36-month shelf life for the finished product.
Other recommended changes concern treatment indications. Felpreva would add treatment of tick infestations involving Ixodes hexagonus and Rhipicephalus sanguineus. Vectra 3D would add an indication for reducing the risk of infection with Leishmania infantum transmitted by Phlebotomus sand flies for one month after administration.
Three products would receive updated adverse-event information. ‘Seizure’ would be added as a very rare adverse event for Credelio/AdTab, ‘application site inflammation’ for Easotic, and ‘gastrointestinal ulceration’ for Galliprant. These changes followed the marketing-authorisation holders’ signal-management processes, which review safety information for patterns that may require updates to product information.
Antimicrobial and safety guidance moves to consultation
The committee agreed to extend the timetable for scientific advice on veterinary medicines containing amoxicillin as a single active substance for pigs, when used in drinking water or feed for respiratory indications. The revised schedule allows for a report from the temporary Working Party on Dosage Review and Adjustment of established Antibiotics, followed by a two-month public consultation before final adoption of the scientific advice.
Separately, the CVMP adopted a concept paper for a three-month public consultation on revising its guideline for the summary of product characteristics of veterinary medicines containing antimicrobial substances. The proposed revision would add standard statements reflecting legal restrictions on prophylactic and metaphylactic antimicrobial use under Regulation (EU) 2019/6. Prophylactic use is intended to prevent disease, while metaphylactic use generally involves treating a group when infection is present or expected after cases have been identified.
The committee also adopted a revised guideline on veterinary good pharmacovigilance practices covering signal management. It sets out scientific, quality and procedural guidance, including the roles and responsibilities involved in the EU signal-management process. Revised guidelines on user safety for pharmaceutical and topically administered veterinary medicines were also opened to three-month public consultations.
Other decisions included an amendment to the list of substances treated as outside the scope of the EU maximum-residue-limit regulation when used as excipients. The change covers intradermal and intramuscular administration of macrogol cetostearyl ether. The CVMP additionally adopted three scientific-advice reports for products for salmon, dogs and cats, and classified products for horses and Atlantic salmon under the EU’s limited-market provisions.
The announcement records CVMP opinions, guidance decisions and consultation steps. It does not provide the supporting efficacy or safety datasets, and it does not state when any final marketing-authorisation decisions for Cirbloc or AviGate S. Typhimurium will be issued.