Meeting highlights from the Committee for Veterinary Medicinal Products (CVMP) 8-10 September 2026

CVMP opinions on veterinary medicinal products

The Committee adopted a positive opinion for a marketing authorisation for Cirbloc, for the active immunisation of pigs from three weeks of age to reduce viraemia, virus load in the lungs and lymphoid tissues, and virus shedding caused by porcine circovirus type 2 (PCV2) infection.

The Committee adopted a positive opinion for a marketing authorisation for AviGate S. Typhimurium, for the active immunisation of healthy chickens to reduce faecal excretion and colonisation of internal organs with Salmonella Typhimurium.

The Committee adopted a positive opinion for a variation for Vectormune HVT-AIV, to add turkeys as a new target species and to increase the minimum titre per dose.

The Committee adopted a positiveopinion for a variation for Firocoxib CP-Pharma (firocoxib), to add horses as a new target species.

The Committee adopted a positive opinion for a variation for Innovax ND-H5, to fulfil the specific obligation concerning stability data, by providing the missing data required to support the 36-month shelf-life of the finished product.

The Committee adopted a positive opinion for a variation for Felpreva (tigolaner / emodepside / praziquantel) concerning change(s) to therapeutic indication(s) - addition of a new therapeutic indication or modification of an approved one: treatment of tick infestations with Ixodes hexagonus, Rhipicephalus sanguineus.

The Committee adopted a positiveopinion for a variation for Vectra 3D (dinotefuran / pyriproxyfen / permethrin), concerning change(s) to therapeutic indication(s) - addition of a new therapeutic indication or modification of an approved one: reduction of the risk of infection with the parasite Leishmania infantum transmitted by sand flies (Phlebotomus spp.) for 1 month following administration.

The Committee adopted a positive opinion for a variation for Credelio / AdTab (lotilaner), to implement the outcome of the MAH’s signal management process to include ‘seizure’ as a very rare adverse event in the product information.

The Committee adopted a positive opinion for a variation for Easotic(hydrocortisone aceponate / gentamicin sulfate / miconazole nitrate), to implement the outcome of the MAH’s signal management process to include ‘application site inflammation’ as a very rare adverse event in the product information.

The Committee adopted a positive opinion for a variation for Galliprant (grapiprant), to implement the outcome of the MAH’s signal management process to include ‘gastrointestinal ulceration’ as a very rare adverse event in the product information.

Procedure under Article 141(1)(i) of Regulation (EU) 2019/6

The Committee agreed to extend the timetable for the scientific advice procedure on veterinary medicinal products (VMPs) containing amoxicillin (as a single active substance) in pigs for use in drinking water or in feed, for respiratory indications. The extension takes into account the revised timeline for submission of the report from the temporary Working Party on Dosage Review and Adjustment of established Antibiotics (ADRA tWP) to the rapporteur and co-rapporteur, as well as the inclusion of a 2-month public consultation prior to the final adoption of the scientific advice, allowing stakeholders to provide comments. Further details are available on the dedicated procedure webpage.

Maximum residue limits

The Committee agreed to amend the entry for Macrogol cetostearyl ether in the list of substances considered as not falling within the scope of Regulation (EC) No 470/2009 under the heading of excipients in order to include intradermal and intramuscular administration and adopted a revised list (EMA/CVMP/519714/2009-Rev.63). This decision followed the Committee’s review of a request that had been submitted in accordance with the relevant CVMP guidance.

Scientific advice

The Committee adopted three scientific advice reports concerning an immunological product for salmon, a pharmaceutical product for dogs, and a biological product for cats. The Committee also endorsed a report in response to a clarification request regarding an immunological product for dogs.

Limited market classifications and eligibility according to Article 23 of Regulation (EU) 2019/6

Following a request, the CVMP classified a product (ATCvet classification: nervous system) for horses as intended for a limited market and not eligible for authorisation under Article 23 of Regulation (EU) 2019/6.

Following a request, the CVMP classified a product (ATCvet classification: immunologicals) for Atlantic salmon as intended for a limited market and eligible for authorisation under Article 23 of Regulation (EU) 2019/6.

Concept papers, guidelines

Antimicrobials

The Committee adopted a concept paper on a revision of the CVMP Guideline on the summary of product characteristics (SPC) for veterinary medicinal products containing antimicrobial substances for a 3-month period of public consultation. The concept paper provides guidance to revise the SPC guideline so that it includes clear standard statements reflecting the legal restrictions on prophylactic and metaphylactic use of antimicrobials under Regulation (EU) 2019/6.

Pharmacovigilance

The Committee adopted a revised guideline on veterinary good pharmacovigilance practices (VGVP) Module: Signal Management (EMA/522332/2021 Rev.1) for a 3-month period of public consultation. This guideline has been revised to reflect the current approach to the signal management process. The guideline provides general guidance on scientific and quality aspects of signal management for veterinary medicinal products (VMPs), and describes the roles, responsibilities and procedural aspects of the EU signal management process for VMPs.

Quality

The Committee adopted a Q&A document on post-approval change management protocols for VMPs (EMA/CVMP/84805/2026).

Safety

The Committee adopted a revised guideline on user safety for pharmaceutical veterinary medicinal products (EMA/CVMP/543/03-Rev.2) for a 3-month period of public consultation.

The Committee adopted a revised guideline on user safety of topically administered veterinary medicinal products (EMA/CVMP/SWP/721059/2014-Rev.1) for a 3-month period of public consultation.

Working parties

The Committee elected Sonia Gil Morales as chair of the Efficacy Working Party (EWP-V) 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”.