CVMP opinions on veterinary medicinal products
The Committee adopted, by majority, a positive opinion for a marketing authorisation from Zoetis Belgium for Portela (relfovetmab), for the alleviation of pain associated with osteoarthritis in cats.
The Committee adopted, by consensus, a positive opinion for a variation requiring assessment for Divence Tetra (Bovine viral diarrhoea (subunit), bovine parainfluenza 3 virus (inactivated)) to implement the outcome of the MAH’s signal management process to add new, uncommon adverse events in the product information: milk production decrease, reduced food intake and decreased activity. Information on allowing the vaccine to reach room temperature before use was also added to the product information.
The Committee adopted, by consensus, a positive opinion for a variation requiring assessment for Bravecto TriUNO (fluralaner/ moxidectin/ pyrantel) concerning change(s) to therapeutic indication(s) – addition of a new therapeutic indication or modification of an approved one: for the treatment of infections with Angiostrongylus vasorum. Additionally, the product information has been aligned with version 9.1 of the QRD template.
The Committee adopted, by consensus, positive opinions for variations requiring assessment concerning quality-related changes for:
- Arthricox
- BTVPUR
- Credelio, Lotimax, AdTab, Credelio Plus (worksharing procedure)
- Cytopoint
- Draxxin
- Easotic
- Emevet
- Equilis Te, Equilis Prequenza Te (worksharing procedure)
- Equioxx
- Felpreva
- ProZinc
- RenuTend
- Semintra (2 procedures)
- Senvelgo
- Simparica Trio
- Strangvac
- Tulinovet
The Committee adopted, by consensus, positive opinions for variations requiring assessment to align the product information with version 9/9.1 of the QRD template for:
- Chanhold
- Evicto
- Meloxidolor
- Novaquin
- Osurnia
- Strangvac
- Zulvac 1+8 Bovis
- Zulvac 1+8 Ovis
- Zulvac SBV
Maximum residue limits
The Committee agreed to include polyethylenimine as a new entry in the list of substances considered as not falling within the scope of Regulation (EC) No. 470/2009 under the heading of ’Excipients’. This decision followed the Committee’s review of a request that had been submitted by an applicant, in accordance with the relevant CVMP guidance.
Scientific advice
The Committee adopted five scientific advice reports for two biological products, two immunological products and one pharmaceutical product for dogs (1 product), horses (1 product), cats (2 products) and Atlantic salmon (1 product).
Limited market classifications and eligibility according to Article 23 of Regulation (EU) 2019/6
Following three requests, the CVMP classified:
- A product (ATCvet classification: Antineoplastic and immunomodulating agents) for dogs as intended for a limited market and eligible for authorisation under Article 23 of Regulation (EU) 2019/6.
- A product (ATCvet classification: Immunologicals) for pigs as not intended for a limited market and not eligible for authorisation under Article 23 of Regulation (EU) 2019/6.
- A product (ATCvet classification: Alimentary tract and metabolism) for horses as intended for a limited market and eligible for authorisation under Article 23 of Regulation (EU) 2019/6.
Concept papers, guidelines
Immunologicals
The Committee adopted a revised guideline on the procedure to be followed when a batch of a vaccine finished product is suspected to be contaminated with bovine viral diarrhoea virus (EMA/CVMP/IWP/225007/2025). The revision consists of administrative changes to align the guideline with the definitions and terminology provided in Article 4 of Regulation (EU) 2019/6. The references to the applicable legislation and other scientific guidelines have also been updated. As no changes were made to the scientific content, no concept paper or public consultation was deemed necessary. The revision will come into effect on 1 April 2026.
The Committee adopted a revised Guideline on duration of immunity achieved by veterinary vaccines (EMA/CVMP/IWP/224985/2025). The revision consists of administrative changes to align the guideline with the definitions and terminology provided in Article 4 of Regulation (EU) 2019/6. The references to the legislation applicable and other scientific guidelines have also been updated. As no changes were made to the scientific content, no concept paper or public consultation was deemed necessary. The revision will come into effect on 1 April 2026.
Quality
The Committee adopted a guideline on in-use stability testing of VMPs (EMA/CVMP/QWP/59158/2025). This guideline replaces and merges the ‘Note for guidance on in-use stability testing of veterinary medicinal products (excluding immunological veterinary medicinal products)’ (EMEA/CVMP/424/01 – FINAL) and the ‘Note for guidance on maximum shelf-life for sterile medicinal products after first opening or following reconstitution’ (EMEA/CVMP/198/99 – FINAL). Administrative changes have been made to align the guideline with Regulation (EU) 2019/6 and the current EMA template for Guidance. The references to the applicable legislation and other scientific guidelines have also been updated. As no changes were made to the scientific content, no concept paper or public consultation were deemed necessary. The guideline will come into effect immediately after publication.
The Committee adopted a question and answer on histamine limits for gentamicin-containing parenteral VMPs for horses. The question and answer will be published within the Quality of medicines questions and answers: Part 1 on the Agency’s website.
International harmonisation
The Committee adopted:
- VICH GL22(R) on Studies to evaluate the safety of residues of veterinary drugs in human food: reproduction testing (Revision 1) for implementation
- VICH GL23(R1) on Studies to evaluate the safety of residues of veterinary drugs in human food: genotoxicity testing (Revision 2) for implementation
- VICH GL62 on Target animal safety of veterinary monoclonal antibody products for release for 5 months of public consultation.
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 under “Related content”.