CVMP opinions on veterinary medicinal products
The Committee adopted a positive opinion for a marketing authorisation from Elanco GmbH for Varenzin (molidustat), for the management of non-regenerative anaemia associated with chronic kidney disease (CKD) in cats, by increasing haematocrit/ packed cell volume.
The Committee adopted a positive opinion, in exceptional circumstances, for a marketing authorisation from Laboratorios Syva S.A. for Epizootic haemorrhagic disease vaccine for the active immunisation of cattle to reduce viraemia and fever caused by epizootic haemorrhagic disease virus serotype 8.
The Committee adopted a positive opinion for a marketing authorisation from CP-Pharma Handelsgesellschaft mbH for Firocoxib CP-Pharma (firocoxib), for the relief of pain and inflammation associated with osteoarthritis and for the relief of post-operative pain and inflammation associated with soft-tissue, orthopaedic and dental surgery in dogs.
The Committee adopted a positive opinion for a variation for Dexdomitor (dexmedetomidine) concerning change(s) to therapeutic indication(s) – addition of a new therapeutic indication or modification of an approved one for Dexdomitor 0.5 mg/ml solution for injection: to be administered intravenously as a constant rate infusion in dogs and cats as part of a multimodal protocol during inhalation anaesthesia.
The Committee adopted a positive opinion for a variation for Felpreva (meloxicam) to change the frequency of the adverse event “Application site reaction (e.g. scratching, erythema, hair loss, inflammation)” from very rare to rare.
The Committee adopted a positive opinion for a variation to align the product information with version 9.1 of the QRD template for Mirataz.
The Committee adopted positive opinions for variation applications concerning quality-related (manufacturing) changes for:
- AdTab
- Dexdomitor
- Duotic/ Osurnia
- Eluracat
- Meloxidyl
- Nexgard / Nexgard Spectra / Frontpro
- ProteqFlu – Te Equine influenza (live recombinant) and tetanus vaccine
- Sileo
- Zuprevo
Withdrawals of applications
The Committee was informed of the formal notification from Vetbiobank of their decision to withdraw the application for an initial marketing authorisation for Livencia. More information about this application and the state of the scientific assessment at the time of the withdrawal will be made available in a public assessment report. The document, together with the withdrawal letter from the applicant, will be published on the Agency’s website in due course.
Union referrals and related procedures
The Committee concluded the procedure for Phenoxypen WSP, 325 mg/g powder for use in drinking water for chickens (phenoxymethylpenicillin) from Dopharma Research B.V. The European Commission (EC) had requested clarifications from the Committee under Article 54(8) of Regulation (EU) 2019/6 on a variation requiring assessment, due to lack of consensus between Member States in the CMDv review procedure on grounds of efficacy. The CVMP, having considered the request by the EC and all available data, concluded, by majority, that the benefit-risk balance of Phenoxypen WSP for the proposed indication and target species is positive, provided some amendments are implemented as outlined in the CVMP opinion.
Maximum residue limits
Further to a request from the European Commission, the Committee adopted, by consensus, a positive opinion recommending the modification of maximum residue limits for lidocaine in porcine species, to allow for the injection into the scrotum, testicles and spermatic cord in piglets up to 7 days of age. Lidocaine is currently included in Table 1 (Allowed substances) of the Annex to Commission Regulation (EU) No 37/2010 with a ‘No MRL required’ classification for porcine but only for cutaneous and epilesional use.
Scientific advice
The Committee adopted seven scientific advice reports following requests for initial advice for two pharmaceutical products, three biological products and two immunological products for cattle (2), Atlantic salmon (1), horses (1), dogs (2) and pigs (1).
Limited market classifications and eligibility according to Article 23 of Regulation (EU) 2019/6
Following two requests, the CVMP classified:
- 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.
- A product (ATCvet classification: musculo-skeletal system) for horses as intended for a limited market and eligible for authorisation under Article 23 of Regulation (EU) 2019/6.
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
Quality
The Committee adopted a guideline on development and manufacture of synthetic peptides. This guideline has been developed to address specific aspects regarding the manufacturing process, characterisation, specifications and analytical control for synthetic peptides which are not covered in the Guideline on the Chemistry of Active Substances (EMA/454576/2016) or Chemistry of Active Substances for Veterinary Medicinal Products (EMA/CVMP/QWP/707366/2017). It also contains requirements and considerations related to conjugation, to medicinal product development, to synthetic peptide development using biological peptides as European reference medicinal product, and to clinical trial applications (human products only). The guideline will come into effect on 1 June 2026.
Antimicrobial resistance
Under Regulation (EU) 2019/6, the collection of data on sales of veterinary antimicrobials and on the use of antimicrobials in animals became a mandatory activity for Member States, who are obliged to report this data to the EMA. The Agency, in turn, cooperates with Member States to publish an annual report on the data.
This month, the Committee adopted the second European Sales and Use of Antimicrobials for veterinary medicine (ESUAvet) report, which constitutes the annual surveillance report for 2024. It will be published on the EMA website on 9 December 2025.
Organisational matters
The Committee adopted the CVMP work plan for 2026.
Working parties
The Committee adopted the AWP, ERAWP, ESUAvet, EWP-V, IWP-V, NTWP, PhVWP-V, SAWP-V, SWP-V work plans for 2026, and the QWP, 3RsWP 3-year work plans for 2026-2028.
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.