Meeting highlights from the Committee for Veterinary Medicinal Products (CVMP) 10-12 June 2025

The Committee re-elected Dr Frida Hasslung Wikström from Sweden as its Vice-chair for a further 3-year mandate.

CVMP opinions on veterinary medicinal products

The Committee adopted by consensus a positive opinion for a marketing authorisation from Aquilón CyL S.L. for Biobhyo for the active immunisation of pigs against infections caused by Brachyspira hyodysenteriae.

The Committee adopted by consensus a positive opinion for a marketing authorisation from Intervet International B.V. for Numelvi (atinvicitinib) for treatment of pruritus associated with allergic dermatitis including atopic dermatitis in dogs and treatment of clinical manifestations of atopic dermatitis in dogs.

The Committee adopted by consensus a positive opinion for a marketing authorisation from Intervet International B.V. for BRAVECTO CombiUNO (fluralaner/milbemycin oxime) for treatment of tick and flea infestations in dogs.

The Committee adopted by consensus a positive opinion for a marketing authorisation from Elanco GmbH for Zenrelia (ilunocitinib) for treatment of pruritus associated with allergic dermatitis in dogs and treatment of clinical manifestations of atopic dermatitis in dogs.

The Committee adopted by consensus a positive opinion for a grouping of variations requiring assessment for Daxocox (enflicoxib) concerning change(s) to therapeutic indication(s) - addition of a new therapeutic indication or modification of an approved one: treatment of pain and inflammation associated with orthopaedic or soft tissue surgery and alignment of the product information with version 9.1 of the QRD template.

The Committee adopted by consensus a positive opinion for a worksharing grouping of variations requiring assessment for NexGard (afoxolaner) and NexGard Spectra (afoxolaner/milbemycin oxime) concerning change(s) to therapeutic indication(s) – addition of a new therapeutic indication or modification of an approved one: for the reduction of the risk of infection with Babesia canis canis via transmission by Dermacentor reticulatus for 28 days and for reduction of the risk of infection with Dipylidium caninum via transmission by Ctenocephalides felis for 30 days.

The Committee adopted by consensus a positive opinion for a variation requiring assessment for Bravecto (fluralaner) to implement the outcome of the MAH's signal management process to add new adverse events (pruritus, diarrhoea, ataxia) to the product information.

The Committee adopted by consensus a positive opinion for a workshared variation requiring assessment for Nobivac L4, Nobivac LoVo L4 (canine leptospirosis vaccine (inactivated))– addition of a new therapeutic indication or modification of an approved one and addition of associated non-mixed use with Nobivac Rabies. The procedure included a name update from L4 to L6.

The Committee adopted by consensus positive opinions for variations requiring assessment concerning quality-related changes for:

Ecoporc Shiga
Nobilis IB Primo QX / Nobilis IB 4-91

The Committee adopted, by consensus, positive opinions for variations requiring assessment to align the product information with version 9.0/9.1 of the QRD template for:

Imoxat
Meloxidyl
Mometamax Ultra
Reconcile

The Committee adopted by consensus a negative opinion for a variation requiring assessment for Poulvac E. coli (avian colibacillosis vaccine (live)) to reflect in the product information that administration of the vaccine was shown to reduce the use of antibiotics used to treat colibacillosis in the vaccinated chicken flocks.

Union referrals and related procedures

The Committee started a procedure for veterinary medicinal products containing albendazole as a single active substance, presented as oral suspension and indicated against gastrointestinal nematodes in sheep. The matter was referred to the Committee by Germany under Article 82 of Regulation (EU) 2019/6 due to concerns that doses or lower dose limits of 3.75 – 5.0 mg/kg bodyweight may no longer be appropriate to ensure the effective use of these products, which could also contribute to the further development of antiparasitic resistance. The CVMP invites all stakeholders (e.g. veterinary healthcare professionals, farmers, academia) to submit data relevant to this procedure.

Re-examinations of marketing authorisations in exceptional circumstances

For Innovax-ND-H5, the Committee recommended, based on evaluation of data submitted by the marketing authorisation holder, to extend by one year the validity of the marketing authorisation under exceptional circumstances.

Scientific advice

The Committee adopted one scientific advice report for a pharmaceutical product for rats and mice.

Concept papers, guidelines

Environmental Risk Assessment

The Committee adopted a concept paper for the development of a guideline on the methodology of environmental risk assessment for parasiticidal VMPs for cats and dogs (EMA/CVMP/ERA/499198/2024) for a 4-month period of public consultation.

Quality

The Committee adopted a draft concept paper on the need for revision of note for guidance on quality aspects of pharmaceutical veterinary medicines for administration via drinking water (EMA/CVMP/QWP/85848/2025) for a 4-month period of public consultation.

Pharmacovigilance

The Committee adopted the following standard list and associated documents for electronic reporting of suspected adverse reactions following the yearly review and update:

CVMP combined VeDDRA list of clinical terms for reporting suspected adverse reactions in animals and humans to veterinary medicinal products (EMA/CVMP/PhVWP/10418/2009-Rev.16);
List of changes to VeDDRA list of clinical terms for reporting suspected adverse reactions in animals and humans to veterinary medicinal products for 2025 (EMA/CVMP/PhVWP/118833/2025);
Non-current VeDDRA low level terms (LLT) and codes (EMA/CVMP/PhVWP/360871/2010-Rev 6);
Guidance notes on the use of VeDDRA terminology for reporting suspected adverse reactions in animals and humans (EMA/CVMP/PhVWP/288284/2007); and
Call for comments (EMA/123352/2004).

The implementation of the standard VeDDRA list in EudraVigilance Veterinary is provisionally scheduled for 1 October 2025.

Working parties

The Committee elected Dr Hanna Bremer as Vice-chair of the Scientific Advice working Party – Veterinary 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”.