The Committee adopted by consensus a positive opinion for a marketing authorisation from Axience for Hemosyvet (etamsylate) for prevention and treatment of surgical, post traumatic, obstetric and gynaecological haemorrhages in cattle, sheep, goats, pigs, horses, dogs and cats.
The Committee adopted by consensus a positive opinion for a marketing authorisation from FILAVIE for Cevac REOMUNE for passive immunisation of broilers induced by active immunisation of broiler breeders to reduce clinical signs of tenosynovitis induced by avian reovirus infection.
The Committee adopted by consensus a positive opinion for a variation requiring assessment for Syvazul BTV 3 (Bluetongue virus, serotype 3, strain BTV-3/NET2023, inactivated) to add cattle as target species, and to increase of the minimum specification for antigen content in the finished product.
The Committee adopted by consensus a revised positive opinion for a worksharing 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 proposed subsequent update of the name suffix from L4 to L6 (G.I.7.a) was not accepted.
The Committee adopted by consensus a positive opinion for a variation requiring assessment for Eluracat to implement the outcome of the MAH's signal management process to add ‘Anorexia’ and ‘Behavioural disorder’ as rare, and ‘Dyspnoea’, ‘Loss of consciousness, Sedation’, ‘Recumbency’, ‘Muscle weakness’ and ‘Hiding’ as very rare adverse events in the product information.
The Committee adopted by consensus a positive opinion for a variation requiring assessment for Divence IBR Marker Live 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 Neptra to implement the outcome of the MAH's signal management process to include ‘Facial paralysis’ as a very rare adverse event in the product information.
The Committee adopted by consensus positive opinions for variations requiring assessment concerning quality-related changes for:
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:
The Committee was informed of the formal notification from Elanco GmbH of their decision to withdraw the application for a variation requiring assessment for Galliprant during the initial phase of the evaluation and before the CVMP could finalise a list of questions to be addressed to the applicant. No CVMP withdrawal assessment report will be produced in line with standard process for a withdrawal at this timepoint.
The Committee agreed to include sunflower oil 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 ’Normal foodstuffs’. This decision followed the Committee’s review of a request that had been submitted by an applicant in accordance with the relevant CVMP guidance.
The Committee started a procedure to provide a scientific advice on quarter-based selective dry cow therapy. The matter was referred to the Committee by Germany under Article 141(1)(i) of Regulation (EU) 2019/6, and is aimed at potentially updating the product information of intramammary veterinary medicines used in cattle to allow for selective administration at quarter level, without contradicting national policies. Individually treating only subclinically infected mastitis quarters with antibiotics at drying-off might result in a significant reduction in overall antibiotic use. The potential for this approach was already shown in various studies. The CVMP invites all stakeholders (e.g. marketing authorisation holders, veterinary healthcare professionals, farmers, academia) to submit data relevant to this procedure. Further details, including guidance on the submission of data and relevant timelines, are available on the dedicated procedure webpage.
The CVMP is aware of suspected adverse events that have been reported for Librela (bedinvetmab), a medicine for the treatment of pain caused by osteoarthritis in dogs, which are not currently listed in the EU product information. These reports include very rare cases with the suspicion of an abnormal progress of osteoarthritis in dogs following the use of Librela. In a limited number of cases, radiographical findings have also been observed that are not usually seen in the normal progression of osteoarthritis.
The CVMP has therefore requested the MAH, Zoetis, to carry out an in-depth analysis of all available information on suspected musculoskeletal disorders reported since the medicine’s authorisation. Results of this analysis are expected to be submitted by the MAH by end of September 2025.
The CVMP will review the information provided by the MAH, as well as all available evidence to assess the potential risk of musculoskeletal disorders in dogs treated with Librela and determine whether any change, for example an update of the product information, will be needed. EMA will communicate further once the review has concluded towards the end of 2025, or sooner if new important information arises.
The Committee adopted two scientific advice reports, one concerning an immunological product for wild boars and the other one concerning a pharmaceutical product for cats.
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.
Efficacy
The Committee adopted a revised guideline on demonstration of efficacy for veterinary medicinal products containing anticoccidial substances (EMA/CVMP/EWP/755916/2016) together with the overview of comments received during the two public consultations. The revision will come into effect on 1 February 2026.
The Committee re-elected Dr Sonja Beken as chair of the 3Rs Working Party for another 3-year mandate.
The Committee re-elected Dr Sarah Adler-Flindt as vice-chair of the 3Rs Working Party for another 3-year mandate.
The Committee appointed Dr Carina Bergman as co-opted member to complement its expertise in residues and toxicology 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.