The Committee adopted by consensus a positive opinion for a marketing authorisation from Zoetis Belgium for Lenivia (izenivetmab), for the reduction of pain associated with osteoarthritis in dogs.
The Committee adopted a positive opinion by consensus, recommending the granting of a marketing authorisation for Vaxxitek HVT+IBD+H5 (Avian influenza vaccine (live recombinant)), intended for:
The applicant for this veterinary product is Boehringer Ingelheim Vetmedica GmbH. The marketing authorisation is being granted under exceptional circumstances.
The Committee adopted by consensus a positive opinion for a variation requiring assessment for Yurvac RHD (rabbit haemorrhagic disease and RHDV2 vaccine (recombinant)) to implement the outcome of the MAH’s signal management process to add transient anorexia and intestinal stasis as very rare adverse events.
The Committee adopted, by consensus, a positive opinion for a variation requiring assessment for Vectormune HVT-AIV (avian influenza vaccine (live recombinant)) to submit additional in-use stability data, to solve the first of three specific obligations identified during the initial marketing authorisation.
The Committee adopted by consensus positive opinions for variations concerning quality-related changes for:
The Committee adopted by consensus positive opinions for variations to align the product information with version 9/9.1 of the QRD template for:
The Committee started a procedure for Phenoxypen WSP, 325 mg/g powder for oral solution use in drinking water for pigs and chickens (phenoxymethylpenicillin) from Dopharma Research B.V. The matter was referred to the Committee by the European Commission under Article 54(8) of Regulation (EU) 2019/6 due to lack of consensus between Member States in the CMDv review procedure on a variation requiring assessment, on grounds of efficacy of this veterinary medicinal product.
The Committee was informed of the formal notification from CP-Pharma Handelsgesellschaft of their decision to withdraw the application for an initial marketing authorisation for Equidormin. 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.
The Committee adopted one scientific advice report for an immunological product for dogs.
Following a request, the CVMP classified:
The Committee adopted the quality questions and answers on skip testing to be published Quality of medicines questions and answers: Part 2.
The Committee elected, by majority, Mary O’Grady as the co-opted member for Quality (Chemicals).
The Committee elected, by majority, Rory Breathnach as the co-opted member for General Clinical Veterinary Practice.
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”.