On 15 February 2023, the Committee for Veterinary Medicinal Products (CVMP) adopted a positive opinion1, recommending the granting of a marketing authorisation for the veterinary medicinal product Prolevare film-coated tablets for dogs. The applicant for this veterinary medicinal product is Zoetis Belgium.
Prolevare contains oclacitinib maleate (ATCvet code QD11AH90) as active substance, a janus kinase (JAK) inhibitor, which inhibits the production of pro-inflammatory cytokines in various types of cells.
The application for Prolevare was an informed consent application. In an informed consent application, reference is made to an authorised medicine where the marketing authorisation holder of the reference medicine has given consent to the use of their dossier in the application procedure. The reference product for Prolevare is Apoquel (EU/2/13/154/001–036).
The full indication is: "Treatment of pruritus associated with allergic dermatitis in dogs" and "Treatment of clinical manifestations of atopic dermatitis in dogs".
Detailed conditions for the use of this product are described in the summary of product characteristics (SPC), which will be published in the Union Product Database (UPD) and will be available in all official European Union languages after the marketing authorisation has been granted by the European Commission.
1 Applicants may appeal any CVMP opinion, provided they notify the European Medicines Agency in writing of their intention to appeal within 15 days of receipt of the opinion.
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