On 19 June 2024, the Committee for Veterinary Medicinal Products (CVMP) adopted a positive opinion1, recommending the granting of a group of variations to the terms of the marketing authorisation for the veterinary medicinal product Daxocox. The marketing authorisation holder for this veterinary medicinal product is Ecuphar NV.
Daxocox is currently authorised as tablets for use in dogs. The variation concerns the addition of two new tablet strengths (140 and 200 mg) to the existing range and the amendment of the dosing table for the currently approved tablet strengths (15, 30, 45, 70 and 100 mg).
Detailed conditions for the use of this product are described in the summary of product characteristics (SPC), for which an updated version reflecting the changes will be published in the Union Product Database (UPD) and will be available in all official European Union languages after the variation to 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.
CVMP post-authorisation summary of positive opinion for Daxocox (VRA-0003-G)
English (EN) (139.37 KB - PDF)