Daxocox - opinion on variation to marketing authorisation

Opinion

EMA has issued an opinion on a change to this medicine's authorisation.

enflicoxib

Opinion

On 12 June 2025, the Committee for Veterinary Medicinal Products (CVMP) adopted a positive opinion*, 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.

Daxocox is currently authorised as tablets for use in dogs for the treatment of pain and inflammation associated with osteoarthritis (or degenerative joint disease). The grouped variation concerns 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.

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.

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*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 (VRA0000246340)

AdoptedReference Number: EMADOC-1700519818-2194512

Key facts

• Name of medicine:
  Daxocox
• EMA product number:
  EMEA/V/C/005354
• Active substance:
  enflicoxib
• International non-proprietary name (INN) or common name:
  enflicoxib
• Species:
  Dogs
• Anatomical therapeutic chemical veterinary (ATCvet) code:
  QM01AH95
• Marketing authorisation holder:
  Ecuphar NV
• Date of opinion:
  12/06/2025
• Status:
  Positive