Firocoxib CP-Pharma - opinion on variation to marketing authorisation

Opinion

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

firocoxib

Opinion

On 10 September 2026, the Committee for Veterinary Medicinal Products (CVMP) adopted a positive opinion, recommending the granting of a variation to the terms of the marketing authorisation for the veterinary medicinal product Firocoxib CP-Pharma. The marketing authorisation holder for this veterinary medicinal product is CP-Pharma Handelsgesellschaft mbH.

Firocoxib CP-Pharma is currently authorised as chewable tablets for use in dogs. The variation concerns the addition of horses as a new target species, for the alleviation of pain and inflammation associated with osteoarthritis and reduction of associated lameness.

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.

---

Note: 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 Firocoxib CP-Pharma (VRA-I-326568)

Adopted Reference Number: EMADOC-1700519818-3426541

Key facts

• Name of medicine:
  Firocoxib CP-Pharma
• EMA product number:
  EMEA/V/C/006921
• Active substance:
  firocoxib
• International non-proprietary name (INN) or common name:
  firocoxib
• Date of opinion:
  10/09/2026
• Status:
  Positive