Firocoxib CP-Pharma

Opinion

EMA has issued an opinion on this medicine

firocoxib

Overview

On 4 December 2025, the Committee for Veterinary Medicinal Products (CVMP) adopted a positive opinion, recommending the granting of a marketing authorisation for the veterinary medicinal product Firocoxib CP-Pharma, Chewable tablet, intended for dog. The applicant for this veterinary medicinal product is CP-Pharma Handelsgesellschaft mbH.

Firocoxib CP-Pharma is a medicinal product containing firocoxib (ATCvet code QM01AH90) as active substance which is a non-steroidal anti-inflammatory drug (NSAID) belonging to the coxib group which acts by selective inhibition of cyclooxygenase-2 (COX-2) – mediated prostaglandin synthesis.

The application for Firocoxib CP-Pharma 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 Firocoxib CP-Pharma is Coxatab 57 mg chewable tablets for dogs (EU/2/22/286/007-012).

The full indication is for the relief of pain and inflammation associated with osteoarthritis in dogs, and for the relief of post-operative pain and inflammation associated with soft-tissue, orthopaedic and dental surgery 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.

The CVMP considers that there is a favourable benefit-risk balance for Firocoxib CP-Pharma and therefore recommends the granting of the marketing authorisation.

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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 summary of positive opinion for Firocoxib CP-Pharma

Adopted Reference Number: EMA/CVMP/367445/2025

Product details

• Name of medicine:
  Firocoxib CP-Pharma
• Active substance:
  firocoxib
• International non-proprietary name (INN) or common name:
  firocoxib
• Species:
  Dogs
• Anatomical therapeutic chemical veterinary (ATCvet) code:
  QM01AH90
• EMA product number:
  EMEA/V/C/006921
• Marketing authorisation applicant:
  CP-Pharma Handelsgesellschaft mbH
• Opinion adopted:
  04/12/2025
• Opinion status:
  Positive