Portela

Opinion

EMA has issued an opinion on this medicine

relfovetmab

Overview

On 10 September 2025, the Committee for Veterinary Medicinal Products (CVMP) adopted a positive opinion¹, recommending the granting of a marketing authorisation for the veterinary medicinal product Portela, solution for injection, intended for cats. The applicant for this veterinary medicinal product is Zoetis Belgium.

Portela is an analgesic veterinary medicinal product containing relfovetmab (ATCvet code QN02BG92) as the active substance, which is a felinised monoclonal antibody targeting nerve growth factor (NGF). NGF binds to TrkA receptors located on immune cells to elicit the release of additional proinflammatory mediators, including NGF itself. These inflammatory mediators lead to further peripheral sensitisation involved in pain perception. The inhibition of NGF was demonstrated to provide relief from pain associated with osteoarthritis.

The full indication for Portela is: For the alleviation of pain associated with osteoarthritis in cats.

The benefits of Portela are significantly improved scores as assessed by cat owners using client-specific outcome measures, and reduced pain as assessed by veterinarians using a categorical pain assessment. These improvements were consistent over a 270-day period.

The most common side effects are immediate pain upon injection (very common), dermatitis (common), and pruritus, skin scabs, injection site swelling and injection site hair loss (uncommon).

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, on the basis of quality, safety and efficacy data submitted, considers that there is a favourable benefit-risk balance for Portela and therefore recommends the granting of the marketing authorisation.

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¹Applicants 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 Portela

Adopted Reference Number: EMA/CVMP/285092/2025

Product details

• Name of medicine:
  Portela
• Active substance:
  relfovetmab
• International non-proprietary name (INN) or common name:
  relfovetmab
• Species:
  Cats
• Anatomical therapeutic chemical veterinary (ATCvet) code:
  QN02BG92
• EMA product number:
  EMEA/V/C/005890
• Marketing authorisation applicant:
  Zoetis Belgium
• Opinion adopted:
  10/09/2025
• Opinion status:
  Positive