Bravecto TriUNO - opinion on variation to marketing authorisation

Opinion

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

fluralaner / moxidectin / pyrantel

Opinion

On 10 September 2025, the Committee for Veterinary Medicinal Products (CVMP) adopted a positive opinion¹, recommending the granting of a variation to the terms of the marketing authorisation for the veterinary medicinal product Bravecto TriUNO. The marketing authorisation holder for this veterinary medicinal product is Intervet International B.V.

Bravecto TriUNO is currently authorised as chewable tablets for use in dogs. The variation concerns change(s) to therapeutic indication(s) - addition of a new therapeutic indication or modification of an approved one: treatment of infections with Angiostrongylus vasorum. Additionally, the product information has been aligned 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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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 post-authorisation summary of positive opinion for Bravecto TriUNO (EMAVRA0000263135)

Adopted Reference Number: EMADOC-1700519818-2407766

Key facts

• Name of medicine:
  Bravecto TriUNO
• EMA product number:
  EMEA/V/C/006311
• Active substance:
  • fluralaner
  • moxidectin
  • pyrantel
• International non-proprietary name (INN) or common name:
  • fluralaner
  • moxidectin
  • pyrantel
• Date of opinion:
  10/09/2025
• Status:
  Positive