Simparica Trio - opinion on variation to marketing authorisation

Opinion

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

sarolaner / moxidectin / pyrantel embonate

Opinion

On 12 February 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 Simparica Trio. The marketing authorisation holder for this veterinary medicinal product is Zoetis Belgium.

Simparica Trio 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: reduction of the risk of infection with Dipylidium caninum via transmission by Ctenocephalides felis for one month after treatment.

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 summary of positive opinion for Simparica Trio

AdoptedReference Number: EMADOC-1700519818-1896425

Key facts

• Name of medicine:
  Simparica Trio
• EMA product number:
  EMEA/V/C/004846
• Active substance:
  • moxidectin
  • sarolaner
  • pyrantel embonate
• International non-proprietary name (INN) or common name:
  • sarolaner
  • moxidectin
  • pyrantel embonate
• Date of opinion:
  12/02/2025
• Status:
  Positive