Stronghold Plus - opinion on variation to marketing authorisation

Opinion

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

selamectin / sarolaner

Opinion

On 15 May 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 Stronghold Plus. The marketing authorisation holder for this veterinary medicinal product is Zoetis Belgium.

Stronghold Plus is currently authorised as spot-on solution for use in cats. 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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¹ 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 Stronghold Plus (VRA-0000243880)

AdoptedReference Number: EMADOC-1700519818-2108863

Key facts

• Name of medicine:
  Stronghold Plus
• EMA product number:
  EMEA/V/C/004194
• Active substance:
  • selamectin
  • sarolaner
• International non-proprietary name (INN) or common name:
  • selamectin
  • sarolaner
• Species:
  Cats
• Anatomical therapeutic chemical veterinary (ATCvet) code:
  QP54AA55
• Marketing authorisation holder:
  Zoetis Belgium SA
• Date of opinion:
  15/05/2025
• Status:
  Positive