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