Summary of opinion: Stronghold Plus, 19/06/2024 Positive
On 19 June 2024, 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 a spot-on solution for use in cats with, or at risk from, mixed parasitic infestations by ticks and fleas, lice, mites, gastrointestinal nematodes or heartworm. The product is exclusively indicated when use against ticks and one or more of the other target parasites is indicated at the same time. The variation concerns the addition of a new therapeutic indication for the treatment of notoedric mange (Notoedres cati).
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.
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