Summary of opinion: NexGard Combo,esafoxolaner,eprinomectin,praziquantel, 13/07/2023, Positive
On 13 July 2023, the Committee for Veterinary Medicinal Products (CVMP) adopted a positive opinion1, recommending the granting of a group of variations to the terms of the marketing authorisation for the veterinary medicinal product NexGard Combo. The marketing authorisation holder for this veterinary medicinal product is Boehringer Ingelheim Vetmedica GmbH.
NexGard Combo is currently authorised as spot-on solution for use in cats. The grouped variation concerns the addition of two new therapeutic indications for persistent tick killing activity against Ixodes hexagonus and for persistent tick killing activity against Rhipicephalus sanguineus, and the alignment of the product information with version 9.0 of the QRD templates.
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.
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.
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