On 8 December 2022, 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 Credelio Plus. The marketing authorisation holder for this veterinary medicinal product is Elanco GmbH.
Credelio Plus is currently authorised as chewable tablets for use in dogs. The variation concerns the addition of a new therapeutic indication for the treatment of demodicosis (caused by Demodex canis).
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 revised European public assessment report (EPAR) 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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Meeting highlights from the Committee for Medicinal Products for Veterinary Use (CVMP) 16-17 February 202119/02/2021