Bravecto - withdrawal of application for variation to marketing authorisation
Application withdrawn
The application for a change to this medicine's authorisation has been withdrawn
fluralaner
Post-authorisationVeterinary
In accordance with Article 16 of Commission Regulation (EC) No 1234/2008, the marketing authorisation holder, Intervet International B.V. (the applicant), submitted to the European Medicines Agency (the Agency) on 3 December 2020 an application for a type II variation for Bravecto.
On 3 August 2021, the applicant withdrew the application at day 150 of the procedure. In its letter notifying the Agency of the withdrawal of application, the applicant states that “This withdrawal is based on the reason that the CVMP considers the data provided do not allow the committee to conclude on a positive benefit risk balance.”