Bravecto: Withdrawal of the application to change the marketing authorisation

fluralaner

Overview

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.”

Key facts

Name
Bravecto
Product number
EMEA/V/C/002526
Date of issue of market authorisation valid throughout the European Union (if applicable)
11/02/2014
International non-proprietary name (INN) or common name
  • fluralaner
Active substance
  • fluralaner
Date of withdrawal
03/08/2021
Company making the application
Intervet International B.V
Withdrawal type
Post-authorisation

Related information on withdrawals

The question-and-answer (Q&A) document provides a summary of the CVMP's evaluation of the medicine at the time of the withdrawal of the application, and includes a link to the company's formal withdrawal letter. An assessment report is published when the application is withdrawn after the first stage of the CVMP's evaluation is completed ('day 120').

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