Vectra 3D - withdrawal of application for variation to marketing authorisation

Application withdrawn

The application for a change to this medicine's authorisation has been withdrawn

dinotefuran, permethrin, and pyriproxyfen

Overview

In accordance with Article 64 of Regulation (EU) 2019/6, the marketing authorisation holder, Ceva Santé Animale (the applicant), submitted to the European Medicines Agency (the Agency) on 30 April 2024 an application for a group of variations requiring assessment for Vectra 3D.

On 27 November 2024, the applicant withdrew the application. In its letter notifying the Agency of the withdrawal of application, the applicant stated that “This withdrawal is based on the following reason: the CVMP considers that the data provided do not allow the committee to conclude on a positive opinion.”

Key facts

• Name of medicine:
  Vectra 3D
• EMA product number:
  EMEA/V/C/002555
• Active substance:
  • dinotefuran
  • pyriproxyfen
  • permethrin
• International non-proprietary name (INN) or common name:
  dinotefuran, permethrin, and pyriproxyfen
• Date of withdrawal:
  27/11/2024

Dokumenty

Withdrawal assessment report for Vectra 3D (VRA/0026/G)

Adopted Reference Number: EMA/563432/2024

Withdrawal letter : Vectra 3D (VRA/0026/G)