Vectra 3D - opinion on variation to marketing authorisation

Opinion

EMA has issued an opinion on a change to this medicine's authorisation

dinotefuran, permethrin, and pyriproxyfen

Opinion

On 10 September 2026, the Committee for Veterinary Medicinal Products (CVMP) adopted a positive opinion, recommending the granting of a variation to the terms of the marketing authorisation for the veterinary medicinal product Vectra 3D. The marketing authorisation holder for this veterinary medicinal product is Ceva Sante Animale.

Vectra 3D is currently authorised as spot-on solution for use in dogs. The variation concerns change(s) to therapeutic indication(s) - addition of a new therapeutic indication or modification of an approved one: reduction of the risk of infection with the parasite Leishmania infantum transmitted by sand flies (Phlebotomus spp.) for 1 month following administration. The effect is indirect due to the product’s activity against the vector.

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.

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Note: 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.

CVMP post-authorisation summary of positive opinion for Vectra 3D (VRA0000334831)

Adopted Reference Number: Vectra 3D

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 opinion:
  10/09/2026
• Status:
  Positive