NexGard Combo - opinion on variation to marketing authorisation

Opinion

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

esafoxolaner / eprinomectin / praziquantel

Opinion

On 15 May 2025, the Committee for Veterinary Medicinal Products (CVMP) adopted a positive opinion¹, recommending the granting of a group of variations to the terms of the marketing authorisation for the veterinary medicinal product NexGard Combo. The marketing authorisation holder for this veterinary medicinal product is Boehringer Ingelheim Vetmedica GmbH.

NexGard Combo is currently authorised as spot-on solution for use in cats. The grouped variation concerns change(s) to therapeutic indication(s) - addition of a new therapeutic indication or modification of an approved one: treatment of infections with eye worms (Thelazia callipaeda) and immediate tick killing activity against Ixodes hexagonus.

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.

---

¹Applicants 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 NexGard Combo (VRA-0012-G)

AdoptedReference Number: EMA/CVMP/82901/2025

Key facts

• Name of medicine:
  NexGard Combo
• EMA product number:
  EMEA/V/C/005094
• Active substance:
  • eprinomectin
  • esafoxolaner
  • praziquantel
• International non-proprietary name (INN) or common name:
  • esafoxolaner
  • eprinomectin
  • praziquantel
• Date of opinion:
  15/05/2025
• Status:
  Positive