Frontpro (previously Afoxolaner Merial) - opinion on variation to marketing authorisation

Opinion

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

afoxolaner

Opinion

On 6 November 2025, the Committee for Veterinary Medicinal Products (CVMP) adopted a positive opinion, recommending the granting of a group of variations requiring assessment to the terms of the marketing authorisation for the veterinary medicinal product Frontpro. The marketing authorisation holder for this veterinary medicinal product is Boehringer Ingelheim Vetmedica GmbH.

Frontpro is currently authorised as chewable tablets for use in dogs. The grouped variation concerns change(s) to therapeutic indication(s) - addition of a new therapeutic indication or modification of an approved one: treatment of tick infestation with Hyalomma marginatum, reduction of the risk of infection with Dipylidium caninum via transmission by Ctenocephalides felis for 30 days, and reduction of the risk of infection with Babesia canis canis via transmission by Dermacentor reticulatus for 28 days. Additionally, the product information has been aligned with version 9.1 of the QRD template.

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 Frontpro

Adopted Reference Number: EMADOC-1700519818-2578983

Key facts

• Name of medicine:
  Frontpro (previously Afoxolaner Merial)
• EMA product number:
  EMEA/V/C/005126
• Active substance:
  afoxolaner
• International non-proprietary name (INN) or common name:
  afoxolaner
• Status:
  Positive