Credelio - opinion on variation to marketing authorisation

Opinion

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

lotilaner

Opinion

On 5 November 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 Credelio. The marketing authorisation holder for this veterinary medicinal product is Elanco GmbH. 

Credelio is currently authorised as chewable tablets for use in dogs and cats. The variation concerns change(s) to therapeutic indication(s) in cats - addition of a new therapeutic indication or modification of an approved one: treatment of ear mite infestations (Otodectes cynotis).

Detailed conditions for the use of this product are described in the updated 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 Credelio (VRA/0000358561)

Adopted Reference Number: EMADOC-1700519818-3548140

Key facts

• Name of medicine:
  Credelio
• EMA product number:
  EMEA/V/C/004247
• Active substance:
  lotilaner
• International non-proprietary name (INN) or common name:
  lotilaner
• Date of opinion:
  05/11/2026
• Status:
  Positive