Credelio - opinion on variation to marketing authorisation

Opinion

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

lotilaner

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 following a worksharing procedure for the veterinary medicinal products Credelio, Lotimax and Credelio Plus. The marketing authorisation holder for these veterinary medicinal products is Elanco GmbH.

Credelio is currently authorised as chewable tablets for use in dogs and cats, while Lotimax and Credelio Plus are authorised as chewable tablets for use in dogs. The grouped variation concerns change(s) to therapeutic indication(s) in dogs - addition of a new therapeutic indication or modification of an approved one: ‘for the treatment of sarcoptic mange (Sarcoptes scabiei var. canis)’ and ‘for reduction of the risk of infection with Babesia canis canis via transmission by Dermacentor reticulatus for one month. The effect is indirect due to the activity of the veterinary medicinal product against the vector.’ Additionally, the product information for all three products has been aligned with version 9.1 of the QRD template.

Detailed conditions for the use of these products are described in the summary of product characteristics (SPC), for which updated versions 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, Lotimax, Credelio Plus

Adopted Reference Number: EMADOC-1700519818-2563727

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:
  06/11/2025
• Status:
  Positive