Cunitraxx

Application withdrawn

The application for this medicine has been withdrawn

fenbendazole

Overview

The applicant Avimedical B.V. submitted on 1 October 2024 an application for a marketing authorisation to the European Medicines Agency (The Agency) for Cunitraxx, through the centralised procedure under Article 42(4) of Regulation (EU) 2019/6 (optional scope). 

The eligibility to the centralised procedure was agreed upon by the CVMP on 22 May 2024 as no other marketing authorisation had been granted for the veterinary medicinal product within the Union.
At the time of submission, the applicant applied for the following indication: “Treatment and control of protozoan parasites in rabbits infected with Encephalitozoon cuniculi.”

The active substance of Cunitraxx is fenbendazole, an antiparasitic belonging to the benzimidazole-carbamate group, which inhibits the polymerisation of tubulin to microtubules. This interferes with essential structural and functional properties of cells.

The intended target species was rabbits (non-food-producing). However, at the time of the application, rabbits were considered a food producing species, as Regulation (EU) 2019/6 was not considered to include a basis to treat them otherwise. Consequently, the restriction to non-food producing rabbits was not accepted and the applicant was requested to adjust the application to take this into account.

Cunitraxx oral suspension contained 25 mg/ml fenbendazole and was presented in Type III amber glass bottles of 10 ml, 30 ml and 50 ml with packs containing 1 or 10 bottles. The applicant was registered as an SME pursuant to the definition set out in Commission Recommendation 2003/361/EC.

The dossier was submitted in line with the requirements for submissions under Article 23 of Regulation (EU) 2019/6 - an application for limited markets.

On 23 April 2025, Avimedical B.V. withdrew the application during the clock-stop at day 120 of the procedure. In its letter notifying the Agency of the withdrawal of the application, the applicant stated the reason for the withdrawal was the magnitude of the request for supplementary information.

Key facts

• Name of medicine:
  Cunitraxx
• Active substance:
  fenbendazole
• International non-proprietary name (INN) or common name:
  fenbendazole
• Species:
  Rabbits
• Anatomical therapeutic chemical veterinary (ATCvet) code:
  QP52AC13
• EMA product number:
  EMEA/V/C/006595
• Marketing authorisation applicant:
  Avimedical B.V.
• Withdrawal of application:
  23/04/2025

All documents

Withdrawal assessment report for Cunitraxx

Adopted Reference Number: EMA/171245/2025

Withdrawal letter: Cunitraxx