Aivlosin - withdrawal of application for variation to marketing authorisation

Application withdrawn

The application for a change to this medicine's authorisation has been withdrawn

tylvalosin

Overview

On 28 November 2012, ECO Animal Health Ltd submitted an application for an extension to the Community marketing authorisation for Aivlosin to the European Medicines Agency for addition of a new food-producing target species, chicken.Aivlosin contains tylvalosin (as tylvalosin tartrate), a macrolide antibiotic, and was first authorised for use in the Community on 9 September 2004. It is currently available in different pharmaceutical forms (premix for medicated feeding stuff, oral powder, granules for use in drinking water) for different target species (pigs, chickens, pheasants). This extension application concerns the addition of a new food-producing target species, chicken, to the already authorised 42.5 mg premix for medicated feeding stuff for pigs, for the following indication: Treatment of respiratory disease associated with Mycoplasma gallisepticum in chickens.The application was validated on 12 December 2012 and the assessment was carried out by the Committee for Medicinal Products for Veterinary Use (CVMP) in line with the standard timetable. In response to questions, supplementary information was provided by the applicant on 9 August 2013, and oral and written explanations were provided by the applicant on 11 December 2013. At day 180 of the procedure, the CVMP considered on the basis of quality, safety and efficacy data submitted, that the product was not approvable, since major objections had been identified, which precluded a recommendation for the granting of a marketing authorisation. The major concerns were mainly in relation to the efficacy (proposed dose) of the use of the pharmaceutical form in the proposed new target species.On 6 January 2014, ECO Animal Health withdrew the application at day 200 of the procedure. In its letter notifying the Agency of the withdrawal of application, the applicant stated the reason for the withdrawal: “CVMP considers that the data provided do not allow the Committee to conclude on a positive benefit-risk balance”.

Key facts

• Name of medicine:
  Aivlosin
• EMA product number:
  EMEA/V/C/000083
• Active substance:
  tylvalosin
• International non-proprietary name (INN) or common name:
  tylvalosin
• Date of withdrawal:
  06/01/2014

Documents

Withdrawal letter: Aivlosin

Withdrawal assessment report for Aivlosin: Extension (new target species)

Reference Number: EMA/CVMP/12822/2014