Cheristin

Application withdrawn

The application for this medicine has been withdrawn

Overview

The applicant Elanco Europe Ltd submitted on 1 September 2016 an application for a marketing authorisation to the European Medicines Agency (The Agency) for Cheristin, through the centralised procedure under Article 3(2)(a) of Regulation (EC) No 726/2004 (optional scope).The eligibility to the centralised procedure was agreed upon by the CVMP on 8 October 2015 as Cheristin contains a new active substance (spinetoram) which was not authorised as a veterinary medicinal product in the Union on the date of entry into force of Regulation (EC) No 726/2004.The applicant applied for the following indication: “for the treatment and prevention of flea infestations (Ctenocephalides felis) in cats”. The target species is cats.The active substance of Cheristin is spinetoram, a multicomponent tetracyclic macrolide of the spinosyn family, which has an insecticidal activity by activation of nicotinic acetylcholine receptors (nAChRs).Cheristin spot-on solution contains 130 mg/ml spinetoram and is available as a unit dose pipette delivering 91 mg of spinetoram (in 0.7 ml of product). The product is presented in aluminium blister packs packed into carton boxes containing 3 or 6 pipettes.The dossier has been submitted in line with the requirements for submissions under Article 12(3) of Directive 2001/82/EC - full application.On 29 March 2017, Elanco Europe Ltd withdrew the application during the clock-stop at day 120 of the procedure. In its letter notifying the Agency of the withdrawal of application, the applicant stated that the reason for the withdrawal is the nature of the major objections.

Withdrawal assessment report for Cheristin

AdoptedReference Number: EMA/221301/2017

Key facts

• Name of medicine:
  Cheristin
• Species:
  Cats
• Anatomical therapeutic chemical veterinary (ATCvet) code:
  QP53AX
• EMA product number:
  EMEA/V/C/004316
• Marketing authorisation applicant:
  Elanco Europe Ltd
• Withdrawal of application:
  29/03/2017

All documents

Withdrawal assessment report for Cheristin

AdoptedReference Number: EMA/221301/2017

Withdrawal letter: Cheristin