Cevazuril

Table of contents

Current status
European Commission final decision

Overview

Toltrazuril is a triazinon derivative administered orally to piglets for the prevention of clinical signs of coccidiosis in neonatal piglets on farms with a confirmed history of coccidiosis caused by Isospora suis.

The Applicant, Ceva Santé Animale, submitted an application for a decentralised procedure for CEVAZURIL 50 mg/ml oral suspension for piglets. The application was submitted in the framework of Article 32 of Directive 2001/82/EC, where the Reference Member State was France and the Concerned Member States were Austria, Belgium, Bulgaria, Cyprus, Czech Republic, Denmark, Estonia, Germany, Greece, Hungary, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, The Netherlands, Poland, Portugal, Romania, Slovakia, Spain and United Kingdom. The Decentralised Procedure FR/V/195/01/DC started on 29 February 2008.

On 6 May 2009 France, referred the matter to the Agency under Article 33(4) of Directive 2001/82/EC, due to concerns, raised by Germany, Spain, Portugal, Poland and the United Kingdom, that the marketing authorisation of CEVAZURIL 50 mg/ml oral suspension for piglets may present a potential serious risk to the environment.

The referral procedure started on 12 May 2009. The Rapporteur and Co-Rapporteur appointed were: Dr A. Holm and Dr B. Kolar, respectively. Written explanations were provided by the Applicant on 18 August 2009. Oral explanations were given on 8 December 2009.

Based on the evaluation of the rapporteur's assessment of the currently available data, on 9 December 2009 the CVMP considered that the objections raised during the decentralised procedure should not prevent the granting of a Marketing Authorisation for CEVAZURIL 50 mg/ml oral suspension for piglets.

The list of product names concerned is given in Annex I. The scientific conclusions are provided in Annex II.

The final opinion was converted into a Decision by the European Commission on 26 March 2010.

Key facts

Approved name
Cevazuril
International non-proprietary name (INN) or common name
toltrazuril
Current status
European Commission final decision
Reference number
EMA/214243/2009
Type
Article 33

Mutual-recognition and decentralised referral: initiated because of disagreement between Member States within the framework of the mutual-recognition or decentralised procedure.
Opinion date
09/12/2009
EC decision date
26/03/2010

All documents

Description of documents published

Please note that some of the listed documents apply only to certain procedures.

  • Overview - lay-language summary of the stage of the procedure
  • Notification – a letter from a Member State, the European Commission or the marketing authorisation holder requesting the initiation of the procedure
  • List of questions – questions agreed by the Committee requesting further information from the marketing authorisation holder(s) / applicant(s) to evaluate the issues identified
  • Timetable for the procedure – agreed timeframe to respond to the list of questions, to assess the issues and to adopt a conclusion
  • List of medicines concerned by the procedure – medicine(s) / active substance(s) concerned, and marketing authorisation holder(s) / applicant(s)
  • List of questions to be addressed by the stakeholders – call for data to be submitted by stakeholders (e.g. veterinary healthcare professionals, farmers, academia) (if applicable)
  • Stakeholder submission form – form to be used by stakeholders to submit data (if applicable)
  • Scientific conclusions – scientific conclusions of CVMP
  • Divergent positions – divergent positions of the CVMP members (if applicable)
  • Changes to the summary of product characteristics, labelling and package leaflet (amended sections or fully revised version) (if applicable)
  • Condition(s) to the marketing authorisation(s) – condition(s) for the safe and effective use of the medicine(s) (if applicable)
  • Condition for lifting the suspension – condition to be fulfilled for the suspension of the marketing authorisation(s) to be lifted (if applicable)

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