Cevazuril

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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.

Name Language First published Last updated
Opinion following an Article 33(4) referral for CEVAZURIL 50 mg/ml oral suspension for piglets: Background information BG = bălgarski 2010-05-05  
Opinion following an Article 33(4) referral for CEVAZURIL 50 mg/ml oral suspension for piglets: Background information ES = español 2010-05-05  
Opinion following an Article 33(4) referral for CEVAZURIL 50 mg/ml oral suspension for piglets: Background information CS = čeština 2010-05-05  
Opinion following an Article 33(4) referral for CEVAZURIL 50 mg/ml oral suspension for piglets: Background information DA = dansk 2010-05-05  
Opinion following an Article 33(4) referral for CEVAZURIL 50 mg/ml oral suspension for piglets: Background information DE = Deutsch 2010-05-05  
Opinion following an Article 33(4) referral for CEVAZURIL 50 mg/ml oral suspension for piglets: Background information ET = eesti keel 2010-05-05  
Opinion following an Article 33(4) referral for CEVAZURIL 50 mg/ml oral suspension for piglets: Background information EL = elliniká 2010-05-05  
Opinion following an Article 33(4) referral for CEVAZURIL 50 mg/ml oral suspension for piglets: Background information EN = English 2010-05-05  
Opinion following an Article 33(4) referral for CEVAZURIL 50 mg/ml oral suspension for piglets: Background information FR = français 2010-05-05  
Opinion following an Article 33(4) referral for CEVAZURIL 50 mg/ml oral suspension for piglets: Background information IT = italiano 2010-05-05  
Opinion following an Article 33(4) referral for CEVAZURIL 50 mg/ml oral suspension for piglets: Background information LV = latviešu valoda 2010-05-05  
Opinion following an Article 33(4) referral for CEVAZURIL 50 mg/ml oral suspension for piglets: Background information LT = lietuvių kalba 2010-05-05  
Opinion following an Article 33(4) referral for CEVAZURIL 50 mg/ml oral suspension for piglets: Background information HU = magyar 2010-05-05  
Opinion following an Article 33(4) referral for CEVAZURIL 50 mg/ml oral suspension for piglets: Background information MT = Malti 2010-05-05  
Opinion following an Article 33(4) referral for CEVAZURIL 50 mg/ml oral suspension for piglets: Background information NL = Nederlands 2010-05-05  
Opinion following an Article 33(4) referral for CEVAZURIL 50 mg/ml oral suspension for piglets: Background information PL = polski 2010-05-05  
Opinion following an Article 33(4) referral for CEVAZURIL 50 mg/ml oral suspension for piglets: Background information PT = português 2010-05-05  
Opinion following an Article 33(4) referral for CEVAZURIL 50 mg/ml oral suspension for piglets: Background information RO = română 2010-05-05  
Opinion following an Article 33(4) referral for CEVAZURIL 50 mg/ml oral suspension for piglets: Background information SK = slovenčina 2010-05-05  
Opinion following an Article 33(4) referral for CEVAZURIL 50 mg/ml oral suspension for piglets: Background information SL = slovenščina 2010-05-05  
Opinion following an Article 33(4) referral for CEVAZURIL 50 mg/ml oral suspension for piglets: Background information FI = suomi 2010-05-05  
Opinion following an Article 33(4) referral for CEVAZURIL 50 mg/ml oral suspension for piglets: Background information SV = svenska 2010-05-05  

Key facts

Approved nameCevazuril
International non-proprietary name (INN) or common name

Toltrazuril

Associated names
Class
Reference numberEMA/214243/2009
TypeArticle 33
StatusEuropean Commission final decision
Opinion date09/12/2009
EC decision date26/03/2010

All documents

Name Language First published Last updated
Opinion following an Article 33(4) referral for CEVAZURIL 50 mg/ml oral suspension for piglets: Background information BG = bălgarski 2010-05-05  
Opinion following an Article 33(4) referral for CEVAZURIL 50 mg/ml oral suspension for piglets: Background information ES = español 2010-05-05  
Opinion following an Article 33(4) referral for CEVAZURIL 50 mg/ml oral suspension for piglets: Background information CS = čeština 2010-05-05  
Opinion following an Article 33(4) referral for CEVAZURIL 50 mg/ml oral suspension for piglets: Background information DA = dansk 2010-05-05  
Opinion following an Article 33(4) referral for CEVAZURIL 50 mg/ml oral suspension for piglets: Background information DE = Deutsch 2010-05-05  
Opinion following an Article 33(4) referral for CEVAZURIL 50 mg/ml oral suspension for piglets: Background information ET = eesti keel 2010-05-05  
Opinion following an Article 33(4) referral for CEVAZURIL 50 mg/ml oral suspension for piglets: Background information EL = elliniká 2010-05-05  
Opinion following an Article 33(4) referral for CEVAZURIL 50 mg/ml oral suspension for piglets: Background information EN = English 2010-05-05  
Opinion following an Article 33(4) referral for CEVAZURIL 50 mg/ml oral suspension for piglets: Background information FR = français 2010-05-05  
Opinion following an Article 33(4) referral for CEVAZURIL 50 mg/ml oral suspension for piglets: Background information IT = italiano 2010-05-05  
Opinion following an Article 33(4) referral for CEVAZURIL 50 mg/ml oral suspension for piglets: Background information LV = latviešu valoda 2010-05-05  
Opinion following an Article 33(4) referral for CEVAZURIL 50 mg/ml oral suspension for piglets: Background information LT = lietuvių kalba 2010-05-05  
Opinion following an Article 33(4) referral for CEVAZURIL 50 mg/ml oral suspension for piglets: Background information HU = magyar 2010-05-05  
Opinion following an Article 33(4) referral for CEVAZURIL 50 mg/ml oral suspension for piglets: Background information MT = Malti 2010-05-05  
Opinion following an Article 33(4) referral for CEVAZURIL 50 mg/ml oral suspension for piglets: Background information NL = Nederlands 2010-05-05  
Opinion following an Article 33(4) referral for CEVAZURIL 50 mg/ml oral suspension for piglets: Background information PL = polski 2010-05-05  
Opinion following an Article 33(4) referral for CEVAZURIL 50 mg/ml oral suspension for piglets: Background information PT = português 2010-05-05  
Opinion following an Article 33(4) referral for CEVAZURIL 50 mg/ml oral suspension for piglets: Background information RO = română 2010-05-05  
Opinion following an Article 33(4) referral for CEVAZURIL 50 mg/ml oral suspension for piglets: Background information SK = slovenčina 2010-05-05  
Opinion following an Article 33(4) referral for CEVAZURIL 50 mg/ml oral suspension for piglets: Background information SL = slovenščina 2010-05-05  
Opinion following an Article 33(4) referral for CEVAZURIL 50 mg/ml oral suspension for piglets: Background information FI = suomi 2010-05-05  
Opinion following an Article 33(4) referral for CEVAZURIL 50 mg/ml oral suspension for piglets: Background information SV = svenska 2010-05-05  
CEVAZURIL - Article 33 Referral - Annexes I, II, III BG = bălgarski 2010-05-05  
CEVAZURIL - Article 33 Referral - Annexes I, II, III ES = español 2010-05-05  
CEVAZURIL - Article 33 Referral - Annexes I, II, III CS = čeština 2010-05-05  
CEVAZURIL - Article 33 Referral - Annexes I, II, III DA = dansk 2010-05-05  
CEVAZURIL - Article 33 Referral - Annexes I, II, III DE = Deutsch 2010-05-05  
CEVAZURIL - Article 33 Referral - Annexes I, II, III ET = eesti keel 2010-05-05  
CEVAZURIL - Article 33 Referral - Annexes I, II, III EL = elliniká 2010-05-05  
CEVAZURIL - Article 33 Referral - Annexes I, II, III EN = English 2010-05-05  
CEVAZURIL - Article 33 Referral - Annexes I, II, III FR = français 2010-05-05  
CEVAZURIL - Article 33 Referral - Annexes I, II, III IT = italiano 2010-05-05  
CEVAZURIL - Article 33 Referral - Annexes I, II, III LV = latviešu valoda 2010-05-05  
CEVAZURIL - Article 33 Referral - Annexes I, II, III LT = lietuvių kalba 2010-05-05  
CEVAZURIL - Article 33 Referral - Annexes I, II, III HU = magyar 2010-05-05  
CEVAZURIL - Article 33 Referral - Annexes I, II, III MT = Malti 2010-05-05  
CEVAZURIL - Article 33 Referral - Annexes I, II, III NL = Nederlands 2010-05-05  
CEVAZURIL - Article 33 Referral - Annexes I, II, III PL = polski 2010-05-05  
CEVAZURIL - Article 33 Referral - Annexes I, II, III PT = português 2010-05-05  
CEVAZURIL - Article 33 Referral - Annexes I, II, III RO = română 2010-05-05  
CEVAZURIL - Article 33 Referral - Annexes I, II, III SK = slovenčina 2010-05-05  
CEVAZURIL - Article 33 Referral - Annexes I, II, III SL = slovenščina 2010-05-05  
CEVAZURIL - Article 33 Referral - Annexes I, II, III FI = suomi 2010-05-05  
CEVAZURIL - Article 33 Referral - Annexes I, II, III SV = svenska 2010-05-05  

Document description

  • Questions and answers (Q&A)- easy-to-understand summary of key issues and Committee conclusions
  • List of the medicines affected by the referral (annex I)
  • Scientific conclusions of the Committee (annex II)

The following two documents may not always be available:

  • Changes to the summary of product characteristics, labeling or package leaflet ('annex III') - available when changes have been recommended by the Committee
  • Conditions of the marketing authorisation (Annex IV) - available when the Committee recommends measures to be taken for the marketing authorisation(s) such as safety measures or extra studies

Current status:
European Commission final decision