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 |
|---|---|
| INN | Toltrazuril |
| Associated Names | |
| Class | |
| Reference Number | EMA/214243/2009 |
| Type | Article 33 |
| Status | final |
| Opinion Date | 09/12/2009 |
All Documents
Document description
- Opinion - contains the CVMP opinion of the referred medicine(s)
- 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 (also known as 'Annex III') - available when changes have been recommended by the Committee
- Conditions of the Marketing Authorisation (also known as Annex IV) - available when the Committee recommends measures to be taken for the marketing authorisation(s) such as safety measures or extra studies