Nuflor Swine Once

Table of contents

Current status
European Commission final decision

Overview

Nuflor Swine Once 450-mg-per-ml solution for injection contains florfenicol as active ingredient and is intended for use in pigs for the treatment of respiratory infections caused by strains of Actinobacillus pleuropneumoniae, Haemophilus parasuis and Pasteurella multocida susceptible to florfenicol. The proposed dose is 30 mg florfenicol per kilogram bodyweight given by intramuscular administration as a single injection. Florfenicol is structurally related to thiamphenicol and has a similar pharmacological profile.

The applicant, Intervet International BV, submitted an application for a decentralised procedure for Nuflor Swine Once 450-mg/ml solution for injection. This was a 'hybrid application' according to Article 13(3) Directive 2001/82/EC, as amended, referring to the reference product, Nuflor Swine 300-mg/ml solution for injection (FR/V/0118/001). Nuflor Swine Once 450-mg/ml solution for injection differs from the reference veterinary medicinal product by a higher concentration of active substance, single administration, a change in therapeutic indication but also by a different co-solvent. The application was submitted to Germany as reference Member State and Austria, Belgium, Bulgaria, Cyprus, the Czech Republic, Denmark, Estonia, France, Greece, Hungary, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, the Netherlands, Poland, Portugal, Romania, Slovakia, Slovenia, Spain and the United Kingdom as concerned Member States.

The decentralised procedure (DE/V/0122/002/DC) started on 12 November 2010. Potential serious risks were identified during the decentralised procedure by Denmark regarding the cumulative failure rate observed in the pivotal clinical field trial and potential for development of antimicrobial resistance to florfenicol.

On day 210, these issues remained unsolved and therefore a referral under Article 33(1) of Directive 2001/82/EC to the Coordination Group for Mutual Recognition and Decentralised procedures - Veterinary (CMDv) was started on 17 October 2011. Day 60 of the CMD(v) procedure was on 15 December 2011, and since the Member States concerned failed to reach an agreement regarding the product the procedure was referred to the CVMP.

On 19 December 2011, the reference Member State, Germany, notified the European Medicines Agency that the CMDv had failed to reach an agreement regarding the product and referred the matter to the CVMP pursuant to Article 33(4) of Directive 2001/82/EC.

The referral procedure started on 10 January 2012. The Committee appointed Prof. Christian Friis as rapporteur and Dr Cornelia Ibrahim as co-rapporteur. Written explanations were provided by the applicant on 20 March 2012. Oral explanations were given on 15 May 2012.

Based on the evaluation of the available data, the CVMP adopted, on 13 June 2012, an opinion recommending the granting of marketing authorisations for Nuflor Swine Once 450-mg/ml solution for injection, subject to certain conditions.

On 31 August 2012, the Netherlands submitted an objection to the opinion adopted by CVMP on 13 June 2012 during the written phase of the Standing Committee procedure.

On 27 September 2012 a plenary meeting of the Standing Committee on Veterinary Medicinal Products took place and on 3 October 2012 the European Commission sent a letter to the CVMP requesting a reconsideration of the opinion adopted on 13 June 2012.

The reconsideration procedure started on 10 October 2012. The Committee re-appointed Prof Christian Friis as rapporteur and Dr Cornelia Ibrahim as co-rapporteur for the reconsideration procedure. Oral explanations were given by the applicant on 10 January 2013.

On 7 February 2013 the CVMP adopted a reconsidered opinion, concluding that the application does not comply with Article 13 of Directive 2001/82/EC, and consequently does not satisfy the criteria for authorisation in respect of efficacy. Therefore the CVMP recommended the refusal of the granting of the marketing authorisations and the suspension of the existing marketing authorisations.

The list of product names concerned is given in Annex I. The scientific conclusions are provided in Annex II, together with the condition to lift the suspension of the marketing authorisation in Annex III.

The reconsidered opinion was converted into a decision by the European Commission on 16 May 2013.

Key facts

Approved name
Nuflor Swine Once
International non-proprietary name (INN) or common name
florfenicol
Associated names
PigFlor Once
Class
-
Current status
European Commission final decision
Reference number
EMEA/V/A/080
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
07/02/2013
EC decision date
16/05/2013

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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