Resflor solution injectable and associated names

Table of contents

Current status
European Commission final decision

Overview

Resflor is a solution for injection for use in cattle containing florfenicol and flunixin as active ingredients. It is indicated for the treatment of respiratory infections caused by Mannheimia haemolytica, Pasteurella multocida and Histophilus somni associated with pyrexia. A single subcutaneous injection of 40 mg florfenicol and 2.2 mg flunixin per kg body weight (2 mL/15 kg bw) is recommended.

The marketing authorisation holder Intervet International BV submitted an application for a type II variation to add Mycoplasma bovis as a target pathogen. The reference Member State (RMS) is France and 25 concerned Member States (CMS) are involved: Austria, Belgium, Bulgaria, Cyprus, Czech Republic, Denmark, Estonia, Finland, Germany, Greece, Hungary, Ireland, Italy, Latvia, Lithuania, Luxembourg, the Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain and the United Kingdom.

The variation procedure (FR/V/0167/01/II/017) started on 28 January 2013. Potential serious risks to animal health were identified during the decentralised procedure by Denmark and Germany regarding the demonstration of efficacy in the clinical trials and the justification of the recommended treatment dose of Resflor in the treatment of respiratory infections caused by Mycoplasma bovis, which may be associated with an increased risk of development of antimicrobial resistance.

On day 90, these issues remained unsolved and therefore a referral under Article 13(1) of Commission Regulation (EC) No. 1234/2008 to the Coordination group for Mutual recognition and Decentralised procedures (veterinary) (CMD(v)) was started on 25 November 2013. Day 60 of the CMD(v) procedure was on 23 January 2014, and since the Member States concerned failed to reach an agreement, the procedure was referred to the CVMP.

On 24 January 2014, the reference Member State, France, notified the European Medicines Agency that the CMD(v) had failed to reach an agreement and referred the matter to the CVMP pursuant to Article 13(2) of Commission Regulation (EC) No. 1234/2008.

The referral procedure started on 12 February 2014. The Committee appointed C. Ibrahim as rapporteur and M. Holzhauser-Alberti as co-rapporteur. Written explanations were provided by the marketing authorisation holder on 12 May 2014 and 19 June 2014. Oral explanations were given on
10 September 2014.

Based on the evaluation of the available data the CVMP adopted by majority, on 7 October 2014, an opinion recommending the granting of the variation of the marketing authorisations for Resflor solution injectable and its associated names. The CVMP concluded that the clinical benefit of Resflor in the treatment of respiratory infections associated with M. bovis has been demonstrated and no specific risk of antimicrobial resistance has been identified with the use of this product.

The list of product names concerned is given in Annex I. The scientific conclusions are provided in Annex II, together with the Summary of Product Characteristics and package leaflet in Annex III.

The opinion was converted into a Decision by the European Commission on 5 December 2014.

Key facts

Approved name
Resflor solution injectable and associated names
International non-proprietary name (INN) or common name
  • florfenicol
  • flunixin
Current status
European Commission final decision
Reference number
EMEA/V/A/101
Type
Article 13

This type of referral is triggered for a medicine that has been authorised by mutual recognition or via the decentralised procedure when there is disagreement between Member States on a variation (type II).
Opinion date
07/10/2014
EC decision date
05/12/2014

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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