Strenzen 500/125-mg/g powder

Current status:
European Commission final decision

Overview

Strenzen 500/125-mg/g powder for use in drinking water for pigs contains amoxicillin and clavulanic acid as active ingredients and is intended for use in pigs for the treatment of respiratory-tract infections caused by microorganisms susceptible to the combination amoxicillin / clavulanic acid, i.e. Actinobacillus pleuropneumoniae, Pasteurella spp. and Streptococcus spp., and gastrointestinal infections caused by Clostridium spp., Escherichia coli and Salmonella spp.

The applicant, Novartis Animal Health Inc., submitted an application for a decentralised procedure for Strenzen 500/125-mg/g powder for use in drinking water for pigs and associated names. This is a generic application according to Article 13(1) Directive 2001/82/EC, as amended, referring to the reference product Amoksiklav 500/125-mg/g powder for use in drinking water authorised in the Czech Republic (marketing-authorisation number 96/069/98-C). The Czech Republic is the reference Member State and Austria, Denmark, France, Germany, Ireland, Italy, the Netherlands, Portugal, Spain and the United Kingdom are the concerned Member States.

The decentralised procedure started on 29 November 2010. Potential serious risks were identified during the decentralised procedure by the Netherlands and the United Kingdom regarding the environmental safety of the product.

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 2 May 2012. Day 60 of the CMDv procedure was on 29 June 2012, and since the Member States concerned failed to reach an agreement regarding the product, the procedure was referred to the CVMP.

On 11 July 2012, the reference Member State, the Czech Republic, 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 11 July 2012. The Committee appointed Mr J. Schefferlie as rapporteur and Dr J. Bureš as co-rapporteur. Written explanations were provided by the applicant on 11 September 2012 and 6 February 2013. Oral explanations were given on 9 April 2013.

Based on the evaluation of the currently available data, the CVMP considered that the benefit-risk profile of Strenzen 500/125-mg/g powder for use in drinking water for pigs is positive. Therefore, the Committee adopted by consensus a positive opinion on 10 April 2013 recommending the granting of a marketing authorisation for Strenzen 500/125-mg/g powder for use in drinking water for pigs and associated names.

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 12 August 2013.

Key facts

Approved name
Strenzen 500/125-mg/g powder
International non-proprietary name (INN) or common name

amoxicillin / clavulanic acid

Reference number
EMEA/V/A/085
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.

Status
European Commission final decision
Opinion date
10/04/2013
EC decision date
12/08/2013

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:

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