Strenzen 500/125-mg/g powder - referral

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.

Opinion following an Article-33(4) referral for Strenzen 500/125-mg/g powder for use in drinking water for pigs and associated names

Reference Number: EMA/325274/2013

Key facts

About this medicine

• Approved name:
  Strenzen 500/125-mg/g powder
• International non-proprietary name (INN) or common name:
  • amoxicillin
  • clavulanic acid

About this procedure

• Current status:
  European Commission final decision
• 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.

Key dates and outcomes

• Opinion date:
  10/04/2013
• EC decision date:
  12/08/2013

All documents

European Commission final decision

Strenzen 500/125mg/g Article-33(4) referral - Annex I-III

Opinion following an Article-33(4) referral for Strenzen 500/125-mg/g powder for use in drinking water for pigs and associated names

Reference Number: EMA/325274/2013

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)