Clavudale 50mg tablet for cats and dogs - referral

Current status

European Commission final decision

Overview

Clavudale 50 mg tablet for cats and dogs and associated names (Clavudale 50 mg) contains amoxicillin and clavulanic acid. Clavudale 50 mg is intended for the treatment of pathogen-specific skin infections, infections of the oral cavity, urinary tract infections, respiratory disease and enteritis.

The marketing authorisation holder, Dechra Ltd, submitted an application for Clavudale 50 mg via a mutual recognition procedure in Austria, Belgium, the Czech Republic, Denmark, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Luxembourg, the Netherlands, Norway, Poland, Portugal, Slovakia, Spain and Sweden on the basis of the marketing authorisation granted by the United Kingdom. The application was submitted as a generic of the reference product, Synulox Palatable Tablets 50 mg marketed by Pfizer Ltd. The mutual recognition procedure (UK/V/0373/001/MR) started on 29 July 2010.

On 28 January 2011, the United Kingdom, as reference Member State, referred the matter to the European Medicines Agency under Article 33(4) of Directive 2001/82/EC, due to concerns raised by two of the concerned Member States, the Netherlands and Sweden, that the safety and efficacy of the product had not been sufficiently demonstrated. There was disagreement between the reference Member State and these concerned Member States on the demonstration of bioequivalence in the cat target species.

The referral procedure started on 9 February 2011. The Committee appointed Dr Karolina Törneke as rapporteur and Ms Helen Jukes as co-rapporteur. Written explanations were provided by the marketing authorisation holder on 11 April 2011.

Based on the evaluation of the rapporteur's assessment of the currently available data, the CVMP considered that the benefit/risk profile of Clavudale 50 mg tablet for cats and dogs and associated names is positive, and therefore adopted an opinion on 6 April 2011 recommending the granting of the marketing authorisation.

The list of product names concerned is given in Annex I. The scientific conclusions for the granting of the marketing authorisation are provided in Annex II. The summary of product characteristics, labelling and package leaflet are provided in Annex III.

The final opinion was converted into a Decision by the European Commission on 24 August 2011.

Opinion following an Article 33(4) referral for Clavudale 50 mg tablet for cats and dogs and associated names

AdoptedReference Number: EMEA/V/A/068

Key facts

About this medicine

• Approved name:
  Clavudale 50mg tablet for cats and dogs
• 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/068
• 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:
  08/06/2011
• EC decision date:
  24/08/2011

All documents

Clavudale - Article 33 referral- Annexes I, II, III

AdoptedReference Number: EMEA/V/A/068

Opinion following an Article 33(4) referral for Clavudale 50 mg tablet for cats and dogs and associated names

AdoptedReference Number: EMEA/V/A/068

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)