Clavudale 50mg tablet for cats and dogs

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.

Key facts

Approved name
Clavudale 50mg tablet for cats and dogs
International non-proprietary name (INN) or common name

amoxicillin / clavulanic acid

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.

Status
European Commission final decision
Opinion date
08/06/2011
EC decision date
24/08/2011

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:

  • Changes to the summary of product characteristics, labeling or package leaflet ('annex III') - available when changes have been recommended by the Committee
  • Conditions of the marketing authorisation (Annex IV) - available when the Committee recommends measures to be taken for the marketing authorisation(s) such as safety measures or extra studies

How useful was this page?

Add your rating