Cobactan DC and its associated names - referral

Current status

European Commission final decision

Overview

Cobactan DC and its associated names contain cefquinome, a fourth-generation cephalosporin, indicated for the treatment of subclinical mastitis at drying off and the prevention of new bacterial infections of the udder, during the dry period, in the dairy cows caused by the following bacteria: Streptococcus uberis, Streptococcus disgalactiae, Streptococcus agalactiae, Staphylococcus aureus and coagulase negative staphylococci.

The marketing authorisation holder, Intervet International B.V., submitted an application for a type II variation to shorten the withdrawal period for milk from 49 days to 35 days after treatment for Cobactan DC and its associated names, according to Article 6 of Commission Regulation (EC) No 1084/2003. The reference Member State is France. The concerned Member States are: Austria, Belgium, Cyprus, Czech Republic, Estonia, Germany, Greece, Ireland, Italy, Latvia, Lithuania, Luxembourg, Poland, Portugal, Slovakia, Slovenia, Spain and United Kingdom.

On 6 April 2006, the reference and concerned Member States rejected the terms of the variation proposed by the marketing authorisation holder and agreed on a different withdrawal period to that proposed by the marketing authorisation holder.

On 13 April 2006, Intervet Innovation GmbH, referred the matter to the CVMP under Article 6(13) of Commission Regulation (EC) No 1084/2003.

The referral procedure started on 19 April 2006. The Committee appointed J. Schefferlie as rapporteur and C. Friis as co-rapporteur. Written explanations were provided by the marketing authorisation holder on 20 June 2006. Oral explanations were given on 18 July 2006.

Based on the evaluation of the available data, the CVMP considered that the withdrawal period for milk should be 1 day after calving when the dry period is more than 5 weeks and 36 days after treatment when the dry period is 5 weeks or less. Therefore, the CVMP adopted a positive opinion on 20 July 2006 recommending the granting of the variation of the marketing authorisations for the above-mentioned products.

The list of product names concerned is given in Annex I. The scientific conclusions are provided in Annex II.

The opinion was converted into a Decision by the European Commission on 13 October 2006.

Opinion following an article 6(13) referral for Cobactan DC and its associated names

Reference Number: EMA/250892/2014

Key facts

About this medicine

• Approved name:
  Cobactan DC and its associated names
• International non-proprietary name (INN) or common name:
  cefquinome
• Associated names:
  • Cephaguard DC
  • Cobactan DC intramam Susp. Ad us. Vet
  • Cobactan DC suspension intramammaire

About this procedure

• Current status:
  European Commission final decision
• Reference number:
  EMEA/V/A/014
• 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).

Key dates and outcomes

• Opinion date:
  20/07/2006
• EC decision date:
  13/10/2006

All documents

European Commission final decision

Cobactan DC Article-6(13) referral - Annex I, II

Opinion following an article 6(13) referral for Cobactan DC and its associated names

Reference Number: EMA/250892/2014

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)