Cobactan IV 4.5% powder and solvent for solution for injection and its associated names - referral

Current status

European Commission final decision

Overview

Cobactan IV 4.5% and its associated names are a powder and solvent for solution for injection. Cobactan IV 4.5% contains cefquinome as an active substance at 45 mg per ml. Cefquinome is a fourth-generation cephalosporin. The veterinary medicinal product is intended for use in horses as an intravenous or an intramuscular injection for the treatment of respiratory diseases caused by Streptococcus equi subsp. zooepidemicus and severe bacterial infections with a high risk of septicaemia in foals in which Escherichia coli is involved.

The marketing authorisation holder, Intervet International B.V., submitted an application for a mutual recognition procedure for Cobactan IV 4.5%. The reference Member State is Germany. The concerned Member States are Austria, Belgium, Denmark, Greece, France, Hungary, Ireland, Italy, Luxembourg, The Netherlands, Poland, Portugal, Spain and United Kingdom.

The mutual recognition procedure started on 22 September 2005. Potential serious risks were identified during the mutual recognition procedure by United Kingdom regarding the safety of the product.

On 2 March 2006, in view of the remaining unsolved issues, Germany submitted a referral notification under Article 33 of Directive 2001/82/EC to the CVMP.

The referral procedure started on 15 March 2006. The Committee appointed C. Friis as rapporteur and H. Hoogland as co-rapporteur. Written explanations were provided by the marketing authorisation holder on 23 March 2006.

Based on the evaluation of the available data, the CVMP considered that the objections raised by the United Kingdom during the mutual recognition procedure should not prevent the granting of a marketing authorisation for Cobactan IV 4.5% and its associated names. Therefore, the CVMP adopted a positive opinion on 17 May 2006 recommending the granting of the marketing authorisation for the above-mentioned product.

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

The opinion was converted into a Decision by the European Commission on 21 August 2006.

Opinion following an article 33 referral for Cobactan IV 4.5% powder and solvent for solution for injection and its associated names

Reference Number: EMA/249659/2014

Key facts

About this medicine

• Approved name:
  Cobactan IV 4.5% powder and solvent for solution for injection and its associated names
• International non-proprietary name (INN) or common name:
  cefquinome
• Associated names:
  • Cobactan
  • Cobactan Vet.
  • Cobactan 4.5%
  • Cobactan IV IM 4.5%
  • Cobactan IV 4.5% A.U.V.
  • Cephaguard IV IM 4.5%

About this procedure

• Current status:
  European Commission final decision
• Reference number:
  EMEA/V/A/012
• 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:
  17/05/2006
• EC decision date:
  21/08/2006

All documents

European Commission final decision

Cobactan IV 4.5% powder and solvent for solution for injection Article-33 referral - Annex I, II

Opinion following an article 33 referral for Cobactan IV 4.5% powder and solvent for solution for injection and its associated names

Reference Number: EMA/249659/2014

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)