Cephalosporins - referral

Current status

European Commission final decision

Overview

On 17 March 2011, the European Commission presented to the Agency a referral notification under Article 35 of Directive 2001/82/EC, regarding all veterinary medicinal products containing systemically administered (parenteral and oral) 3rd and 4th generation cephalosporins intended for use in food-producing species. The CVMP was requested to give its opinion regarding the inclusion of prudent use advice for these antimicrobials in line with the revised reflection paper on the use of 3rd and 4th generation cephalosporins in food producing animals in the European Union: development of resistance and impact on human and animal health (EMEA/CVMP/SAGAM/81730/2006-Rev.1) and to address the risk associated with potential misuse in poultry and the need for specific measures, in particular the need for warning sentences in the product information.

The referral procedure started on 6 April 2011. The Committee appointed Dr Karolina Törneke as rapporteur and Dr Claire Chauvin as co-rapporteur. Written explanations were provided by the applicants/marketing authorisation holders on 22 August 2011.

Based on the rapporteurs' assessment of the currently available data, the CVMP considered that the overall benefit-risk balance for these products remains positive subject to the recommended changes of the product information and that variations are necessary to the terms of the marketing authorisation for all veterinary medicinal products containing systemically administered (parenteral and oral) 3rd and 4th generation cephalosporins intended for use in food producing species. The Committee adopted a positive opinion on 13 October 2011.

The list of product names concerned is given in Annex I. The scientific conclusions are provided in Annex II together with the amended summary of product characteristics and package leaflet in the Annex III.

The final opinion was converted into a Decision by the European Commission on 13 January 2012.

Opinion following an Article 35 referral for all veterinary medicinal products containing systemically administered (parenteral and oral) 3rd and 4th generation cephalosporins intended for use in food producing species

Adopted Reference Number: EMA/967448/2011

Key facts

About this medicine

• Approved name:
  Cephalosporins
• International non-proprietary name (INN) or common name:
  • ceftiofur
  • cefquinome
• Associated names:
  • Cobactan
  • Cefenil
  • Ceftiocyl
  • Cevaxel
  • Eficur
  • Excenel
  • Readycef
  • Virbacef
  • Truleva
  • Ceftiomax
  • Cefenil
  • Ceftiosan
  • Actionis
  • Cemay

About this procedure

• Current status:
  European Commission final decision
• Reference number:
  EMEA/V/A/070
• Type:
  Article 35 referrals (prior to January 2022)

  This type of referral is initiated in cases involving the interests of the Community or concerns relating to the protection of human or animal health or the environment.

Key dates and outcomes

• Opinion date:
  13/10/2011
• EC decision date:
  13/01/2012

All documents

Opinion following an Article 35 referral for all veterinary medicinal products containing systemically administered (parenteral and oral) 3rd and 4th generation cephalosporins intended for use in food producing species

Adopted Reference Number: EMA/967448/2011

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)