Cephalosporins

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.

Key facts

Approved name
Cephalosporins
International non-proprietary name (INN) or common name
ceftiofur and cefquinome
Associated names
  • Cobactan
  • Cefenil
  • Ceftiocyl
  • Cevaxel
  • Eficur
  • Excenel
  • Readycef
  • Virbacef
  • Truleva
  • Ceftiomax
  • Ceftiosan
  • Actionis
  • Cemay
Reference number
EMEA/V/A/070
Type
Article 35

Community interest referral: initiated in cases involving the interests of the Community or concerns relating to the protection of human or animal health or the environment.

Status
European Commission final decision
Opinion date
13/10/2011
EC decision date
13/01/2012

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