Cephalosporins

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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.

Name Language First published Last updated
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 BG = bălgarski 2012-02-01  
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 ES = español 2012-02-01  
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 CS = čeština 2012-02-01  
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 DA = dansk 2012-02-01  
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 DE = Deutsch 2012-02-01  
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 ET = eesti keel 2012-02-01  
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 EL = elliniká 2012-02-01  
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 EN = English 2012-02-01  
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 FR = français 2012-02-01  
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 IT = italiano 2012-02-01  
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 LV = latviešu valoda 2012-02-01  
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 LT = lietuvių kalba 2012-02-01  
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 HU = magyar 2012-02-01  
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 MT = Malti 2012-02-01  
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 NL = Nederlands 2012-02-01  
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 PL = polski 2012-02-01  
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 PT = português 2012-02-01  
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 RO = română 2012-02-01  
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 SK = slovenčina 2012-02-01  
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 SL = slovenščina 2012-02-01  
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 FI = suomi 2012-02-01  
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 SV = svenska 2012-02-01  

Key facts

Approved nameCephalosporins
International non-proprietary name (INN) or common name

ceftiofur and cefquinome

Associated namesCobactan, Cefenil, Ceftiocyl, Cevaxel, Eficur, Excenel, Readycef, Virbacef, Truleva, Ceftiomax, Cefenil, Ceftiosan, Actionis, Cemay,
Class
Reference numberEMEA/V/A/070
TypeArticle 35
StatusEuropean Commission final decision
Opinion date13/10/2011
EC decision date13/01/2012

All documents

Name Language First published Last updated
Cephalosporins - Article 35 referral - Annexes I, II, III BG = bălgarski 2012-02-01  
Cephalosporins - Article 35 referral - Annexes I, II, III ES = español 2012-02-01  
Cephalosporins - Article 35 referral - Annexes I, II, III CS = čeština 2012-02-01  
Cephalosporins - Article 35 referral - Annexes I, II, III DA = dansk 2012-02-01  
Cephalosporins - Article 35 referral - Annexes I, II, III DE = Deutsch 2012-02-01  
Cephalosporins - Article 35 referral - Annexes I, II, III ET = eesti keel 2012-02-01  
Cephalosporins - Article 35 referral - Annexes I, II, III EL = elliniká 2012-02-01  
Cephalosporins - Article 35 referral - Annexes I, II, III EN = English 2012-02-01  
Cephalosporins - Article 35 referral - Annexes I, II, III FR = français 2012-02-01  
Cephalosporins - Article 35 referral - Annexes I, II, III IT = italiano 2012-02-01  
Cephalosporins - Article 35 referral - Annexes I, II, III LV = latviešu valoda 2012-02-01  
Cephalosporins - Article 35 referral - Annexes I, II, III LT = lietuvių kalba 2012-02-01  
Cephalosporins - Article 35 referral - Annexes I, II, III HU = magyar 2012-02-01  
Cephalosporins - Article 35 referral - Annexes I, II, III MT = Malti 2012-02-01  
Cephalosporins - Article 35 referral - Annexes I, II, III NL = Nederlands 2012-02-01  
Cephalosporins - Article 35 referral - Annexes I, II, III PL = polski 2012-02-01  
Cephalosporins - Article 35 referral - Annexes I, II, III PT = português 2012-02-01  
Cephalosporins - Article 35 referral - Annexes I, II, III RO = română 2012-02-01  
Cephalosporins - Article 35 referral - Annexes I, II, III SK = slovenčina 2012-02-01  
Cephalosporins - Article 35 referral - Annexes I, II, III SL = slovenščina 2012-02-01  
Cephalosporins - Article 35 referral - Annexes I, II, III FI = suomi 2012-02-01  
Cephalosporins - Article 35 referral - Annexes I, II, III SV = svenska 2012-02-01  
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 BG = bălgarski 2012-02-01  
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 ES = español 2012-02-01  
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 CS = čeština 2012-02-01  
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 DA = dansk 2012-02-01  
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 DE = Deutsch 2012-02-01  
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 ET = eesti keel 2012-02-01  
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 EL = elliniká 2012-02-01  
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 EN = English 2012-02-01  
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 FR = français 2012-02-01  
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 IT = italiano 2012-02-01  
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 LV = latviešu valoda 2012-02-01  
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 LT = lietuvių kalba 2012-02-01  
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 HU = magyar 2012-02-01  
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 MT = Malti 2012-02-01  
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 NL = Nederlands 2012-02-01  
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 PL = polski 2012-02-01  
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 PT = português 2012-02-01  
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 RO = română 2012-02-01  
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 SK = slovenčina 2012-02-01  
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 SL = slovenščina 2012-02-01  
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 FI = suomi 2012-02-01  
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 SV = svenska 2012-02-01  
Questions and answers on the referral procedure on veterinary medicinal products containing 3rd and 4th generation cephalosporins (English only) 2012-05-10 2012-05-15

Document description

  • Questions and answers (Q&A)- easy-to-understand summary of key issues and Committee conclusions
  • 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

Current status:
European Commission final decision

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