Colistin oral

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Colistin sulfate belongs to the polymyxin group of antibiotics. This group of antibiotics has a polypeptide structure, with mainly bactericidal activity and a medium antibacterial spectrum, which covers Gram-negative microorganisms only.

Veterinary medicinal products containing colistin as a sole active substance for oral administration in food producing animals are widely used in almost all EU Member States. Oral colistin formulations including powder, solution, premix, tablets and paste have been authorised, mainly for group and flock treatment for the treatment and prevention of different specified gastrointestinal diseases caused by sensitive Enterobacteriacea species (e.g. Salmonella and Escherichia coli), but marketing authorisations without more specific indications do also exist. The most common target species are pigs followed by chicken and cattle then other poultry species (e.g. turkeys), horses, rabbits, sheep and goats.

On 12 May 2014, the European Commission presented to the Agency a referral notification under Article 35 of Directive 2011/82/EC, regarding veterinary medicinal products containing colistin to be administered orally. The CVMP was requested to give its opinion on the measures that need to be taken in order to ensure the prudent use of colistin in food-producing animals across the EU and to minimise potential risks with the use of the identified products; inter alia whether there is a need to include adequate indications and warnings on prudent use in the product information and/or restrict indications for the identified products taking into account the CVMP revised guideline on the SPC for antimicrobial products (EMEA/CVMP/SAGAM/383441/2005).

The referral started on 4 June 2014. The Committee appointed C. Ibrahim as rapporteur and M. Holzhauser-Alberti as co-rapporteur. No written comments on the recommendations and proposed changes in the product information were provided by the applicants and marketing authorisation holders.

Based on the evaluation of the currently available data, the CVMP considered that the overall benefit-risk profile for these products remains positive subject to amendments in the product information. Therefore, on 11 December 2014 the Committeeadopted by consensus a positive opinion, recommending variations to the terms of the marketing authorisations for veterinary medicinal products containing colistin to be administered orally.

The list of product names concerned is given in Annex I. The scientific conclusions are provided in Annex II together with the amendments in the summaries of product characteristics, labelling and package leaflets in Annex III.

The final opinion was converted into a Decision by the European Commission on 16 March 2015.

Name Language First published Last updated
Opinion following an Article 35 referral for veterinary medicinal products containing colistin to be administered orally BG = bălgarski 2015-04-13  
Opinion following an Article 35 referral for veterinary medicinal products containing colistin to be administered orally ES = español 2015-04-13  
Opinion following an Article 35 referral for veterinary medicinal products containing colistin to be administered orally CS = čeština 2015-04-13  
Opinion following an Article 35 referral for veterinary medicinal products containing colistin to be administered orally DA = dansk 2015-04-13  
Opinion following an Article 35 referral for veterinary medicinal products containing colistin to be administered orally DE = Deutsch 2015-04-13  
Opinion following an Article 35 referral for veterinary medicinal products containing colistin to be administered orally ET = eesti keel 2015-04-13  
Opinion following an Article 35 referral for veterinary medicinal products containing colistin to be administered orally EL = elliniká 2015-04-13  
Opinion following an Article 35 referral for veterinary medicinal products containing colistin to be administered orally EN = English 2015-04-13  
Opinion following an Article 35 referral for veterinary medicinal products containing colistin to be administered orally FR = français 2015-04-13  
Opinion following an Article 35 referral for veterinary medicinal products containing colistin to be administered orally IT = italiano 2015-04-13  
Opinion following an Article 35 referral for veterinary medicinal products containing colistin to be administered orally LV = latviešu valoda 2015-04-13  
Opinion following an Article 35 referral for veterinary medicinal products containing colistin to be administered orally LT = lietuvių kalba 2015-04-13  
Opinion following an Article 35 referral for veterinary medicinal products containing colistin to be administered orally HU = magyar 2015-04-13  
Opinion following an Article 35 referral for veterinary medicinal products containing colistin to be administered orally MT = Malti 2015-04-13  
Opinion following an Article 35 referral for veterinary medicinal products containing colistin to be administered orally NL = Nederlands 2015-04-13  
Opinion following an Article 35 referral for veterinary medicinal products containing colistin to be administered orally PL = polski 2015-04-13  
Opinion following an Article 35 referral for veterinary medicinal products containing colistin to be administered orally PT = português 2015-04-13  
Opinion following an Article 35 referral for veterinary medicinal products containing colistin to be administered orally RO = română 2015-04-13  
Opinion following an Article 35 referral for veterinary medicinal products containing colistin to be administered orally SK = slovenčina 2015-04-13  
Opinion following an Article 35 referral for veterinary medicinal products containing colistin to be administered orally SL = slovenščina 2015-04-13  
Opinion following an Article 35 referral for veterinary medicinal products containing colistin to be administered orally FI = suomi 2015-04-13  
Opinion following an Article 35 referral for veterinary medicinal products containing colistin to be administered orally SV = svenska 2015-04-13  
Opinion following an Article 35 referral for veterinary medicinal products containing colistin to be administered orally HR = Hrvatski 2015-04-13  

Key facts

Approved nameColistin oral
International non-proprietary name (INN) or common name

colistin

Associated names
ClassPolymyxins
Reference numberEMEA/V/A/106
TypeArticle 35
StatusEuropean Commission final decision
Opinion date11/12/2014
EC decision date16/03/2015

All documents

Name Language First published Last updated
Opinion following an Article 35 referral for veterinary medicinal products containing colistin to be administered orally BG = bălgarski 2015-04-13  
Opinion following an Article 35 referral for veterinary medicinal products containing colistin to be administered orally ES = español 2015-04-13  
Opinion following an Article 35 referral for veterinary medicinal products containing colistin to be administered orally CS = čeština 2015-04-13  
Opinion following an Article 35 referral for veterinary medicinal products containing colistin to be administered orally DA = dansk 2015-04-13  
Opinion following an Article 35 referral for veterinary medicinal products containing colistin to be administered orally DE = Deutsch 2015-04-13  
Opinion following an Article 35 referral for veterinary medicinal products containing colistin to be administered orally ET = eesti keel 2015-04-13  
Opinion following an Article 35 referral for veterinary medicinal products containing colistin to be administered orally EL = elliniká 2015-04-13  
Opinion following an Article 35 referral for veterinary medicinal products containing colistin to be administered orally EN = English 2015-04-13  
Opinion following an Article 35 referral for veterinary medicinal products containing colistin to be administered orally FR = français 2015-04-13  
Opinion following an Article 35 referral for veterinary medicinal products containing colistin to be administered orally IT = italiano 2015-04-13  
Opinion following an Article 35 referral for veterinary medicinal products containing colistin to be administered orally LV = latviešu valoda 2015-04-13  
Opinion following an Article 35 referral for veterinary medicinal products containing colistin to be administered orally LT = lietuvių kalba 2015-04-13  
Opinion following an Article 35 referral for veterinary medicinal products containing colistin to be administered orally HU = magyar 2015-04-13  
Opinion following an Article 35 referral for veterinary medicinal products containing colistin to be administered orally MT = Malti 2015-04-13  
Opinion following an Article 35 referral for veterinary medicinal products containing colistin to be administered orally NL = Nederlands 2015-04-13  
Opinion following an Article 35 referral for veterinary medicinal products containing colistin to be administered orally PL = polski 2015-04-13  
Opinion following an Article 35 referral for veterinary medicinal products containing colistin to be administered orally PT = português 2015-04-13  
Opinion following an Article 35 referral for veterinary medicinal products containing colistin to be administered orally RO = română 2015-04-13  
Opinion following an Article 35 referral for veterinary medicinal products containing colistin to be administered orally SK = slovenčina 2015-04-13  
Opinion following an Article 35 referral for veterinary medicinal products containing colistin to be administered orally SL = slovenščina 2015-04-13  
Opinion following an Article 35 referral for veterinary medicinal products containing colistin to be administered orally FI = suomi 2015-04-13  
Opinion following an Article 35 referral for veterinary medicinal products containing colistin to be administered orally SV = svenska 2015-04-13  
Opinion following an Article 35 referral for veterinary medicinal products containing colistin to be administered orally HR = Hrvatski 2015-04-13  
Colistin oral - Article 35 referral - Annex I, II, III BG = bălgarski 2015-04-13  
Colistin oral - Article 35 referral - Annex I, II, III ES = español 2015-04-13  
Colistin oral - Article 35 referral - Annex I, II, III CS = čeština 2015-04-13  
Colistin oral - Article 35 referral - Annex I, II, III DA = dansk 2015-04-13  
Colistin oral - Article 35 referral - Annex I, II, III DE = Deutsch 2015-04-13  
Colistin oral - Article 35 referral - Annex I, II, III ET = eesti keel 2015-04-13  
Colistin oral - Article 35 referral - Annex I, II, III EL = elliniká 2015-04-13  
Colistin oral - Article 35 referral - Annex I, II, III EN = English 2015-04-13  
Colistin oral - Article 35 referral - Annex I, II, III FR = français 2015-04-13  
Colistin oral - Article 35 referral - Annex I, II, III IT = italiano 2015-04-13  
Colistin oral - Article 35 referral - Annex I, II, III LV = latviešu valoda 2015-04-13  
Colistin oral - Article 35 referral - Annex I, II, III LT = lietuvių kalba 2015-04-13  
Colistin oral - Article 35 referral - Annex I, II, III HU = magyar 2015-04-13  
Colistin oral - Article 35 referral - Annex I, II, III MT = Malti 2015-04-13  
Colistin oral - Article 35 referral - Annex I, II, III NL = Nederlands 2015-04-13  
Colistin oral - Article 35 referral - Annex I, II, III PL = polski 2015-04-13  
Colistin oral - Article 35 referral - Annex I, II, III PT = português 2015-04-13  
Colistin oral - Article 35 referral - Annex I, II, III RO = română 2015-04-13  
Colistin oral - Article 35 referral - Annex I, II, III SK = slovenčina 2015-04-13  
Colistin oral - Article 35 referral - Annex I, II, III SL = slovenščina 2015-04-13  
Colistin oral - Article 35 referral - Annex I, II, III FI = suomi 2015-04-13  
Colistin oral - Article 35 referral - Annex I, II, III SV = svenska 2015-04-13  
Colistin oral - Article 35 referral - Annex I, II, III HR = Hrvatski 2015-04-13  
Colistin oral - Article 35 referral - Annex I, II, III IS = Islenska 2015-04-13  

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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