Colistin oral

Current status:
European Commission final decision

Overview

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.

Key facts

Approved name
Colistin oral
International non-proprietary name (INN) or common name
colistin
Class
Polymyxins
Reference number
EMEA/V/A/106
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
11/12/2014
EC decision date
16/03/2015

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

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