Colistin

Current status:
European Commission final decision

Overview

Colistin sulfate is a polypeptide antibiotic belonging to the polymyxins group of antibiotics. Veterinary medicinal formulations containing colistin sulfate at 2 000 000 IU per ml and intended for administration via drinking water to calves, pigs, lambs and poultry are used for the treatment of infections of the gastrointestinal tract caused by Escherichia coli and Salmonella spp susceptible to colistin.

Due to concerns that the differences in posology and withdrawal periods established across the European Union for veterinary medicinal formulations containing colistin at 2 000 000 IU per ml and intended for administration in drinking water to food producing species may present a potential serious risk to public and animal health, the United Kingdom referred the matter to the Agency on 1 April 2009, under Article 35 of Directive 2001/82/EC.

The referral procedure started on 16 April 2009. The rapporteur and co-rapporteur appointed were: Prof. Christian Friis and Dr Karolina Törneke, respectively. Written explanations were provided by the applicants/marketing authorisation holders on 15 July 2009 and 13 January 2010.

Based on the rapporteurs' assessment of the currently available data, the CVMP, adopted, on 10 February 2010, an opinion recommending variations of the marketing authorisations for veterinary medicinal formulations containing colistin at 2 000 000 IU per ml and intended for administration in drinking water to food producing species in order to amend the summary of the product characteristics (SPC), labelling and package leaflet to harmonise the posology and withdrawal periods (where applicable) for the concerned products.

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

The final opinion was converted into a Decision by the European Commission on 10 June 2010.

Key facts

Approved name
Colistin
International non-proprietary name (INN) or common name
Colistin sulfate
Reference number
EMA/189829/2010
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
10/02/2010
EC decision date
10/06/2010

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