Colistin combinations

Current status:
European Commission final decision

Overview

On 21 April 2016, the European Medicines Agency (the Agency) completed a review of the effectiveness of and antimicrobial resistance to all veterinary medicinal products containing colistin in combination with other antimicrobial substances to be administered orally. The Agency's Committee for Medicinal Products for Veterinary Use (CVMP) concluded that the overall benefit-risk balance for the aforementioned products is negative, due to a lack of clinical relevance and in view of over-exposure of colistin that could pose a potential risk to animal and human health from an acceleration of the occurrence of colistin resistance. The CVMP recommended that all marketing authorisations for veterinary medicinal products containing colistin in combination with other antimicrobial substances to be administered orally should be withdrawn throughout the European Union (EU).

Key facts

Approved name
Colistin combinations
International non-proprietary name (INN) or common name
colistin and amoxicillin; ampicillin; chlortetracycline; doxycycline; enrofloxacin; erythromycin; neomycin; oxytetracycline; spiramycin; sulfadimethoxine; sulfaguanidine; sulfamethoxypyridazine ...
Associated names
Please see Annex I
Reference number
EMEA/V/A/111
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
21/04/2016
EC decision date
14/07/2016

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:

How useful was this page?

Add your rating
Average
1 rating