Colistin combinations
Table of contents
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products containing colistin in combination with other antimicrobial substances to be administered orally should be withdrawn throughout the European Union (EU).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
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List item
Questions and answers on veterinary medicinal products containing colistin in combination with other antimicrobial substances to be administered orally (PDF/121.53 KB)
First published: 05/08/2016
Last updated: 05/08/2016
EMA/461505/2016 -
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List item
Colistin combinations Article 35 referral - Annexes I, II, III (PDF/138.6 KB)
First published: 05/08/2016
Last updated: 05/08/2016
EMA/461505/2016 -
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