Veterinary medicines containing enrofloxacin to be administered via the drinking water to chickens and/or turkeys
Table of contents
Current status:
European Commission final decision
Overview
Questions and answers on use of enrofloxacin-containing veterinary medicines administered via drinking water to chickens and turkeys
Follow-up assessment after the referral under Article 35 of Directive 2001/82/EC (EMEA/V/A/089)
On 14 February 2018, the European Medicines Agency updated its recommendations for enrofloxacin-containing medicines administered via drinking water to chickens and turkeys. The Agency's Committee for Medicinal Products for Veterinary Use (CVMP) concluded that these products should no longer be used in chickens and turkeys to treat Escherichia coli infections and that the product information for the products should be amended accordingly.
Key facts
Approved name |
Veterinary medicines containing enrofloxacin to be administered via the drinking water to chickens and/or turkeys
|
International non-proprietary name (INN) or common name |
enrofloxacin |
Reference number |
EMEA/V/A/089
|
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 |
07/11/2013
|
EC decision date |
28/02/2014
|
All documents
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Enrofloxacin Article-35 referral - Questions and answers on use of enrofloxacin-containing veterinary medicines administered via drinking water to chickens and turkeys (PDF/77.37 KB)
First published: 16/04/2018
Last updated: 16/04/2018 -
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Enrofloxacin Article-35 referral - Opinion following an Article-35 referral for all veterinary medicines containing enrofloxacin to be administered via the drinking water to chickens and/or turkeys (PDF/90.36 KB)
First published: 10/04/2014
Last updated: 10/04/2014
EMEA/V/A/089 -
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Enrofloxacin Article-35 referral - Veterinary medicines containing enrofloxacin to be administered via the drinking water to chickens and/or turkeys Article-35 referral - Annexes (PDF/422.88 KB)
First published: 10/04/2014
Last updated: 10/04/2014
EMEA/V/A/089 -
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