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
|
| Current status |
European Commission final decision
|
| 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. |
| Opinion date |
07/11/2013
|
| EC decision date |
28/02/2014
|
All documents
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List item
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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List item
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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List item
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 -
Description of documents published
Please note that some of the listed documents apply only to certain procedures.
- Overview - lay-language summary of the stage of the procedure
- Notification – a letter from a Member State, the European Commission or the marketing authorisation holder requesting the initiation of the procedure
- List of questions – questions agreed by the Committee requesting further information from the marketing authorisation holder(s) / applicant(s) to evaluate the issues identified
- Timetable for the procedure – agreed timeframe to respond to the list of questions, to assess the issues and to adopt a conclusion
- List of medicines concerned by the procedure – medicine(s) / active substance(s) concerned, and marketing authorisation holder(s) / applicant(s)
- List of questions to be addressed by the stakeholders – call for data to be submitted by stakeholders (e.g. veterinary healthcare professionals, farmers, academia) (if applicable)
- Stakeholder submission form – form to be used by stakeholders to submit data (if applicable)
- Scientific conclusions – scientific conclusions of CVMP
- Divergent positions – divergent positions of the CVMP members (if applicable)
- Changes to the summary of product characteristics, labelling and package leaflet (amended sections or fully revised version) (if applicable)
- Condition(s) to the marketing authorisation(s) – condition(s) for the safe and effective use of the medicine(s) (if applicable)
- Condition for lifting the suspension – condition to be fulfilled for the suspension of the marketing authorisation(s) to be lifted (if applicable)