Solamocta 697 mg/g powder for use in drinking water for chickens, ducks and turkeys
Table of contents
Overview
On 4 November 2015, the European Medicines Agency (the Agency) completed an arbitration procedure following a disagreement among Member States of the European Union (EU) regarding the authorisation of the veterinary medicinal product Solamocta 697 mg/g Powder for Use in Drinking Water for Chickens, Ducks and Turkeys. The Agency's Committee for Medicinal Products for Veterinary Use (CVMP) concluded that the marketing authorisation for Solamocta can be granted provided that the recommended revised instructions on product administration and prudent use warnings are added to the product information.
Key facts
| Approved name |
Solamocta 697 mg/g powder for use in drinking water for chickens, ducks and turkeys
|
| International non-proprietary name (INN) or common name |
Amoxicillin trihydrate
|
| Class |
-
|
| Current status |
European Commission final decision
|
| Reference number |
EMEA/V/A/112
|
| Type |
Article 33
Mutual-recognition and decentralised referral: initiated because of disagreement between Member States within the framework of the mutual-recognition or decentralised procedure. |
| Opinion date |
04/11/2015
|
| EC decision date |
07/01/2016
|
All documents
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List item
Questions and answers on Solamocta 697 mg/g Powder for Use in Drinking Water for Chickens, Ducks and Turkeys (amoxicillin trihydrate) (PDF/77.47 KB)
First published: 05/02/2016
Last updated: 05/02/2016
EMA/23095/2016 -
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List item
Solamocta Article-33(4) referral - Annex I, II, III (PDF/82.68 KB)
First published: 05/02/2016
Last updated: 05/02/2016 -
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List item
Solamocta Article-33(4) referral - Divergent position (PDF/48.08 KB)
First published: 05/02/2016
Last updated: 05/02/2016
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)