Closamectin Pour-on Solution and associated names
Table of contents
Overview
On 8 October 2015, the European Medicines Agency (the Agency) completed a review of the animal safety of Closamectin Pour-On Solution and associated names. The Agency's Committee for Medicinal Products for Veterinary Use (CVMP) concluded that the benefits of Closamectin Pour-On Solution and associated names continue to outweigh their risks subject to variation of the marketing authorisations to include new adverse reactions and precautionary measures and conditions concerning risk mitigation and surveillance measures.
Key facts
| Approved name |
Closamectin Pour-on Solution and associated names
|
| International non-proprietary name (INN) or common name |
|
| Current status |
European Commission final decision
|
| Reference number |
EMEA/V/A/113
|
| Type |
Article 78
Pharmacovigilance urgent measures: initiated when, as a result of the evaluation of veterinary pharmacovigilance data, a Member State considers that a marketing authorisation should be suspended, withdrawn or varied to restrict the indications or availability, amend the posology, add a contraindication or add a new precautionary measure. |
| Opinion date |
08/10/2015
|
| EC decision date |
22/03/2016
|
All documents
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List item
Questions and answers on Closamectin Pour-On Solution and associated names (PDF/83.07 KB)
First published: 31/05/2016
Last updated: 31/05/2016
EMA/672999/2015 -
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List item
Opinion following an Article-78 procedure for Closamectin Pour-On Solution and associated names (PDF/156.27 KB)
First published: 31/05/2016
Last updated: 31/05/2016
EMA/CVMP/511375/2015 -
List item
Closamectin Article-78 referral - Annex I-IV (PDF/101.42 KB)
First published: 31/05/2016
Last updated: 31/05/2016
EMEA/V/A/113 -
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)