Moxidectin-containing veterinary medicines used in cattle, sheep and horses
Table of contents
Overview
On 11 May 2017, the European Medicines Agency completed a review of oral, topical and injectable moxidectin-containing veterinary medicines used in cattle, sheep and horses. The Agency's Committee for Medicinal Products for Veterinary Use (CVMP) concluded that these medicines might have a long-term impact on the environment due to their persistent, bioaccumulative and toxic (PBT) properties. Consequently, the CVMP recommended measures to mitigate against the environmental risks, as well as warnings, to be included within the product information. In addition, a condition was placed on the marketing authorisations with the purpose of obtaining field data to determine whether, under actual conditions of use and relevant environmental conditions, the hazards due to the PBT properties of these products can be prevented.
Key facts
| Approved name |
Moxidectin-containing veterinary medicines used in cattle, sheep and horses
|
| International non-proprietary name (INN) or common name |
moxidectin
|
| Associated names |
See annex I
|
| Current status |
European Commission final decision
|
| Reference number |
EMEA/V/A/116
|
| 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 |
11/05/2017
|
All documents
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List item
Moxidectin Article-35 referral - Questions and answers on the environmental impact of moxidectin-containing veterinary medicines used in cattle, sheep and horses (PDF/67.8 KB)
First published: 24/10/2017
Last updated: 24/10/2017
EMA/587529/2017 -
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List item
Moxidectin Article-35 referral - Annex I, II, III, IV (PDF/442.32 KB)
First published: 24/10/2017
Last updated: 24/10/2017 -
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)