Closantel
Table of contents
Overview
On 21 February 2019, the European Medicines Agency (the Agency) completed a review of the consumer safety of the withdrawal periods (meat and offal) for sheep for veterinary medicinal products containing 50 mg closantel per ml (as a single active substance) presented as solutions for injection. The Agency’s Committee for Medicinal Products for Veterinary Use (CVMP) concluded that the overall benefit-risk balance for the concerned products is positive and recommended amendments to the withdrawal periods for sheep to provide assurance for consumer safety. Withdrawal period refers to the minimum period of time from administering the last dose of veterinary medicinal product and the production of meat or other animal-derived products for food.
Key facts
| Approved name |
Closantel
|
| International non-proprietary name (INN) or common name |
closantel
|
| Current status |
European Commission final decision
|
| Reference number |
EMEA/V/A/126
|
| 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 |
21/02/2019
|
| EC decision date |
20/05/2019
|
All documents
-
List item
Closantel Article-35 referral - Questions and answers on veterinary medicinal products containing 50 mg closantel per ml (as a single active substance) presented as solutions for injection for subcutaneous use in sheep (PDF/75.82 KB)
First published: 27/06/2019
EMA/246018/2019 -
-
List item
Closantel Article-35 referral - Annex I, II, III (PDF/57.07 KB)
First published: 27/06/2019 -
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)