Veterinary medicinal products containing toltrazuril to be administered orally to chickens
Table of contents
Overview
On 14 July 2022, the European Medicines Agency (the Agency) completed a review of the safety of oral veterinary medicines containing toltrazuril for use in chickens. The Agency’s Committee for Veterinary Medicinal Products (CVMP) concluded that the benefits of these veterinary medicines continue to outweigh their risks but that risk mitigation measures should be taken to assure consumer safety, including the amendment of the restriction period before the onset of lay. The restriction period is the time between the administration of a medicine and the start of the laying period in which chickens must not be treated.
Key facts
| Approved name |
Veterinary medicinal products containing toltrazuril to be administered orally to chickens
|
| International non-proprietary name (INN) or common name |
toltrazuril
|
| Current status |
European Commission final decision
|
| Reference number |
EMEA/V/A/144
|
| 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. |
| Authorisation model |
Nationally authorised product(s)
|
| Opinion date |
14/07/2022
|
| EC decision date |
09/11/2022
|
All documents
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List item
Questions and answers on the review of oral veterinary medicines containing toltrazuril for use in chickens (PDF/123.48 KB)
First published: 14/12/2022
EMA/709204/2022 -
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List item
Veterinary medicinal products containing toltrazuril to be administered orally to chickens – Article 35 referral – Annex I, II, III (PDF/307.73 KB)
First published: 14/12/2022 -
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)