Stresnil 40 mg/ml solution for injection for pigs and associated names, and generic products thereof
Table of contents
Overview
On 16 July 2020, the European Medicines Agency (the Agency) completed a review of the withdrawal periods (meat and offal) for pigs for Stresnil 40 mg/ml solution for injection and associated names, and generic products thereof. The withdrawal period is the minimum time that has to elapse before an animal treated with a medicine can be slaughtered so that its meat or other animal derived products may be used for human consumption.
The Agency’s Committee for Medicinal Products for Veterinary Use (CVMP) concluded that the benefits of these medicines continue to outweigh the risks, but that the maximum injection volume per site and the withdrawal periods for pigs should be changed to provide assurance for consumer safety.
Key facts
| Approved name |
Stresnil 40 mg/ml solution for injection for pigs and associated names, and generic products thereof
|
| International non-proprietary name (INN) or common name |
azaperone
|
| Current status |
European Commission final decision
|
| Reference number |
EMEA/V/A/138
|
| 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 |
16/07/2020
|
| EC decision date |
12/10/2020
|
All documents
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List item
Questions and answers on the review of withdrawal periods for Stresnil 40 mg/ml solution for injection for pigs and associated names, and generic products thereof (PDF/95.13 KB)
First published: 30/10/2020
EMA/460836/2020 -
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List item
Stresnil and generics referral Article-35 - Annex I-III (PDF/234.98 KB)
First published: 30/10/2020 -
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)