Stresnil 40 mg/ml solution for injection for pigs and associated names, and generic products thereof

Current status:
European Commission final decision

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

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.

Status
European Commission final decision
Opinion date
16/07/2020
EC decision date
12/10/2020

All documents

Document description

  • Opinion - contains the CVMP opinion of the referred medicine(s)
  • List of the medicines affected by the referral (Annex I)
  • Scientific conclusions of the Committee (Annex II)

The following two documents may not always be available:

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