Problem Or Issue:
Following the outcome of a referral procedure to the European Medicines Agency on 16/07/2020 and the subsequent implementing decision by the European Commission on 12/10/2020, the withdrawal periods for Stresnil 40 mg/ml solution for injection for pigs and associated names, and generic products thereof, which contain the active substance azaperone, have been harmonised throughout the European Union for pigs.
The injection volume per injection site has been restricted to 5 ml.
Actions To Be Taken:
In accordance with the applicable legislation, in order to change the withdrawal periods for the products concerned to be in line with the outcome of the EU referral procedure, the marketing authorisation holders for the products involved have submitted a variation to amend the terms of their marketing authorisations to the HPRA and this has been approved.
The following revised withdrawal period and restriction of injection volume have been established for both products:
Meat and offal: 18 days
The maximum injection volume has been restricted to 5 ml per injection site.
The HPRA advises veterinary practitioners and users of these veterinary medicinal products to adhere to the conditions of the marketing authorisations as set out on the HPRA website (www.hpra.ie), pending the availability of new stock with updated labelling reflecting the revised withdrawal periods and method of administration for the products concerned.
Any adverse events occurring following use of veterinary medicinal products should be reported to the HPRA via the online reporting form available at https://www.hpra.ie/homepage/about-us/report-an-issue/veterinary-medicines-adverse-reaction or to the marketing authorisation holder of the relevant product(s), at the earliest opportunity.
Commission decision (2020)7117 of 12 Oct 2020
Extent of change:
Meat and offal withdrawal period
New harmonised EU
Stresnil 40 mg/ml Solution for Injection for Pigs
Sedanol 40 mg/ml Solution for Injection for Pigs
Previously, there was no restriction on the maximum injection volume per injection site.