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Stresnil 40 mg/ml Solution for Injection for Pigs and Sedanol 40 mg/ml Solution for Injection for Pigs - change in withdrawal period (meat and offal) and restriction of injection volume

Notice type: Advisory

Date: 25/02/2021

The Health Products Regulatory Authority (HPRA) wishes to advise that the withdrawal periods for meat and offal derived from pigs treated with the products identified below have been increased, the maximum injection volumes at each administration site have been restricted.
These changes have been made following a review of the available residue data by the European Medicines Agency, in order to implement a harmonised withdrawal period for the products concerned throughout the EU.

Product name or type:
Stresnil 40 mg/ml Solution for Injection for Pigs, Sedanol 40 mg/ml Solution for Injection for Pigs

Authorisation Number:
VPA22020/007/001, VPA10801/015/001

Active Substance:
Azaperone

Product Classification:
The concerned products are supplied in Ireland under the ‘Prescription Only Medicine’ (POM) category.

Authorisation Holder:

The following products are concerned:

Name of VMP	VPA number	MAH
Stresnil 40 mg/ml Solution for Injection for Pigs	22020/007/001	Elanco GmbH
Sedanol 40 mg/ml Solution for Injection for Pigs	10801/015/001	Richter Pharma AG

Prescription Required:
Yes

Target Audience:
Veterinary practitioners, pharmacists, farmers

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.

Background Information Or Related Documents:

Withdrawal periods are established by the competent authorities for veterinary medicines in the individual Member States where the products are marketed, based on the maximum residue limit established by the EMA for the relevant drug residues in meat.

Such withdrawal periods are established in line with EU guidelines, which may be updated periodically in line with scientific advances.

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.

Further Information:

Commission decision (2020)7117 of 12 Oct 2020

https://ec.europa.eu/health/documents/community-register/html/vo27175.htm

Extent of change:

Product	Meat and offal withdrawal period
Product	Previous national	New harmonised EU
Stresnil 40 mg/ml Solution for Injection for Pigs	10 days	18 days
Sedanol 40 mg/ml Solution for Injection for Pigs	14 days	18 days

Previously, there was no restriction on the maximum injection volume per injection site.

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