My HPRA: Register

Multimin Solution for Injection (VPA 10431/001/001) change in withdrawal period (meat and offal)

Notice type: Advisory

Date: 14/05/2021

 The Health Products Regulatory Authority (HPRA) wishes to advise that the withdrawal period for meat and offal derived from cattle treated with Multimin Solution for Injection has been increased. This change has been made following a review of the available residue data for selenium.

Product name or type:
Multimin Solution for Injection (VPA 10431/001/001)

Authorisation Number:
VPA 10431/001/001

Active Substance:
Manganese (as manganese carbonate), copper (as copper carbonate), zinc (as zinc oxide) and selenium (as sodium selenite)

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

Authorisation Holder:
Warburton Technology Limited

Prescription Required:
Yes

Target Audience:
Veterinary practitioners, pharmacists, farmers.

Problem Or Issue:
As a result of submission of the product dossier into an EU Member State, that country raised concerns that the existing withdrawal period might not be adequate. Although the existing withdrawal period of 8 days was not considered unsafe, the marketing authorisation holder agreed to increase the withdrawal period for meat and offal to 28 days to address the concerns raised.

Background Information Or Related Documents:
The withdrawal periods are calculated in line with EU guidelines, which have been updated over time.

Actions To Be Taken:
The following revised withdrawal period has been
established for cattle:

Meat and offal: 28 days
Milk: zero hours

The HPRA advises veterinary practitioners and users of Multimin Solution for Injection to follow the updated conditions of the marketing authorisation, as set out on the HPRA website (www.hpra.ie). New stock with updated labelling reflecting the revised withdrawal
period will become available with the manufacture of new batches of the product.

As with all veterinary medicines, 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:
Extent of change:

Withdrawal periods

Previous

national

New

national

Meat and offal: 8days

Milk: zerohours

Meat and offal: 28days

Milk: zero hours


« Back