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Duotech Oral Suspension for Sheep, Parafend Plus Oral Suspension - Change to the meat withdrawal period

Notice type: Advisory

Date: 03/12/2018

  

Product name or type:
Duotech Oral Suspension for Sheep, Parafend Plus Oral Suspension

Authorisation Number:
VPA 10999/082/001, VPA 10999/099/001

Active Substance:
Oxfendazole, closantel

Product Classification:
The products concerned are supplied in Ireland under the 'Licensed Merchant' (LM) category. This means that they are available, without the need for a veterinary prescription, from veterinary practitioners, pharmacies and from outlets that are licensed by the Department of Agriculture, Food and the Marine (e.g. co-operative stores) to supply certain classes of veterinary medicines to the farming community).

Authorisation Holder:
Norbrook Laboratories Limited

Recall Classification:
A recall of the products concerned is not required, as the change has arisen in order to align the withdrawal periods for these products with other similar products. There is not considered to be a risk to consumer safety.

Target Audience:
Veterinary practitioners, pharmacists, licensed merchants and farmers.

Problem Or Issue:

Taking into account available information and as a precautionary approach the sheep meat withdrawal period has been increased from 18 to 42 days for both products. The new withdrawal period is as follows:

Sheep meat and offal: 42 days

Background Information Or Related Documents:

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

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

Actions To Be Taken:

The marketing authorisation holder for the products involved has submitted variations to the terms of the marketing authorisations to the HPRA and these have been approved. The following revised withdrawal period for sheep meat and offal has been established for the products concerned:

Sheep meat and offal: 42 days.

Veterinary practitioners, pharmacists, licensed merchants and farmers should follow the amended withdrawal period and apply it forthwith (even where the product labelling indicates otherwise).

The HPRA advises users of these veterinary medicinal products to follow 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 for the products concerned.

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