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Change of meat and offal withdrawal period for Closivet Pour on for cattle and Closamectin Pour on for cattle

Notice type: Advisory

Date: 26/03/2019

Taking into account available information and as a precautionary approach the meat and offal withdrawal period has been increased from 28 to 58 days for both products. The new withdrawal period is as follows:
Cattle meat and offal: 58 days.
 

Product name or type:
Closivet 5 mg/ml + 200 mg/ml Pour-on solution for Cattle, and Closamectin 5 mg/ml + 200 mg/ml Pour-on solution for Cattle

Authorisation Number:
VPA 22664/102/001 (previously 10999/141/001), and VPA 22664/088/001 (previously 10999/124/001).

Active Substance:
Ivermectin, 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).

Manufacturer Or Supplier:
Norbrook Laboratories (Ireland) Limited

Serial Or Batch Number And Expiry Date:

Authorisation Holder:
Norbrook Laboratories (Ireland) Limited

Recall Classification:
A recall of the products concerned is not required, as 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 meat and offal withdrawal period has been increased from 28 days to 58 days for both products.

There will be a delay between existing stock indicating a 28 days withdrawal period on the labelling being utilised, and new stock with the updated withdrawal period information being available on the market.
Users should follow the new withdrawal period for meat and offal (58 days) with immediate effect.  
 

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 has been established for the products concerned: Meat and offal: 58 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.

Further Information:
Note that due to Brexit, the marketing authorisation numbers (VPAs) of the products concerned have been changed recently. More information on the background to this change is available here.

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