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Santiola 50 mg/ml solution for injection for cattle and sheep - Change to the meat & offal withdrawal period

Notice type: Advisory

Date: 28/08/2019

Following the opinion of the Committee for Medicinal Products for Veterinary Use (CVMP) of the European Medicines Agency (EMA), the Health Products Regulatory Authority (HPRA) wishes to advise users that the withdrawal period for meat & offal for the product concerned is being increased.

Product name or type:
Santiola 50 mg/ml solution for injection for cattle and sheep

Authorisation Number:
VPA10774/048/001

Active Substance:
Closantel

Product Classification:
The product concerned is supplied in Ireland under the 'Licensed Merchant' (LM) category. This means that it is 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:
Krka, d.d., Novo mesto

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

Problem Or Issue:
Following the outcome of a referral procedure to the European Medicines Agency in February 2018 and the subsequent implementing decision by the European Commission on 20^th May 2019, the withdrawal periods for meat and offal for products containing 50 mg closantel per ml (as a single active substance) presented as solutions for injection for subcutaneous use in sheep have been harmonised throughout the European Union and are being increased.

Background Information Or Related Documents:
There were different withdrawal periods (meat and offal) in existence in the EU Member States for animal remedies containing 50 mg closantel per ml (as a single active substance) presented as a solution for injection for subcutaneous use in sheep. The CVMP reviewed all available residue depletion data and recommended a revised (longer) withdrawal period for meat & offal in sheep.

Actions To Be Taken:
Users should note that the withdrawal period for meat and offal has increased from 77 days to 107 days and that if treatment is to be repeated in sheep, the re-treatment interval should not be less than 107 days.

Further Information:

https://www.ema.europa.eu/en/medicines/veterinary/referrals/closantel

Commission decision (2019)3912 of 20/05/2019

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