Veterinary medicinal products containing tylosin presented as solution for injection to be administered to sheep

Tylosin is a macrolide antibiotic used mainly to treat infections caused by bacteria known as Gram-positive bacteria. Veterinary medicines containing tylosin are used in adult cattle, calves, pigs, sheep and goats and are given by injection into the muscle. In addition, cattle may also be treated by injection given slowly into a vein.

On 28 September 2018, the Dutch medicines authority requested that the CVMP review all available data and recommend withdrawal periods for milk, meat and offal from sheep treated with injectable veterinary medicines containing tylosin.

The Dutch authority considered that the withdrawal periods for sheep in the EU might not be adequate to ensure consumer safety, noting that withdrawal periods differed across the EU: from 8 to 42 days for sheep meat and offal and from 4 to 7 days for sheep milk.

The CVMP reviewed available data on residue depletion, which indicates how long a medicine takes to fall below maximum residue limits (MRLs) in the animal’s body. These included data from companies and from the published literature.

Based on the evaluation of the currently available data and the scientific discussion within the Committee, the CVMP concluded that, for 49 out of 50 products, those containing benzyl alcohol and propylene glycol as a non-active ingredient, the withdrawal periods for meat and offal from treated sheep should be 42 days, while the withdrawal periods for milk from treated sheep should be 108 hours. The Committee concluded that the injection should be divided over two injection sites (maximum 2.5 ml injection volume per injection site). The CVMP recommended the variation of the marketing authorisations for these veterinary medicines.

For one medicine, Tilocen, which contains the non-active ingredient polyethylene glycol 400, there were no data available that could be used to set adequate withdrawal periods in sheep. Therefore, the CVMP concluded that the benefit-risk balance for the veterinary medicine Tilocen is not favourable for sheep and recommended a change to its marketing authorisation to remove any reference to use in sheep.

The full changes made to the product information are detailed in Annex III of the CVMP opinion under 'All documents'.

The European Commission issued a decision on 20 September 2019.