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

Current status:
European Commission final decision

Overview

Questions and answers on withdrawal periods for injectable veterinary medicines containing tylosin when given to sheep

Outcome of a referral procedure under Article 35 of Directive 2001/82/EC (EMEA/V/A/130)

On 20 June 2019, the European Medicines Agency completed a review of the withdrawal periods for injectable veterinary medicines containing tylosin when used in sheep. The withdrawal period is the minimum time that has to elapse before an animal treated with a medicine can be slaughtered and its meat or other animal derived products may be used for human consumption.

The Agency’s Committee for Medicinal Products for Veterinary Use (CVMP) concluded that for some of these medicines, the maximum injection volume per site and the withdrawal periods for sheep meat, offal and milk should be changed. However, for one medicine, Tilocen, the Committee concluded that there were insufficient data to determine the withdrawal period and that it should therefore no longer be used in sheep.

Key facts

Approved name
Veterinary medicinal products containing tylosin presented as solution for injection to be administered to sheep
International non-proprietary name (INN) or common name

tylosin

Associated names
See annex I
Reference number
EMEA/V/A/130
Type
Article 35

Community interest referral: initiated in cases involving the interests of the Community or concerns relating to the protection of human or animal health or the environment.

Status
European Commission final decision
Opinion date
20/06/2019
EC decision date
20/09/2019

All documents

Document description

  • Opinion - contains the CVMP opinion of the referred medicine(s)
  • List of the medicines affected by the referral (Annex I)
  • Scientific conclusions of the Committee (Annex II)

The following two documents may not always be available:

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