Veterinary medicinal products containing tylosin to be administered orally via feed or the drinking water to pigs

Current status:
European Commission final decision

Overview

Tylosin is a macrolide antibiotic which is produced by Streptomyces fradiae. It is active mostly against Gram-positive bacteria and mycoplasmas. It is ineffective against Enterobacteriaceae. Tylosin and its phosphate and tartrate salts are used in food producing species for the treatment of conditions caused by sensitive organisms. It may be administered by oral or parenteral routes. Tylosin is not used in human medicine.

On 30 October 2013, Sweden presented to the Agency a referral notification under Article 35 of Directive 2011/82/EC, regarding veterinary medicinal products containing tylosin to be administered orally via feed or the drinking water to pigs. The CVMP was requested to consider whether tylosin is still effective against swine dysentery (caused by Brachyspira hyodysenteriae) and whether the treatment durations beyond three weeks are justified.

The referral started on 6 November 2013. The Committee appointed E. Persson as rapporteur and A. Wachnik-Święcicka as co-rapporteur. Written comments on the recommendations and proposed changes in the product information were provided by the applicants and marketing authorisation holders on 7 March 2014.

Based on the evaluation of the currently available data, the CVMP considered that the overall benefitrisk profile for these products remains positive subject to amendments in the product information. Therefore, on 8 May 2014 the Committee adopted by consensus a positive opinion, recommending variations to the terms of the marketing authorisations for veterinary medicinal products containing tylosin to be administered orally via feed or the drinking water to pigs.

The list of product names concerned is given in Annex I. The scientific conclusions are provided in Annex II together with the amendments in the summaries of product characteristics, labelling and package leaflets in Annex III.

The final opinion was converted into a Decision by the European Commission on 31 July 2014.

Key facts

Approved name
Veterinary medicinal products containing tylosin to be administered orally via feed or the drinking water to pigs
International non-proprietary name (INN) or common name
tylosin
Associated names
See annex I
Reference number
EMEA/V/A/100
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
08/05/2014
EC decision date
31/07/2014

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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