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

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.

Opinion following an Article-35 referral for veterinary medicinal products containing tylosin to be administered orally via feed or the drinking water to pigs

Reference Number: EMA/492247/2014 Summary:

Tylosin is a macrolide antibiotic which is produced by Streptomyces fradiae. It is active mostly against

Gram-positive bacteria and mycoplasmas.

Key facts

About this medicine

• 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

About this procedure

• Current status:
  European Commission final decision
• Reference number:
  EMEA/V/A/100
• Type:
  Article 35 referrals (prior to January 2022)

  This type of referral is initiated in cases involving the interests of the Community or concerns relating to the protection of human or animal health or the environment.

Key dates and outcomes

• Opinion date:
  08/05/2014
• EC decision date:
  31/07/2014

All documents

European Commission final decision

Veterinary medicinal products containing tylosin to be administered orally via feed or the drinking water to pigs Article-35 referral - Annex I, II, III

Opinion following an Article-35 referral for veterinary medicinal products containing tylosin to be administered orally via feed or the drinking water to pigs

Reference Number: EMA/492247/2014 Summary:

Tylosin is a macrolide antibiotic which is produced by Streptomyces fradiae. It is active mostly against

Gram-positive bacteria and mycoplasmas.

Description of documents published

Please note that some of the listed documents apply only to certain procedures.

• Overview - lay-language summary of the stage of the procedure
• Notification – a letter from a Member State, the European Commission or the marketing authorisation holder requesting the initiation of the procedure
• List of questions – questions agreed by the Committee requesting further information from the marketing authorisation holder(s) / applicant(s) to evaluate the issues identified
• Timetable for the procedure – agreed timeframe to respond to the list of questions, to assess the issues and to adopt a conclusion
• List of medicines concerned by the procedure – medicine(s) / active substance(s) concerned, and marketing authorisation holder(s) / applicant(s)
• List of questions to be addressed by the stakeholders – call for data to be submitted by stakeholders (e.g. veterinary healthcare professionals, farmers, academia) (if applicable)
• Stakeholder submission form – form to be used by stakeholders to submit data (if applicable)
• Scientific conclusions – scientific conclusions of CVMP
• Divergent positions – divergent positions of the CVMP members (if applicable)
• Changes to the summary of product characteristics, labelling and package leaflet (amended sections or fully revised version) (if applicable)
• Condition(s) to the marketing authorisation(s) – condition(s) for the safe and effective use of the medicine(s) (if applicable)
• Condition for lifting the suspension – condition to be fulfilled for the suspension of the marketing authorisation(s) to be lifted (if applicable)