All pre-mixes for medicated feedingstuff containing 40 g, 100 g or 200 g tilmicosin per kg pre-mix and administered to rabbits

Current status:
European Commission final decision

Overview

Tilmicosin is a semi-synthetic antibiotic of the macrolide group. The pre-mixes for medicated feedingstuffs containing 40 g, 100 g or 200 g of tilmicosin per kg pre-mix, are veterinary medicinal products which are indicated in pigs and rabbits for the prevention and treatment of respiratory diseases caused by microorganisms susceptible to tilmicosin.

On 8 April 2011, the European Commission presented to the Agency a referral notification under Article 35 of Directive 2011/82/EC, regarding all pre-mixes for medicated feedingstuffs containing 40 g, 100 g or 200 g tilmicosin per kg premix and administered to rabbits. The Committee for Medicinal Products for Veterinary Use (CVMP) was requested to give its opinion regarding the recommended dose and inclusion rates in feed for these veterinary medicinal products administered to rabbits.

The referral started on 5 May 2011. The Committee appointed Dr Cristina Muñoz Madero as rapporteur and Dr Petras Mačiulskis as co-rapporteur. Written explanations were provided by the marketing authorisation holders on 31 August 2011 and 20 January 2012.

Based on the evaluation of the currently available data, the CVMP considered that the overall benefit-risk profile for these products remains positive subject to recommended changes of the product information and conditions affecting the marketing authorisations for all pre-mixes for medicated feedingstuff containing 40 g, 100 g or 200 g tilmicosin per kg pre-mix and administered to rabbits. Therefore, the Committee adopted a positive opinion on 7 March 2012, recommending variations to the terms of the marketing authorisations for all pre-mixes for medicated feedingstuffs containing 40 g, 100 g or 200 g tilmicosin per kg pre-mix and administered to rabbits.

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 summary of product characteristics, labelling in annex III and the conditions of the marketing authorisations in annex IV.

The final opinion was converted into a decision by the European Commission on 14 June 2012.

Key facts

Approved name
All pre-mixes for medicated feedingstuff containing 40 g, 100 g or 200 g tilmicosin per kg pre-mix and administered to rabbits
International non-proprietary name (INN) or common name
tilmicosin
Associated names
See annex I
Reference number
EMEA/V/A/071
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
07/03/2012
EC decision date
14/06/2012

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:

  • Changes to the summary of product characteristics, labeling or package leaflet ('annex III') - available when changes have been recommended by the Committee
  • Conditions of the marketing authorisation (Annex IV) - available when the Committee recommends measures to be taken for the marketing authorisation(s) such as safety measures or extra studies

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