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

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.

Opinion following an Article 35 referral for all pre-mixes for medicated feedingstuff containing 40 g, 100 g or 200 g tilmicosin per kg pre-mix and administered to rabbits

Reference Number: EMA/294698/2012

Key facts

About this medicine

• 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

About this procedure

• Current status:
  European Commission final decision
• 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.

Key dates and outcomes

• Opinion date:
  07/03/2012
• EC decision date:
  14/06/2012

All documents

All pre-mixes for medicated feedingstuff containing 40 g, 100 g or 200 g tilmicosin per kg pre-mix and administered to rabbits - Article 35 referral - Annexes I, II, III, IV

Opinion following an Article 35 referral for all pre-mixes for medicated feedingstuff containing 40 g, 100 g or 200 g tilmicosin per kg pre-mix and administered to rabbits

Reference Number: EMA/294698/2012

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)