Tiamutin - referral

Current status

European Commission final decision

Overview

Tiamulin is a semi-synthetic antibiotic belonging to the pleuromutilin group of antibiotics and it is used only in veterinary medicine. Tiamulin is used for the treatment and prevention of gastrointestinal and respiratory infections caused by different bacterial pathogens in pigs, poultry and rabbits.

Premixes containing tiamulin are marketed across the European Union under a variety of invented names and the authorised premix formulations are based on tiamulin hydrogen fumarate in a variety of concentrations: 0.8%, 2%, 10% and 80%. The target species are: pigs, chickens, turkeys and rabbits.

Due to differences among the nationally authorised summaries of product characteristics for Tiamutin premix and associated names across the European Union, especially as regards indications for use, amount to be administered and administration route and withdrawal periods, on 18 September 2008 Ireland and Belgium referred the matter to the European Medicines Agency under Article 34 of Directive 2001/82/EC.

The referral procedure started on 15 October 2008. The rapporteur and co-rapporteur appointed were: Prof. Stane Srčič and Dr Karolina Törneke respectively. Written explanations were provided by the marketing authorisation holders on 20 April 2009 and 16 November 2009. Oral explanations were given on 10 February 2010.

Based on the rapporteurs' assessment of the currently available data, the CVMP adopted, on 10 March 2010, an opinion recommending the amendment of the marketing authorisations in terms of the summary of the product characteristics and labelling in order to harmonise the indications for use, amount to be administered and administration route and withdrawal periods.

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

The final opinion was converted into a Decision by the European Commission on 27 July 2010.

Opinion following an Article 34 referral for Tiamutin premix and associated names

AdoptedReference Number: EMA/118068/2010

Key facts

About this medicine

• Approved name:
  Tiamutin
• International non-proprietary name (INN) or common name:
  tiamulin hydrogen fumarate

About this procedure

• Current status:
  European Commission final decision
• Reference number:
  V-A-042
• Type:
  Article 34

  Divergent decision referral: initiated in order to obtain harmonisation within the EU of the conditions of authorisation for products already authorised by Member States.

Key dates and outcomes

• Opinion date:
  10/03/2010
• EC decision date:
  27/07/2010

All documents

Tiamutin - Article 34 Referral - Annex I, II, III

AdoptedReference Number: V-A-042

Opinion following an Article 34 referral for Tiamutin premix and associated names

AdoptedReference Number: EMA/118068/2010

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)