Pulmotil Premix - referral

Current status

European Commission final decision

Overview

Pulmotil 40 VET Premix, Pulmotil 100 VET Premix, Pulmotil 200 VET Premix and associated names are premixes for medicated feeding stuff whose active ingredient is tilmicosin which is a chemically modified macrolide antibiotic with properties broadly similar to other macrolides. Marketing Authorisations for three different strengths (40g, 100g and 200g per kg) were granted in 19 Member States of the European Union via different authorisation procedures (mutual recognition procedures or national procedures).

Due to divergences (i.e. indications for use, amount to be administered and withdrawal period) amongst the nationally authorised Summary of Product Characteristics for Pulmotil 40 VET Premix, Pulmotil 100 VET Premix and Pulmotil 200 VET Premix, Belgium referred the matter to the EMEA on 3 July 2008, under Article 34 of Directive 2001/82/EC.

The referral procedure started on 16 July 2008. The Committee appointed Dr C. Rubio Montejano as rapporteur and Dr L. Jodkonis as co-rapporteur. Written explanations were provided by the Marketing Authorisation Holders on 15 January 2009 and supplementary information was submitted on 16 March 2009. Oral explanations were given by the Marketing Authorisation Holders 15 April 2009.

Based on evaluation of currently available data and the rapporteur's assessment report, the CVMP considered that the benefit/risk profile of Pulmotil 40 VET Premix, Pulmotil 100 VET Premix, Pulmotil 200 VET Premix and associated names is positive subject to the recommended changes of the Summary of the Product Characteristics and product information and therefore adopted an Opinion in May 2009 recommending amendments of the Marketing Authorisations. A revised Opinion, necessitated by purely administrative changes, was adopted in July 2009.

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 the Annex III

The final opinion was converted into a Decision by the European Commission on 15 October 2009.

Opinion following an Article 34 referral Pulmotil 40 VET Premix, Pulmotil 100 VET Premix, Pulmotil 200 VET Premix and associated names: Background information

AdoptedReference Number: EMEA/608931/2009

Key facts

About this medicine

• Approved name:
  Pulmotil Premix
• International non-proprietary name (INN) or common name:
  tilmicosin

About this procedure

• Current status:
  European Commission final decision
• Reference number:
  EMEA/608931/2009
• 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:
  16/07/2009
• EC decision date:
  15/10/2009

All documents

Pulmotil Premix - Article 34 Referral - Annex I, II, III

Adopted

Opinion following an Article 34 referral Pulmotil 40 VET Premix, Pulmotil 100 VET Premix, Pulmotil 200 VET Premix and associated names: Background information

AdoptedReference Number: EMEA/608931/2009

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)