Micotil 300 Injectie - referral

Current status

European Commission final decision

Overview

Micotil 300 Injectie is a solution for injection containing tilmicosin with a strength of 300 mg per ml. Tilmicosin is a macrolide antibiotic synthesized from tylosin which has an antibacterial spectrum similar to tylosin with enhanced activity against Pasteurella multocida and Mannheimia haemolytica. Micotil 300 Injectie and its associated names are veterinary medicinal products authorised for use in the target species cattle, sheep and rabbits for treatment of various infections caused by microorganisms susceptible to tilmicosin.

Due to divergent national decisions taken by Member States concerning the authorisations of Micotil 300 Injectie and its associated names, on 24 April 2012 the Netherlands referred the issue to the CVMP under Article 34(1) of Directive 2001/82/EC, in order to resolve discrepancies in the product information across the European Union.

The referral procedure started on 15 May 2012. The Committee appointed Mr G. Johan Schefferlie as rapporteur and Dr Michael Holzhauser-Alberti as co-rapporteur.

Written explanations were provided by the marketing authorisation holders on 18 September 2012, 11 February 2013 and 26 May 2013. Oral explanations were given on 11 June 2013.

Based on the currently available data, the CVMP considered that the benefit-risk profile of Micotil 300 Injectie and its associated names remains positive, subject to variation of the marketing authorisations in accordance with the recommended product information. The Committee adopted a positive opinion by consensus on 18 July 2013.

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, labelling and package leaflet in Annex III.

The final opinion was converted into a Decision by the European Commission on 18 October 2013.

Opinion following an Article 34 referral for Micotil 300 Injectie and its associated names

AdoptedReference Number: EMA/539469/2013

Key facts

About this medicine

• Approved name:
  Micotil 300 Injectie
• International non-proprietary name (INN) or common name:
  tilmicosin

About this procedure

• Current status:
  European Commission final decision
• Reference number:
  EMEA/V/A-34/82
• 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:
  18/07/2013
• EC decision date:
  18/10/2013

All documents

European Commission final decision

Micotil 300 Injectie Article-34 referral - Annexes I, II, III

Adopted

Opinion following an Article 34 referral for Micotil 300 Injectie and its associated names

AdoptedReference Number: EMA/539469/2013

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)