Micotil 300 Injectie
Table of contents
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.
Key facts
| Approved name |
Micotil 300 Injectie
|
| International non-proprietary name (INN) or common name |
Tilmicosin |
| 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. |
| Status |
European Commission final decision
|
| Opinion date |
18/07/2013
|
| EC decision date |
18/10/2013
|
All documents
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List item
Opinion following an Article 34 referral for Micotil 300 Injectie and its associated names (PDF/97.92 KB)
Adopted
First published: 20/11/2013
Last updated: 20/11/2013
EMA/539469/2013 -
-
List item
Micotil 300 Injectie Article-34 referral - Annexes I, II, III (PDF/241.1 KB)
Adopted
First published: 20/11/2013
Last updated: 20/11/2013 -
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