Tiamutin

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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.

Name Language First published Last updated
Opinion following an Article 34 referral for Tiamutin premix and associated names BG = bălgarski 21/07/2010 30/07/2010
Opinion following an Article 34 referral for Tiamutin premix and associated names ES = español 21/07/2010 30/07/2010
Opinion following an Article 34 referral for Tiamutin premix and associated names CS = čeština 21/07/2010 30/07/2010
Opinion following an Article 34 referral for Tiamutin premix and associated names DA = dansk 21/07/2010 30/07/2010
Opinion following an Article 34 referral for Tiamutin premix and associated names DE = Deutsch 21/07/2010 30/07/2010
Opinion following an Article 34 referral for Tiamutin premix and associated names ET = eesti keel 21/07/2010 30/07/2010
Opinion following an Article 34 referral for Tiamutin premix and associated names EL = elliniká 21/07/2010 30/07/2010
Opinion following an Article 34 referral for Tiamutin premix and associated names EN = English 21/07/2010 30/07/2010
Opinion following an Article 34 referral for Tiamutin premix and associated names FR = français 21/07/2010 30/07/2010
Opinion following an Article 34 referral for Tiamutin premix and associated names IT = italiano 21/07/2010 30/07/2010
Opinion following an Article 34 referral for Tiamutin premix and associated names LV = latviešu valoda 21/07/2010 30/07/2010
Opinion following an Article 34 referral for Tiamutin premix and associated names LT = lietuvių kalba 21/07/2010 30/07/2010
Opinion following an Article 34 referral for Tiamutin premix and associated names HU = magyar 21/07/2010 30/07/2010
Opinion following an Article 34 referral for Tiamutin premix and associated names MT = Malti 21/07/2010 30/07/2010
Opinion following an Article 34 referral for Tiamutin premix and associated names NL = Nederlands 21/07/2010 30/07/2010
Opinion following an Article 34 referral for Tiamutin premix and associated names PL = polski 21/07/2010 30/07/2010
Opinion following an Article 34 referral for Tiamutin premix and associated names PT = português 21/07/2010 30/07/2010
Opinion following an Article 34 referral for Tiamutin premix and associated names RO = română 21/07/2010 30/07/2010
Opinion following an Article 34 referral for Tiamutin premix and associated names SK = slovenčina 21/07/2010 30/07/2010
Opinion following an Article 34 referral for Tiamutin premix and associated names SL = slovenščina 21/07/2010 30/07/2010
Opinion following an Article 34 referral for Tiamutin premix and associated names FI = suomi 21/07/2010 30/07/2010
Opinion following an Article 34 referral for Tiamutin premix and associated names SV = svenska 21/07/2010 30/07/2010

Key facts

Approved nameTiamutin
International non-proprietary name (INN) or common name

Tiamulin hydrogen fumarate

Associated names
Class
Reference numberV-A-042
TypeArticle 34
StatusEuropean Commission final decision
Opinion date10/03/2010
EC decision date27/07/2010

All documents

Name Language First published Last updated
Opinion following an Article 34 referral for Tiamutin premix and associated names BG = bălgarski 21/07/2010 30/07/2010
Opinion following an Article 34 referral for Tiamutin premix and associated names ES = español 21/07/2010 30/07/2010
Opinion following an Article 34 referral for Tiamutin premix and associated names CS = čeština 21/07/2010 30/07/2010
Opinion following an Article 34 referral for Tiamutin premix and associated names DA = dansk 21/07/2010 30/07/2010
Opinion following an Article 34 referral for Tiamutin premix and associated names DE = Deutsch 21/07/2010 30/07/2010
Opinion following an Article 34 referral for Tiamutin premix and associated names ET = eesti keel 21/07/2010 30/07/2010
Opinion following an Article 34 referral for Tiamutin premix and associated names EL = elliniká 21/07/2010 30/07/2010
Opinion following an Article 34 referral for Tiamutin premix and associated names EN = English 21/07/2010 30/07/2010
Opinion following an Article 34 referral for Tiamutin premix and associated names FR = français 21/07/2010 30/07/2010
Opinion following an Article 34 referral for Tiamutin premix and associated names IT = italiano 21/07/2010 30/07/2010
Opinion following an Article 34 referral for Tiamutin premix and associated names LV = latviešu valoda 21/07/2010 30/07/2010
Opinion following an Article 34 referral for Tiamutin premix and associated names LT = lietuvių kalba 21/07/2010 30/07/2010
Opinion following an Article 34 referral for Tiamutin premix and associated names HU = magyar 21/07/2010 30/07/2010
Opinion following an Article 34 referral for Tiamutin premix and associated names MT = Malti 21/07/2010 30/07/2010
Opinion following an Article 34 referral for Tiamutin premix and associated names NL = Nederlands 21/07/2010 30/07/2010
Opinion following an Article 34 referral for Tiamutin premix and associated names PL = polski 21/07/2010 30/07/2010
Opinion following an Article 34 referral for Tiamutin premix and associated names PT = português 21/07/2010 30/07/2010
Opinion following an Article 34 referral for Tiamutin premix and associated names RO = română 21/07/2010 30/07/2010
Opinion following an Article 34 referral for Tiamutin premix and associated names SK = slovenčina 21/07/2010 30/07/2010
Opinion following an Article 34 referral for Tiamutin premix and associated names SL = slovenščina 21/07/2010 30/07/2010
Opinion following an Article 34 referral for Tiamutin premix and associated names FI = suomi 21/07/2010 30/07/2010
Opinion following an Article 34 referral for Tiamutin premix and associated names SV = svenska 21/07/2010 30/07/2010
Tiamutin - Article 34 Referral - Annex I, II, III BG = bălgarski 21/07/2010 14/03/2011
Tiamutin - Article 34 Referral - Annex I, II, III ES = español 21/07/2010 14/03/2011
Tiamutin - Article 34 Referral - Annex I, II, III CS = čeština 21/07/2010 14/03/2011
Tiamutin - Article 34 Referral - Annex I, II, III DA = dansk 21/07/2010 14/03/2011
Tiamutin - Article 34 Referral - Annex I, II, III DE = Deutsch 21/07/2010 14/03/2011
Tiamutin - Article 34 Referral - Annex I, II, III ET = eesti keel 21/07/2010 14/03/2011
Tiamutin - Article 34 Referral - Annex I, II, III EL = elliniká 21/07/2010 14/03/2011
Tiamutin - Article 34 Referral - Annex I, II, III EN = English 21/07/2010 14/03/2011
Tiamutin - Article 34 Referral - Annex I, II, III FR = français 21/07/2010 14/03/2011
Tiamutin - Article 34 Referral - Annex I, II, III IT = italiano 21/07/2010 14/03/2011
Tiamutin - Article 34 Referral - Annex I, II, III LV = latviešu valoda 21/07/2010 14/03/2011
Tiamutin - Article 34 Referral - Annex I, II, III LT = lietuvių kalba 21/07/2010 14/03/2011
Tiamutin - Article 34 Referral - Annex I, II, III HU = magyar 21/07/2010 14/03/2011
Tiamutin - Article 34 Referral - Annex I, II, III MT = Malti 21/07/2010 14/03/2011
Tiamutin - Article 34 Referral - Annex I, II, III NL = Nederlands 21/07/2010 14/03/2011
Tiamutin - Article 34 Referral - Annex I, II, III PL = polski 21/07/2010 14/03/2011
Tiamutin - Article 34 Referral - Annex I, II, III PT = português 21/07/2010 14/03/2011
Tiamutin - Article 34 Referral - Annex I, II, III RO = română 21/07/2010 14/03/2011
Tiamutin - Article 34 Referral - Annex I, II, III SK = slovenčina 21/07/2010 14/03/2011
Tiamutin - Article 34 Referral - Annex I, II, III SL = slovenščina 21/07/2010 14/03/2011
Tiamutin - Article 34 Referral - Annex I, II, III FI = suomi 21/07/2010 14/03/2011
Tiamutin - Article 34 Referral - Annex I, II, III SV = svenska 21/07/2010 14/03/2011

Document description

  • Opinion - contains the opinion of the Committee for Medicinal Products for Veterinary use (CVMP) on 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

Current status:
European Commission final decision

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