Baytril 10% oral solution

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Enrofloxacin is a synthetic chemotherapeutic agent from the class of the fluoroquinolone carboxylic-acid derivatives. It has antibacterial activity against a broad spectrum of Gram-negative and Gram-positive bacteria. Enrofloxacin is for veterinary use only.

Baytril 10% oral solution and its associated names contain 100 mg enrofloxacin per millilitre oral solution for use in drinking water. The products are authorised for use in the target species chickens, turkeys and rabbits for treatment of the respiratory tract and of the digestive tract infections caused by bacteria susceptible to enrofloxacin.

Due to divergent national decisions taken by Member States with respect to target species, indications, amounts to be administered and withdrawal periods concerning the authorisations of Baytril 10% oral solution and its associated names, on 15 October 2010 the United Kingdom referred the issue to the Committee for Medicinal Products for Veterinary Use (CVMP) under Article 34(1) of Directive 2001/82/EC, in order to resolve divergences amongst the nationally authorised product information across the European Union.

The referral procedure started on 11 November 2010. The Committee appointed Mrs Ruth Kearsley, who was later replaced by Ms Helen Jukes, as rapporteur and Dr Lotte Winther, who was later replaced by Dr Ellen-Margrethe Vestergaard, as co-rapporteur.

Written explanations were provided by the marketing authorisation holders on 12 August 2011 and 14 February 2012. Oral explanations were given on 14 May 2012.

Based on the rapporteurs’ assessment of the currently available data, the CVMP considered that the benefit-risk profile of Baytril 10% oral solution and its associated names remains positive, subject to variation of the marketing authorisations in accordance with the recommended product information, and subject to a condition on the marketing authorisations. The Committee adopted a positive opinion by majority on 14 June 2012.

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 condition on the marketing authorisations is in Annex IV.

The final opinion was converted into a decision by the European Commission on 8 October 2012.

Name Language First published Last updated
Opinion following an Article 34(1) referral for Baytril 10% oral solution and associated names: Background information BG = bălgarski 2012-11-20  
Opinion following an Article 34(1) referral for Baytril 10% oral solution and associated names: Background information ES = español 2012-11-20  
Opinion following an Article 34(1) referral for Baytril 10% oral solution and associated names: Background information CS = čeština 2012-11-20  
Opinion following an Article 34(1) referral for Baytril 10% oral solution and associated names: Background information DA = dansk 2012-11-20  
Opinion following an Article 34(1) referral for Baytril 10% oral solution and associated names: Background information DE = Deutsch 2012-11-20  
Opinion following an Article 34(1) referral for Baytril 10% oral solution and associated names: Background information ET = eesti keel 2012-11-20  
Opinion following an Article 34(1) referral for Baytril 10% oral solution and associated names: Background information EL = elliniká 2012-11-20  
Opinion following an Article 34(1) referral for Baytril 10% oral solution and associated names: Background information EN = English 2012-11-20  
Opinion following an Article 34(1) referral for Baytril 10% oral solution and associated names: Background information FR = français 2012-11-20  
Opinion following an Article 34(1) referral for Baytril 10% oral solution and associated names: Background information IT = italiano 2012-11-20  
Opinion following an Article 34(1) referral for Baytril 10% oral solution and associated names: Background information LV = latviešu valoda 2012-11-20  
Opinion following an Article 34(1) referral for Baytril 10% oral solution and associated names: Background information LT = lietuvių kalba 2012-11-20  
Opinion following an Article 34(1) referral for Baytril 10% oral solution and associated names: Background information HU = magyar 2012-11-20  
Opinion following an Article 34(1) referral for Baytril 10% oral solution and associated names: Background information MT = Malti 2012-11-20  
Opinion following an Article 34(1) referral for Baytril 10% oral solution and associated names: Background information NL = Nederlands 2012-11-20  
Opinion following an Article 34(1) referral for Baytril 10% oral solution and associated names: Background information PL = polski 2012-11-20  
Opinion following an Article 34(1) referral for Baytril 10% oral solution and associated names: Background information PT = português 2012-11-20  
Opinion following an Article 34(1) referral for Baytril 10% oral solution and associated names: Background information RO = română 2012-11-20  
Opinion following an Article 34(1) referral for Baytril 10% oral solution and associated names: Background information SK = slovenčina 2012-11-20  
Opinion following an Article 34(1) referral for Baytril 10% oral solution and associated names: Background information SL = slovenščina 2012-11-20  
Opinion following an Article 34(1) referral for Baytril 10% oral solution and associated names: Background information FI = suomi 2012-11-20  
Opinion following an Article 34(1) referral for Baytril 10% oral solution and associated names: Background information SV = svenska 2012-11-20  

Key facts

Approved nameBaytril 10% oral solution
International non-proprietary name (INN) or common name

enrofloxacin

Associated names
Class
Reference numberEMEA/V/A/067
TypeArticle 34
StatusEuropean Commission final decision
Opinion date14/06/2012
EC decision date08/10/2012

All documents

Name Language First published Last updated
Opinion following an Article 34(1) referral for Baytril 10% oral solution and associated names: Background information BG = bălgarski 2012-11-20  
Opinion following an Article 34(1) referral for Baytril 10% oral solution and associated names: Background information ES = español 2012-11-20  
Opinion following an Article 34(1) referral for Baytril 10% oral solution and associated names: Background information CS = čeština 2012-11-20  
Opinion following an Article 34(1) referral for Baytril 10% oral solution and associated names: Background information DA = dansk 2012-11-20  
Opinion following an Article 34(1) referral for Baytril 10% oral solution and associated names: Background information DE = Deutsch 2012-11-20  
Opinion following an Article 34(1) referral for Baytril 10% oral solution and associated names: Background information ET = eesti keel 2012-11-20  
Opinion following an Article 34(1) referral for Baytril 10% oral solution and associated names: Background information EL = elliniká 2012-11-20  
Opinion following an Article 34(1) referral for Baytril 10% oral solution and associated names: Background information EN = English 2012-11-20  
Opinion following an Article 34(1) referral for Baytril 10% oral solution and associated names: Background information FR = français 2012-11-20  
Opinion following an Article 34(1) referral for Baytril 10% oral solution and associated names: Background information IT = italiano 2012-11-20  
Opinion following an Article 34(1) referral for Baytril 10% oral solution and associated names: Background information LV = latviešu valoda 2012-11-20  
Opinion following an Article 34(1) referral for Baytril 10% oral solution and associated names: Background information LT = lietuvių kalba 2012-11-20  
Opinion following an Article 34(1) referral for Baytril 10% oral solution and associated names: Background information HU = magyar 2012-11-20  
Opinion following an Article 34(1) referral for Baytril 10% oral solution and associated names: Background information MT = Malti 2012-11-20  
Opinion following an Article 34(1) referral for Baytril 10% oral solution and associated names: Background information NL = Nederlands 2012-11-20  
Opinion following an Article 34(1) referral for Baytril 10% oral solution and associated names: Background information PL = polski 2012-11-20  
Opinion following an Article 34(1) referral for Baytril 10% oral solution and associated names: Background information PT = português 2012-11-20  
Opinion following an Article 34(1) referral for Baytril 10% oral solution and associated names: Background information RO = română 2012-11-20  
Opinion following an Article 34(1) referral for Baytril 10% oral solution and associated names: Background information SK = slovenčina 2012-11-20  
Opinion following an Article 34(1) referral for Baytril 10% oral solution and associated names: Background information SL = slovenščina 2012-11-20  
Opinion following an Article 34(1) referral for Baytril 10% oral solution and associated names: Background information FI = suomi 2012-11-20  
Opinion following an Article 34(1) referral for Baytril 10% oral solution and associated names: Background information SV = svenska 2012-11-20  
Baytril 10% oral solution and associated names: Annex I, II, III, IV BG = bălgarski 2012-11-20  
Baytril 10% oral solution and associated names: Annex I, II, III, IV ES = español 2012-11-20  
Baytril 10% oral solution and associated names: Annex I, II, III, IV CS = čeština 2012-11-20  
Baytril 10% oral solution and associated names: Annex I, II, III, IV DA = dansk 2012-11-20  
Baytril 10% oral solution and associated names: Annex I, II, III, IV DE = Deutsch 2012-11-20  
Baytril 10% oral solution and associated names: Annex I, II, III, IV ET = eesti keel 2012-11-20  
Baytril 10% oral solution and associated names: Annex I, II, III, IV EL = elliniká 2012-11-20  
Baytril 10% oral solution and associated names: Annex I, II, III, IV EN = English 2012-11-20  
Baytril 10% oral solution and associated names: Annex I, II, III, IV FR = français 2012-11-20  
Baytril 10% oral solution and associated names: Annex I, II, III, IV IT = italiano 2012-11-20  
Baytril 10% oral solution and associated names: Annex I, II, III, IV LV = latviešu valoda 2012-11-20  
Baytril 10% oral solution and associated names: Annex I, II, III, IV LT = lietuvių kalba 2012-11-20  
Baytril 10% oral solution and associated names: Annex I, II, III, IV HU = magyar 2012-11-20  
Baytril 10% oral solution and associated names: Annex I, II, III, IV MT = Malti 2012-11-20  
Baytril 10% oral solution and associated names: Annex I, II, III, IV NL = Nederlands 2012-11-20  
Baytril 10% oral solution and associated names: Annex I, II, III, IV PL = polski 2012-11-20  
Baytril 10% oral solution and associated names: Annex I, II, III, IV PT = português 2012-11-20  
Baytril 10% oral solution and associated names: Annex I, II, III, IV RO = română 2012-11-20  
Baytril 10% oral solution and associated names: Annex I, II, III, IV SK = slovenčina 2012-11-20  
Baytril 10% oral solution and associated names: Annex I, II, III, IV SL = slovenščina 2012-11-20  
Baytril 10% oral solution and associated names: Annex I, II, III, IV FI = suomi 2012-11-20  
Baytril 10% oral solution and associated names: Annex I, II, III, IV SV = svenska 2012-11-20  
Divergent position on a CVMP opinion on an Article 34(1) referral of Directive 2001/82/EC for Baytril 10% oral solution and associated names (English only) 2012-11-20  

Document description

  • Questions and answers (Q&A)- easy-to-understand summary of key issues and Committee conclusions
  • 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