Baytril 10% oral solution - referral

Current status

European Commission final decision

Overview

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.

Opinion following an Article 34(1) referral for Baytril 10% oral solution and associated names: Background information

AdoptedReference Number: EMA/511421/2012

Key facts

About this medicine

• Approved name:
  Baytril 10% oral solution
• International non-proprietary name (INN) or common name:
  enrofloxacin

About this procedure

• Current status:
  European Commission final decision
• Reference number:
  EMEA/V/A/067
• 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:
  14/06/2012
• EC decision date:
  08/10/2012

All documents

Opinion provided by Committee for Medicinal Products for veterinary Use

Baytril 10% oral solution and associated names: Annex I, II, III, IV

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

Opinion following an Article 34(1) referral for Baytril 10% oral solution and associated names: Background information

AdoptedReference Number: EMA/511421/2012

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)