Baytril injectable - 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 2.5% injectable, Baytril 5% injectable and Baytril 10% injectable and their associated names are solutions for injection containing enrofloxacin at 25 mg/ml, 50 mg/ml and 100 mg/ml respectively.

Due to divergent national decisions taken by Member States with respect to target species, indications, posology and withdrawal periods concerning the authorisations of Baytril 2.5% injectable, Baytril 5% injectable and Baytril 10% injectable and their associated names, on 26 October 2012 France referred the issue to the CVMP under Article 34(1) of Directive 2001/82/EC, in order to resolve the divergence in the product information of nationally authorised products across the European Union.

The referral procedure started on 7 November 2012. The Committee appointed M. Holzhauser-Alberti as rapporteur and C. Muñoz Madero as co-rapporteur. Written explanations were provided by the marketing authorisation holders on 17 June 2013, 10 January 2014 and 12 March 2014.

Based on the evaluation of the currently available data, the CVMP considered that the benefit-risk profile of Baytril 2.5% injectable, Baytril 5% injectable and Baytril 10% injectable and their associated names remains positive, subject to amendments in the product information. The Committee adopted a positive opinion by majority on 9 April 2014.

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 1 September 2014.

Opinion following an Article 34 referral for Baytril 2.5% injectable, Baytril 5% injectable and Baytril 10% injectable and their associated names: Background information

Reference Number: EMA/538940/2014

Key facts

About this medicine

• Approved name:
  Baytril injectable
• International non-proprietary name (INN) or common name:
  enrofloxacin

About this procedure

• Current status:
  European Commission final decision
• Reference number:
  EMEA/V/A/091
• 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:
  09/04/2014
• EC decision date:
  01/09/2014

All documents

European Commission final decision

Baytril 2.5% injectable, Baytril 5% injectable and Baytril 10% injectable and their associated names: Annex I, II, III

Divergent position on a CVMP opinion on an Article 34 referral of Directive 2001/82/EC for Baytril 2.5% injectable, Baytril 5% injectable and Baytril 10% injectable and their associated names

Opinion following an Article 34 referral for Baytril 2.5% injectable, Baytril 5% injectable and Baytril 10% injectable and their associated names: Background information

Reference Number: EMA/538940/2014

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)