Baytril injectable and generics - 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.

On 22 April 2013, Spain presented to the Agency a referral notification under Article 35 of Directive 2011/82/EC, regarding Baytril 2.5% injectable, Baytril 5% injectable, Baytril 10% injectable and associated names, and related veterinary medicinal products. The CVMP was requested to consider what indications, dosage regimens and durations of treatments should be applied for the products concerned in order to ensure efficacy and target animal safety and to minimise the development of antimicrobial resistance, taking into account the available data. The CVMP was also requested to consider what withdrawal periods should be applied to the concerned products for each target species.

The referral started on 15 May 2013. The Committee appointed C. Muñoz Madero as rapporteur and M. Holzhauser-Alberti as co-rapporteur. Written explanations were provided by some of the applicants and marketing authorisation holders by 30 September 2013 and 3 February 2014.

Based on the evaluation of the currently available data, the CVMP considered that the overall benefit-risk profile for these products remains positive subject to amendments in the product information. Therefore, on 9 April 2014 the Committee adopted by majority a positive opinion, recommending variations to the terms of the marketing authorisations for Baytril 2.5% injectable, Baytril 5% injectable, Baytril 10% injectable and associated names, and related veterinary medicinal products.

The list of product names concerned is given in Annex I. The scientific conclusions are provided in Annex II together with the amendments in the summaries of product characteristics, labelling and package leaflets in Annex III.

The final opinion was converted into a Decision by the European Commission on 1 September 2014.

Opinion following an Article 35 referral for Baytril 2.5% injectable, Baytril 5% injectable and Baytril 10% injectable and their associated names, and related veterinary medicinal products: Background information

Reference Number: EMA/538947/2014

Key facts

About this medicine

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

About this procedure

• Current status:
  European Commission final decision
• Reference number:
  EMEA/V/A/097
• Type:
  Article 35 referrals (prior to January 2022)

  This type of referral is initiated in cases involving the interests of the Community or concerns relating to the protection of human or animal health or the environment.

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, and related veterinary medicinal products: Annex I, II, III

Divergent position on a CVMP opinion on an Article 35 referral of Directive 2001/82/EC for Baytril 2.5% injectable, Baytril 5% injectable, Baytril 10% injectable and associated names, and related veterinary medicinal pr...

Opinion following an Article 35 referral for Baytril 2.5% injectable, Baytril 5% injectable and Baytril 10% injectable and their associated names, and related veterinary medicinal products: Background information

Reference Number: EMA/538947/2014

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)