Veterinary medicines containing enrofloxacin to be administered via the drinking water to chickens and/or turkeys - referral

Current status

European Commission final decision

Overview

Questions and answers on use of enrofloxacin-containing veterinary medicines administered via drinking water to chickens and turkeys

Follow-up assessment after the referral under Article 35 of Directive 2001/82/EC (EMEA/V/A/089)

On 14 February 2018, the European Medicines Agency updated its recommendations for enrofloxacin-containing medicines administered via drinking water to chickens and turkeys. The Agency's Committee for Medicinal Products for Veterinary Use (CVMP) concluded that these products should no longer be used in chickens and turkeys to treat Escherichia coli infections and that the product information for the products should be amended accordingly.

What is enrofloxacin?

Enrofloxacin is an antibiotic belonging to class 'fluoroquinolones'. It works against a broad spectrum of Gram-negative and Gram-positive bacteria as well as Mycoplasma spp.

Enrofloxacin is for veterinary use only.

Why were enrofloxacin-containing veterinary medicines administered via drinking water to chickens and turkeys reviewed?

In November 2013, the CVMP made recommendations for these products to ensure that they are used appropriately in chickens and turkeys, and to lower the risk of bacteria developing resistance to enrofloxacin. At that time, marketing authorisation holders were required to provide more data to justify the dosage of enrofloxacin used in poultry. The CVMP has now reviewed these data and has updated its recommendations on the use of enrofloxacin in chickens and turkeys.

Which data has the CVMP reviewed?

The CVMP reviewed the available pre-clinical (laboratory) and clinical data (in chickens and turkeys) on enrofloxacin. These included data from companies and from the published literature.

What are the conclusions of the CVMP after the follow-up assessment?

Following review of the relevant information submitted in 2013 (during the initial phase of the referral procedure) and the additional data provided by the marketing authorisation holders as a follow-up of the Commission Implementing Decision (C(2014) 1484), in February 2018 the CVMP concluded that the outstanding concern over optimisation of the dosage regimen for the treatment of Escherichia coli infections was not resolved. The CVMP noted that the marketing authorisation holders had not demonstrated that the current dosage regimen for Escherichia coli in chickens and turkeys is optimal from a clinical perspective nor proposed a new dosage regimen.

The CVMP considered that the currently-approved dosage may accelerate development of bacterial resistance to enrofloxacin, which would limit its use as treatment of last resort for colibacillosis in poultry. Therefore, the CVMP concluded that enrofloxacin should no longer be used for treatment of Escherichia coli infections in chickens and turkeys and recommended that the product information of the concerned products be amended accordingly.

The marketing authorisation holders were advised to contact the National Competent Authorities of the Member States in order to discuss the next steps for the implementation of CVMP's recommended changes to the product information.

Enrofloxacin Article-35 referral - Questions and answers on use of enrofloxacin-containing veterinary medicines administered via drinking water to chickens and turkeys

Key facts

About this medicine

• Approved name:
  Veterinary medicines containing enrofloxacin to be administered via the drinking water to chickens and/or turkeys
• International non-proprietary name (INN) or common name:
  enrofloxacin

About this procedure

• Current status:
  European Commission final decision
• Reference number:
  EMEA/V/A/089
• Type:
  Article 35

  Community interest referral: 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:
  07/11/2013
• EC decision date:
  28/02/2014

All documents

European Commission final decision

Enrofloxacin Article-35 referral - Opinion following an Article-35 referral for all veterinary medicines containing enrofloxacin to be administered via the drinking water to chickens and/or turkeys

Reference Number: EMEA/V/A/089

Enrofloxacin Article-35 referral - Veterinary medicines containing enrofloxacin to be administered via the drinking water to chickens and/or turkeys Article-35 referral - Annexes

Reference Number: EMEA/V/A/089

Enrofloxacin Article-35 referral - Questions and answers on use of enrofloxacin-containing veterinary medicines administered via drinking water to chickens and turkeys

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)