Hipralona Enro-S - referral

Current status

European Commission final decision

Overview

Enrofloxacin is a synthetic chemotherapeutic agent from the class 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.

Hipralona Enro-S and its generics are veterinary medicinal products that contain enrofloxacin as the active substance and are indicated in rabbits for the treatment of respiratory infections caused by Pasteurella multocida. The pharmaceutical form is an oral solution administered via the drinking water. The dosage is 10 mg enrofloxacin per kilogram bodyweight for five days.

On 30 September 2011, France initiated a referral procedure under Article 35 of Directive 2001/82/EC, as amended, for the veterinary medicinal product Hipralona Enro-S and its generics indicated for use in rabbits, due to concerns that the use of the products in rabbit production would increase Escherichia coli and Staphylococcus aureus resistance to enrofloxacin.

The referral procedure started on 12 October 2011. The Committee for Medicinal Products for Veterinary Use (CVMP) appointed Dr M. Holzhauser-Alberti as rapporteur and Dr C. Muñoz Madero as co-rapporteur. Supplementary information was provided in writing by an applicant and marketing-authorisation holders on 16 January 2012.

Based on the evaluation of the available data, on 11 April 2012, the CVMP adopted by majority an opinion recommending the maintenance of the marketing authorisations for the veterinary medicinal product Hipralona Enro-S and its generics in accordance with the previously approved product information.

On 14 May 2012, the European Commission requested the CVMP to review its opinion, mainly to clarify some aspects related to antimicrobial resistance and the prudent use of antimicrobials in veterinary medicine.

On 13 September 2012, the CVMP adopted by majority a revised opinion confirming the recommendation included in its opinion of 11 April 2012, that the marketing authorisations for the veterinary medicinal product Hipralona Enro-S and its generics should be maintained in accordance with the previously approved product information.

The list of product names concerned is given in annex I. The scientific conclusions are provided in annex II.

The final opinion was converted into a decision by the European Commission on 17 December 2012.

Opinion following an Article-35 referral for Hipralona Enro-S and its generics indicated for use in rabbits

Reference Number: EMA/789897/2012

Key facts

About this medicine

• Approved name:
  Hipralona Enro-S
• International non-proprietary name (INN) or common name:
  enrofloxacin
• Class:
  -

About this procedure

• Current status:
  European Commission final decision
• Reference number:
  EMEA/V/A/079
• 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:
  13/09/2012
• EC decision date:
  17/12/2012

All documents

European Commission final decision

Divergent position on a revised CVMP opinion on an Article-35 referral for Hipralona Enro-S and its generics indicated for use in rabbits

Hipralona Enro-S Article-35 referral - Annexes I, II

Opinion following an Article-35 referral for Hipralona Enro-S and its generics indicated for use in rabbits

Reference Number: EMA/789897/2012

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)