Hipralona Enro-S

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.

Key facts

Approved name
Hipralona Enro-S
International non-proprietary name (INN) or common name
enrofloxacin
Class
-
Reference number
EMEA/V/A/079
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.

Status
European Commission final decision
Opinion date
13/09/2012
EC decision date
17/12/2012

All documents

Document description

  • Opinion - contains the CVMP opinion of the referred medicine(s)
  • List of the medicines affected by the referral (Annex I)
  • Scientific conclusions of the Committee (Annex II)

The following two documents may not always be available:

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