Ibaflin

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ibafloxacin

Withdrawn
This medicine is now withdrawn from use in the European Union.

Overview

The marketing authorisation for Ibaflin has been withdrawn at the request of the marketing authorisation holder.

This EPAR was last updated on 10/07/2013

Authorisation details

Product details
Name
Ibaflin
Agency product number
EMEA/V/C/000052
Active substance
ibafloxacin
International non-proprietary name (INN) or common name
ibafloxacin
Species
  • Dogs
  • Cats
Anatomical therapeutic chemical veterinary (ATCvet) codes
QJ01MA96
Publication details
Marketing-authorisation holder
Intervet International BV
Revision
7
Date of issue of marketing authorisation valid throughout the European Union
13/06/2000
Contact address
Intervet International B.V.
Wim de Körverstraat 35
5831 AN Boxmeer
The Netherlands

Product information

26/05/2010 Ibaflin - EMEA/V/C/000052 - R/0019

Contents

  • Annex I - Summary of product characteristics
  • Annex IIA - Manufacturing-authorisation holder responsible for batch release
  • Annex IIB - Conditions of the marketing authorisation
  • Annex IIIA - Labelling
  • Annex IIIB - Package leaflet

Please note that the size of the above document can exceed 50 pages.

You are therefore advised to be selective about which sections or pages you wish to print.

Pharmacotherapeutic group

ANTIBACTERIALS FOR SYSTEMIC USE

Therapeutic indication

Dogs:

Ibaflin is indicated for the treatment of the following conditions in dogs:

  • dermal infections (pyoderma - superficial and deep, wounds, abscesses) caused by susceptible strains of Staphylococci, Escherichia coli and Proteus mirabilis;
  • acute, uncomplicated urinary-tract infections, caused by susceptible strains of Staphylococci, Proteus species, Enterobacter spp., E. coli and Klebsiella spp.;
  • respiratory-tract infections (upper tract) caused by susceptible strains of Staphylococci, E. coli, and Klebsiella spp.

Ibaflin gel is indicated in dogs for the treatment of the following conditions:

  • dermal infections (pyoderma - superficial and deep, wounds, abscesses) caused by susceptible pathogens such as Staphylococcus spp., E. coli and P. mirabilis.

Cats:

Ibaflin gel is indicated in cats for treatment of the following conditions:

  • dermal infections (soft-tissue infections - wounds, abscesses) caused by susceptible pathogens such as Staphylococcus spp., E. coli, Proteus spp. and Pasteurella spp.;
  • upper respiratory-tract infections caused by susceptible pathogens such as Staphylococcus spp., E. coli, Klebsiella spp. and Pasteurella spp.

Assessment history

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