Ibaflin

Withdrawn

This medicine's authorisation has been withdrawn

ibafloxacin

Overview

The marketing authorisation for Ibaflin has been withdrawn at the request of the marketing authorisation holder.

Ibaflin : EPAR - Summary for the public

Product information

Ibaflin : EPAR - Product Information

Ibaflin : EPAR - All Authorised presentations

Product details

• Name of medicine:
  Ibaflin
• Active substance:
  ibafloxacin
• International non-proprietary name (INN) or common name:
  ibafloxacin
• Species:
  • Dogs
  • Cats
• Anatomical therapeutic chemical veterinary (ATCvet) code:
  QJ01MA96

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.

Authorisation details

• EMA product number:
  EMEA/V/C/000052
• Marketing authorisation holder:
  Intervet International BV

  Intervet International B.V.; Wim de Körverstraat 35; 5831 AN Boxmeer; The Netherlands

• Marketing authorisation issued:
  13/06/2000
• Revision:
  7

Assessment history

Changes since initial authorisation of medicine

Ibaflin : EPAR - Procedural steps taken and scientific information after authorisation

Initial marketing authorisation documents

Ibaflin : EPAR - Procedural steps taken before authorisation

Ibaflin : EPAR - Scientific Discussion