Veraflox

RSS

pradofloxacin

Authorised
This medicine is authorised for use in the European Union.

Overview

This is a summary of the European public assessment report. Its purpose is to explain how the assessment done by the Committee for Medicinal Products for Veterinary Use (CVMP), on the basis of the documentation provided, led to the recommendations on the conditions of use.

This summary cannot replace a face-to-face discussion with your veterinarian. If you need more information about your animal’s medical condition or treatment, contact your veterinarian. If you want more information on the basis of the CVMP recommendations, read the scientific discussion (also part of the EPAR).

This EPAR was last updated on 09/04/2018

Authorisation details

Product details
Name
Veraflox
Agency product number
EMEA/V/C/000159
Active substance
pradofloxacin
International non-proprietary name (INN) or common name
pradofloxacin
Species
  • Dogs
  • Cats
Anatomical therapeutic chemical veterinary (ATCvet) codes
QJ01MA97
Publication details
Marketing-authorisation holder
Bayer Animal Health GmbH 
Revision
7
Date of issue of marketing authorisation valid throughout the European Union
12/04/2011
Contact address
Bayer Animal Health GmbH
D-51368 Leverkusen
Germany

Product information

27/03/2018 Veraflox - EMEA/V/C/000159 - IAIN-0018

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
  • Fluoroquinolones

Therapeutic indication

Dogs

Treatment of:

  • wound infections caused by susceptible strains of the Staphylococcus intermedius group (including S. pseudintermedius);
  • superficial and deep pyoderma caused by susceptible strains of the Staphylococcus intermedius group (including S. pseudintermedius);
  • acute urinary-tract infections caused by susceptible strains of Escherichia coli and the Staphylococcus intermedius group (including S. pseudintermedius);
  • as adjunctive treatment to mechanical or surgical periodontal therapy in the treatment of severe infections of the gingiva and periodontal tissues caused by susceptible strains of anaerobic organisms, for example Porphyromonas spp. and Prevotella spp.

Cats

Treatment of acute infections of the upper respiratory tract caused by susceptible strains of Pasteurella multocida, Escherichia coli and the Staphylococcus intermedius group (including S. pseudintermedius).

Assessment history

How useful was this page?

Add your rating