Dicural

RSS

difloxacin

Withdrawn
This medicine is now withdrawn from use in the European Union.

Overview

The marketing authorisation for Dicural has been withdrawn at the request of the marketing authorisation holder.

This EPAR was last updated on 29/10/2015

Authorisation details

Product details
Name
Dicural
Agency product number
EMEA/V/C/000031
Active substance
difloxacin
International non-proprietary name (INN) or common name
difloxacin
Species
  • Turkeys
  • Dogs
  • Cattle
  • Chicken
Anatomical therapeutic chemical veterinary (ATCvet) codes
QJ01MA94
Publication details
Marketing-authorisation holder
Pfizer Limited
Revision
7
Date of issue of marketing authorisation valid throughout the European Union
16/01/1998
Contact address
Ramsgate Road
Sandwich
Kent
CT13 9NJ
United Kingdom

Product information

28/10/2015 Dicural - EMEA/V/C/000031 - IAIN/0021

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

  • general anti infectives for systemic use
  • antibacterials for systemic use, quinolone antibacterials

Therapeutic indication

Chickens:

for the treatment of chronic respiratory infections caused by sensitive strains of Escherichia coli and Mycoplasma gallisepticum.

Turkeys:

  • For the treatment of chronic respiratory infections caused by sensitive strains of Escherichia coli and Mycoplasma gallisepticum.
  • Also for the treatment of infections caused by Pasteurella multocida.

Dogs:

  • For the treatment of acute uncomplicated urinary-tract infections caused by Escherichia coli or Staphylococcus spp. and superficial pyoderma caused by Staphylococcus intermedius.

Cattle:

  • For the treatment of bovine respiratory disease (shipping fever, calf pneumonia) caused by single or mixed infections with Pasteurella haemolytica, Pasteurella multocida and / or Mycoplasma spp.

Assessment history

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