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Withdrawn
This medicine is now withdrawn from use in the European Union.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The marketing authorisation for Dicural has been withdrawn at the request of the marketing authorisation holder.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

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Select ‘available languages’ to access the language you need.

 

Product information documents contain:

  • summary of product characteristics (annex I);
  • manufacturing authorisation holder responsible for batch release (annex IIA);
  • conditions of the marketing authorisation (annex IIB);
  • labelling (annex IIIA);
  • package leaflet (annex IIIB).

You can find product information documents for centrally authorised human medicines on this website. For centrally authorised veterinary medicines authorised or updated from February 2022, see the Veterinary Medicines Information website.

Pharmacotherapeutic group

  • Antibacterials for systemic use

  • Antiinfectives for systemic use

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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