Dicural

Withdrawn

This medicine's authorisation has been withdrawn

difloxacin

Overview

The marketing authorisation for Dicural has been withdrawn at the request of the marketing authorisation holder.

Dicural : EPAR - Summary for the public

Product information

Dicural : EPAR - Product Information

Dicural : EPAR - All Authorised presentations

Product details

• Name of medicine:
  Dicural
• Active substance:
  difloxacin
• International non-proprietary name (INN) or common name:
  difloxacin
• Species:
  • Turkeys
  • Dogs
  • Cattle
  • Chicken
• Anatomical therapeutic chemical veterinary (ATCvet) code:
  QJ01MA94

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.

Authorisation details

• EMA product number:
  EMEA/V/C/000031
• Marketing authorisation holder:
  Pfizer Limited

  Ramsgate Road; Sandwich; Kent; CT13 9NJ; United Kingdom

• Marketing authorisation issued:
  16/01/1998
• Revision:
  7

Assessment history

Changes since initial authorisation of medicine

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

Initial marketing authorisation documents

Dicural : EPAR - Scientific Discussion

Dicural : EPAR - Procedural steps taken before authorisation