Dicural

difloxacin

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The marketing authorisation for Dicural has been withdrawn at the request of the marketing authorisation holder.

Name Language First published Last updated
Dicural : EPAR - Summary for the public BG = bălgarski 2008-11-27 2015-10-29
Dicural : EPAR - Summary for the public ES = español 2008-11-27 2015-10-29
Dicural : EPAR - Summary for the public CS = čeština 2008-11-27 2015-10-29
Dicural : EPAR - Summary for the public DA = dansk 2008-11-27 2015-10-29
Dicural : EPAR - Summary for the public DE = Deutsch 2008-11-27 2015-10-29
Dicural : EPAR - Summary for the public ET = eesti keel 2008-11-27 2015-10-29
Dicural : EPAR - Summary for the public EL = elliniká 2008-11-27 2015-10-29
Dicural : EPAR - Summary for the public EN = English 2008-11-27 2015-10-29
Dicural : EPAR - Summary for the public FR = français 2008-11-27 2015-10-29
Dicural : EPAR - Summary for the public IT = italiano 2008-11-27 2015-10-29
Dicural : EPAR - Summary for the public LV = latviešu valoda 2008-11-27 2015-10-29
Dicural : EPAR - Summary for the public LT = lietuvių kalba 2008-11-27 2015-10-29
Dicural : EPAR - Summary for the public HU = magyar 2008-11-27 2015-10-29
Dicural : EPAR - Summary for the public MT = Malti 2008-11-27 2015-10-29
Dicural : EPAR - Summary for the public NL = Nederlands 2008-11-27 2015-10-29
Dicural : EPAR - Summary for the public PL = polski 2008-11-27 2015-10-29
Dicural : EPAR - Summary for the public PT = português 2008-11-27 2015-10-29
Dicural : EPAR - Summary for the public RO = română 2008-11-27 2015-10-29
Dicural : EPAR - Summary for the public SK = slovenčina 2008-11-27 2015-10-29
Dicural : EPAR - Summary for the public SL = slovenščina 2008-11-27 2015-10-29
Dicural : EPAR - Summary for the public FI = suomi 2008-11-27 2015-10-29
Dicural : EPAR - Summary for the public SV = svenska 2008-11-27 2015-10-29

This EPAR was last updated on 29/10/2015 .

Authorisation details

Product details

Product details for Dicural
NameDicural
Agency product numberEMEA/V/C/000031
Active substance

difloxacin

International non-proprietary name (INN) or common name

difloxacin

Species ChickenDogsTurkeysCattle
Anatomical therapeutic chemical veterinary (ATCvet) codeQJ01MA94

Publication details

Publication details for Dicural
Marketing-authorisation holder

Pfizer Limited

Revision7
Date of issue of marketing authorisation valid throughout the European Union16/01/1998

Contact address:

Pfizer Limited
Ramsgate Road
Sandwich
Kent CT13 9NJ
United Kingdom

Product information

Product information

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

Name Language First published Last updated
Dicural : EPAR - Product Information SV = svenska 2008-10-30 2015-10-29
Dicural : EPAR - Product Information SV = svenska 2008-10-30 2015-10-29
Dicural : EPAR - Product Information SV = svenska 2008-10-30 2015-10-29
Dicural : EPAR - Product Information SV = svenska 2008-10-30 2015-10-29
Dicural : EPAR - Product Information SV = svenska 2008-10-30 2015-10-29
Dicural : EPAR - Product Information SV = svenska 2008-10-30 2015-10-29
Dicural : EPAR - Product Information SV = svenska 2008-10-30 2015-10-29
Dicural : EPAR - Product Information SV = svenska 2008-10-30 2015-10-29
Dicural : EPAR - Product Information SV = svenska 2008-10-30 2015-10-29
Dicural : EPAR - Product Information SV = svenska 2008-10-30 2015-10-29
Dicural : EPAR - Product Information SV = svenska 2008-10-30 2015-10-29
Dicural : EPAR - Product Information SV = svenska 2008-10-30 2015-10-29
Dicural : EPAR - Product Information SV = svenska 2008-10-30 2015-10-29
Dicural : EPAR - Product Information SV = svenska 2008-10-30 2015-10-29
Dicural : EPAR - Product Information SV = svenska 2008-10-30 2015-10-29
Dicural : EPAR - Product Information SV = svenska 2008-10-30 2015-10-29
Dicural : EPAR - Product Information SV = svenska 2008-10-30 2015-10-29
Dicural : EPAR - Product Information SV = svenska 2008-10-30 2015-10-29
Dicural : EPAR - Product Information SV = svenska 2008-10-30 2015-10-29
Dicural : EPAR - Product Information SV = svenska 2008-10-30 2015-10-29
Dicural : EPAR - Product Information SV = svenska 2008-10-30 2015-10-29
Dicural : EPAR - Product Information SV = svenska 2008-10-30 2015-10-29
Dicural : EPAR - Product Information SV = svenska 2008-10-30 2015-10-29
Dicural : EPAR - Product Information SV = svenska 2008-10-30 2015-10-29

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.


Name Language First published Last updated
Dicural : EPAR - All Authorised presentations SV = svenska 2008-10-30 2015-10-29
Dicural : EPAR - All Authorised presentations SV = svenska 2008-10-30 2015-10-29
Dicural : EPAR - All Authorised presentations SV = svenska 2008-10-30 2015-10-29
Dicural : EPAR - All Authorised presentations SV = svenska 2008-10-30 2015-10-29
Dicural : EPAR - All Authorised presentations SV = svenska 2008-10-30 2015-10-29
Dicural : EPAR - All Authorised presentations SV = svenska 2008-10-30 2015-10-29
Dicural : EPAR - All Authorised presentations SV = svenska 2008-10-30 2015-10-29
Dicural : EPAR - All Authorised presentations SV = svenska 2008-10-30 2015-10-29
Dicural : EPAR - All Authorised presentations SV = svenska 2008-10-30 2015-10-29
Dicural : EPAR - All Authorised presentations SV = svenska 2008-10-30 2015-10-29
Dicural : EPAR - All Authorised presentations SV = svenska 2008-10-30 2015-10-29
Dicural : EPAR - All Authorised presentations SV = svenska 2008-10-30 2015-10-29
Dicural : EPAR - All Authorised presentations SV = svenska 2008-10-30 2015-10-29
Dicural : EPAR - All Authorised presentations SV = svenska 2008-10-30 2015-10-29
Dicural : EPAR - All Authorised presentations SV = svenska 2008-10-30 2015-10-29
Dicural : EPAR - All Authorised presentations SV = svenska 2008-10-30 2015-10-29
Dicural : EPAR - All Authorised presentations SV = svenska 2008-10-30 2015-10-29
Dicural : EPAR - All Authorised presentations SV = svenska 2008-10-30 2015-10-29
Dicural : EPAR - All Authorised presentations SV = svenska 2008-10-30 2015-10-29
Dicural : EPAR - All Authorised presentations SV = svenska 2008-10-30 2015-10-29
Dicural : EPAR - All Authorised presentations SV = svenska 2008-10-30 2015-10-29
Dicural : EPAR - All Authorised presentations SV = svenska 2008-10-30 2015-10-29
Dicural : EPAR - All Authorised presentations SV = svenska 2008-10-30 2015-10-29
Dicural : EPAR - All Authorised presentations SV = svenska 2008-10-30 2015-10-29

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

Changes since initial authorisation of medicine

Name Language First published Last updated
Dicural : EPAR - Procedural steps taken and scientific information after authorisation SV = svenska 2008-11-17 2015-10-29

Initial marketing-authorisation documents

Name Language First published Last updated
Dicural : EPAR - Procedural steps taken before authorisation SV = svenska 2008-10-30 2015-10-29
Dicural : EPAR - Scientific Discussion SV = svenska 2008-12-14 2015-10-29