Pharmaceuticals - Community Register

  

Community register of veterinary medicinal products


AUTHORISED  

Product information

Invented name: Veraflox   
Auth. number : EU/2/10/107
INN : Pradofloxacin
ATC: Anatomical main group: QJ - Antiinfectives for systemic use
Therapeutic subgroup: QJ01 - Antibacterials for systemic use
Pharmacological subgroup: QJ01M - Quinolone and quinoxaline antibacterials
Chemical subgroup: QJ01MA - Fluoroquinolones
Chemical substance: QJ01MA97 - Pradofloxacin
(See WHO ATCvet Index)
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) and
- as adjunctive treatment to mechanical or surgical periodontal therapy in the treatment of moderate and 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).
Marketing Authorisation Holder: Bayer Animal Health GmbH
D-51368 Leverkusen, Deutschland

  EPAR and active package presentations

Package presentations

Information about presentations can be found in the website of the European Medicines Agency under the section "Product Information".
Likewise, presentations on which there has been a Commission decision are referred in the Summary of Product Characteristics (Annex I to the Commission Decision granting the marketing authorisation) which is available in the Community Register.

 

European Commission proceduresGoto top of the page

Close date procedure Procedure type EMEA number Decision summary publ decision docs annex
14/04/2011 Centralised - Authorisation EMEA/V/C/159 (2011)2696 of 12/04/2011
26/06/2012 Centralised - Variation EMEA/V/C/159/IA/3
Updated with Decision(2012)6384 of 10/09/2012
12/09/2012 Centralised - Variation (2012)6384 of 10/09/2012