Posatex

RSS

orbifloxacin / mometasone furoate / posaconazole

Authorised
This medicine is authorised for use in the European Union.

Overview

This is a summary of the European public assessment report (EPAR). Its purpose is to explain how the assessment done by the Committee for Medicinal Products for Veterinary Use (CVMP) on the basis of the documentation provided, led to the recommendations on the conditions of use.

This summary cannot replace a face-to-face discussion with your veterinarian. If you need more information about your animal’s medical condition or treatment, contact your veterinarian. If you want more information on the basis of the CVMP recommendations, read the scientific discussion (also part of the EPAR).

This EPAR was last updated on 11/06/2013

Authorisation details

Product details
Name
Posatex
Agency product number
EMEA/V/C/000122
Active substance
  • orbifloxacin
  • Mometasone furoate
  • posaconazole
International non-proprietary name (INN) or common name
orbifloxacin / mometasone furoate / posaconazole
Species
Dogs
Anatomical therapeutic chemical veterinary (ATCvet) codes
QS02CA91
Publication details
Marketing-authorisation holder
Intervet International BV
Revision
7
Date of issue of marketing authorisation valid throughout the European Union
23/06/2008
Contact address
Wim de Körverstraat 35
5831 AN Boxmeer
The Netherlands

Product information

14/05/2013 Posatex - EMEA/V/C/000122 - R/0018

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

OTOLOGICALS

Therapeutic indication

Treatment of acute otitis externa and acute exacerbations of recurrent otitis externa, associated with bacteria susceptible to orbifloxacin and fungi susceptible to posaconazole, in particular Malassezia pachydermatis.

Assessment history

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