Veterinary Medicines

Mitex Ohrentropfen und Suspension zur Anwendung auf der Haut für Hunde und Katzen

Authorised
  • Miconazole nitrate
  • Prednisolone acetate
  • POLYMYXIN B SULFATE
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Product identification

Medicine name:
Mitex Ohrentropfen und Suspension zur Anwendung auf der Haut für Hunde und Katzen
Aurimic Suspensie voor cutaan gebruik en Oordruppels, suspensie
Aurimic Suspension pour application cutanée et Suspension auriculaire en gouttes
Aurimic Suspension zur Anwendung auf der Haut und Ohrentropfen, Suspension
Active substance:
  • Miconazole nitrate
  • Prednisolone acetate
  • POLYMYXIN B SULFATE
Target species:
  • Dog
  • Cat
Route of administration:
  • Auricular use
  • Cutaneous use

Product details

Active substance and strength:
  • Miconazole nitrate
    23.00
    milligram(s)
    /
    1.00
    millilitre(s)
  • Prednisolone acetate
    5.00
    milligram(s)
    /
    1.00
    millilitre(s)
  • POLYMYXIN B SULFATE
    5500.00
    international unit(s)
    /
    1.00
    millilitre(s)
Pharmaceutical form:
  • Cutaneous/ear drops suspension
Withdrawal period by route of administration:
  • Auricular use
    • Dog
    • Cat
  • Cutaneous use
    • Dog
    • Cat
Anatomical therapeutic chemical veterinary (ATCvet) codes:
  • QS02CA01
Legal status of supply:
  • Veterinary medicinal product subject to veterinary prescription
Authorisation status:
  • Valid
Authorised in:
  • Belgium
Available in:
  • Belgium
Package description:
  • Dropper container of white, opaque LDPE with white, opaque HDPE screw cap in a cardboard box. Pack size: 1 x 20 ml

Additional information

Entitlement type:
  • Marketing Authorisation
Legal basis of product authorisation:
  • Generic application (Article 13(1) of Directive No 2001/82/EC)
Marketing authorisation holder:
  • Vetviva Richter GmbH
Marketing authorisation date:
Manufacturing sites for batch release:
  • Vetviva Richter GmbH
Responsible authority:
  • Federal Agency For Medicines And Health Products
Authorisation number:
  • BE-V473804
Date of authorisation status change:
Reference member state:
  • Austria
Procedure number:
  • AT/V/0014/001
Concerned member states:
  • Belgium
  • Bulgaria
  • Croatia
  • Czechia
  • Denmark
  • Estonia
  • Finland
  • France
  • Germany
  • Greece
  • Hungary
  • Iceland
  • Ireland
  • Italy
  • Latvia
  • Lithuania
  • Netherlands
  • Norway
  • Poland
  • Portugal
  • Romania
  • Slovakia
  • Slovenia
  • Spain
  • Sweden
  • United Kingdom (Northern Ireland)

Documents

Summary of Product Characteristics

This document does not exist in this language (English). You can find it in another language below.
Dutch (PDF)
Published on: 19/03/2025
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French (PDF)
Published on: 19/03/2025
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Package Leaflet

This document does not exist in this language (English). You can find it in another language below.
Dutch (PDF)
Published on: 19/03/2025
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French (PDF)
Published on: 19/03/2025
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German (PDF)
Published on: 19/03/2025
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Labelling

This document does not exist in this language (English). You can find it in another language below.
Dutch (PDF)
Published on: 19/03/2025
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French (PDF)
Published on: 19/03/2025
Download
German (PDF)
Published on: 19/03/2025
Download
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