Veterinary Medicines

Auriotic 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:
Auriotic Ohrentropfen und Suspension zur Anwendung auf der Haut für Hunde und Katzen
Mitex Plus ušná instilácia a dermálna suspenzia pre psy a mačky
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
Anatomical therapeutic chemical veterinary (ATCvet) codes:
  • QS02CA01
Legal status of supply:
  • Veterinary medicinal product subject to veterinary prescription
Authorisation status:
  • Valid
Authorised in:
  • Slovakia
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:
  • Institute For State Control Of Veterinary Biologicals And Medicaments
Authorisation number:
  • 96/034/MR/21-S
Date of authorisation status change:
Reference member state:
  • Austria
Procedure number:
  • AT/V/0027/001
Concerned member states:
  • Czechia
  • France
  • Slovakia
  • United Kingdom (Northern Ireland)

Documents

Combined File of all Documents

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Slovak (PDF)
Published on: 4/03/2022
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