Veterinary Medicines

Ototop Ear Drops and Cutaneous Suspension for Dogs, Cats and Guinea Pigs

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

Medicine name:
Ototop Ear Drops and Cutaneous Suspension for Dogs, Cats and Guinea Pigs
Ototop, Ohrentropfen und Suspension zur Anwendung auf der Haut für Hunde, Katzen und Meerschweinchen
Active substance:
  • POLYMYXIN B SULFATE
  • Prednisolone acetate
  • Miconazole nitrate
Target species:
  • Dog
  • Cat
  • Guinea pig
Route of administration:
  • Cutaneous use
  • Auricular use

Product details

Active substance and strength:
  • POLYMYXIN B SULFATE
    0.53
    milligram(s)
    /
    1.00
    millilitre(s)
  • Prednisolone acetate
    5.00
    milligram(s)
    /
    1.00
    millilitre(s)
  • Miconazole nitrate
    23.00
    milligram(s)
    /
    1.00
    millilitre(s)
Pharmaceutical form:
  • Cutaneous/ear drops suspension
Withdrawal period by route of administration:
  • Cutaneous use
    • Dog
    • Cat
    • Guinea pig
  • Auricular 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:
  • Austria
Available in:
  • Austria
Package description:

Additional information

Entitlement type:
  • Marketing Authorisation
Legal basis of product authorisation:
  • Hybrid application (Article 13(3) of Directive No 2001/82/EC)
Marketing authorisation holder:
  • Industrial Veterinaria S.A.
Marketing authorisation date:
Manufacturing sites for batch release:
  • Industrial Veterinaria S.A.
  • aniMedica Herstellungs GmbH
  • aniMedica GmbH
Responsible authority:
  • Austrian Agency For Health And Food Safety
Authorisation number:
  • 840106
Date of authorisation status change:
Reference member state:
  • Germany
Procedure number:
  • DE/V/0321/001
Concerned member states:
  • Austria
  • Belgium
  • Cyprus
  • Czechia
  • Estonia
  • Greece
  • Hungary
  • Italy
  • Latvia
  • Lithuania
  • Malta
  • Poland
  • Portugal
  • Romania
  • Slovakia
  • Slovenia
  • Spain

Documents

Labelling

This document does not exist in this language (English). You can find it in another language below.
German (PDF)
Published on: 23/10/2024
Updated on: 16/04/2025
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Package Leaflet

This document does not exist in this language (English). You can find it in another language below.
German (PDF)
Published on: 23/10/2024
Updated on: 16/04/2025
Download

Summary of Product Characteristics

English (PDF)
Published on: 11/02/2022
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German (PDF)
Published on: 23/10/2024
Updated on: 16/04/2025
Download
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