Veterinary Medicines

Surolan 5,0 mg/0,5293 mg/23,0 mg/ml, Ohrentropfen, Suspension zur Anwendung auf der Haut für Hunde und Katzen

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

Medicine name:
Surolan 5,0 mg/0,5293 mg/23,0 mg/ml, Ohrentropfen, Suspension zur Anwendung auf der Haut für Hunde und Katzen
Active substance:
  • Miconazole nitrate
  • POLYMYXIN B SULFATE
  • Prednisolone acetate
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)
  • POLYMYXIN B SULFATE
    0.53
    milligram(s)
    /
    1.00
    millilitre(s)
  • Prednisolone acetate
    5.00
    milligram(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:
  • Austria
Available in:
  • Austria
Package description:

Additional information

Entitlement type:
  • Marketing Authorisation
Legal basis of product authorisation:
  • Full application (Article 12(3) of Directive No 2001/82/EC)
Marketing authorisation holder:
  • Elanco GmbH
Marketing authorisation date:
Manufacturing sites for batch release:
  • Lusomedicamenta Sociedade Tecnica Farmaceutica S.A.
Responsible authority:
  • Austrian Agency For Health And Food Safety
Authorisation number:
  • 16388
Date of authorisation status change:

Documents

Package Leaflet

This document does not exist in this language (English). You can find it in another language below.
German (PDF)
Published on: 15/11/2023
Updated on: 22/04/2025
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Summary of Product Characteristics

This document does not exist in this language (English). You can find it in another language below.
German (PDF)
Published on: 15/11/2023
Updated on: 22/04/2025
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Labelling

This document does not exist in this language (English). You can find it in another language below.
German (PDF)
Published on: 15/11/2023
Updated on: 22/04/2025
Download