Veterinary Medicines

Surolan vet. Örondroppar/kutan suspension

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

Medicine name:
Surolan vet. Örondroppar/kutan suspension
Active substance:
  • Miconazole nitrate
  • POLYMYXIN B SULFATE
  • Prednisolone acetate
Target species:
  • Dog
  • Cat
Route of administration:
  • Auricular 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:
  • Sweden
Available in:
  • Sweden
Package description:

Additional information

Entitlement type:
  • Marketing Authorisation
Legal basis of product authorisation:
  • Legal basis not covered by Directive 2001/82/EC
Marketing authorisation holder:
  • Elanco GmbH
Marketing authorisation date:
Manufacturing sites for batch release:
  • Lusomedicamenta Sociedade Tecnica Farmaceutica S.A.
  • Janssen Pharmaceutica
Responsible authority:
  • Swedish Medical Products Agency
Authorisation number:
  • 11842
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.
Swedish (PDF)
Published on: 28/11/2023
Updated on: 29/11/2023
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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.
Swedish (PDF)
Published on: 28/11/2023
Updated on: 29/11/2023
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Labelling

This document does not exist in this language (English). You can find it in another language below.
Swedish (PDF)
Published on: 28/11/2023
Updated on: 29/11/2023
Download