Veterinary Medicines

Otisur

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

Medicine name:
Otisur
Otisur 23,0 mg/ml + 5,0 mg/ml + 5500 IU/ml kapljice za uho, suspenzija za mačke in pse
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:
  • 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:
  • Slovenia
Package description:
  • 30 ml white low-density polyethylene squeeze dropper bottle with a white, high-density polyethylene cap (screw fit), and a white, low-density polyethylene dropper.
  • 15 ml white low-density polyethylene squeeze dropper bottle with a white, high-density polyethylene cap (screw fit), and a white, low-density polyethylene dropper.

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:
  • Chanelle Pharmaceuticals Manufacturing Limited
Marketing authorisation date:
Manufacturing sites for batch release:
  • Chanelle Pharmaceuticals Manufacturing Limited
Responsible authority:
  • Agency For Medicinal Products And Medical Devices Of The Republic Of Slovenia
Authorisation number:
  • MR/V/0795/001
Date of authorisation status change:
Reference member state:
  • Ireland
Procedure number:
  • IE/V/0659/001
Concerned member states:
  • Austria
  • Belgium
  • Bulgaria
  • Croatia
  • Cyprus
  • Czechia
  • Denmark
  • Estonia
  • Finland
  • France
  • Germany
  • Greece
  • Hungary
  • Italy
  • Latvia
  • Lithuania
  • Netherlands
  • Norway
  • Poland
  • Portugal
  • Romania
  • Slovenia
  • Spain
  • Sweden

Documents

Summary of Product Characteristics

English (PDF)
Published on: 3/05/2024
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Slovenian (PDF)
Published on: 13/12/2023
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Package Leaflet

This document does not exist in this language (English). You can find it in another language below.
Slovenian (PDF)
Published on: 13/12/2023
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Labelling

This document does not exist in this language (English). You can find it in another language below.
Slovenian (PDF)
Published on: 13/12/2023
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