Veterinary Medicine Information website

Otisan 3 mg/ml + 10 mg/ml + 1 mg/ml ear drops, suspension for dogs

Authorised
  • Marbofloxacin
  • Clotrimazole
  • Dexamethasone acetate
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Product identification

Medicine name:
Otisan 3 mg/ml + 10 mg/ml + 1 mg/ml ear drops, suspension for dogs
Active substance:
  • Marbofloxacin
  • Clotrimazole
  • Dexamethasone acetate
Target species:
  • Dog
Route of administration:
  • Auricular use

Product details

Active substance and strength:
  • Marbofloxacin
    3.00
    milligram(s)
    /
    1.00
    millilitre(s)
  • Clotrimazole
    10.00
    milligram(s)
    /
    1.00
    millilitre(s)
  • Dexamethasone acetate
    1.00
    milligram(s)
    /
    1.00
    millilitre(s)
Pharmaceutical form:
  • Ear drops, suspension
Anatomical therapeutic chemical veterinary (ATCvet) codes:
  • QS02CA06
Legal status of supply:
  • Veterinary medicinal product subject to veterinary prescription
Authorisation status:
  • Valid
Authorised in:
  • Slovakia
Available in:
  • Slovakia
Package description:
  • Cardboard box with 1 bottle of 15 ml
  • Cardboard box with 1 bottle of 25 ml.

Additional information

Entitlement type:
  • Marketing Authorisation
Legal basis of product authorisation:
  • Hybrid application - change in active substance(s) (Article 19(1)(a) of Regulation (EU) 2019/6)
Marketing authorisation holder:
  • Przedsiebiorstwo Wielobranzowe Vet-Agro Sp. z o.o.
Marketing authorisation date:
Manufacturing sites for batch release:
  • Przedsiebiorstwo Wielobranzowe Vet-Agro Sp. z o.o.
Responsible authority:
  • Institute For State Control Of Veterinary Biologicals And Medicaments
Authorisation number:
  • 96/006/DC/24-S
Date of authorisation status change:
Reference member state:
  • Spain
Procedure number:
  • ES/V/0425/001
Concerned member states:
  • Belgium
  • Bulgaria
  • Croatia
  • Czechia
  • Greece
  • Ireland
  • Italy
  • Lithuania
  • Netherlands
  • Poland
  • Portugal
  • Romania
  • Slovakia
  • United Kingdom (Northern Ireland)

Documents

Combined File of all Documents

This document does not exist in this language (English). You can find it in another language below.
Slovak (PDF)
Published on: 10/06/2024
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Summary of Product Characteristics

English (PDF)
Published on: 27/06/2024
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Package Leaflet

English (PDF)
Published on: 27/06/2024
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Labelling

English (PDF)
Published on: 27/06/2024
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