Veterinary Medicines

OTOMAX, Ušní kapky, suspenze

Authorised
  • Gentamicin sulfate
  • Betamethasone
  • Clotrimazole
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Product identification

Medicine name:
OTOMAX, Ušní kapky, suspenze
Active substance:
  • Gentamicin sulfate
  • Betamethasone
  • Clotrimazole
Target species:
  • Dog
Route of administration:
  • Auricular use

Product details

Active substance and strength:
  • Gentamicin sulfate
    2640.00
    international unit(s)
    /
    1.00
    millilitre(s)
  • Betamethasone
    0.88
    milligram(s)
    /
    1.00
    millilitre(s)
  • Clotrimazole
    8.80
    milligram(s)
    /
    1.00
    millilitre(s)
Pharmaceutical form:
  • Ear drops, suspension
Anatomical therapeutic chemical veterinary (ATCvet) codes:
  • QS02CA90
Legal status of supply:
  • Veterinary medicinal product subject to veterinary prescription
Authorisation status:
  • Valid
Authorised in:
  • Czechia
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:
  • Intervet International B.V.
Marketing authorisation date:
Manufacturing sites for batch release:
  • Trirx Segre
Responsible authority:
  • Institute For State Control Of Veterinary Biologicals And Medicaments
Authorisation number:
  • 96/050/00-C
Date of authorisation status change:

Documents

Summary of Product Characteristics

This document does not exist in this language (English). You can find it in another language below.
Czech (PDF)
Published on: 25/10/2024
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Package Leaflet

This document does not exist in this language (English). You can find it in another language below.
Czech (PDF)
Published on: 25/10/2024
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Labelling

This document does not exist in this language (English). You can find it in another language below.
Czech (PDF)
Published on: 23/09/2025
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