Veterinary Medicines

OTOMAX, kapi za uho, suspenzija, za pse

Not authorised
  • GENTAMICIN SULPHATE
  • BETAMETHASONE VALERATE
  • CLOTRIMAZOLE
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Product identification

Medicine name:
OTOMAX, kapi za uho, suspenzija, za pse
Active substance:
  • GENTAMICIN SULPHATE
  • BETAMETHASONE VALERATE
  • CLOTRIMAZOLE
Target species:
  • Dog
Route of administration:
  • Auricular use

Product details

Active substance and strength:
  • GENTAMICIN SULPHATE
    2640.00
    international unit(s)
    /
    1.00
    millilitre(s)
  • BETAMETHASONE VALERATE
    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:
  • Surrendered
Authorised in:
  • Croatia
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. Subsidiary In The Republic Of Croatia
Marketing authorisation date:
Manufacturing sites for batch release:
  • Intervet International B.V.
Responsible authority:
  • MPS
Authorisation number:
  • UP/I-322-05/13-01/568
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.
Croatian (PDF)
Published on: 20/03/2023
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