Veterinary Medicines

Otomax kapljice za uho, suspenzija

Not authorised
  • Gentamicin
  • Betamethasone
  • Clotrimazole
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Product identification

Medicine name:
Otomax kapljice za uho, suspenzija
Active substance:
  • Gentamicin
  • Betamethasone
  • Clotrimazole
Target species:
  • Dog
Route of administration:
  • Auricular use

Product details

Active substance and strength:
  • Gentamicin
    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:
  • Surrendered
Authorised in:
  • Slovenia
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:
  • Intervet International B.V.
Marketing authorisation date:
Manufacturing sites for batch release:
  • Trirx Segre
Responsible authority:
  • Agency For Medicinal Products And Medical Devices Of The Republic Of Slovenia
Authorisation number:
  • NP/V/0246/001
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.
Slovenian (PDF)
Published on: 2/12/2021
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Package Leaflet

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Slovenian (PDF)
Published on: 2/12/2021
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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: 2/12/2021
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