Veterinary Medicines

Otomax (2640 j.m. + 0,88 mg + 8,8 mg)/ml Zawiesina do uszu

Authorised
  • Clotrimazole
  • Gentamicin sulfate
  • Betamethasone valerate
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Product identification

Medicine name:
Otomax (2640 j.m. + 0,88 mg + 8,8 mg)/ml Zawiesina do uszu
Active substance:
  • Clotrimazole
  • Gentamicin sulfate
  • Betamethasone valerate
Target species:
  • Dog
Route of administration:
  • Auricular use

Product details

Active substance and strength:
  • Clotrimazole
    8.80
    milligram(s)
    /
    1.00
    millilitre(s)
  • Gentamicin sulfate
    2640.00
    international unit(s)
    /
    1.00
    millilitre(s)
  • Betamethasone valerate
    0.88
    milligram(s)
    /
    1.00
    millilitre(s)
Pharmaceutical form:
  • Ear drops, suspension
Withdrawal period by route of administration:
  • Auricular use
    • Dog
Anatomical therapeutic chemical veterinary (ATCvet) codes:
  • QS02CA90
Legal status of supply:
  • Veterinary medicinal product subject to veterinary prescription
Authorisation status:
  • Valid
Authorised in:
  • Poland
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:
  • Office For Registration Of Medicinal Products Medical Devices And Biocidal Products
Authorisation number:
  • 1103
Date of authorisation status change:

Documents

Package Leaflet

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Polish (PDF)
Published on: 4/02/2022
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Summary of Product Characteristics

This document does not exist in this language (English). You can find it in another language below.
Polish (PDF)
Published on: 4/02/2022
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Labelling

This document does not exist in this language (English). You can find it in another language below.
Polish (PDF)
Published on: 4/02/2022
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