Veterinary Medicines

OTOMAX EAR DROPS SUSPENSION

Authorised
  • Gentamicin sulfate
  • Clotrimazole
  • Betamethasone valerate
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Product identification

Medicine name:
OTOMAX EAR DROPS SUSPENSION
OTOMAX GOTAS OTICAS EN SUSPENSION
Active substance:
  • Gentamicin sulfate
  • Clotrimazole
  • Betamethasone valerate
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)
  • Clotrimazole
    8.80
    milligram(s)
    /
    1.00
    millilitre(s)
  • Betamethasone valerate
    1.07
    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:
  • Spain
Available in:
  • Spain
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:
  • Merck Sharp & Dohme Animal Health S.L.
Marketing authorisation date:
Manufacturing sites for batch release:
  • Trirx Segre
Responsible authority:
  • Spanish Agency Of Medicines And Medical Devices
Authorisation number:
  • 1294 ESP
Date of authorisation status change:
Reference member state:
  • France
Procedure number:
  • FR/V/0110/001
Concerned member states:
  • Austria
  • Belgium
  • Denmark
  • Finland
  • Germany
  • Greece
  • Ireland
  • Italy
  • Luxembourg
  • Portugal
  • Spain
  • Sweden
  • United Kingdom (Northern Ireland)

Documents

Summary of Product Characteristics

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Spanish (PDF)
Published on: 5/03/2025
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Package Leaflet

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Spanish (PDF)
Published on: 5/03/2025
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Labelling

This document does not exist in this language (English). You can find it in another language below.
Spanish (PDF)
Published on: 5/03/2025
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