Veterinary Medicine Information website

Otoxolan ear drops, suspension for dogs

Authorised
  • Marbofloxacin
  • Clotrimazole
  • Dexamethasone acetate
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Product identification

Medicine name:
Otoxolan ear drops, suspension for dogs
Active substance:
  • Marbofloxacin
  • Clotrimazole
  • Dexamethasone acetate
Target species:
  • Dog
Route of administration:
  • Auricular use

Product details

Active substance and strength:
  • Marbofloxacin
    3.00
    milligram(s)
    /
    1.00
    millilitre(s)
  • Clotrimazole
    10.00
    milligram(s)
    /
    1.00
    millilitre(s)
  • Dexamethasone acetate
    1.00
    milligram(s)
    /
    1.00
    millilitre(s)
Pharmaceutical form:
  • Ear drops, suspension
Anatomical therapeutic chemical veterinary (ATCvet) codes:
  • QS02CA06
Legal status of supply:
  • Veterinary medicinal product subject to veterinary prescription
Authorisation status:
  • Valid
Authorised in:
  • Slovakia
Available in:
  • Slovakia
Package description:
  • Box containing 1 x 10 ml LDPE bottle with an LDPE dropper and HDPE screw cap, anda thermoplastic elastomer dropper with cap.
  • Box containing 1 x 20 ml LDPE bottle with an LDPE dropper and HDPE screw cap, and2 thermoplastic elastomer dropper with cap.
  • Box containing 1 x 30 ml LDPE bottle with an LDPE dropper and HDPE screw cap, and3 thermoplastic elastomer dropper with cap.

Additional information

Entitlement type:
  • Marketing Authorisation
Legal basis of product authorisation:
  • Generic application (Article 13(1) of Directive No 2001/82/EC)
Marketing authorisation holder:
  • KRKA tovarna zdravil d.d. Novo mesto
Marketing authorisation date:
Manufacturing sites for batch release:
  • KRKA tovarna zdravil d.d. Novo mesto
  • TAD Pharma GmbH
Responsible authority:
  • Institute For State Control Of Veterinary Biologicals And Medicaments
Authorisation number:
  • 96/073/DC/16-S
Date of authorisation status change:
Reference member state:
  • Ireland
Procedure number:
  • IE/V/0438/001
Concerned member states:
  • Austria
  • Belgium
  • Bulgaria
  • Croatia
  • Czechia
  • Denmark
  • Estonia
  • France
  • Germany
  • Hungary
  • Italy
  • Latvia
  • Lithuania
  • Netherlands
  • Poland
  • Portugal
  • Romania
  • Slovakia
  • Slovenia
  • Spain
  • United Kingdom (Northern Ireland)

Documents

Combined File of all Documents

This document does not exist in this language (English). You can find it in another language below.
Slovak (PDF)
Published on: 11/11/2024
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Summary of Product Characteristics

English (PDF)
Published on: 26/08/2024
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