Veterinary Medicines

Otoxolan ear drops, suspension for dogs

Authorised
  • Dexamethasone acetate
  • Clotrimazole
  • Marbofloxacin
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Product identification

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

Product details

Active substance and strength:
  • Dexamethasone acetate
    1.00
    milligram(s)
    /
    1.00
    millilitre(s)
  • Clotrimazole
    10.00
    milligram(s)
    /
    1.00
    millilitre(s)
  • Marbofloxacin
    3.00
    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:
  • QS02CA06
Legal status of supply:
  • Veterinary medicinal product subject to veterinary prescription
Authorisation status:
  • Valid
Authorised in:
  • Germany
Package description:
  • Box containing 1 x 30 ml LDPE bottle with an LDPE dropper and HDPE screw cap, and3 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 10 ml LDPE bottle with an LDPE dropper and HDPE screw cap, anda 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:
  • TAD Pharma GmbH
Marketing authorisation date:
Manufacturing sites for batch release:
  • Tad Pharma GmbH
  • Krka d.d. Novo Mesto
Responsible authority:
  • Federal Office Of Consumer Protection And Food Safety
Authorisation number:
  • 402309.00.00
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
  • Greece
  • Hungary
  • Italy
  • Latvia
  • Lithuania
  • Netherlands
  • Poland
  • Portugal
  • Romania
  • Slovakia
  • Slovenia
  • Spain
  • United Kingdom (Northern Ireland)

Documents

Summary of Product Characteristics

English (PDF)
Published on: 8/03/2023
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