Veterinary Medicines

OTOGENT

Authorised
  • Gentamicin sulfate
  • Flumetasone pivalate
  • Tetracaine hydrochloride
  • Econazole nitrate
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Product identification

Medicine name:
OTOGENT
Active substance:
  • Gentamicin sulfate
  • Flumetasone pivalate
  • Tetracaine hydrochloride
  • Econazole nitrate
Target species:
  • Dog
  • Cat
Route of administration:
  • Auricular use

Product details

Active substance and strength:
  • Gentamicin sulfate
    833.00
    milligram(s)
    /
    100.00
    millilitre(s)
  • Flumetasone pivalate
    30.00
    milligram(s)
    /
    100.00
    millilitre(s)
  • Tetracaine hydrochloride
    500.00
    milligram(s)
    /
    100.00
    millilitre(s)
  • Econazole nitrate
    1.00
    gram(s)
    /
    100.00
    millilitre(s)
Pharmaceutical form:
  • Ear drops, solution
Withdrawal period by route of administration:
  • Auricular use
    • Dog
      • Unspecified
        0
        day
    • Cat
      • Unspecified
        0
        day
Anatomical therapeutic chemical veterinary (ATCvet) codes:
  • QS02CA02
Legal status of supply:
  • Veterinary medicinal product subject to veterinary prescription
Authorisation status:
  • Valid
Authorised in:
  • Italy
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 Productions S.r.l.
Marketing authorisation date:
Manufacturing sites for batch release:
  • Intervet Productions S.r.l.
Responsible authority:
  • Ministry Of Health
Authorisation number:
This information is not available for this product.
Date of authorisation status change:

Documents

Combined File of all Documents

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Italian (PDF)
Published on: 3/06/2022
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