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Otiderm, oordruppels voor hond en kat

Authorised
  • Enrofloxacin
  • Ketoconazole
  • Triamcinolone acetonide
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Product identification

Medicine name:
Otiderm, oordruppels voor hond en kat
Active substance:
  • Enrofloxacin
  • Ketoconazole
  • Triamcinolone acetonide
Target species:
  • Dog
  • Cat
Route of administration:
  • Auricular use

Product details

Active substance and strength:
  • Enrofloxacin
    3.40
    milligram(s)
    /
    1.00
    gram(s)
  • Ketoconazole
    6.80
    milligram(s)
    /
    1.00
    gram(s)
  • Triamcinolone acetonide
    0.68
    milligram(s)
    /
    1.00
    gram(s)
Pharmaceutical form:
  • Ear drops, suspension
Anatomical therapeutic chemical veterinary (ATCvet) codes:
  • QS02CA04
Legal status of supply:
  • Veterinary medicinal product subject to veterinary prescription
Authorisation status:
  • Valid
Authorised in:
  • Netherlands
Available in:
  • Netherlands
Package description:

Additional information

Entitlement type:
  • Marketing Authorisation
Legal basis of product authorisation:
  • Full application - Known active substance (Article 12(3) of Directive No 2001/82/EC)
Marketing authorisation holder:
  • Ast Farma B.V.
Marketing authorisation date:
Manufacturing sites for batch release:
  • Produlab Pharma B.V.
Responsible authority:
  • Medicines Evaluation Board
Authorisation number:
  • REG NL 100764
Date of authorisation status change:

Documents

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Dutch (PDF)
Published on: 9/02/2022
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