Veterinary Medicines

TRIDERM cutaneous spray solution for dogs

Authorised
  • Marbofloxacin
  • Ketoconazole
  • Prednisolone
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Product identification

Medicine name:
TRIDERM cutaneous spray solution for dogs
Active substance:
  • Marbofloxacin
  • Ketoconazole
  • Prednisolone
Target species:
  • Dog
Route of administration:
  • Cutaneous use

Product details

Active substance and strength:
  • Marbofloxacin
    1.03
    milligram(s)
    /
    1.00
    millilitre(s)
  • Ketoconazole
    2.04
    milligram(s)
    /
    1.00
    millilitre(s)
  • Prednisolone
    0.93
    milligram(s)
    /
    1.00
    millilitre(s)
Pharmaceutical form:
  • Cutaneous spray, solution
Anatomical therapeutic chemical veterinary (ATCvet) codes:
  • QD06C
Legal status of supply:
  • Veterinary medicinal product subject to veterinary prescription
Authorisation status:
  • Valid
Authorised in:
  • Malta
Package description:
  • box containing 1 bottle of 30 ml

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:
  • Organit Kft.
Marketing authorisation date:
Manufacturing sites for batch release:
  • Alpha-Vet Kft.
Responsible authority:
  • Veterinary And Phytosanitary Regulation Department
Authorisation number:
  • VMA77
Date of authorisation status change:
Reference member state:
  • Spain
Procedure number:
  • ES/V/0287/001
Concerned member states:
  • Croatia
  • Cyprus
  • Greece
  • Latvia
  • Lithuania
  • Malta
  • Poland
  • Portugal

Documents

Summary of Product Characteristics

English (PDF)
Published on: 12/04/2023
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Package Leaflet

English (PDF)
Published on: 29/09/2025
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eu-PUAR-triderm-cutaneous-spray-solution-for-dogs-en.pdf

English (PDF)
Published on: 12/04/2023
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