Veterinary Medicines

Gefriderm cutaneous spray solution for dogs

Suspended
  • Marbofloxacin
  • Ketoconazole
  • Prednisolone
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Product identification

Medicine name:
Gefriderm cutaneous spray solution for dogs
GEFRIDERM SOLUCION PARA PULVERIZACION CUTANEA PARA PERROS
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
Withdrawal period by route of administration:
  • Cutaneous use
    • Dog
Anatomical therapeutic chemical veterinary (ATCvet) codes:
  • QD07CA03
Legal status of supply:
  • Veterinary medicinal product subject to veterinary prescription
Authorisation status:
  • Suspended
Authorised in:
  • Spain
Package description:
  • Child resistant polyethylene container with 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:
  • Alpha-Vet Kft.
Marketing authorisation date:
Manufacturing sites for batch release:
  • Alpha-Vet Kft.
Responsible authority:
  • Spanish Agency For Medicines And Health Products
Authorisation number:
  • 3978 ESP
Date of authorisation status change:
Reference member state:
  • Spain
Procedure number:
  • ES/V/0371/001
Concerned member states:
  • Estonia
  • Germany
  • Ireland
  • United Kingdom (Northern Ireland)

Documents

Combined File of all Documents

English (PDF)
Published on: 22/11/2022
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Summary of Product Characteristics

This document does not exist in this language (English). You can find it in another language below.
Spanish (PDF)
Published on: 2/02/2024
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Package Leaflet

This document does not exist in this language (English). You can find it in another language below.
Spanish (PDF)
Published on: 2/02/2024
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Labelling

This document does not exist in this language (English). You can find it in another language below.
Spanish (PDF)
Published on: 2/02/2024
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eu-PUAR-gefriderm-cutaneous-spray-solution-for-dogs-en.pdf

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