Veterinary Medicines

ALPHADERM Plus cutaneous spray solution for dogs

Authorised
  • Prednisolone
  • Ketoconazole
  • Marbofloxacin
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Product identification

Medicine name:
ALPHADERM Plus cutaneous spray solution for dogs
Alphaderm Plus, Kožní sprej, roztok
Active substance:
  • Prednisolone
  • Ketoconazole
  • Marbofloxacin
Target species:
  • Dog
Route of administration:
  • External use

Product details

Active substance and strength:
  • Prednisolone
    0.93
    milligram(s)
    /
    1.00
    millilitre(s)
  • Ketoconazole
    2.04
    milligram(s)
    /
    1.00
    millilitre(s)
  • Marbofloxacin
    1.03
    milligram(s)
    /
    1.00
    millilitre(s)
Pharmaceutical form:
  • Cutaneous spray
Anatomical therapeutic chemical veterinary (ATCvet) codes:
  • QD07CA03
Legal status of supply:
  • Veterinary medicinal product subject to veterinary prescription
Authorisation status:
  • Valid
Authorised in:
  • Czechia
Package description:
  • 100 ml PET bottle with a spray pump in cardboard box
  • 30 ml PET bottle with a spray pump in cardboard box

Additional information

Entitlement type:
  • Marketing Authorisation
Legal basis of product authorisation:
  • Fixed combination application (Article 13b of Directive No 2001/82/EC)
Marketing authorisation holder:
  • Alphavet Zrt.
Marketing authorisation date:
Manufacturing sites for batch release:
  • Alpha-Vet Kft.
Responsible authority:
  • Institute For State Control Of Veterinary Biologicals And Medicaments
Authorisation number:
  • 96/038/14-C
Date of authorisation status change:
Reference member state:
  • Hungary
Procedure number:
  • HU/V/0117/001
Concerned member states:
  • Austria
  • Bulgaria
  • Czechia
  • Italy
  • Romania
  • Slovakia
  • Slovenia

Documents

Summary of Product Characteristics

This document does not exist in this language (English). You can find it in another language below.
Czech (PDF)
Published on: 13/02/2025
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Package Leaflet

This document does not exist in this language (English). You can find it in another language below.
Czech (PDF)
Published on: 13/02/2025
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Labelling

This document does not exist in this language (English). You can find it in another language below.
Czech (PDF)
Published on: 8/04/2025
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Combined File of all Documents

English (PDF)
Published on: 6/08/2025
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