Veterinary Medicines

FUNGICONAZOL 400 MG TABLETS FOR DOGS

Authorised
  • Ketoconazole
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Product identification

Medicine name:
FUNGICONAZOL 400 MG TABLETS FOR DOGS
Canizol vet 400 mg tabletti
Active substance:
  • Ketoconazole
Target species:
  • Dog
Route of administration:
  • Oral use

Product details

Active substance and strength:
  • Ketoconazole
    400.00
    milligram(s)
    /
    1.00
    Tablet
Pharmaceutical form:
  • Tablet
Withdrawal period by route of administration:
  • Oral use
    • Dog
Anatomical therapeutic chemical veterinary (ATCvet) codes:
  • QJ02AB02
Legal status of supply:
  • Veterinary medicinal product subject to veterinary prescription
Authorisation status:
  • Valid
Authorised in:
  • Finland
Package description:
  • Carton containing 2 Aluminium/PVC/PE/PVDC blisters
  • Carton containing 3 Aluminium/PVC/PE/PVDC blisters
  • Carton containing 4 Aluminium/PVC/PE/PVDC blisters
  • Carton containing 5 Aluminium/PVC/PE/PVDC blisters
  • Carton containing 6 Aluminium/PVC/PE/PVDC blisters
  • Carton containing 7 Aluminium/PVC/PE/PVDC blisters
  • Carton containing 8 Aluminium/PVC/PE/PVDC blisters
  • Carton containing 9 Aluminium/PVC/PE/PVDC blisters
  • Carton containing 10 Aluminium/PVC/PE/PVDC blisters
  • Carton containing 1 Aluminium/PVC/PE/PVDC blister

Additional information

Entitlement type:
  • Marketing Authorisation
Legal basis of product authorisation:
  • Hybrid application (Article 13(3) of Directive No 2001/82/EC)
Marketing authorisation holder:
  • Dechra Regulatory B.V.
Marketing authorisation date:
Manufacturing sites for batch release:
  • Genera d.d.
  • Lelypharma B.V.
Responsible authority:
  • Finnish Medicines Agency
Authorisation number:
  • 31797
Date of authorisation status change:
Reference member state:
  • France
Procedure number:
  • FR/V/0263/002
Concerned member states:
  • Austria
  • Belgium
  • Croatia
  • Czechia
  • Denmark
  • Estonia
  • Finland
  • Greece
  • Hungary
  • Iceland
  • Ireland
  • Italy
  • Latvia
  • Lithuania
  • Luxembourg
  • Netherlands
  • Norway
  • Poland
  • Portugal
  • Romania
  • Slovakia
  • Slovenia
  • Spain
  • Sweden
  • United Kingdom (Northern Ireland)

Documents

Summary of Product Characteristics

This document does not exist in this language (English). You can find it in another language below.
Finnish (PDF)
Published on: 7/06/2023
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Package Leaflet

This document does not exist in this language (English). You can find it in another language below.
Finnish (PDF)
Published on: 7/06/2023
Download
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