Veterinary Medicines

FUNGICONAZOL 400 MG TABLETS FOR DOGS

Authorised
  • Ketoconazole
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Product identification

Medicine name:
FUNGICONAZOL 400 MG TABLETS FOR DOGS
Fungiconazol, 400 mg, tablete za pse
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
Anatomical therapeutic chemical veterinary (ATCvet) codes:
  • QJ02AB02
Legal status of supply:
  • Veterinary medicinal product subject to veterinary prescription
Authorisation status:
  • Valid
Authorised in:
  • Croatia
Package description:
  • Cardboard box of 1 Aluminium/PVC/PE/PVDC blister containing 10 tablets each.
  • Cardboard box of 10 Aluminium/PVC/PE/PVDC blisters containing 10 tablets each.
  • Cardboard box of 9 Aluminium/PVC/PE/PVDC blisters containing 10 tablets each.
  • Cardboard box of 8 Aluminium/PVC/PE/PVDC blisters containing 10 tablets each.
  • Cardboard box of 7 Aluminium/PVC/PE/PVDC blisters containing 10 tablets each.
  • Cardboard box of 6 Aluminium/PVC/PE/PVDC blisters containing 10 tablets each.
  • Cardboard box of 5 Aluminium/PVC/PE/PVDC blisters containing 10 tablets each.
  • Cardboard box of 4 Aluminium/PVC/PE/PVDC blisters containing 10 tablets each.
  • Cardboard box of 3 Aluminium/PVC/PE/PVDC blisters containing 10 tablets each.
  • Cardboard box of 2 Aluminium/PVC/PE/PVDC blisters containing 10 tablets each.

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:
  • Ministry Of Agriculture Veterinary And Food Safety Directorate
Authorisation number:
  • UP/I-322-05/19-01/487
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

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Croatian (PDF)
Published on: 21/03/2023
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