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 Tablet
Fungiconazol 400 mg Comprimé
Fungiconazol 400 mg Tablette
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:
  • Belgium
Package description:

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:
  • Federal Agency For Medicines And Health Products
Authorisation number:
  • BE-V471582
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.
Dutch (PDF)
Published on: 18/06/2025
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French (PDF)
Published on: 18/06/2025
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German (PDF)
Published on: 18/06/2025
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Package Leaflet

This document does not exist in this language (English). You can find it in another language below.
Dutch (PDF)
Published on: 18/06/2025
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French (PDF)
Published on: 18/06/2025
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German (PDF)
Published on: 18/06/2025
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Labelling

This document does not exist in this language (English). You can find it in another language below.
Dutch (PDF)
Published on: 18/06/2025
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French (PDF)
Published on: 18/06/2025
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German (PDF)
Published on: 18/06/2025
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eu-puar-frv0263002-mr-rpe965-en.pdf

English (PDF)
Published on: 7/01/2026
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