Veterinary Medicines

Itrafungol 10 mg/ml Oral Solution

Authorised
  • Itraconazole
Download as PDF

Product identification

Medicine name:
Itrafungol 10 mg/ml Oral Solution
Itrafungol 10 mg/ml Drank
Itrafungol 10 mg/ml Solution buvable
Itrafungol 10 mg/ml Lösung zum Einnehmen
Active substance:
  • Itraconazole
Target species:
  • Cat
Route of administration:
  • Oral use

Product details

Active substance and strength:
  • Itraconazole
    10.00
    milligram(s)
    /
    1.00
    millilitre(s)
Pharmaceutical form:
  • Oral solution
Withdrawal period by route of administration:
  • Oral use
    • Cat
Anatomical therapeutic chemical veterinary (ATCvet) codes:
  • QJ02AC02
Legal status of supply:
  • Veterinary medicinal product subject to veterinary prescription
Authorisation status:
  • Valid
Authorised in:
  • Belgium
Available in:
  • Belgium
Package description:
  • Amber glass bottle (type III) containing 52 ml oral solution, closed with a child resistant polypropylene screw cap with a LDPE insert packed in a cardboard box with a graduated dosing syringe.

Additional information

Entitlement type:
  • Marketing Authorisation
Legal basis of product authorisation:
  • Full application (Article 12(3) of Directive No 2001/82/EC)
Marketing authorisation holder:
  • Virbac
Marketing authorisation date:
Manufacturing sites for batch release:
  • Lusomedicamenta Sociedade Tecnica Farmaceutica S.A.
Responsible authority:
  • Federal Agency For Medicines And Health Products
Authorisation number:
  • BE-V266664
Date of authorisation status change:
Reference member state:
  • Ireland
Procedure number:
  • IE/V/0431/001
Concerned member states:
  • Austria
  • Belgium
  • Czechia
  • Denmark
  • Finland
  • France
  • Germany
  • Greece
  • Hungary
  • Italy
  • Luxembourg
  • Netherlands
  • Norway
  • Portugal
  • Spain
  • Sweden
  • United Kingdom (Northern Ireland)

Documents

Summary of Product Characteristics

English (PDF)
Published on: 17/11/2024
Download
Dutch (PDF)
Published on: 18/08/2025
Download
French (PDF)
Published on: 18/08/2025
Download

Package Leaflet

This document does not exist in this language (English). You can find it in another language below.
Dutch (PDF)
Published on: 18/08/2025
Download
French (PDF)
Published on: 18/08/2025
Download
German (PDF)
Published on: 18/08/2025
Download

Labelling

This document does not exist in this language (English). You can find it in another language below.
Dutch (PDF)
Published on: 18/08/2025
Download
French (PDF)
Published on: 18/08/2025
Download
German (PDF)
Published on: 18/08/2025
Download

Combined File of all Documents

English (PDF)
Published on: 29/09/2024
Download
How useful was this page?:
No votes yet
"Please do not include any personal data, such as your name or contact details. If you do, you consent to the processing of that data in accordance with EMA’s Privacy Statement concerning requests for information or access to documents. If you would like a reply from EMA, please Send a question to EMA instead."