Veterinary Medicines

Itrafungol 10 mg/ml Oral Solution

Authorised
  • Itraconazole
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Product identification

Medicine name:
Itrafungol 10 mg/ml Oral Solution
ITRAFUNGOL
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:
  • Spain
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:
  • Spanish Agency Of Medicines And Medical Devices
Authorisation number:
  • 1593 ESP
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
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Spanish (PDF)
Published on: 13/09/2024
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Package Leaflet

This document does not exist in this language (English). You can find it in another language below.
Spanish (PDF)
Published on: 13/09/2024
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Labelling

This document does not exist in this language (English). You can find it in another language below.
Spanish (PDF)
Published on: 22/02/2023
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Combined File of all Documents

English (PDF)
Published on: 29/09/2024
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