Veterinary Medicines

Fugasol 10 mg/ml oral solution for cats

Authorised
  • Itraconazole
Download as PDF

Product identification

Medicine name:
Fugasol 10 mg/ml oral solution for cats
Fugasol vet 10 mg/ml oraaliliuos kissalle
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:
  • Finland
Package description:
  • Cardboard box with 1 HDPE vial of 25 ml and an oral syringe of 3 ml as dosing device.
  • Cardboard box with 1 HDPE vial of 100 ml and an oral syringe of 3 ml as dosing device.
  • Cardboard box with 1 glass vial of 50 ml and an oral syringe of 3 ml as dosing device.
  • Cardboard box with 1 HDPE vial of 50 ml and an oral syringe of 3 ml as dosing device.
  • Cardboard box with 1 glass vial of 100 ml and an oral syringe of 3 ml as dosing device.
  • Cardboard box with 1 glass vial of 25 ml and an oral syringe of 3 ml as dosing device.

Additional information

Entitlement type:
  • Marketing Authorisation
Legal basis of product authorisation:
  • Generic application (Article 13(1) of Directive No 2001/82/EC)
Marketing authorisation holder:
  • CP-Pharma Handelsgesellschaft mbH
Marketing authorisation date:
Manufacturing sites for batch release:
  • CP-Pharma Handelsgesellschaft mbH
Responsible authority:
  • Finnish Medicines Agency
Authorisation number:
  • 40257
Date of authorisation status change:
Reference member state:
  • Netherlands
Procedure number:
  • NL/V/0374/001
Concerned member states:
  • Austria
  • Belgium
  • Denmark
  • Estonia
  • Finland
  • France
  • Germany
  • Hungary
  • Ireland
  • Italy
  • Latvia
  • Lithuania
  • Poland
  • Portugal
  • 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: 5/06/2024
Download

Package Leaflet

This document does not exist in this language (English). You can find it in another language below.
Finnish (PDF)
Published on: 5/06/2024
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."