Veterinary Medicines

Isathal 10 mg/g eye drops, suspension for dogs

Authorised
  • Fusidic acid
  • Fusidic acid
Download as PDF

Product identification

Medicine name:
Isathal 10 mg/g eye drops, suspension for dogs
Isathal 10 mg/g kapljice za oko, suspenzija za pse
Active substance:
  • Fusidic acid
  • Fusidic acid
Target species:
  • Dog
Route of administration:
  • Ocular use

Product details

Active substance and strength:
  • Fusidic acid
    10.17
    milligram(s)
    /
    1.00
    gram(s)
  • Fusidic acid
    10.17
    milligram(s)
    /
    1.00
    gram(s)
Pharmaceutical form:
  • Eye drops, suspension
Anatomical therapeutic chemical veterinary (ATCvet) codes:
  • QS01AA13
Legal status of supply:
  • Veterinary medicinal product subject to veterinary prescription
Authorisation status:
  • Valid
Authorised in:
  • Slovenia
Package description:
  • 3 g tube in a cardboard box
  • 5 g tube in a cardboard box

Additional information

Entitlement type:
  • Marketing Authorisation
Legal basis of product authorisation:
  • Legal basis not covered by Directive 2001/82/EC
Marketing authorisation holder:
  • Dechra Veterinary Products A/S
Marketing authorisation date:
Manufacturing sites for batch release:
  • Leo Laboratories Limited
Responsible authority:
  • Agency For Medicinal Products And Medical Devices Of The Republic Of Slovenia
Authorisation number:
  • MR/V/0699/001
Date of authorisation status change:
Reference member state:
  • Denmark
Procedure number:
  • DK/V/0100/001
Concerned member states:
  • Austria
  • Croatia
  • Hungary
  • Italy
  • Portugal
  • Romania
  • Slovenia
  • Spain

Documents

Summary of Product Characteristics

This document does not exist in this language (English). You can find it in another language below.
Slovenian (PDF)
Published on: 7/03/2022
Download

Package Leaflet

This document does not exist in this language (English). You can find it in another language below.
Slovenian (PDF)
Published on: 7/03/2022
Download

Labelling

This document does not exist in this language (English). You can find it in another language below.
Slovenian (PDF)
Published on: 7/03/2022
Download

PI Isathal.pdf

English (PDF)
Published on: 25/01/2022
Download