Veterinary Medicines

Isathal 10 mg/g eye drops, suspension for dogs

Authorised
  • Fusidic acid
  • Fusidic acid
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Product identification

Medicine name:
Isathal 10 mg/g eye drops, suspension for dogs
Isathal 10 mg/g colírio, suspensão para cães.
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:
  • Portugal
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:
  • Directorate General For Food And Veterinary
Authorisation number:
  • 51279
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

PI Isathal.pdf

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