Veterinary Medicines

Isaderm 5 mg/g + 1 mg/g gel for dogs

Authorised
  • Fusidic acid
  • Betamethasone valerate
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Product identification

Medicine name:
Isaderm 5 mg/g + 1 mg/g gel for dogs
Isaderm 5 mg/g + 1 mg/g, gel za pse
Active substance:
  • Fusidic acid
  • Betamethasone valerate
Target species:
  • Dog
Route of administration:
  • Cutaneous use

Product details

Active substance and strength:
  • Fusidic acid
    5.00
    milligram(s)
    /
    1.00
    gram(s)
  • Betamethasone valerate
    1.21
    milligram(s)
    /
    1.00
    gram(s)
Pharmaceutical form:
  • Gel
Withdrawal period by route of administration:
  • Cutaneous use
    • Dog
Anatomical therapeutic chemical veterinary (ATCvet) codes:
  • QD07CC01
Legal status of supply:
  • Veterinary medicinal product subject to veterinary prescription
Authorisation status:
  • Valid
Authorised in:
  • Croatia
Package description:
  • Internally lacquered aluminium tubes of 30 g closed with a white HDPE screw cap.
  • Internally lacquered aluminium tubes of 15 g closed with a white HDPE screw cap.

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:
  • Dechra Veterinary Products A/S
Marketing authorisation date:
Manufacturing sites for batch release:
  • Genera d.d.
Responsible authority:
  • Ministry Of Agriculture Veterinary And Food Safety Directorate
Authorisation number:
  • UP/I-322-05/19-01/359
Date of authorisation status change:
Reference member state:
  • Ireland
Procedure number:
  • IE/V/0496/001
Concerned member states:
  • Austria
  • Belgium
  • Bulgaria
  • Croatia
  • Czechia
  • Denmark
  • Estonia
  • Finland
  • Germany
  • Greece
  • Italy
  • Latvia
  • Lithuania
  • Netherlands
  • Norway
  • Poland
  • Portugal
  • Romania
  • Slovakia
  • Slovenia
  • Spain
  • United Kingdom (Northern Ireland)

Documents

Summary of Product Characteristics

English (PDF)
Published on: 28/01/2022
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Croatian (PDF)
Published on: 21/03/2022
Download
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