Veterinary Medicines

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

Authorised
  • Betamethasone valerate
  • Fusidic acid
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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 gél pre psy
Active substance:
  • Betamethasone valerate
  • Fusidic acid
Target species:
  • Dog
Route of administration:
  • Cutaneous use

Product details

Active substance and strength:
  • Betamethasone valerate
    1.21
    milligram(s)
    /
    1.00
    gram(s)
  • Fusidic acid
    5.00
    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:
  • Slovakia
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:
  • Institute For State Control Of Veterinary Biologicals And Medicaments
Authorisation number:
  • 96/070/DC/14-S
Date of authorisation status change:
Reference member state:
  • Ireland
Procedure number:
  • IE/V/0496/001
Concerned member states:
  • Belgium
  • Bulgaria
  • Croatia
  • Czechia
  • Greece
  • Italy
  • Netherlands
  • Norway
  • Poland
  • Portugal
  • Romania
  • Slovakia
  • Slovenia
  • United Kingdom (Northern Ireland)

Documents

Combined File of all Documents

This document does not exist in this language (English). You can find it in another language below.
Slovak (PDF)
Published on: 3/02/2022
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Summary of Product Characteristics

English (PDF)
Published on: 3/05/2024
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