Veterinary Medicines

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

Authorised
  • Betamethasone valerate
  • Fusidic acid
Download as PDF

Product identification

Medicine name:
Isaderm 5 mg/g + 1 mg/g gel for dogs
ISADERM 5 mg/g + 1 mg/g gel pentru caini
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:
  • Romania
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 Control Of Biological Products And Veterinary Medicines
Authorisation number:
  • 190194
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

Summary of Product Characteristics

English (PDF)
Published on: 3/05/2024
Download
Romanian (PDF)
Published on: 14/06/2022
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."