Isaderm 5 mg/g + 1 mg/g gel for dogs
Isaderm 5 mg/g + 1 mg/g gel for dogs
Authorised
- Fusidic acid
- Betamethasone valerate
Product identification
Medicine name:
Isaderm 5 mg/g + 1 mg/g gel for dogs
Active substance:
- Fusidic acid
- Betamethasone valerate
Target species:
-
Dog
Route of administration:
-
Cutaneous use
Product details
Active substance and strength:
-
Fusidic acid5.00/milligram(s)1.00gram(s)
-
Betamethasone valerate1.21/milligram(s)1.00gram(s)
Pharmaceutical form:
-
Gel
Anatomical therapeutic chemical veterinary (ATCvet) codes:
- QD07CC01
Legal status of supply:
-
Veterinary medicinal product subject to veterinary prescription
Authorisation status:
-
Valid
Authorised in:
-
Belgium
Package description:
- Internally lacquered aluminium tubes of 15 g closed with a white HDPE screw cap.
- Internally lacquered aluminium tubes of 30 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:
- Federal Agency For Medicines And Health Products
Authorisation number:
- BE-V458880
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)
To consult adverse reactions on veterinary medicinal products please go to www.adrreports.eu/vet
Documents
Package Leaflet
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Labelling
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Combined File of all Documents
English (PDF)
Download Published on: 12/10/2025
