Betafuse 1 mg/g + 5 mg/g gel for dogs
Betafuse 1 mg/g + 5 mg/g gel for dogs
Authorised
- Betamethasone valerate
- Fusidic acid hemihydrate
Product identification
Medicine name:
Betafuse 1 mg/g + 5 mg/g gel for dogs
Active substance:
- Betamethasone valerate
- Fusidic acid hemihydrate
Target species:
-
Dog
Route of administration:
-
Cutaneous use
Product details
Active substance and strength:
-
Betamethasone valerate1.21/milligram(s)1.00gram(s)
-
Fusidic acid hemihydrate10.17/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:
-
Netherlands
Package description:
- White polyethylene coated aluminium tubes of 30 g closed with a polypropylene cap.
- White polyethylene coated aluminium tubes of 15 g closed with a polypropylene cap.
Additional information
Entitlement type:
-
Marketing Authorisation
Legal basis of product authorisation:
-
Hybrid application (Article 13(3) of Directive No 2001/82/EC)
Marketing authorisation holder:
- Norbrook Laboratories (Ireland) Limited
Marketing authorisation date:
Manufacturing sites for batch release:
- Norbrook Laboratories Limited
- Norbrook Manufacturing Limited
Responsible authority:
- Medicines Evaluation Board
Authorisation number:
- REG NL 117880
Date of authorisation status change:
Reference member state:
-
Ireland
Procedure number:
- IE/V/0558/001
Concerned member states:
-
Austria
-
Belgium
-
Denmark
-
Estonia
-
Finland
-
Germany
-
Greece
-
Italy
-
Latvia
-
Lithuania
-
Netherlands
-
Portugal
-
Spain
-
Sweden
-
United Kingdom (Northern Ireland)
To consult adverse reactions on veterinary medicinal products please go to www.adrreports.eu/vet
