Veterinary Medicines

Fuselieve 1 mg/g + 5 mg/g Gel for Dogs

Authorised
  • Betamethasone valerate
  • Fusidic acid hemihydrate
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Product identification

Medicine name:
Fuselieve 1 mg/g + 5 mg/g Gel for Dogs
Fuselieve 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 valerate
    1.21
    milligram(s)
    /
    1.00
    gram(s)
  • Fusidic acid hemihydrate
    10.17
    milligram(s)
    /
    1.00
    gram(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:
  • Ireland
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 Manufacturing Limited
  • Norbrook Laboratories Limited
Responsible authority:
  • Health Products Regulatory Authority
Authorisation number:
  • VPA22664/147/001
Date of authorisation status change:
Reference member state:
  • Ireland
Procedure number:
  • IE/V/0624/001
Concerned member states:
  • France
  • United Kingdom (Northern Ireland)

Documents

Summary of Product Characteristics

English (PDF)
Published on: 15/12/2024
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Combined File of all Documents

English (PDF)
Published on: 15/12/2024
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