Veterinary Medicines

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

Authorised
  • Betamethasone valerate
  • Fusidic acid hemihydrate
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Product identification

Medicine name:
Betafuse 1 mg/g + 5 mg/g gel for dogs
Betafuse 1 mg/g + 5 mg/g, gel per cani
Active substance:
  • Betamethasone valerate
  • Fusidic acid hemihydrate
Target species:
  • Dog
Route of administration:
  • Topical 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
Withdrawal period by route of administration:
  • Topical 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:
  • Italy
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:
  • Ministry Of Health
Authorisation number:
  • 104942
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)

Documents

Combined File of all Documents

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Italian (PDF)
Published on: 19/12/2022
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Summary of Product Characteristics

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