Register of
Medicinal Products

Product class: Medicinal product with marketing authorization
Medicinal product class: Veterinary medicine
Name of medicinal product: Betafuse
Active substances:
Betamethasone+Fusidic acid
Estonian, English, Latin
ATC code: QD07CC80
Dosage form: gel
Strength: 1mg+5mg 1g
Legal status for supply*: Subject to medicinal prescription
Summary of product characteristics (SPC):  (last updated September 2, 2021)
Package information leaflet (PIL): EST  (last updated September 2, 2021)
Labelling:  (last updated September 2, 2021)
Indication: For the treatment of acute surface pyoderma in the dog, such as acute moist dermatitis (‘hot spots’) and intertrigo (skin fold dermatitis), caused by Gram-positive bacteria sensitive to fusidic acid.
Safety features: No
Marketing authorization holder: Norbrook Laboratories (Ireland) Limited 
Marketing authorization number: 1992 
Marketing authorization issued on: September 30, 2016 
Marketing authorization expires on: Unlimited 
Marketing authorization procedure type: Decentralised 
Assessment report:  (last updated February 7, 2017) 
Package code Name of medicinal product Dosage form Package Legal status Reimbursements Reference price Last imported PƤritolumaa Additional information
1693368  Betafuse  gel  1mg +5mg 1g 15g 1TK  Prescription      09.02.2023     
1693492  Betafuse  gel  1mg +5mg 1g 30g 1TK  Prescription           
Legal status for supply – medicinal product on medical prescription or not subject to medical prescription

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