AMOROL amorolfine 5% w/v (as hydrochloride) nail lacquer application bottle
Country: Australia
Language: English
Source: Department of Health (Therapeutic Goods Administration)
Public Assessment Report
(PAR)
27-11-2017
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Active ingredient:
amorolfine hydrochloride, Quantity: 55.7 mg/mL
Available from:
Arrotex Pharmaceuticals Pty Ltd
INN (International Name):
amorolfine hydrochloride
Pharmaceutical form:
Application
Composition:
Excipient Ingredients: triacetin; ammonio methacrylate copolymer; ethanol; butyl acetate; ethyl acetate
Administration route:
Topical
Units in package:
5mL, 2.5mL
Prescription type:
(S2) Pharmacy Medicine
Therapeutic indications:
For the treatment of onychomycoses caused by dermatophytes, yeasts and moulds.
Product summary:
Visual Identification: Clear liquid; Container Type: Bottle; Container Material: Glass Type III Coloured; Container Life Time: 36 Months; Container Temperature: Store below 25 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert
Authorization status:
Licence status A
Authorization date:
2013-04-08
