CURANAIL Medicated nail lacquer Ref.[49838] Active ingredients: Amorolfine

Source: Health Products Regulatory Authority (IE)  Revision Year: 2019  Publisher: Galderma International S.A.S., Tour Europlaza, La Défense 4, 20 Avenue André Prothin, France

Product name and form

Curanail 5% w/v medicated nail lacquer.

Pharmaceutical Form

Medicated nail lacquer.

A clear colourless to almost colourless liquid.

Qualitative and quantitative composition

Curanail nail lacquer contains 5% w/v (50 mg/ml) amorolfine in the form of amorolfine hydrochloride.

For the full list of excipients, see section 6.1.

Active Ingredient Description
Amorolfine

Amorolfine is a broad spectrum antimycotic. Amorolfine belongs to a new chemical class, and its fungicidal action is based on an alteration of the fungal cell membrane targeted primarily on sterol biosynthesis. The ergosterol content is reduced, and at the same time unusual sterically nonplanar sterols accumulate.

List of Excipients

Ammonio methacrylate copolymer type A (EUDRAGIT RL100)
Triacetin
Butyl acetate
Ethyl acetate
Ethanol anhydrous

Pack sizes and marketing

Amber glass type I bottle with screw thread and plastic screw closure 2.5 ml-glass bottle with accessories (30 nail files, 30 cleaning swabs, 30 applicators).

or

Amber glass type III bottle with screw thread and plastic screw closure with integretated applicator. 1.25 ml or 2.5 ml – glass bottle with accessories (nail files, cleaning swabs, applicator)

Not all pack sizes may be marketed.

Marketing authorization holder

Galderma International S.A.S., Tour Europlaza, La Défense 4, 20 Avenue André Prothin, France

Marketing authorization dates and numbers

PA22743/004/001

Date of first authorisation: 16th March 2012
Date of last renewal: 27th August 2014

Drugs

Drug Countries
CURANAIL Hong Kong, Ireland

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