ONYTEC Medicated nail lacquer Ref.[49848] Active ingredients: Ciclopirox olamine

Source: Health Products Regulatory Authority (IE)  Revision Year: 2018  Publisher: Polichem S.A., 50, Val Fleuri, L-1526 Luxembourg, Luxembourg

Product name and form

Onytec 80mg/g medicated nail lacquer.

Pharmaceutical Form

Medicated nail lacquer.

Clear, colourless to slightly yellowish solution.

Qualitative and quantitative composition

One gram of medicated nail lacquer contains 80 mg of ciclopirox.

Excipient with known effect: 10 mg cetostearyl alcohol / g solution.

For the full list of excipients, see section 6.1.

Active Ingredient Description
Ciclopirox olamine

Ciclopirox is a hydroxypyridone antifungal agent which is active in vitro inhibiting the growth of various fungal species including the yeast Malassezia furfur (formerly known as Pityrosporum ovale or Pityrosporum orbiculare).

List of Excipients

Ethyl acetate
Ethanol (96%)
Cetostearyl alcohol
Hydroxypropyl-chitosan
Purified water

Pack sizes and marketing

Clear glass bottles with polypropylene screw caps which are fitted with a brush.

Pack sizes: 3.3 ml, 6.6 ml.

Not all pack sizes may be marketed.

Marketing authorization holder

Polichem S.A., 50, Val Fleuri, L-1526 Luxembourg, Luxembourg

Marketing authorization dates and numbers

PA1005/002/001

Date of first authorisation: 28th September 2012
Date of latest renewal: 14th March 2017

Drugs

Drug Countries
ONYTEC Estonia, Finland, France, Ireland, Lithuania

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