CANDIPLAS Cream Ref.[28049] Active ingredients: Miconazole

Source: Υπουργείο Υγείας (CY)  Revision Year: 2015  Publisher: MEDOCHEMIE LTD, 1-10 Constantinoupoleos street, 3011 Limassol, Cyprus

Product name and form

Candiplas 2% w/w cream.

Pharmaceutical Form

Cream.

White, soft, homogeneous, smooth, odourless cream for topical application.

Qualitative and quantitative composition

Each 15g and 30g tube of cream contains miconazole nitrate 2% w/w.

Excipients with known effect: chlorocresol and cetostearyl alcohol (quantity).

Each 1g of Candiplas contains 1mg chlorocresol and 77mg cetostearyl alcohol.

For the full list of excipients, see section 6.1.

Active Ingredient Description
Miconazole

Miconazole possesses an antifungal activity against the common dermatophytes and yeasts as well as an antibacterial activity against certain gram-positive bacilli and cocci. Its activity is based on the inhibition of the ergosterol biosynthesis in fungi and the change in the composition of the lipid components in the membrane, resulting in fungal cell necrosis.

List of Excipients

Candiplas also contains:

Purified water
Chlorocresol
Cetomacrogol 1000
Cetostearyl alcohol
White petrolatum
Mineral oil
Sodium biphosphate
Phosphoric acid

Pack sizes and marketing

Lacquered pilfer proof collapsible aluminium tubes, crimped at bottom and sealed with a polypropylene screw cap containing 15g or 30g of cream, in a carton with a patient information leaflet.

Not all pack sizes may be marketed.

Marketing authorization holder

MEDOCHEMIE LTD, 1-10 Constantinoupoleos street, 3011 Limassol, Cyprus

Marketing authorization dates and numbers

19935

Date of first authorisation: 13/03/1990
Date of renewal authorization: 14/09/2011

Drugs

Drug Countries
CANDIPLAS Cyprus, Hong Kong, Singapore

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