CANESPOR Cream Ref.[50290] Active ingredients: Bifonazole

Source: Health Products Regulatory Authority (IE)  Revision Year: 2018  Publisher: Bayer Limited, The Atrium, Blackthorn Road, Dublin 18, Ireland

Product name and form

Canespor 10 mg/g Cream.

Pharmaceutical Form

Cream.

White cream.

Qualitative and quantitative composition

Contains bifonazole 1% w/w. 1 g of cream contains 10 mg bifonazole.

Excipient(s) with known effect:

Cetostearyl alcohol 100 mg/g
Benzyl alcohol 20mg/g

For the full list of excipients, see section 6.1.

Active Ingredient Description
Bifonazole

Bifonazole is an imidazole derivative with a broad antimycotic spectrum, which includes dermatophytes, yeasts, moulds and other fungi such as Malassezia furfur. It is also effective against Corynebacterium minutissimum.

List of Excipients

Benzyl alcohol
Cetostearyl alcohol
Cetyl palmitate
Octyldodecanol
Polysorbate 60
Purified water
Sorbitan stearate

Pack sizes and marketing

Aluminium tube with inner lacquer (epoxy phenolic resin) and polyethylene (PE) screw cap. A membrane is also included to guarantee the first opening of the tube.

Pack sizes of 20 g or 30 g.

Not all pack sizes may be marketed.

Marketing authorization holder

Bayer Limited, The Atrium, Blackthorn Road, Dublin 18, Ireland

Marketing authorization dates and numbers

PA1410/083/001

Date of first authorisation: 9th March 2018

Drugs

Drug Countries
CANESPOR Finland, Croatia, Ireland, Poland, Romania, South Africa

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