WINLEVI Cream Ref.[116166] Active ingredients: Clascoterone

Source: European Medicines Agency (EU)  Revision Year: 2026  Publisher: Cassiopea S.p.A., Via C. Colombo, 1, Lainate, 20045, Milan, Italy

Product name and form

Winlevi 10 mg/g cream.

Pharmaceutical Form

Cream.

White to almost white cream.

Qualitative and quantitative composition

Each gram of cream contains 10 mg of clascoterone.

Excipients with known effect:

Each gram of cream contains 25 mg of cetyl alcohol and 250 mg of propylene glycol (E1520).

For the full list of excipients, see section 6.1.

Active Ingredient

Clascoterone is an androgen receptor inhibitor. In vitro studies showed that it potently antagonizes the effects of androgens in primary human sebocytes to reduce sebum production and accumulation and inflammatory mediators which are known drivers of the acne pathogenesis.

List of Excipients

Cetyl alcohol
Citric acid monohydrate (E330) (for pH-adjustment)
Glycerol monostearate 40-55 Type I
Liquid paraffin
Polysorbate 80
Propylene glycol (E1520)
Purified water
Disodium edetate
all-rac-α-tocopherol (E307)

Pack sizes and marketing

Epoxy-lined aluminium tube with a polypropylene screw cap.

Pack sizes: tubes of 10 g, 30 g or 60 g.

Not all pack sizes may be marketed.

Marketing authorization holder

Cassiopea S.p.A., Via C. Colombo, 1, Lainate, 20045, Milan, Italy

Marketing authorization dates and numbers

EU/1/25/1927/001
EU/1/25/1927/002
EU/1/25/1927/003

Drugs

Drug Countries
WINLEVI Austria, Estonia, Lithuania, United Kingdom, United States

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