Archive · 18 Nov 2025
Glenmark, Cosmo Get EU Approval for Winlevi Acne Treatment
Two pharmaceutical companies, Glenmark and Cosmo, have been given permission by the European Union to sell their new acne cream, Winlevi, in 15 different European countries.
This is a big deal for Glenmark because it's the first new medicine they've launched in Europe.
Winlevi can be used by both adults and teenagers, but teenagers can only use it on their face.
Glenmark Pharmaceuticals Ltd and Cosmo Pharmaceuticals N.V. received EU approval for Winlevi (clascoterone 10 mg/g cream) for acne vulgaris treatment
The approval covers 15 European countries, including France, Spain, and Sweden
Winlevi is the first new chemical entity (NCE) launch by Glenmark in Europe
It's authorized for use in both adults and adolescents aged 12 to 18, with facial application only for adolescents
The approval follows a positive opinion from the European Medicines Agency's CHMP
- Who
- Glenmark Pharmaceuticals Ltd and Cosmo Pharmaceuticals N.V.
- What
- Received EU approval for Winlevi (clascoterone 10 mg/g cream) for acne vulgaris treatment
- When
- November 18, 2025
- Where
- European Union (15 countries)
- Why
- To treat acne vulgaris
- Active Ingredient
- Clascoterone 10 mg/g
- Indication
- Acne vulgaris
- Age Group
- Adults and adolescents aged 12 to 18
- Application
- Facial application for adolescents
- Countries
- Bulgaria, Czech Republic, Denmark, Finland, France, Hungary, Iceland, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Spain, Sweden