9 months ago
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
- Where
- European Union (15 countries)
- When
- November 18, 2025
- Why
- To treat acne vulgaris
Key facts
- 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
Quotes
Christoph Stoller, President & Business Head, Europe and Emerging Markets, Glenmark Pharmaceuticals Ltd
Christoph Stoller is the President and Business Head of Europe and Emerging Markets for Glenmark Pharmaceuticals Ltd.
“The approval is a key milestone in executing our mission to become a research-led, global pharmaceutical company. Winlevi is the first NCE (new chemical entity) launch of Glenmark in Europe and is key to strengthening our presence in Dermatology in the region.”
thehindubusinessline.com
Giovanni Di Napoli, CEO, Cosmo Pharmaceuticals N.V.
Giovanni Di Napoli is the CEO of Cosmo Pharmaceuticals N.V.
“This approval reflects the strength of our collaboration with Glenmark and our shared commitment to advancing dermatologic care. Winlevi represents a first-in-class topical innovation that redefines how acne is treated, and we are excited to see it become accessible to patients throughout Europe.”
thehindubusinessline.com
Sources
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