Cosmo and Glenmark receive EC marketing authorization for Winlevi
Used in treatment of acne
Cosmo Pharmaceuticals N.V. and Glenmark Pharmaceuticals announced that the European Commission (EC) has granted Marketing Authorization (MA) for Winlevi (clascoterone 10 mg/g cream), following the positive opinion issued by the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) on 25 August 2025.
Winlevi is authorized in EU for the treatment of acne vulgaris in both adults and adolescents aged 12 to <18 years, with usage in adolescents limited to facial application. With receipt of this approval, Glenmark will initiate commercializing Winlevi across 15 countries in EU namely Bulgaria, the Czech Republic, Denmark, Finland, France, Hungary, Iceland, the Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Spain and Sweden.
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