Cosmo announces submission of Winlevi® to the European Medicines Agency (EMA)
This filing marks a significant milestone in pipeline progression, as approval will open the substantial EU market to already selected, high-standing partners.
- This filing marks a significant milestone in pipeline progression, as approval will open the substantial EU market to already selected, high-standing partners.
- Cosmo has officially submitted the Marketing Authorisation Application (MAA) for its innovative acne treatment clascoterone 1% cream (Winlevi®) to the European Medicine Agency (EMA) through the centralized procedure, aimed at obtaining a single Marketing Authorization for the product in the European Union.
- The EMA's rigorous evaluation process will assess the product's safety, quality, and efficacy, ultimately determining its suitability for approval within the European market.
- This submission to the EMA is a pivotal step forward in our mission as well as a testament to our ongoing commitment to innovation.