US Distribution Update
This overview provides an update to financial markets and CLINUVEL’s owners on the distribution plan of SCENESSE® in the United States, following marketing authorization granted by the US Food and Drug Administration (FDA) on 08 October 2019. Comprehensive information is publicly disclosed while various parts of knowhow and expertise are retained for commercial reasons. The update is provided in lay terms for all stakeholders to learn about SCENESSE® and its use in the United States.
National authorities do not allow content to be made available which can be interpreted as promotion and which would be in breach of relevant legislation, including, but not limited to:
The Human Medicines Regulation (2012; UK), the Federal Food, Drug, and Cosmetic Act (1938) and Title 21 of the Code of Federal Regulations Part 202 (USA), the Geneesmiddelenwet (Dutch Medicines Act), and the Arzneimittelgesetz and Heilmittelwerbegesetz (German Drug Law and Act on Advertising in the Field of Health,