Re-approval and marketing authorisation from German regulatory authorities (BfArM) of a herbal medicinal product which has been classified as a NCE and the notification from the FDA in the US where it is available since 2010. The preclinical and clinical research and development programme for this medication was set-up in 2002 and conducted by HRS on behalf of the pharmaceutical manufacturer. HRS developed the patents for the use of this medication also in additional indications. This product is now marketed abroad world-wide by HRS who coordinates the regulatory requirements including pharmacovigilance.
