Provepharm, a biotech start-up specialized in the development of pharmaceutical applications, reports it has received official marketing authorization for its Methylthioninium Chloride Proveblue from the European Medicines Agency.
Clinicians will be able to treat European patients with this injectable drug based on the active principal methylthioninium chloride Proveblue (TM) (or methylene blue).
The active principal Proveblue is the only methylene blue that is compliant with the monograph of the European pharmacopoeia and to ICH Q3A standards on impurities in new active substances. It is virtually free of metallic contaminants such as heavy metals, the company reports.
Securing European marketing approval for Provepharm in commercial development terms effectively gives the company access to the markets of all 27 European Union countries, as well as Norway, Iceland, and Liechtenstein.
Release Date: May 24, 2011
Filed Under: Drug Discovery