The active principal Proveblue is compliant with the monograph of the European pharmacopoeia and to ICH Q3A standards on impurities in new active substances.
With is approval, Provepharm has got access to the markets of all 27 European Union countries, as well as the three countries linked to the EU (Norway, Iceland and Liechtenstein) for the approved product.
The marketing authorization allows the clinicians to treat with this injectable drug based on the active principal methylthioninium chloride Proveblue.