Principal Display Panel (8 mL Vial Label)
This is a description of a pharmaceutical product by BioMarin Pharmaceutical Inc. The product is called "ROCTAVIAN" and is a suspension formulated for intravenous infusion. It is a single-dose treatment containing a specific gene therapy called "valoctocogene roxaparvovec-rvox." Each dose contains 16 x 10% vector genomes in 8 mL, with a concentration of 2 x 102 vector genomes/mL. The product is manufactured by BioMarin Pharmaceutical Inc. and is available in Novato, CA 94949, under the US License No. 1649.*