Roctavian
Product Images NDC 68135-927

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Product Visual Gallery

This gallery contains 2 technical images submitted to the FDA as part of the official labeling for Roctavian (NDC 68135-927). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Biomarin Pharmaceutical Inc., these visuals offer a comprehensive scientific overview of the product's physical and chemical identity, aiding pharmacists and researchers in product verification and study.

FDA Label Image

Principal Display Panel (8 mL Vial Label)

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.*
FDA Label Image

Principal Display Panel (8 mL Vial Carton)

* These product label images have been analyzed using experimental machine learning. Please verify findings with the primary label text.