Product Details for: Roctavian Product Label Grayed out Product Label links indicate that there is no product label available for the product.
Product Label Grayed out Product Label links indicate that there is no product label available for the product.
| Product Number | Dosage Form | Route of Administration | Strength | Product Presentation | License Type | Proprietary Name | Marketing Status |
|---|---|---|---|---|---|---|---|
| 001 | Injection | Intravenous | 16X 10E13GENOMES PER ML | Single-Dose Vial | 351(a) | Roctavian | Rx |
Proper Name
valoctocogene roxaparvovec-rvox
BLA Number
125720
Applicant
Biomarin Pharmaceutical Inc.
Original Approval Date
June 29, 2023
Date of First Licensure