Byooviz Injection, Solution
Product Images NDC 64406-019

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Product Visual Gallery

This gallery contains 24 technical images submitted to the FDA as part of the official labeling for Byooviz (NDC 64406-019). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Biogen 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.

Product Images & Figures Index

FDA Label Image

Figure (Sb11 01)

Figure (Sb11 01)
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Figure 1 (Sb11 06)

Figure 1 (Sb11 06)
This is a chart showing the mean change in visual acuity, measured in letters, over a period of 24 months for AMD-2. The data is presented in a table with values ranging from -10 to 15. There is no indication of the units used for the measurement.*
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Figure (Sb11 07)

Figure (Sb11 07)
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Figure (Sb11 08)
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Figure (Sb11 09)
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Figure 2 (Sb11 11)

Figure 2 (Sb11 11)
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Figure (Sb11 12)
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Figure 3 (Sb11 14)

Figure 3 (Sb11 14)
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Figure (Sb11 15)
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Figure 4 (Sb11 17)

Figure 4 (Sb11 17)
This is a graph showcasing the distribution of the number of injections received by patients using the drug NB0. The horizontal axis shows the range of the number of injections administered, while the vertical axis shows the percentage of patients who received that specific number of injections. The mean number of injections administered is 10.3.*
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Figure 5 (Sb11 18)

Figure 5 (Sb11 18)
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Figure (Sb11 21)

Figure (Sb11 21)
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Figure (Sb11 22)
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Figure 6 (Sb11 23)

Figure 6 (Sb11 23)
This appears to be a table with some data related to a study involving a Ranibizumab Group 1, Ranibizumab Group 2, and a Control group. The numerals 15, 124, and 3 are likely related to some metrics used in the study, but not enough context is present to determine their exact meaning. The text "Mean change in BCVA from baseline" suggests that the study may be related to visual acuity, and "Letters ETDRS" could refer to a common measurement tool for grading visual impairment. Overall, without additional information, it is unclear what specific insights or conclusions can be drawn from this text.*
FDA Label Image

Principal Display Panel (0.5 mg Vial Carton)

Principal Display Panel (0.5 mg Vial Carton)
This is a description of a medicine called Byooviz. Byooviz is a 0.5mg single-dose vial, which contains ranibizumab-nuna. The vial is designed to deliver 0.05mL of 10mg/mL of ranibizumab-nuna aqueous solution, which includes 10mM histidine HCl, 10% a,a-trehalose dihydrate, and 0.01% polysorbate 20, and has a pH of 5.5. Byooviz is indicated for Neovascular (wet) age-related macular degeneration (AMD), Macular edema following retinal vein occlusion (RVO), Myopic choroidal neovascularization (CNV). The vial should be kept refrigerated and should be protected from light. The medicine is manufactured by Samsung Bioepis Co., Ltd., located in Incheon, Republic of Korea, and distributed by Biogen Inc.*

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