Byooviz Injection, Solution
Product Images NDC 64406-019

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.

FDA Label Image

Figure (Sb11 01)

An instructional illustration showing the process of vial needle cap removal or preparation for extracting medication. The left side depicts a vial with a needle pointing downward above it, while the right side shows a vial tilted and a needle attached at an angle to the vial's cap.*

FDA Label Image

Figure (Sb11 02)

An instructional illustration showing a syringe being removed from a vial. An arrow indicates the direction for pulling the syringe out of the vial, suggesting a step in the preparation or drawing process for an injectable medication.*

FDA Label Image

Figure (Sb11 03)

An instructional illustration showing the assembly steps of a syringe with a needle. The sequence depicts placing and securing a needle onto the syringe barrel by aligning, twisting, and lifting the needle cap off the syringe.*

FDA Label Image

Figure (Sb11 04)

An instructional illustration showing two hands adjusting or holding a syringe, likely related to preparation or administration of an intravitreal injection. One hand holds the syringe steady while the other hand is positioned near the syringe plunger, indicating a manual action such as tapping or pressing.*

FDA Label Image

Figure (Sb11 05)

An instructional diagram showing an injection syringe with a needle and a plunger. The syringe volume is marked to indicate a 0.05 mL dose, highlighted with an arrow pointing to the level on the syringe barrel.*

FDA Label Image

Figure 1 (Sb11 06)

Two line graphs labeled AMD-1 and AMD-2 showing mean change in visual acuity in letters over 24 months. Each graph has two lines; one shows a positive change and the other a negative change, with the positive lines ending near +6.6 and +10.7 letters, respectively, and the negative lines ending near -14.9 and -9.8 letters.*

FDA Label Image

Figure (Sb11 07)

Byooviz 10 mg/mL intravitreal injection solution carton label. The label indicates the product contains ranibizumab-nuna and is manufactured by Biogen Inc. The packaging features a white background with blue and green design elements and includes usage information. The NDC 64406-019 is visible.*

FDA Label Image

Figure (Sb11 08)

Byooviz 10 mg/mL injection, solution in a vial for intravitreal use. The blue and white vial label shows the brand name Byooviz, active ingredient ranibizumab-nuna, along with concentration and dosing form information. The label includes manufacturer Biogen Inc. and dosage instructions in small print.*

FDA Label Image

Figure (Sb11 09)

Chemical structure of ranibizumab-nuna shown as a molecular diagram with connected atoms and bonds, representing the active ingredient in Byooviz 10 mg/mL injection solution by Biogen Inc.*

FDA Label Image

Figure (Sb11 10)

Byooviz 10 mg/mL injection, solution in a vial for intravitreal use. The label displays the product name, strength, dosage form, route, labeler BIOGEN INC., and storage information on a white background with black text and blue highlights.*

FDA Label Image

Figure 2 (Sb11 11)

A line graph titled 'AMD-3' showing mean change in visual acuity (letters) over 12 months. The y-axis represents mean change in letters from -20 to 10, and the x-axis shows time in months from 0 to 12. Two data series are plotted: one with squares showing stable or improving visual acuity near zero, and another with circles indicating a decline reaching approximately -16 letters by month 12.*

FDA Label Image

Figure (Sb11 12)

Byooviz 10 mg/mL injection, solution in a vial, intended for intravitreal use. The label shows the product name, dosage strength, and administration route. It includes labeling information indicating it is a human prescription drug by Biogen Inc., with the NDC 64406-019.*

FDA Label Image

Figure (Sb11 13)

Byooviz 10 mg/mL injection, solution in a vial for intravitreal use. The clear vial has a white label with black text, showing the product name Byooviz, and displays the strength 10 mg/mL. The vial is labeled by Biogen Inc.*

FDA Label Image

Figure 3 (Sb11 14)

A line chart titled 'AMD-4' showing mean change in visual acuity (letters) on the y-axis and months on the x-axis. Two data series represented by filled and open square markers track changes in visual acuity over a 24-month period, with final values noted as approximately 9.1 and 7.9 letters.*

FDA Label Image

Figure (Sb11 15)

Byooviz 10 mg/mL intravitreal injection, solution carton label. The packaging shows the proprietary name Byooviz and the active ingredient ranibizumab-nuna. The label displays the dosage strength of 10 mg/mL and identifies Biogen Inc. as the labeler. The product NDC 64406-019 is shown on the label along with standard packaging information.*

FDA Label Image

Figure (Sb11 16)

Byooviz 10 mg/mL intravitreal injection, solution in a carton box. The carton is primarily white with text in blue and gray. The label indicates the proprietary name Byooviz, generic name ranibizumab-nuna, concentration of 10 mg/mL, and that it is a human prescription drug. The labeler is Biogen Inc. The image shows the front and one side panel of the box.*

FDA Label Image

Figure 4 (Sb11 17)

A bar graph showing the distribution of the number of injections administered, with the x-axis labeled 'Number of Injections' ranging from 0 to 20, and the y-axis labeled 'Percentage of Patients (%)'. The graph notes a mean of 10.3 injections per patient and depicts varying patient percentages across injection counts.*

FDA Label Image

Figure 5 (Sb11 18)

Two line graphs labeled RVO-1 and RVO-2 show mean change in visual acuity (letters) over 6 months. Both graphs plot time (days and months) on the x-axis against mean change in visual acuity on the y-axis. RVO-1 shows a higher increase in visual acuity reaching +18.3 letters for one group and +7.3 letters for the other. RVO-2 shows a smaller increase with +14.9 letters for one group and +0.8 letters for the other.*

FDA Label Image

Figure (Sb11 19)

Byooviz 10 mg/mL injection, solution in an intravitreal dosage form. The image shows a single-use vial filled with clear liquid and labeled with product information including the proprietary name Byooviz and the concentration 10 mg/mL. The vial is part of the packaging supplied by Biogen Inc.*

FDA Label Image

Figure (Sb11 20)

Chemical structure of ranibizumab-nuna, the active ingredient in Byooviz injection solution. The image shows a molecular diagram representing the compound used in this human prescription drug dosed at 10 mg/mL and labeled by Biogen Inc.*

FDA Label Image

Figure (Sb11 21)

Byooviz 10 mg/mL injection, solution, intravitreal. The label shows the product name Byooviz and the strength 10 mg/mL. It is an injectable solution labeled for intravitreal use. The manufacturer is Biogen Inc. The label includes information such as lot number, expiration date, and storage conditions but these details are not fully legible in the image.*

FDA Label Image

Figure (Sb11 22)

Chemical structure of ranibizumab-nuna, the active ingredient in Byooviz 10 mg/mL intravitreal injection solution by Biogen Inc. The image displays the molecular structure with atoms and bonds represented in a schematic diagram.*

FDA Label Image

Figure 6 (Sb11 23)

A line graph comparing mean change in BCVA (Best Corrected Visual Acuity) from baseline over three months among three groups: Ranibizumab Group 1, Ranibizumab Group 2, and Control (vPDT). The y-axis shows mean change in letters (ETDRS), and the x-axis shows time in months. Both Ranibizumab groups show increased BCVA over time, while the control group shows minimal change.*

FDA Label Image

Principal Display Panel (0.5 mg Vial Carton)

Byooviz 0.5 mg (ranibizumab-nuna) injection carton label for a 0.5 mg single-dose vial. The label includes storage instructions to keep refrigerated and protect from light, manufacturer details for Biogen Inc. and Samsung Bioepis, dosage information, and indicated uses for conditions like wet age-related macular degeneration, retinal vein occlusion, and myopic choroidal neovascularization. The label also specifies intravitreal injection route and includes barcode and regulatory information.*

* About these descriptions: Image descriptions on this page are generated by automated AI analysis of the product label images from the manufacturer's FDA label submission (SPL). They are provided for reference only and may contain errors or omissions. Always rely on the printed label itself and the official FDA labeling, and consult a pharmacist or healthcare professional with any questions about this product.