Fulvestrant Injection
Product Images NDC 0781-9055

Product Visual Gallery

This gallery contains 16 technical images submitted to the FDA as part of the official labeling for Fulvestrant (NDC 0781-9055). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Sandoz 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-1 (Fulvestrant Room Nvp 01)

An instructional diagram showing the steps to remove a cap or cover from a vial. It depicts a hand holding a syringe while twisting the vial cap, with labeled parts A, B, and C indicating components of the vial and cap.*

FDA Label Image

Figure-2 (Fulvestrant Room Nvp 02)

An instructional illustration showing how to prepare an injection by attaching a vial to a syringe. The image highlights loosening a cap from the vial and securing the vial onto the syringe with labeled parts A, B, and C presumably indicating specific components involved in the connection process.*

FDA Label Image

Figure 3.jpg (Fulvestrant Room Nvp 03)

Black and white line drawing showing two hands preparing an injection syringe. One hand holds the syringe barrel, and the other holds the needle or cap, illustrating the proper handling or assembly technique for an intramuscular injection.*

FDA Label Image

Figure 4.jpg (Fulvestrant Room Nvp 04)

An illustration diagram showing a medical device, likely an injection pen or injector, with highlights on the needle and parts of the mechanism used for administering the dose. The diagram emphasizes the needle tip and loading or activation components.*

FDA Label Image

Figure 5.jpg (Fulvestrant Room Nvp 05)

An illustration showing a hand holding a syringe with the cap being pulled off in an upward direction, indicating preparation of the injection.*

FDA Label Image

Structural Formula (Fulvestrant Room Nvp 06)

Chemical structure of fulvestrant, showing its steroid backbone with hydroxyl groups and a side chain containing sulfoxide and trifluoromethyl groups, consistent with its labeled active ingredient.*

FDA Label Image

Figure 6.jpg (Fulvestrant Room Nvp 07)

A line graph titled 'Progression Free Survival (ITT Population)' showing the proportion of patients progression free over time in months for Fulvestrant 250 mg and 500 mg doses. The graph includes survival curves with the 500 mg dose represented by a solid line and the 250 mg dose by a dashed line. Below the x-axis, the number of patients at risk is listed for both dosage groups over time.*

FDA Label Image

Figure 7.jpg (Fulvestrant Room Nvp 08)

A survival curve chart showing the proportion of patients alive over time in months for Fulvestrant dosages of 500 mg and 250 mg. The graph includes tick marks for censored observations and a table below indicating the number of patients at risk at various time points up to 80 months. The chart compares the survival outcomes for these two Fulvestrant dose groups.*

FDA Label Image

Figure 8.jpg (Fulvestrant Room Nvp 09)

A Kaplan-Meier curve showing the probability of progression-free survival (PFS) over time in months from randomisation. It compares two treatments: Fulvestrant 500 mg (solid line, N=230) and Anastrozole 1 mg (dashed line, N=232). The graph includes the number of patients at risk for each treatment group at various time points up to 39 months.*

FDA Label Image

Figure-9 (Fulvestrant Room Nvp 10)

A Kaplan-Meier survival curve chart depicting progression-free survival over time in months for two groups: patients treated with Fulvestrant plus palbociclib and patients treated with placebo plus palbociclib. The vertical axis represents the percentage of progression-free subjects, and the horizontal axis represents time in months. The chart includes patient numbers at risk at various time points.*

FDA Label Image

Figure-10 (Fulvestrant Room Nvp 11)

A survival curve plot depicting overall survival probability over time in months for two groups: Fulvestrant combined with palbociclib (solid line) and Fulvestrant combined with placebo (dashed line). The x-axis represents time in months up to 54 months, and the y-axis represents overall survival probability as a percentage. The chart includes a numerical table of patients at risk at various time points for each group.*

FDA Label Image

Figure 11.jpg (Fulvestrant Room Nvp 12)

A Kaplan-Meier progression-free survival probability graph comparing Fulvestrant plus Abemaciclib versus Fulvestrant plus Placebo over time (months). The y-axis shows progression-free survival probability (%) and the x-axis shows time in months, with patient risk numbers at intervals. The solid line represents Fulvestrant plus Abemaciclib, and the dashed line represents Fulvestrant plus Placebo, with censored observations indicated.*

FDA Label Image

Figure 12.jpg (Fulvestrant Room Nvp 13)

A Kaplan-Meier survival probability graph showing two treatment groups over time in months. The vertical axis represents survival probability (%) and the horizontal axis shows time in months up to 57 months. Two curves compare patients receiving Fulvestrant plus Abemaciclib (N=446) versus Fulvestrant plus Placebo (N=223), with censored observations marked. A table below lists the number of patients at risk at various time points for each group.*

FDA Label Image

Fig_13.jpg (Fulvestrant Room Nvp 14)

A Kaplan-Meier survival curve chart showing event-free probability (%) over time (months) for two groups: Fulvestrant + Ribociclib (N=484) and Fulvestrant + Placebo (N=242). The chart includes censoring times and a table below showing the number of patients still at risk at each time point up to 26 months.*

FDA Label Image

Fig_14.jpg (Fulvestrant Room Nvp 15)

A Kaplan-Meier event-free probability graph comparing two patient groups over 48 months: Fulvestrant plus Ribociclib versus Fulvestrant plus Placebo. The vertical axis shows event-free probability percentage, and the horizontal axis shows time in months. Patient numbers at risk for both groups are provided at intervals along the bottom.*

FDA Label Image

Carton (Fulvestrant Room Nvp 16)

Fulvestrant Injection 250 mg/5 mL (50 mg/mL) intramuscular injection by Sandoz Inc. The carton contains 2 single-dose prefilled syringes totaling 500 mg dosage. The label includes dosing instructions, storage conditions, alcohol content, and safety 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.