Minivelle Film, Extended Release
Product Images NDC 68968-6637

Product Visual Gallery

This gallery contains 17 technical images submitted to the FDA as part of the official labeling for Minivelle (NDC 68968-6637). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

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

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Estradiol Usp (Minivelle Figure 1)

Chemical structure diagram of estradiol, the active ingredient in Minivelle transdermal film. The structure shows the arrangement of its atoms and bonds, including hydroxyl groups and the steroid backbone characteristic of estradiol.*

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Figure D (Minivelle Figure 10)

An instructional illustration showing two hands peeling apart a transdermal film, demonstrating the method to remove the Minivelle estradiol extended-release film from its protective backing before application to the skin.*

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Figures E And F (Minivelle Figure 11)

Illustration showing application sites for the Minivelle estradiol transdermal extended-release film. Figure E depicts placement on the lower back/upper buttock area, while Figure F shows placement on the lower abdomen. Both illustrations demonstrate hand positioning when applying the film to the skin.*

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Figure G (Minivelle Figure 12)

An instructional illustration depicting the application of a transdermal film. The image shows hands placing the film onto the lower abdominal area, demonstrating the proper placement and adherence of the medication patch to the skin.*

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Trade Carton 0.025mg (Minivelle Figure 13)

Packaging label for Minivelle 0.025 mg/day estradiol transdermal film extended release. The label indicates it is a human prescription drug manufactured by Noven Pharmaceuticals, Inc. and distributed by Noven Therapeutics, LLC in Miami, Florida. The package includes eight systems and features dosage and application schedule instructions.*

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Carton 0.0375mg (Minivelle Figure 14)

Minivelle 0.0375 mg/day estradiol transdermal system packaging label. The box is white with teal and pink text, featuring dosage strength prominently. It includes the product name, dosage form as film extended release, labeler Noven Therapeutics, LLC, and instructions for twice-weekly application. The package contains 8 systems and specifies storage and usage information.*

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Carton 0.05mg (Minivelle Figure 15)

Packaging label for Minivelle estradiol transdermal system, delivering 0.05 mg/day. The label shows a twice-weekly film patch with extended-release dosage. It includes directions for patch application days, manufacturer and distributor information (Noven Pharmaceuticals, Inc. and Noven Therapeutics, LLC, Miami, Florida), and states the package contains 8 systems. The label features teal and pink text and a floral pattern design.*

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Carton 0.075mg (Minivelle Figure 16)

Minivelle 0.075 mg/day estradiol transdermal system box label with extended-release film patches. The packaging includes instructions for application scheduling and lists contents as 8 systems. Manufactured by Noven Pharmaceuticals, Inc. and distributed by Noven Therapeutics, LLC, Miami, Florida. The label notes the system delivers 0.075 mg/day of estradiol and emphasizes storage and use precautions.*

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Carton 0.1mg (Minivelle Figure 17)

Minivelle 0.1 mg/day estradiol transdermal system film extended release carton label. Contains 8 systems for twice-weekly prescription use. Manufactured by Noven Pharmaceuticals, Inc. and distributed by Noven Therapeutics, LLC, Miami, Florida. Includes application schedule instructions and storage guidance.*

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Layers Of Minivelle (Minivelle Figure 2)

An instructional diagram showing the layers of the Minivelle estradiol transdermal film, extended release. It identifies three layers: (1) Backing, (2) Adhesive containing estradiol, and (3) Protective liner.*

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Figure 1: Mean Baseline-uncorrected Estradiol Serum Concentration-time Profiles Following A Single Dose Of Minivelle 0.1 mg Per Day (treatment A), 0.05 mg Per Day (treatment B), And 0.025 mg Per Day ( (Minivelle Figure 3)

A line graph depicting serum concentration (pg/mL) over time (days) for Minivelle estradiol transdermal film at three different doses: 0.1 mg/day, 0.05 mg/day, and 0.025 mg/day. The graph shows initial baseline concentrations, a rapid increase after day 0, peak levels, and a decline back to baseline by day 5, with higher doses reaching higher peak serum estradiol concentrations.*

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Figure 2: Mean (sd) Change From Baseline In Mean Daily Number Of Hot Flushes For Vivelle 0.0375 mg Versus Placebo In A 12 Week Trial. (Minivelle Figure 4)

A bar chart comparing mean (SD) reduction from baseline over 12 weeks between Minivelle 0.0375 mg/day and placebo groups. Data show greater reduction with Minivelle at weeks 4, 8, and 12, with statistically significant differences noted between Minivelle and placebo.*

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Figure 3: Bone Mineral Density – Ap Lumbar Spine (Minivelle Figure 5)

A line graph illustrating the percent change from baseline over time across four treatment durations (weeks 26, 52, 78, and 104). It compares five groups: Minivelle (estradiol) at 0.1 mg/day, 0.05 mg/day, 0.0375 mg/day, 0.025 mg/day, and placebo, tracking their values throughout the study period.*

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Figure 4 Bone Mineral Density (Femoral neck)

A line graph showing percent change from baseline over treatment duration (weeks 26, 52, 78, and 104) for Minivelle estradiol transdermal film at four dosage strengths (0.1 mg/day, 0.05 mg/day, 0.0375 mg/day, and 0.025 mg/day) compared to placebo. The plot illustrates dose-related changes over time, with statistical significance annotations for comparisons against placebo.*

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Figure A (Minivelle Figure 7)

An instructional diagram showing components of the Minivelle estradiol transdermal system packaging. It includes the carton, a calendar for patch application tracking, patient information and package insert (PI/PPI), and a pouch containing the individual estradiol patch. This layout aids in proper use and adherence to the prescribed transdermal hormone therapy.*

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Figure B (Minivelle Figure 8)

An instructional diagram showing use of the Minivelle estradiol transdermal system patient enrollment or registration form. A hand is shown filling out the form inside a box labeled Minivelle instructional transdermal system with guidance to read enclosed patient information before use.*

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Figure C (Minivelle Figure 9)

Illustration showing hands opening a foil pouch labeled Minivelle, which contains a transdermal estradiol extended-release film. The image depicts the process of peeling open the package to access the medication inside.*

* 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.