Tafinlar Capsule
Product Images NDC 0078-0682

Product Visual Gallery

This gallery contains 7 technical images submitted to the FDA as part of the official labeling for Tafinlar (NDC 0078-0682). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Novartis Pharmaceuticals Corporation, 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

The Following Chemical Structure For Dabrafenib Mesylate Is A Kinase Inhibitor. The Chemical Name For Dabrafenib Mesylate Is N-{3-[5-(2-amino-4-pyrimidinyl)-2-(1,1-dimethylethyl)-1,3-thiazol-4-yl]-2-fluorophenyl}-2,6-difluorobenzene Sulfonamide, Methanesulfonate Salt. It Has The Molecular Formula C23h20f3n5o2s2•ch4o3s And A Molecular Weight Of 615.68. (Tafinlar 01)

Chemical structure of dabrafenib, the active ingredient in Tafinlar. The image shows the molecular components including sulfonamide and heterocyclic rings, alongside a methanesulfonic acid moiety.*

FDA Label Image

Figure 1. Kaplan-meier Curves Of Investigator-assessed Progression-free Survival In The Break-3 Study (Tafinlar 02)

A Kaplan-Meier plot showing probability of progression-free survival over months comparing Tafinlar (dabrafenib) and DTIC treatments. The solid line represents Tafinlar with median progression-free survival of 5.1 months, and the dashed line represents DTIC with median 2.7 months. The chart includes sample sizes, hazard ratio, confidence interval, and p-value indicating statistical significance.*

FDA Label Image

Figure 2. Kaplan-meier Curves For Overall Survival In The Combi-d Study (Tafinlar 03)

A Kaplan-Meier survival curve comparing Tafinlar plus Mekinist versus Tafinlar plus placebo in patients over time. The x-axis shows time from randomization in months, and the y-axis represents the proportion of patients alive. The graph includes median survival times and hazard ratio with confidence intervals for both treatment groups.*

FDA Label Image

Figure 3. Kaplan-meier Curves For Overall Survival In The Combi-v Study (Tafinlar 04)

A survival curve graph showing the proportion alive over time from randomization in months for two treatment groups: Tafinlar plus Mekinist versus Vemurafenib. The solid line represents Tafinlar plus Mekinist with median survival not reached, and the dashed line represents Vemurafenib with median survival of 17.2 months. The chart includes a hazard ratio, confidence interval, and p-value, along with a table of number at risk over time for both groups.*

FDA Label Image

Principal Display Panel (Tafinlar 05)

Label for Tafinlar (dabrafenib) Capsules 75 mg, oral dosage form in a 120-capsule package. Manufactured by Siegfried Barbera, S.L. and distributed by Novartis Pharmaceuticals Corporation. Includes dosage strength, storage instructions, and a note to dispense with a Medication Guide. Product of Singapore.*

FDA Label Image

Principal Display Panel (Tafinlar 06)

Label for Tafinlar (dabrafenib) Capsules 50 mg by Novartis Pharmaceuticals Corporation. The label indicates the bottle contains 120 oral capsules. It states each capsule contains 59.25 mg dabrafenib mesylate equivalent to 50 mg dabrafenib. Storage instructions and a caution about the safety seal under the cap are also visible.*

FDA Label Image

Tafinlar 07

A Kaplan-Meier survival curve chart showing the proportion of subjects alive and relapse-free over time in months comparing Tafinlar plus Mekinist treatment versus placebo. The chart includes the number of subjects at risk at various time points for both groups.*

* 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.