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)

FDA Label Image

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

FDA Label Image

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

FDA Label Image

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

FDA Label Image

Principal Display Panel (Tafinlar 05)

Each capsule contains 88.88 mg of dabrafenib mesylate, indicated for the treatment of patients with melanoma with BRAF V600E mutation as detected by an FDA-approved test. It is recommended to store the capsules at room temperature ranging from 20°C to 25°C (68°F to 77°F), with excursions permitted between 15°C to 30°C (59°F to 86°F). Dosage information is available in the accompanying USP Controlled Room Temperature label. The product is distributed by Hours Pharmaceuticals and manufactured in Singapore. Novartis owns the product trademark Tafinlar®.*

FDA Label Image

Principal Display Panel (Tafinlar 06)

This is a description of a medication called Dabrafenib Mesylate, which is available in capsules. Each capsule contains 59.25mg of the medication and should be stored at 20°C to 25°C (68°F to 77°F). It is equivalent to Afiniar and the dosage is S 50 MG. The container has a safety seal that should not be broken or missing. The information can be found on the packaging with the NDC number 0078-0682-66. The medication is manufactured by Novartis.*

FDA Label Image

Tafinlar 07

This appears to be a table or graph that shows the proportion of subjects who were alive and did not have a relapse over time, comparing a treatment with "TAFINLAR + MEKINIST" to a placebo. The table includes different time points (in months) and the number of subjects at risk at each time point. The graph shows the proportion of subjects over time for both treatment groups. The text does not provide any additional information regarding the context of the study or the conditions being treated.*

* 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.