Chemical Structure (Yulithira 01)
Yulithira Tablet
Product Images NDC 82249-613
View Photos of Packaging, Regulatory Labels, and Product Appearance
Product Visual Gallery
This gallery contains 9 technical images submitted to the FDA as part of the official labeling for Yulithira (NDC 82249-613). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.
As provided by Civicascript, 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.
Product Images & Figures Index
Figure 1 (Yulithira 02)
This text provides information on the Jon-free survival probability, hazard ratio, Kaplan-Meier medians, and logrank p-value for a study comparing Everolimus 10 mg + exemestane with a placebo + exemestane. The results show a significantly longer median survival time for the Everolimus group compared to the placebo group. The hazard ratio of 0.45 suggests a lower risk of an event in the Everolimus group. The provided time axis shows censoring times and the duration of the study in months.*
Figure 2 (Yulithira 03)
This is a statistical analysis report showing a hazard ratio of 0.35 with a 95% confidence interval between 0.27 and 0.45. The Logrank p-value is less than 0.001, indicating a statistically significant result. The Kaplan-Meier medians for Everolimus and Placebo groups are 11.04 months and 4.60 months respectively. The study included 207 participants in the Everolimus group and 203 participants in the Placebo group. Censoring times were observed throughout the study period of up to 28 months.*
Figure 3 (Yulithira 04)
This is a table displaying the probabilities (%) of event-free time (in months) for patients receiving Everolimus + BSC compared to Placebo + BSC. The table shows the number of patients still at risk over different time points. The data reveals how many patients remain event-free at each time interval, providing insights into the efficacy of the treatments.*
Figure 4 (Yulithira 05)
This text provides information on a medical study including probability percentages, hazard ratio, 95% confidence intervals, Logrank p-value, Kaplan-Meier medians for Everolimus and Placebo, as well as censoring times for the study groups. The hazard ratio was found to be 0.33 with a 95% confidence interval of [0.25, 0.43]. The Logrank p-value was less than 0.0001, indicating a significant difference between the two groups. The Kaplan-Meier median survival times were 4.9 months for Everolimus and 1.9 months for Placebo. The study involved 277 participants in the Everolimus group and 139 participants in the Placebo group.*
Principal Display Panel (2.5 mg Tablet Bottle Label)
This text provides information about the dosage instructions, storage conditions, and manufacturer details of a medication containing 2.5 mg everolimus tablets. The medication should be stored between 15°C (59°F) and 30°C (86°F), protected from light and moisture. It is intended for oral use and should be kept out of the reach of children. The product is distributed by CivicaScript, LLC, with manufacturing information from Breckenridge Pharmaceuticals and Natco Pharma Ltd in India. Additional details include package insert information and a QR code for further information.*
Principal Display Panel (5 mg Tablet Bottle Label)
Principal Display Panel (7.5 mg Tablet Bottle Label)
Dosage instructions and storage information for everolimus tablets are provided in the package insert with details on where to find more information. The tablets should be stored within a specific temperature range to maintain their effectiveness. The product is distributed by CivicaScript and contains 7.5 mg of everolimus per tablet. It is intended for oral use, and each package contains 30 tablets.*
Principal Display Panel (10 mg Tablet Bottle Label)
This text provides information about the dosage, storage instructions, and distribution details for a medication called Everolimus. It includes details on the temperature for storage (20°C to 25°C), precautions against light and moisture, and the importance of keeping the drug out of children's reach. The text also mentions the manufacturing details, such as the company names (CivicaScript, Breckenridge Pharmaceutical, Natco Pharma Ltd.), made in India, and the quantity (30 tablets) along with the Lot and expiration date. It suggests referring to the package insert for dosage details and provides a website link for more information.*
* These product label images have been analyzed using experimental machine learning. Please verify findings with the primary label text.
