Gilotrif Tablet, Film Coated
Product Images NDC 0597-0141

View Photos of Packaging, Regulatory Labels, and Product Appearance

Product Visual Gallery

This gallery contains 8 technical images submitted to the FDA as part of the official labeling for Gilotrif (NDC 0597-0141). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Boehringer Ingelheim Pharmaceuticals, 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

Gilotrif 01

FDA Label Image

Gilotrif 02

Gilotrif 02
This data appears to be from a medical or scientific study analyzing the efficacy of two treatments (Afatinib and Pe500+Cis75) on progression-free survival in terms of median time to an event in months. The hazard ratio suggests that Afatinib was more effective than Pe500+Cis75. The number at risk for each treatment at different time points is also provided.*
FDA Label Image

Gilotrif 03

Gilotrif 03
This is a description of the EGFR mutation categories. These categories are divided into Del 19/L858R, Del 19, and LBS8R with their respective number of cases. There is also data presented regarding the treatment with two medications, GILOTRIF and Pem/Cis, including the median progression-free survival (PFS) and median overall survival (OS). The PFS and OS of the two treatments are presented for each of the EGFR mutation categories. The chart and numerical data represent the efficacy of GILOTRIF and Pem/Cis, although there is no explanation of what these drugs are indicated for.*
FDA Label Image

Gilotrif 04

Gilotrif 04
The text appears to be a chart representing the Estimated OS probability and overall survival time (in months) for two treatments: Afatinib and Erlotinib. It also shows the number at risk for each time point under each treatment.*
FDA Label Image

Gilotrif 04a

FDA Label Image

Gilotrif 05

Gilotrif 05
The text appears to be a medication label for CYGILOTRIF, which contains afatinib tablets. The recommended storage conditions and precautions for dispensing and storing the medication are provided. The label also recommends consulting the package insert for dosage information and provides a contact number for more information.*
FDA Label Image

Gilotrif 06

Gilotrif 06
This document is a product information sheet for medication called Gilotrif (afatinib tablets), which comes in a container with 30 tablets. It provides instructions to keep the medication in its original container, protect it from exposure to light and humidity, and keep it out of reach of children. The usual dosage is not provided on the sheet but can be obtained from the package insert. The document also mentions the manufacturer and the distributor of the medication.*
FDA Label Image

Gilotrif 07

Gilotrif 07
The text is a medication label for Gilotrif, which contains 40 mg of afatinib in each tablet. The tablets should be stored at room temperature, away from high humidity and light, and out of reach of children. It is distributed by Boehringer Ingelheim Pharmaceuticals, Inc., and the recommended dosage is provided in the package insert.*

* These product label images have been analyzed using experimental machine learning. Please verify findings with the primary label text.