Example: Nexavar - DRAFT
- Heiner Oberkampf
- Elisa Kendall
Owned by Heiner Oberkampf
Disclaimer
This example is for illustration purposes only. The data provided may not be up-to-date, and in some cases, 'dummy' data has been included. The product information included here shall not be used for any other purpose than for educational purposes regarding the IDMP-O implementation.
Introduction
Nexavar, co-developed by Bayer and Onyx Pharmaceuticals, is a drug that has been approved for the treatment of various cancers, and is presented as tablets containing 274 mg of sorafenib tosylate. As shown in the diagram below, the reference substance for sorafenib tosylate is sorafenib with a reference strength of 200 mg per tablet.
Related Competency Questions
| Question | Answer |
|---|---|
| What is the active ingredient in Nexavar? | Sorafenib tosylate |
| What is the strength of the active ingredient in Nexavar 200 mg tablet? | 274 mg / tablet |
| Reference substance for the BOSS definition in the product Nexavar? | Sorafenib |
| Reference strength of the BOSS in the product ? | 200 mg / tablet |
| What is the basis of strength for SORAFENIB TOSYLATE in the product NEXAVAR? | SORAFENIB |
| Is the strength of SORAFENIB mass-based or activity-based? | mass-based. (not in SPL, not in IDMP standard) |