Approval · Notice of Compliance 9325 · 2008
NEXAVAR: Notice of Compliance 9325
Issued January 28, 2008
A Notice of Compliance is Health Canada’s approval of a drug submission: a new drug, a new use or form, or a change to an approved one. The product itself is in the Drug Product Database, with its current status.
- Notice number
- 9325
- Date
- January 28, 2008
- Company
- Bayer Inc.Elkhart, Indiana, United States
- Product type
- Prescription Pharmaceutical
- Submission
- Supplement to a New Drug Submission (SNDS), supplement
- Submission class
- Priority
- Reason
- New indication: treatment of patients with unresectable hepatocellular carcinoma (hcc)
- Therapeutic class
- Multikinase inhibitor, antineoplastic agent
Products in this notice
| Brand | DIN | Status today |
|---|---|---|
| NEXAVAR | Not yet assigned | — |
Medicinal ingredients
- SORAFENIB TOSYLATE 200 MG per TAB