Approval · Notice of Compliance 9412 · 2008
NEXAVAR: Notice of Compliance 9412
Issued March 3, 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.
Issued with conditions (NOC/c): the company must confirm the benefit in further studies.
- Notice number
- 9412
- Date
- March 3, 2008
- Company
- Bayer Inc.Elkhart, Indiana, United States
- Product type
- Prescription Pharmaceutical
- Submission
- Supplement to a New Drug Submission (SNDS), supplement
- Submission class
- Other
- Reason
- Revisions to the warnings and precautions, adverse reactions, dosage and administration, action and clinical pharmacology sections of the product monograph
- Therapeutic class
- Multikinase inhibitor - antineoplastic agent
- With conditions
- Yes (NOC/c)
Products in this notice
| Brand | DIN | Status today |
|---|---|---|
| NEXAVAR | Not yet assigned | — |
Medicinal ingredients
- SORAFENIB TOSYLATE 200 MG per TAB