Approval · Notice of Compliance 14811 · 2013
STIVARGA: Notice of Compliance 14811
Issued October 4, 2013
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
- 14811
- Date
- October 4, 2013
- Company
- Bayer Inc.Elkhart, Indiana, United States
- Product type
- Prescription Pharmaceutical
- Submission
- Supplement to a New Drug Submission (SNDS), supplement
- Submission class
- Other
- Reason
- New indication: for treatment of adult patients with metastatic and/or unresectable gastrointestinal stromal tumour (gist) who have had desease progression on or intolerance to imatinib mesylate and sunitnib maleate treatment
- Therapeutic class
- Multikinase inhibitor, antineoplastic
Products in this notice
| Brand | DIN | Status today |
|---|---|---|
| STIVARGA | Not yet assigned | — |
Medicinal ingredients
- REGORAFENIB 40 MG per TAB