Approval · Notice of Compliance 18547 · 2016
XTANDI: Notice of Compliance 18547
Issued September 30, 2016
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
- 18547
- Date
- September 30, 2016
- Company
- Astellas Pharma Canada IncMarkham, Ontario, Canada
- Product type
- Prescription Pharmaceutical
- Submission
- Supplement to a New Drug Submission (SNDS), supplement
- Submission class
- Other
- Reason
- Update to the product monograph with data from new drug-drug interaction studies, a hepatic impairment study and final overall survival results from the prevail study
Products in this notice
| Brand | DIN | Status today |
|---|---|---|
| XTANDI | Not yet assigned | — |
Medicinal ingredients
- ENZALUTAMIDE 40 MG per CAP