Approval · Notice of Compliance 16877 · 2015
XTANDI: Notice of Compliance 16877
Issued April 15, 2015
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
- 16877
- Date
- April 15, 2015
- Company
- Astellas Pharma Canada IncMarkham, Ontario, Canada
- Product type
- Prescription Pharmaceutical
- Submission
- Supplement to a New Drug Submission (SNDS), supplement
- Submission class
- Priority
- Reason
- New iindication: for the treatment of metastatic castration-resistant prostate cancer (crpc) in patients who are chemotherapy-naïve with asymptomatic or mildly symptomatic disease after failure of androgen deprivation therapy
- Therapeutic class
- Anti-androgen
Products in this notice
| Brand | DIN | Status today |
|---|---|---|
| XTANDI | Not yet assigned | — |
Medicinal ingredients
- ENZALUTAMIDE 40 MG per CAP