Approval · Notice of Compliance 314 · 2002
CASODEX: Notice of Compliance 314
Issued November 25, 2002
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
- 314
- Date
- November 25, 2002
- Company
- Astrazeneca Canada IncMississauga, Ontario, Canada
- Product type
- Prescription Pharmaceutical
- Submission
- Supplement to a New Drug Submission (SNDS), supplement
- Submission class
- Other
- Reason
- New indication: for immediate therapy in some patients with localized (T1-T2) prostate cancer who are inappropriate for surgery or radiotherapy; new strength: 150mg
- Therapeutic class
- Non-steroidal antiandrogen
- With conditions
- Yes (NOC/c)
Products in this notice
| Brand | DIN | Status today |
|---|---|---|
| CASODEX | 02246768 | — |
Medicinal ingredients
- BICALUTAMIDE 150 MG per TAB