Approval · Notice of Compliance 10885 · 2009
IRESSA: Notice of Compliance 10885
Issued December 18, 2009
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
- 10885
- Date
- December 18, 2009
- 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 the first line treatment of patients with locally advanced (not amenable to curative therapy) or metastatic non-small cell lung cancer (NSCLC) who have activating mutations of the EGFR-TK
- Therapeutic class
- Epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor (TKI)
Products in this notice
| Brand | DIN | Status today |
|---|---|---|
| IRESSA | Not yet assigned | — |
Medicinal ingredients
- GEFITINIB 250 MG per TAB