Approval · Notice of Compliance 13530 · 2012
TARCEVA: Notice of Compliance 13530
Issued July 20, 2012
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
- 13530
- Date
- July 20, 2012
- Company
- Hoffmann-La Roche LimitedMississauga, Ontario, Canada
- Product type
- Prescription Pharmaceutical
- Submission
- Supplement to a New Drug Submission (SNDS), supplement
- Submission class
- Other
- Reason
- New indication: Is indicated as monotherapy for the first-line treatment of patients with locally advanced (stage III b) not amenable to curative therapy) or metastatic (stage IV) nono-mall cell lung cancer (NSCLC) eith EFGR activating mutations
- Therapeutic class
- Epidermal Growth Factor Receptor (EGFR) Tyrosine Kinase Inhibitor
Products in this notice
| Brand | DIN | Status today |
|---|---|---|
| TARCEVA | Not yet assigned | — |
Medicinal ingredients
- ERLOTINIB HYDROCHLORIDE 25 MG per TAB
- ERLOTINIB HYDROCHLORIDE 100 MG per TAB
- ERLOTINIB HYDROCHLORIDE 150 MG per TAB