Approval · Notice of Compliance 12144 · 2011
TARCEVA: Notice of Compliance 12144
Issued March 11, 2011
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
- 12144
- Date
- March 11, 2011
- 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: As monotherapy for maintenance treatment in patients with locally advanced or metastatic non-small cell lung cancer with stable disease after 4 cycles of standard platinum-based first-line chemotherapy
- Therapeutic class
- Epidermal growth factor receptor 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