Approval · Notice of Compliance 19115 · 2017
TARCEVA: Notice of Compliance 19115
Issued March 29, 2017
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
- 19115
- Date
- March 29, 2017
- Company
- Hoffmann-La Roche LimitedMississauga, Ontario, Canada
- Product type
- Prescription Pharmaceutical
- Submission
- Supplement to a New Drug Submission (SNDS), supplement
- Submission class
- Other
- Reason
- Revision to the maintenance indication for lacally advanced or metastatic non-small cell lung cancer (nsclc) based on the iuno study and saturn study results
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