Approval · Notice of Compliance 27396 · 2022
TECENTRIQ: Notice of Compliance 27396
Issued January 14, 2022
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
- 27396
- Date
- January 14, 2022
- Company
- Hoffmann-La Roche LimitedMississauga, Ontario, Canada
- Product type
- Biologic
- Submission
- Supplement to a New Drug Submission (SNDS), supplement
- Submission class
- Priority
- Reason
- Non-Small Cell Lung Cancer (NSCLC): TECENTRIQ as monotherapy, is indicated as adjuvant treatment following complete resection and no progression after platinum-based adjuvant chemotherapy for adult patients with Stage II to IIIA* NSCLC whose tumours have PD-L1 expression on ¿ 50% of tumour cells (TCs) (see Part II: 14 CLINICAL TRIALS). *According to American Joint Committee on Cancer [7th edition].
Products in this notice
| Brand | DIN | Status today |
|---|---|---|
| TECENTRIQ | Not yet assigned | — |
Medicinal ingredients
- ATEZOLIZUMAB 1,200 MG per 20ML
- ATEZOLIZUMAB 840 MG per 14ML