Approval · Notice of Compliance 29758 · 2022
TECENTRIQ: Notice of Compliance 29758
Issued December 21, 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
- 29758
- Date
- December 21, 2022
- Company
- Hoffmann-La Roche LimitedMississauga, Ontario, Canada
- Product type
- Biologic
- Submission
- Supplement to a New Drug Submission (SNDS), supplement
- Submission class
- Other
- Reason
- Fulfillment of commitments 2a of the Letter of Undertaking dated August 20, 2019 issued under SNDS control number 223911, for the following indication: Locally Advanced or Metastatic Triple-Negative Breast Cancer (TNBC) TECENTRIQ in combination with nab-paclitaxel is indicated for the treatment of adult patients with unresectable locally advanced or metastatic triple-negative breast cancer (TNBC) whose tumours have PD-L1 expression on tumour-infiltrating immune cells (IC) covering ¿ 1% of the tumour area, and who have not received prior chemotherapy for metastatic disease. Do not replace nab-paclitaxel with paclitaxel, in combination with TECENTRIQ , when treating patients with unresectable locally advanced or metastatic TNBC.
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