Notice of Compliance Information
From Health Canada
- Notice of Compliance date :
- 2022-01-14
- Manufacturer :
- HOFFMANN-LA ROCHE LIMITED
- Product type:
- Biologic
- NOC with conditions:
- No
- Submission type:
- Supplement to a New Drug Submission (SNDS)
- Reason for supplement:
- 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].
- Submission class:
- Priority
Brand 1 of 1 :
TECENTRIQ
Product 1 of 2 :
Drug identification number:
00000N/A
Dosage form(s):
Solution
Route(s) of administration:
Intravenous
| Ingredient | Strength |
|---|---|
| ATEZOLIZUMAB | 1200 MG/20ML |
Product 2 of 2 :
Drug identification number:
00000N/A
Dosage form(s):
Solution
Route(s) of administration:
Intravenous
| Ingredient | Strength |
|---|---|
| ATEZOLIZUMAB | 840 MG/14ML |