Notice of Compliance Information
From Health Canada
- Notice of Compliance date :
- 2022-08-18
- Manufacturer :
- BRISTOL-MYERS SQUIBB CANADA
- Product type:
- Biologic
- NOC with conditions:
- No
- Submission type:
- Supplement to a New Drug Submission (SNDS)
- Reason for supplement:
- New Indication Opdivo, in combination with platinum-doublet chemotherapy, is indicated for the neoadjuvant treatment of adult patients with resectable NSCLC (tumors ¿4 cm or node positive).
- Submission class:
- Priority
Brand 1 of 1 :
OPDIVO
Product 1 of 2 :
Drug identification number:
00000N/A
Dosage form(s):
Solution
Route(s) of administration:
Intravenous
| Ingredient | Strength |
|---|---|
| NIVOLUMAB | 100 MG/10ML |
Product 2 of 2 :
Drug identification number:
00000N/A
Dosage form(s):
Solution
Route(s) of administration:
Intravenous
| Ingredient | Strength |
|---|---|
| NIVOLUMAB | 40 MG/4ML |