Notice of Compliance Information
From Health Canada
- Notice of Compliance date :
- 2024-02-06
- Manufacturer :
- MERCK CANADA INC
- Product type:
- Biologic
- NOC with conditions:
- No
- Submission type:
- Supplement to a New Drug Submission (SNDS)
- Reason for supplement:
- Keytruda, in combination with trastuzumab, fluoropyrimidine and platinum-containing chemotherapy, is indicated for the first-line treatment of adult patients with locally advanced unresectable or metastatic HER2 positive gastric or gastroesophageal junction (GEJ) adenocarcinoma, whose tumors express PD-L1 (Combined Positive Score [CPS] ¿1) as determined by a validated test.
- Submission class:
- Other
Brand 1 of 1 :
KEYTRUDA
Product 1 of 1 :
Drug identification number:
00000N/A
Dosage form(s):
Solution
Route(s) of administration:
Intravenous
| Ingredient | Strength |
|---|---|
| PEMBROLIZUMAB | 25 MG/ML (calculated as base) |