Notice of Compliance Information
From Health Canada
- Notice of Compliance date :
- 2023-04-19
- Manufacturer :
- MERCK CANADA INC
- Product type:
- Biologic
- NOC with conditions:
- No
- Submission type:
- Supplement to a New Drug Submission (SNDS)
- Reason for supplement:
- New indication: Keytruda as monotherapy is indicated for the adjuvant treatment of adult patients with Stage IB (T2a >/- 4 cm), II, or IIIA NSCLC who have undergone complete resection and platinum-based chemotherapy.
- 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) |