Approval · Notice of Compliance 23010 · 2019
KEYTRUDA: Notice of Compliance 23010
Issued December 13, 2019
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
- 23010
- Date
- December 13, 2019
- Company
- Merck Canada IncKirkland, Quebec, Canada
- Product type
- Biologic
- Submission
- Supplement to a New Drug Submission (SNDS), supplement
- Submission class
- Other
- Reason
- New indicdation: keytruda is indicated for the treatment of patients with advanced or metastatic renal cell carcinoma (rcc) in combination with axitinib in adults with no prior systemic therapy for metastatic rcc
Products in this notice
| Brand | DIN | Status today |
|---|---|---|
| KEYTRUDA | Not yet assigned | — |
Medicinal ingredients
- PEMBROLIZUMAB 50 MG per VIAL
- PEMBROLIZUMAB 25 MG per ML