Approval · Notice of Compliance 28085 · 2022
KEYTRUDA: Notice of Compliance 28085
Issued May 4, 2022
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
- 28085
- Date
- May 4, 2022
- Company
- Merck Canada IncKirkland, Quebec, Canada
- Product type
- Biologic
- Submission
- Supplement to a New Drug Submission (SNDS), supplement
- Submission class
- Other
- Reason
- New Indication : KEYTRUDA in combination with lenvatinib, is indicated for the treatment of adult patients with advanced (not amenable to curative surgery or radiation) or metastatic RCC with no prior systemic therapy for metastatic RCC.
Products in this notice
| Brand | DIN | Status today |
|---|---|---|
| KEYTRUDA | Not yet assigned | — |
Medicinal ingredients
- PEMBROLIZUMAB 25 MG per ML
- PEMBROLIZUMAB 50 MG per VIAL