Approval · Notice of Compliance 30004 · 2023
KEYTRUDA: Notice of Compliance 30004
Issued January 25, 2023
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
- 30004
- Date
- January 25, 2023
- Company
- Merck Canada IncKirkland, Quebec, Canada
- Product type
- Biologic
- Submission
- Supplement to a New Drug Submission (SNDS), supplement
- Submission class
- Other
- Reason
- Fulfillment of commitments a (i) and a (ii) of the Letter of Undertaking dated October 27, 2021 issued under SNDS control number 246373, for the following indication: Triple-Negative Breast Cancer: KEYTRUDA, in combination with chemotherapy, is indicated for the treatment of adult patients with locally recurrent unresectable or metastatic triple-negative breast cancer (TNBC), who have not received prior chemotherapy for metastatic disease and whose tumors express PD-L1 (Combined Positive Score [CPS] ¿ 10) as determined by a validated test.
Products in this notice
| Brand | DIN | Status today |
|---|---|---|
| KEYTRUDA | Not yet assigned | — |
Medicinal ingredients
- PEMBROLIZUMAB 25 MG per ML