Approval · Notice of Compliance 24428 · 2020
KEYTRUDA: Notice of Compliance 24428
Issued October 9, 2020
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
- 24428
- Date
- October 9, 2020
- Company
- Merck Canada IncKirkland, Quebec, Canada
- Product type
- Biologic
- Submission
- Supplement to a New Drug Submission (SNDS), supplement
- Submission class
- Other
- Reason
- New indication: head and neck cancer. keytruda is indicated for the first-line treatment of metastatic or unresectable recurrent head and neck squamous cell carcinoma (hnscc) as monotherapy in adult patients whose tumours have pd-l1 expression (combined positive score [cps] >1) as determined by a validated test. keytruda is indicated for the first-line treatment of metastatic or unresectable recurrent head and neck squamous cell carcinoma (hnscc) in combination with platinum and fluorouracil (fu) chemotherapy in adult patients
Products in this notice
| Brand | DIN | Status today |
|---|---|---|
| KEYTRUDA | Not yet assigned | — |
Medicinal ingredients
- PEMBROLIZUMAB 25 MG per ML