Approval · Notice of Compliance 23357 · 2020
KEYTRUDA: Notice of Compliance 23357
Issued March 16, 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
- 23357
- Date
- March 16, 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: KEYTRUDA as monotherapy is indicated for the first-line treatment of adults with metastatic non-small cell lung carcinoma (NSCLC) or stage Ill disease where patients are not candidates for surgical resection or definitive chemoradiation, expressing PD-L1 [Tumour Proportion Score (TPS) ¿1%] as determined by a validated test, with no EGFR or ALK genomic tumour aberrations.
Products in this notice
| Brand | DIN | Status today |
|---|---|---|
| KEYTRUDA | Not yet assigned | — |
Medicinal ingredients
- PEMBROLIZUMAB 50 MG per VIAL
- PEMBROLIZUMAB 100 MG per 4ML