Approval · Notice of Compliance 21963 · 2019
KEYTRUDA: Notice of Compliance 21963
Issued March 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
- 21963
- Date
- March 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 INDICATION: kEYTRUDA, IN COMBINATION WITH PEMETREXED AND PLATINUM CHEMOTHERAPY, IS INDICATED FOR THE TREATMENT OF METASTATIC NON-SQUAMOUS NSCLC IN ADULTS WITH NO EGFR OR ALK GENOMIC TUMOR ABERRATIONS, AND NO PRIOR SYSTEMIC CHAMOTHERAPY TREATMENT FOR METASTATIC NSCLC
Products in this notice
| Brand | DIN | Status today |
|---|---|---|
| KEYTRUDA | Not yet assigned | — |
Medicinal ingredients
- PEMBROLIZUMAB 50 MG per VIAL
- PEMBROLIZUMAB 25 MG per ML