Approval · Notice of Compliance 19514 · 2017
KEYTRUDA: Notice of Compliance 19514
Issued July 12, 2017
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
- 19514
- Date
- July 12, 2017
- Company
- Merck Canada IncKirkland, Quebec, Canada
- Product type
- Biologic
- Submission
- Supplement to a New Drug Submission (SNDS), supplement
- Submission class
- Other
- Reason
- New indication: for the treatment of patients with metastatic non-small cell lung carcinoma (nsclc) as monotherapy, in adults whose tumour have high pd-l1 expression [tumor proportion score (tps) >50%)] as determined by a validated test, with no efgr or alk genomic tumour aberrations, and no prior systemic chemotherapy treatment for metastatic nsclc
Products in this notice
| Brand | DIN | Status today |
|---|---|---|
| KEYTRUDA | Not yet assigned | — |
Medicinal ingredients
- PEMBROLIZUMAB 100 MG per 4ML
- PEMBROLIZUMAB 25 MG per ML