Approval · Notice of Compliance 17987 · 2016
KEYTRUDA: Notice of Compliance 17987
Issued April 15, 2016
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.
Issued with conditions (NOC/c): the company must confirm the benefit in further studies.
- Notice number
- 17987
- Date
- April 15, 2016
- 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 is indicated for the treatment of patients with metastatic non-small cell lung carcinoma (nsclc) whose tumours express pd-l-1 (as determined by a validated test, see dosage and administration) and who have disease progression on or after platinum-containing chemotherapy. patients with egfr or alk genomic tumour aberrations should have disease progression on authorized therapy for these aberrations prior to receiving keytruda.
- With conditions
- Yes (NOC/c)
Products in this notice
| Brand | DIN | Status today |
|---|---|---|
| KEYTRUDA | Not yet assigned | — |
Medicinal ingredients
- PEMBROLIZUMAB 50 MG per VIAL