Approval · Notice of Compliance 22055 · 2019
KEYTRUDA: Notice of Compliance 22055
Issued April 11, 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.
Issued with conditions (NOC/c): the company must confirm the benefit in further studies.
- Notice number
- 22055
- Date
- April 11, 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 is indicated for the treatment of patients with locally advanced unresectable or metastatic urothelial carcinoma, as monotherapy, in adults who are not eligible for cisplatin-containing chemotherapy and whos tumors express pd-la [combined positive score (cps) >10] as determined by a validated test, or in adults who are not eligible for any platinum-containing chemotherapy regardless of pd-L1 status
- With conditions
- Yes (NOC/c)
Products in this notice
| Brand | DIN | Status today |
|---|---|---|
| KEYTRUDA | Not yet assigned | — |
Medicinal ingredients
- PEMBROLIZUMAB 50 MG per VIAL
- PEMBROLIZUMAB 25 MG per ML