Approval · Notice of Compliance 29813 · 2022
KEYTRUDA: Notice of Compliance 29813
Issued December 29, 2022
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
- 29813
- Date
- December 29, 2022
- Company
- Merck Canada IncKirkland, Quebec, Canada
- Product type
- Biologic
- Submission
- Supplement to a New Drug Submission (SNDS), supplement
- Submission class
- Other
- Reason
- Fulfillment of commitment 2a from the Letter of Undertaking dated March 04, 2019 issued under SNDS control number 209011 and revision of an indication: Keytruda is indicated for the treatment of adult patients with locally advanced unresectable or metastatic urothelial carcinoma, as monotherapy, who are not eligible for any platinum-containing chemotherapy.
Products in this notice
| Brand | DIN | Status today |
|---|---|---|
| KEYTRUDA | Not yet assigned | — |
Medicinal ingredients
- PEMBROLIZUMAB 50 MG per VIAL
- PEMBROLIZUMAB 25 MG per ML