Approval · Notice of Compliance 33057 · 2024
KEYTRUDA: Notice of Compliance 33057
Issued April 12, 2024
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
- 33057
- Date
- April 12, 2024
- Company
- Merck Canada IncKirkland, Quebec, Canada
- Product type
- Biologic
- Submission
- Supplement to a New Drug Submission (SNDS), supplement
- Submission class
- Other
- Reason
- New Indication: Biliary Tract Carcinoma: Keytruda, in combination with gemcitabine-based chemotherapy, is indicated for the treatment of adult patients with locally advanced unresectable or metastatic biliary tract carcinoma (BTC)
Products in this notice
| Brand | DIN | Status today |
|---|---|---|
| KEYTRUDA | Not yet assigned | — |
Medicinal ingredients
- PEMBROLIZUMAB 25 MG per ML