Approval · Notice of Compliance 18077 · 2016
KEYTRUDA: Notice of Compliance 18077
Issued May 6, 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.
- Notice number
- 18077
- Date
- May 6, 2016
- Company
- Merck Canada IncKirkland, Quebec, Canada
- Product type
- Biologic
- Submission
- Supplement to a New Drug Submission (SNDS), supplement
- Submission class
- Priority
- Reason
- New indication: keytruda is indicated for the treatment of patients with unresectable of metastatic melanoma who have not received prior treatment with ipilimubab. subjects with braf v600 mutant melanomy may have received prior braf inhibitor therapy
Products in this notice
| Brand | DIN | Status today |
|---|---|---|
| KEYTRUDA | Not yet assigned | — |
Medicinal ingredients
- PEMBROLIZUMAB 50 MG per VIAL