Approval · Notice of Compliance 24784 · 2020
BAVENCIO: Notice of Compliance 24784
Issued December 10, 2020
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
- 24784
- Date
- December 10, 2020
- Company
- Emd Serono A Division Of Emd Inc CanadaMississauga, Ontario, Canada
- Product type
- Biologic
- Submission
- Supplement to a New Drug Submission (SNDS), supplement
- Submission class
- Priority
- Reason
- Expansion of indication: bavencio is indicated for the maintenance treatment of patients with unresectable locally advanced or metastatic urothelial carcinoma (uc) whose disease has not progressed following first-line platinum-based chemotherapy
Products in this notice
| Brand | DIN | Status today |
|---|---|---|
| BAVENCIO | Not yet assigned | — |
Medicinal ingredients
- AVELUMAB 20 MG per ML