Approval · Notice of Compliance 33843 · 2024
PADCEV: Notice of Compliance 33843
Issued August 20, 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
- 33843
- Date
- August 20, 2024
- Company
- Seagen Inc.
- Product type
- Biologic
- Submission
- Supplement to a New Drug Submission (SNDS), supplement
- Submission class
- Priority
- Reason
- PADCEV (enfortumab vedotin for injection), in combination with pembrolizumab, is indicated for the treatment of adult patients with unresectable locally advanced or metastatic urothelial cancer (mUC) with no prior systemic therapy for mUC.
Products in this notice
| Brand | DIN | Status today |
|---|---|---|
| PADCEV | Not yet assigned | — |
Medicinal ingredients
- ENFORTUMAB VEDOTIN 20 MG per VIAL
- ENFORTUMAB VEDOTIN 30 MG per VIAL