Approval · Notice of Compliance 37779 · 2026
PADCEV: Notice of Compliance 37779
Issued June 26, 2026
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
- 37779
- Date
- June 26, 2026
- Company
- Pfizer Canada UlcKirkland, Quebec, Canada
- Product type
- Biologic
- Submission
- Supplement to a New Drug Submission (SNDS), supplement
- Submission class
- Priority
- Reason
- New indication: Padcev (enfortumab vedotin for injection), in combination with pembrolizumab, as neoadjuvant treatment and then continued after radical cystectomy as adjuvant treatment, is indicated for the treatment of adult patients with muscle invasive bladder cancer (MIBC) who are ineligible for cisplatin-containing chemotherapy.
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