Approval · Notice of Compliance 29485 · 2022
TECARTUS: Notice of Compliance 29485
Issued November 16, 2022
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
- 29485
- Date
- November 16, 2022
- Company
- Gilead Sciences Canada IncMississauga, Ontario, Canada
- Product type
- Biologic
- Submission
- Supplement to a New Drug Submission (SNDS), supplement
- Submission class
- Priority
- Reason
- New indication and new strength: for the treatment of adult patients with relapsed or refractory B-cell precursor acute lymphoblastic leukemia (ALL)
Products in this notice
| Brand | DIN | Status today |
|---|---|---|
| TECARTUS | 02532719 | Marketed |
| TECARTUS | Not yet assigned | — |
Medicinal ingredients
- BREXUCABTAGENE AUTOLEUCEL 100,000,000 CELLS per BAG
- BREXUCABTAGENE AUTOLEUCEL 2,000,000 CELLS per BAG