Approval · Notice of Compliance 31246 · 2023
TRODELVY: Notice of Compliance 31246
Issued July 19, 2023
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
- 31246
- Date
- July 19, 2023
- 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: TRODELVY (sacituzumab govitecan) is indicated for: - the treatment of adult patients with unresectable locally advanced or metastatic hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative (IHC 0, IHC 1+ or IHC 2+/ISH-) breast cancer who have receive endocrinebased therapy and at least two additional systemic therapies in the metastatic setting.
Products in this notice
| Brand | DIN | Status today |
|---|---|---|
| TRODELVY | Not yet assigned | — |
Medicinal ingredients
- SACITUZUMAB GOVITECAN 180 MG per VIAL