Approval · Notice of Compliance 32102 · 2023
JEMPERLI: Notice of Compliance 32102
Issued November 15, 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
- 32102
- Date
- November 15, 2023
- Company
- Glaxosmithkline IncMississauga, Ontario, Canada
- Product type
- Biologic
- Submission
- Supplement to a New Drug Submission (SNDS), supplement
- Submission class
- Priority
- Reason
- New indication: Jemperli (dostarlimab for injection) is indicated in combination with carboplatin and paclitaxel for the treatment of adult patients with primary advanced or recurrent mismatch repair deficient (dMMR) /microsatellite instability-high (MSI-H) endometrial cancer who are candidates for systemic therapy.
Products in this notice
| Brand | DIN | Status today |
|---|---|---|
| JEMPERLI | Not yet assigned | — |
Medicinal ingredients
- DOSTARLIMAB 50 MG per ML