Approval · Notice of Compliance 36698 · 2025
BENLYSTA: Notice of Compliance 36698
Issued December 23, 2025
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
- 36698
- Date
- December 23, 2025
- Company
- Glaxosmithkline IncMississauga, Ontario, Canada
- Product type
- Biologic
- Submission
- Supplement to a New Drug Submission (SNDS), supplement
- Submission class
- Other
- Reason
- Indication extension: Benlysta is indicated in addition to standard therapy for: • reducing disease activity in adult and pediatric patients aged 5 years and older with active, autoantibody-positive, systemic lupus erythematosus (SLE). • treatment of active lupus nephritis in adult and pediatric patients aged 5 years and older.
Products in this notice
| Brand | DIN | Status today |
|---|---|---|
| BENLYSTA | Not yet assigned | — |