Approval · Notice of Compliance 38312 · 2026
ZEJULA: Notice of Compliance 38312
Issued September 17, 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
- 38312
- Date
- September 17, 2026
- Company
- Glaxosmithkline IncMississauga, Ontario, Canada
- Product type
- Prescription Pharmaceutical
- Submission
- Supplement to a New Drug Submission (SNDS), supplement
- Submission class
- Other
- Reason
- Change in the manufacturing process for the drug substance. Addition of a manufacturing site and/or manufacturer involving production of the drug substance
Products in this notice
| Brand | DIN | Status today |
|---|---|---|
| ZEJULA | Not yet assigned | — |
Medicinal ingredients
- NIRAPARIB TOSYLATE 100 MG per TAB
- NIRAPARIB TOSYLATE 100 MG per CAP