Drug · DIN 02489783
ZEJULA
Authorized, but not sold for a year or more
Authorized, but the company reports it has not been sold in Canada for at least 12 months.
Status Dormant since October 26, 2024; first marketed January 9, 2020.
- Drug Identification Number (DIN)
- 02489783
- Company (DIN owner)
- Glaxosmithkline IncMississauga, Ontario, Canada
- Schedule
- Prescription
- Dosage form
- Capsule
- Route
- Oral
- Therapeutic class (ATC)
- Niraparib L01XK02
- Class
- Human
- Record last updated
- June 26, 2025
Active ingredients
As listed in the Drug Product Database.
| Ingredient | Strength | Per |
|---|---|---|
| NIRAPARIB (NIRAPARIB TOSYLATE) | 100 MG |
Notices of Compliance
Health Canada approvals that name this DIN.
- June 27, 2019: NOC 22331New Drug Submission (NDS)
Recalls and safety alerts that mention it
Health Canada’s recall notices do not carry licence numbers, so these are matched by name: notices whose title or product names “zejula”. A notice may cover another product or only some lots: read it to see what it covers.
- ZEJULA (niraparib) - Update on the Maintenance Treatment in Recurrent Ovarian, Fallopian Tube, or Primary Peritoneal Cancer in the Second or Later Line SettingFebruary 16, 2023 · Drugs · New safety information
Other DINs named ZEJULA
- DIN 02530031 · Marketed