AKEEGA DIN 02538563
Status: Marketed
Holder: JANSSEN INC
Health Canada record
| Active ingredient(s) | NIRAPARIB (NIRAPARIB TOSYLATE) 100 MG; ABIRATERONE ACETATE 500 MG |
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| Dosage form | Tablet |
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| Route | Oral |
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| Schedule | PRESCRIPTION |
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| Class | Human |
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| ATC | L01XK52 NIRAPARIB AND ABIRATERONE |
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| Original market date | 14-Aug-2023 |
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| Current status date | 14-Aug-2023 |
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| Source | Health Canada DPD |
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Establishment licence of the holder
Janssen Inc — licence 100239, currently licensed, last inspection rating C (2026-03-09).
No Canadian shortage report is currently matched to this DIN.
Other Canadian products containing NIRAPARIB (NIRAPARIB TOSYLATE)
| DIN | Product | Company | Form | Strength | Status |
|---|
| 02538555 | AKEEGA | JANSSEN INC | Tablet | NIRAPARIB (NIRAPARIB TOSYLATE) 50 MG; ABIRATERONE ACETATE 500 MG | Marketed |
| 02530031 | ZEJULA | GLAXOSMITHKLINE INC | Tablet | NIRAPARIB (NIRAPARIB TOSYLATE) 100 MG | Marketed |
| 02489783 | ZEJULA | GLAXOSMITHKLINE INC | Capsule | NIRAPARIB (NIRAPARIB TOSYLATE) 100 MG | Dormant |
Notices of Compliance
| NOC | Date | Submission | Reason |
|---|
| 30973 | 2023-06-12 | New Drug Submission (NDS) | |
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