AKEEGA® (niraparib/abiraterone) 100/500mg
Product Overview
| Generic Name | AKEEGA® (niraparib/abiraterone) 100/500mg |
| Brand Name(s) | AKEEGA® |
| Category | Antineoplastic / Cancer |
| Form | 60 Film-coated tablets; oral use |
| Strength | 100/500 mg |
| Therapeutic Class | Antineoplastic combination; PARP inhibitor + androgen biosynthesis inhibitor |
| ATC Code | L01XK52 |
Manufacturing & Regulatory
| Manufacturer | Janssen Biotech, Inc |
| GMP Compliance | WHO-GMP, EU-GMP |
| COFEPRIS | Under Registration (2025) |
| Free Sale Certificate | Yes, available as COPP/CPP |
Logistics & Export
| MOQ | 5 Units |
| Shelf Life | 30 Months |
| Storage | store at 20°C to 25°C |
| Incoterms | EXW 30049049 |
| Lead Time | 7 - 10 Business Days |
Documentation Available Upon Request
| Certificate of Analysis (PDF) | Manufacturer provides COA |
| SDS-Safety Data Sheet (PDF) | Upon Request, not publicly posted |
| CTD Summary (PDF) | Not publicly available as parallel traded molecule |
Special Notes
AKEEGA is a new fixed-dose combination (FDC) that combines:
- Niraparib (a PARP inhibitor; originally marketed as ZEJULA)
- Abiraterone acetate (a CYP17 inhibitor; originally marketed as ZYTIGA)
A fixed-dose oral oncology combination containing niraparib, a PARP inhibitor, and abiraterone acetate, a CYP17 androgen-biosynthesis inhibitor. It is used with prednisone or prednisolone for adult male patients with BRCA-mutated metastatic prostate cancer, including metastatic castration-resistant prostate cancer