This brand name is authorized in United States. It is also authorized in Austria, Brazil, Canada, Croatia, Estonia, Finland, France, Hong Kong SAR China, Ireland, Israel, Italy, Japan, Lithuania, Netherlands, New Zealand, Poland, Spain, Turkey, UK.
The drug ZEJULA contains one active pharmaceutical ingredient (API):
1
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UNII
HMC2H89N35 - NIRAPARIB
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Niraparib is an inhibitor of poly(ADP-ribose) polymerase (PARP) enzymes, PARP-1 and PARP-2, which play a role in DNA repair. |
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Below package inserts are available for further reading:
| Document | Type | Information Source | |
|---|---|---|---|
| ZEJULA Hard capsule | MPI, EU: SmPC | European Medicines Agency (EU) |
This drug has been classified in the anatomical therapeutic chemical (ATC) classification system as follows:
| ATC Group | Classification | |
|---|---|---|
| L01XK02 | L Antineoplastic and immunomodulating agents → L01 Antineoplastic agents → L01X Other antineoplastic agents → L01XK Poly (ADP-ribose) polymerase (PARP) inhibitors | |
This drug has been assigned below unique identifiers within the countries it is being marketed:
| Country | Identification scheme | Identifier(s) |
|---|---|---|
| BR | Câmara de Regulação do Mercado de Medicamentos | 510621060058102, 510621060058202 |
| CA | Health Products and Food Branch | 02489783 |
| EE | Ravimiamet | 1757022, 1771590, 1771602, 1849901, 1885114, 1885125, 1885136 |
| ES | Centro de información online de medicamentos de la AEMPS | 1171235001 |
| FI | Lääkealan turvallisuus- ja kehittämiskeskus | 126552, 543349 |
| FR | Base de données publique des médicaments | 67707919 |
| GB | Medicines & Healthcare Products Regulatory Agency | 350175, 350176, 383741, 383743 |
| HK | Department of Health Drug Office | 65945, 67238 |
| IE | Health Products Regulatory Authority | 89065 |
| IL | מִשְׂרַד הַבְּרִיאוּת | 8457 |
| IT | Agenzia del Farmaco | 045690017, 045690029, 045690031, 045690043, 045690056 |
| JP | 医薬品医療機器総合機構 | 4291068F1028, 4291068M1027 |
| LT | Valstybinė vaistų kontrolės tarnyba | 1084492, 1084939, 1084940 |
| NL | Z-Index G-Standaard, PRK | 149284 |
| NZ | Medicines and Medical Devices Safety Authority | 21948 |
| PL | Rejestru Produktów Leczniczych | 100398198 |
| TR | İlaç ve Tıbbi Cihaz Kurumu | 8699522099559, 8699522099566, 8699522154203, 8699522154210, 8699522154227 |
| US | FDA, National Drug Code | 69656-103 |
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