This brand name is authorized in United States. It is also authorized in Australia, Austria, Brazil, Canada, Croatia, Cyprus, Ecuador, Estonia, France, Hong Kong SAR China, Ireland, Israel, Italy, Japan, Lithuania, Mexico, Netherlands, New Zealand, Nigeria, Poland, Romania, Singapore, South Africa, Spain, Tunisia, Turkey, UK.
The drug ZYTIGA contains one active pharmaceutical ingredient (API):
1
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UNII
EM5OCB9YJ6 - ABIRATERONE ACETATE
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Abiraterone acetate is converted in vivo to abiraterone, an androgen biosynthesis inhibitor. Specifically, abiraterone selectively inhibits the enzyme 17α-hydroxylase/C17,20-lyase (CYP17). This enzyme is expressed in and is required for androgen biosynthesis in testicular, adrenal and prostatic tumour tissues. CYP17 inhibition also results in increased mineralocorticoid production by the adrenals. |
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Below package inserts are available for further reading:
| Document | Type | Information Source | |
|---|---|---|---|
| ZYTIGA Tablet | MPI, EU: SmPC | European Medicines Agency (EU) | |
| ZYTIGA Film-coated tablet | MPI, EU: SmPC | Medicines & Healthcare Products Regulatory Agency (GB) |
This drug has been classified in the anatomical therapeutic chemical (ATC) classification system as follows:
| ATC Group | Classification | |
|---|---|---|
| L02BX03 | Abiraterone | L Antineoplastic and immunomodulating agents → L02 Endocrine therapy → L02B Hormone antagonists and related agents → L02BX Other hormone antagonists and related agents |
This drug has been assigned below unique identifiers within the countries it is being marketed:
| Country | Identification scheme | Identifier(s) |
|---|---|---|
| AU | Pharmaceutical Benefits Scheme | 11206T, 2698B |
| BR | Câmara de Regulação do Mercado de Medicamentos | 514512020025102, 514519020035403 |
| CA | Health Products and Food Branch | 02371065, 02457113 |
| EC | Agencia Nacional de Regulación, Control y Vigilancia Sanitaria | H2931212 |
| EE | Ravimiamet | 1539547, 1734757, 1734768 |
| ES | Centro de información online de medicamentos de la AEMPS | 111714003 |
| FR | Base de données publique des médicaments | 67337081 |
| GB | Medicines & Healthcare Products Regulatory Agency | 340657, 383807 |
| HK | Department of Health Drug Office | 61370, 65540 |
| IE | Health Products Regulatory Authority | 88019 |
| IL | מִשְׂרַד הַבְּרִיאוּת | 6934 |
| IT | Agenzia del Farmaco | 041427016, 041427028, 041427030 |
| JP | 医薬品医療機器総合機構 | 4291033F1024, 42910G0F1025 |
| LT | Valstybinė vaistų kontrolės tarnyba | 1061975, 1082037, 1082038 |
| MX | Comisión Federal para la Protección contra Riesgos Sanitarios | 241M2012 |
| NG | Registered Drug Product Database | A4-100495, B4-8220 |
| NL | Z-Index G-Standaard, PRK | 100846, 136913 |
| NZ | Medicines and Medical Devices Safety Authority | 15590, 18307 |
| PL | Rejestru Produktów Leczniczych | 100253258, 100380956 |
| RO | Agenția Națională a Medicamentului și a Dispozitivelor Medicale | W58139001, W63682001, W63682002 |
| SG | Health Sciences Authority | 14146P, 15345P |
| TN | Direction de la Pharmacie et du Médicament | 15273021H, 15273022H |
| TR | İlaç ve Tıbbi Cihaz Kurumu | 8699593015304, 8699593095450 |
| US | FDA, National Drug Code | 57894-150, 57894-195 |
| ZA | Health Products Regulatory Authority | 46/21.12/0379, 52/21.12/0284 |
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