This brand name is authorized in United States. It is also authorized in Australia, Austria, Brazil, Canada, Croatia, Cyprus, Ecuador, Estonia, Finland, France, Hong Kong SAR China, Ireland, Israel, Italy, Japan, Lithuania, Netherlands, New Zealand, Poland, Romania, Singapore, South Africa, Spain, Turkey, UK.
The drug XTANDI contains one active pharmaceutical ingredient (API):
1
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UNII
93T0T9GKNU - ENZALUTAMIDE
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Enzalutamide is a potent androgen receptor signalling inhibitor that blocks several steps in the androgen receptor signalling pathway. Enzalutamide treatment decreases the growth of prostate cancer cells and can induce cancer cell death and tumour regression. |
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Below package inserts are available for further reading:
| Document | Type | Information Source | |
|---|---|---|---|
| XTANDI Soft 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 | |
|---|---|---|
| L02BB04 | L Antineoplastic and immunomodulating agents → L02 Endocrine therapy → L02B Hormone antagonists and related agents → L02BB Anti-androgens | |
This drug has been assigned below unique identifiers within the countries it is being marketed:
| Country | Identification scheme | Identifier(s) |
|---|---|---|
| AU | Pharmaceutical Benefits Scheme | 10174L |
| BR | Câmara de Regulação do Mercado de Medicamentos | 540315030002602, 540315030002702 |
| CA | Health Products and Food Branch | 02407329 |
| EC | Agencia Nacional de Regulación, Control y Vigilancia Sanitaria | 920-MEE-0415 |
| EE | Ravimiamet | 1619175, 1753680, 1753691 |
| ES | Centro de información online de medicamentos de la AEMPS | 113846002 |
| FI | Lääkealan turvallisuus- ja kehittämiskeskus | 118153, 524257 |
| FR | Base de données publique des médicaments | 64093355 |
| GB | Medicines & Healthcare Products Regulatory Agency | 375710, 392924 |
| HK | Department of Health Drug Office | 63493 |
| IE | Health Products Regulatory Authority | 88699, 89025 |
| IL | מִשְׂרַד הַבְּרִיאוּת | 7533, 9339 |
| IT | Agenzia del Farmaco | 042868012, 042868024, 042868036 |
| JP | 医薬品医療機器総合機構 | 4291031F1025, 4291031F2021 |
| LT | Valstybinė vaistų kontrolės tarnyba | 1070787, 1084255, 1084256 |
| NL | Z-Index G-Standaard, PRK | 106100, 148903 |
| NZ | Medicines and Medical Devices Safety Authority | 16222 |
| PL | Rejestru Produktów Leczniczych | 100302608, 100416677, 100416683 |
| RO | Agenția Națională a Medicamentului și a Dispozitivelor Medicale | W66581001 |
| SG | Health Sciences Authority | 14829P |
| TR | İlaç ve Tıbbi Cihaz Kurumu | 8699043890017 |
| US | FDA, National Drug Code | 0469-0125, 0469-0625, 0469-0725 |
| ZA | Health Products Regulatory Authority | 48/26/0404 |
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