This brand name is authorized in Austria, Brazil, Canada, Cyprus, Ecuador, Estonia, Spain, Finland, France, Hong Kong, Croatia, Ireland, Israel, Italy, Japan, Lithuania, Poland, Romania, Turkey, United Kingdom, United States, South Africa
The drug NUBEQA contains one active pharmaceutical ingredient (API):
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1
Darolutamide
UNII X05U0N2RCO - DAROLUTAMIDE
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Darolutamide is an androgen receptor (AR) inhibitor with a flexible polar-substituted pyrazole structure that binds with high affinity directly to the receptor ligand binding domain. Darolutamide competitively inhibits androgen binding, AR nuclear translocation, and AR mediated transcription. Darolutamide treatment decreases prostate tumour cell proliferation leading to potent antitumour activity. |
Below package inserts are available for further reading:
| Title | Information Source | Document Type | |
|---|---|---|---|
| NUBEQA Film-coated tablet | European Medicines Agency (EU) | MPI, EU: SmPC | |
| NUBEQA Film-coated tablet | FDA, National Drug Code (US) | MPI, US: SPL/PLR |
This drug has been classified in the anatomical therapeutic chemical (ATC) classification system as follows:
| ATC code | Group title | Classification |
|---|---|---|
| L02BB06 | 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) |
|---|---|---|
| Country: BR | Câmara de Regulação do Mercado de Medicamentos | Identifier(s): 538920050030507 |
| Country: CA | Health Products and Food Branch | Identifier(s): 02496348 |
| Country: EC | Agencia Nacional de Regulación, Control y Vigilancia Sanitaria | Identifier(s): 6225-MEE-0521 |
| Country: EE | Ravimiamet | Identifier(s): 1814699, 1828560 |
| Country: ES | Centro de información online de medicamentos de la AEMPS | Identifier(s): 1201432001 |
| Country: FI | Lääkealan turvallisuus- ja kehittämiskeskus | Identifier(s): 068230 |
| Country: FR | Base de données publique des médicaments | Identifier(s): 62384935 |
| Country: GB | Medicines & Healthcare Products Regulatory Agency | Identifier(s): 383723 |
| Country: HK | Department of Health Drug Office | Identifier(s): 66877 |
| Country: IL | מִשְׂרַד הַבְּרִיאוּת | Identifier(s): 8779 |
| Country: IT | Agenzia del Farmaco | Identifier(s): 048610012, 048610024 |
| Country: JP | 医薬品医療機器総合機構 | Identifier(s): 4291063F1025 |
| Country: LT | Valstybinė vaistų kontrolės tarnyba | Identifier(s): 1089809, 1090330 |
| Country: PL | Rejestru Produktów Leczniczych | Identifier(s): 100433629 |
| Country: RO | Agenția Națională a Medicamentului și a Dispozitivelor Medicale | Identifier(s): W67431001, W67431002 |
| Country: TR | İlaç ve Tıbbi Cihaz Kurumu | Identifier(s): 8699546093991 |
| Country: US | FDA, National Drug Code | Identifier(s): 50419-395 |
| Country: ZA | Health Products Regulatory Authority | Identifier(s): 55/21.12/0321 |
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