NUBEQA

This brand name is authorized in Austria, Brazil, Canada, Cyprus, Ecuador, Estonia, Spain, Finland, France, Hong Kong, Ireland, Israel, Japan, Lithuania, Poland, Romania, Turkey, United Kingdom, United States, South Africa

Active ingredients

The drug NUBEQA contains one active pharmaceutical ingredient (API):

1 Darolutamide
UNII X05U0N2RCO - DAROLUTAMIDE

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. A major metabolite, keto-darolutamide, exhibited similar in vitro activity to darolutamide. Darolutamide treatment decreases prostate tumour cell proliferation leading to potent antitumour activity.

Read about Darolutamide

Medication package inserts

Below package inserts are available for further reading:

Title Information Source Document Type  
NUBEQA Film-coated tablet FDA, National Drug Code (US) MPI, US: SPL/PLR
NUBEQA Film-coated tablet European Medicines Agency (EU) MPI, EU: SmPC

Medicine classification

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
Discover more medicines within L02BB06

Authorization and marketing

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: 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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