NUBEQA

This brand name is authorized in United States. It is also authorized in Austria, Brazil, Canada, Croatia, Cyprus, Ecuador, Estonia, Finland, France, Hong Kong SAR China, Ireland, Israel, Italy, Japan, Lithuania, Poland, Romania, South Africa, Spain, Turkey, UK.

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. Darolutamide treatment decreases prostate tumour cell proliferation leading to potent antitumour activity.
	Read more about Darolutamide

Medication package inserts

Below package inserts are available for further reading:

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

Medicine classification

This drug has been classified in the anatomical therapeutic chemical (ATC) classification system as follows:

ATC Group		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)
BR	Câmara de Regulação do Mercado de Medicamentos	538920050030507
CA	Health Products and Food Branch	02496348
EC	Agencia Nacional de Regulación, Control y Vigilancia Sanitaria	6225-MEE-0521
EE	Ravimiamet	1814699, 1828560
ES	Centro de información online de medicamentos de la AEMPS	1201432001
FI	Lääkealan turvallisuus- ja kehittämiskeskus	068230
FR	Base de données publique des médicaments	62384935
GB	Medicines & Healthcare Products Regulatory Agency	383723
HK	Department of Health Drug Office	66877
IL	מִשְׂרַד הַבְּרִיאוּת	8779
IT	Agenzia del Farmaco	048610012, 048610024
JP	医薬品医療機器総合機構	4291063F1025
LT	Valstybinė vaistų kontrolės tarnyba	1089809, 1090330
PL	Rejestru Produktów Leczniczych	100433629
RO	Agenția Națională a Medicamentului și a Dispozitivelor Medicale	W67431001, W67431002
TR	İlaç ve Tıbbi Cihaz Kurumu	8699546093991
US	FDA, National Drug Code	50419-395
ZA	Health Products Regulatory Authority	55/21.12/0321