XTANDI

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

Active ingredients

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

1 Enzalutamide UNII 93T0T9GKNU - ENZALUTAMIDE

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. Read about Enzalutamide

Medication package inserts

Below package inserts are available for further reading:

Title	Information Source	Document Type
XTANDI 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
L02BB04		L Antineoplastic and immunomodulating agents → L02 Endocrine therapy → L02B Hormone antagonists and related agents → L02BB Anti-androgens
Discover more medicines within L02BB04

Authorization and marketing

This drug has been assigned below unique identifiers within the countries it is being marketed:

Country	Identification scheme	Identifier(s)
Country: AU	Pharmaceutical Benefits Scheme	Identifier(s): 10174L
Country: BR	Câmara de Regulação do Mercado de Medicamentos	Identifier(s): 540315030002602, 540315030002702
Country: CA	Health Products and Food Branch	Identifier(s): 02407329
Country: EC	Agencia Nacional de Regulación, Control y Vigilancia Sanitaria	Identifier(s): 920-MEE-0415
Country: EE	Ravimiamet	Identifier(s): 1619175, 1753680, 1753691
Country: ES	Centro de información online de medicamentos de la AEMPS	Identifier(s): 113846002
Country: FI	Lääkealan turvallisuus- ja kehittämiskeskus	Identifier(s): 118153, 524257
Country: FR	Base de données publique des médicaments	Identifier(s): 64093355
Country: GB	Medicines & Healthcare Products Regulatory Agency	Identifier(s): 375710, 392924
Country: HK	Department of Health Drug Office	Identifier(s): 63493
Country: IE	Health Products Regulatory Authority	Identifier(s): 88699, 89025
Country: IL	מִשְׂרַד הַבְּרִיאוּת	Identifier(s): 7533, 9339
Country: IT	Agenzia del Farmaco	Identifier(s): 042868012, 042868024, 042868036
Country: JP	医薬品医療機器総合機構	Identifier(s): 4291031F1025, 4291031F2021
Country: LT	Valstybinė vaistų kontrolės tarnyba	Identifier(s): 1070787, 1084255, 1084256
Country: NL	Z-Index G-Standaard, PRK	Identifier(s): 106100, 148903
Country: NZ	Medicines and Medical Devices Safety Authority	Identifier(s): 16222
Country: PL	Rejestru Produktów Leczniczych	Identifier(s): 100302608, 100416677, 100416683
Country: RO	Agenția Națională a Medicamentului și a Dispozitivelor Medicale	Identifier(s): W66581001
Country: SG	Health Sciences Authority	Identifier(s): 14829P
Country: TR	İlaç ve Tıbbi Cihaz Kurumu	Identifier(s): 8699043890017
Country: US	FDA, National Drug Code	Identifier(s): 0469-0125, 0469-0625, 0469-0725
Country: ZA	Health Products Regulatory Authority	Identifier(s): 48/26/0404