ERLEADA

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, Japan, Lithuania, Netherlands, Nigeria, Poland, Romania, Singapore, Spain, Turkey, UK.

Active ingredients

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

1	Apalutamide UNII 4T36H88UA7 - APALUTAMIDE
	Apalutamide is an orally administered, selective Androgen Receptor (AR) inhibitor that binds directly to the ligand-binding domain of the AR. Apalutamide treatment decreases tumor cell proliferation and increases apoptosis leading to potent antitumor activity.
	Read more about Apalutamide

Medication package inserts

Below package inserts are available for further reading:

Document	Type	Information Source
ERLEADA Film-coated tablet	MPI, EU: SmPC	European Medicines Agency (EU)

Medicine classification

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

ATC Group		Classification
L02BB05		L Antineoplastic and immunomodulating agents → L02 Endocrine therapy → L02B Hormone antagonists and related agents → L02BB Anti-androgens
Discover more medicines within L02BB05

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	514519010035302
CA	Health Products and Food Branch	02478374
EC	Agencia Nacional de Regulación, Control y Vigilancia Sanitaria	5596-MEE-1020
EE	Ravimiamet	1787441, 1787452, 1849888
ES	Centro de información online de medicamentos de la AEMPS	1181342001
FI	Lääkealan turvallisuus- ja kehittämiskeskus	428489
FR	Base de données publique des médicaments	60941734
GB	Medicines & Healthcare Products Regulatory Agency	367463
HK	Department of Health Drug Office	66016
IE	Health Products Regulatory Authority	89087
IL	מִשְׂרַד הַבְּרִיאוּת	8301
JP	医薬品医療機器総合機構	4291059F1029
LT	Valstybinė vaistų kontrolės tarnyba	1086925, 1086926, 1086927
NG	Registered Drug Product Database	A4-100817
Switch country to Nigeria in order to find specific presentations of ERLEADA
NL	Z-Index G-Standaard, PRK	196908
PL	Rejestru Produktów Leczniczych	100416849
RO	Agenția Națională a Medicamentului și a Dispozitivelor Medicale	W65819001, W65819002
SG	Health Sciences Authority	15698P
TR	İlaç ve Tıbbi Cihaz Kurumu	8699593095436
US	FDA, National Drug Code	59676-600