ERLEADA

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

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 about Apalutamide

Medication package inserts

Below package inserts are available for further reading:

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

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