This brand name is authorized in Austria, Brazil, Canada, Cyprus, Ecuador, Estonia, Spain, Finland, France, Hong Kong, Croatia, Ireland, Israel, Japan, Lithuania, Netherlands, Poland, Romania, Singapore, Turkey, United Kingdom, United States
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. |
Below package inserts are available for further reading:
| Title | Information Source | Document Type | |
|---|---|---|---|
| ERLEADA Film-coated tablet | European Medicines Agency (EU) | MPI, EU: SmPC |
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 | |
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 |
© All content on this website, including data entry, data processing, decision support tools, "RxReasoner" logo and graphics, is the intellectual property of RxReasoner and is protected by copyright laws. Unauthorized reproduction or distribution of any part of this content without explicit written permission from RxReasoner is strictly prohibited. Any third-party content used on this site is acknowledged and utilized under fair use principles.
