This brand name is authorized in Nigeria. It is also authorized in Austria, Brazil, Canada, Croatia, Cyprus, Ecuador, Estonia, Finland, France, Hong Kong SAR China, Ireland, Israel, Japan, Lithuania, Netherlands, Poland, Romania, Singapore, Spain, Turkey, UK, United States.
The drug ERLEADA contains one active pharmaceutical ingredient (API):
1
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UNII
4T36H88UA7 - APALUTAMIDE
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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. |
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This drug has been approved in Nigeria as follows:
| Identifier | Form | Presentation | Description | Approval |
|---|---|---|---|---|
| A4-100817 | Tablet | ERLEADA 60 MG TABLET TAB 60 mg 1 X 120 | 48 NF-PP-343948 ERLEADA 60 MG TABLET Apalutamide Each film-coated tablet contains 60 mg Apalutamide, Excipients include Tablet core Colloidal anhydrous silica Croscarmellose sodium Hypromellose acetate succinate Magnesium stearate Microcrystalline cellulose Microcrystalline cellulose (silicified) Film-coating Iron oxide black (E172) Iron oxide yellow (E172) Macrogol Polyvinyl alcohol (partially hydrolysed) Talc Titanium dioxide (E171) A4-100817 Drugs Imported Products 1120 POM 2 J & J COMPANY WEST AFRICA LIMITED, SINARI DARANIJO STREET, VICTORIA ISLAND LAGOS LAGOS 9062881239 uugwulek@its.jnj.com JANSSEN ORTHO, LLC, , STATE ROAD 933, KM 0.1, MAMEY WARD, GURABO, 000778 PUERTORICCO, USA, Puerto Rico | 30/04/2024 |
Below package inserts are available for further reading:
| Document | Type | Information Source | |
|---|---|---|---|
| ERLEADA Film-coated tablet | MPI, EU: SmPC | European Medicines Agency (EU) |
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 | |
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 |
| 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 |
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