This brand name is authorized in Nigeria. It is also authorized in Austria, Brazil, Canada, Croatia, Cyprus, Ecuador, Estonia, Finland, France, Germany, Hong Kong SAR China, Ireland, Israel, Italy, Japan, Lithuania, Mexico, Netherlands, Romania, Singapore, South Africa, Spain, Tunisia, Turkey, UK, United States.
The drug CASODEX contains one active pharmaceutical ingredient (API):
1
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UNII
A0Z3NAU9DP - BICALUTAMIDE
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Bicalutamide is a non-steroidal antiandrogen, devoid of other endocrine activity. It binds to androgen receptors without activating gene expression, and thus inhibits the androgen stimulus. Regression of prostatic tumours results from this inhibition. |
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This drug has been approved in Nigeria as follows:
| Identifier | Form | Presentation | Description | Approval |
|---|---|---|---|---|
| 04-2737 | Tablet | CASODEX 50MG TABLETS TAB 50 mg 2X14 | 17 RNW-PP-375411 CASODEX 50MG TABLETS BICALUTAMIDE BICALUTAMIDE 50MG, LACTOSE MONOHYDRATE 7.5MG, POVIDONE 5MG, MAGNESIUM STEARATE 1.5MG, HYPROMELLOSE 2.5MG, MACROGOL 300 0.5MG Apr-37 Drugs Imported Products 2X14 Prescription Only Medicine (POM) ASTRAZENECA NIGERIA LIMITED, ALFRED OLAIYA STREET, AWUSE ESTATE IKEJA LAGOS 12719120 funmi.ogunwale@astrazeneca.com CORDEN PHARMA GMBH, OTTO-HAHN STR 687 PLANKSTADT BADEN WURTTEMBERG GERMANY, Germany | 30/04/2024 |
| B4-0036 | Tablet | CASODEX 150MG TABLET TAB 150 mg 2X14 | 18 RNW-PP-375425 CASODEX 150MG TABLET BICALUTAMIDE BICALUTAMIDE 150MG, LACTOSE MONOHYDRATE 183MG, MAGNESIUM STREARATE 4.5MG, POVIDONE 15MG, CARBOXYMETHYLAMYLUM NATRICUM 22.5MG, WATER PURIFIED 75MG, INDUSTRILA METHYLATED SPIRIT 0.8MG, MACROGOL 300 1.5MG., TITANIUM OXIDE 2.3MG, METHYLHYDROXYPROPYL CELLULOSE 7.5MG B4-0036 Drugs Imported Products 2X14 Prescription Only Medicine (POM) ASTRAZENECA NIGERIA LIMITED, ALFRED OLAIYA STREET, AWUSE ESTATE IKEJA LAGOS 12719120 funmi.ogunwale@astrazeneca.com CORDEN PHARMA GMBH, OTTO-HAHN STR 687 PLANKSTADT BADEN WURTTEMBERG GERMANY, Germany | 30/04/2024 |
Below package inserts are available for further reading:
| Document | Type | Information Source | |
|---|---|---|---|
| CASODEX Film-coated tablets | MPI, EU: SmPC | Medicines & Healthcare Products Regulatory Agency (GB) |
This drug has been classified in the anatomical therapeutic chemical (ATC) classification system as follows:
| ATC Group | Classification | |
|---|---|---|
| L02BB03 | Bicalutamide | 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 | 502301101114318 |
| CA | Health Products and Food Branch | 02184478 |
| DE | Bundesinstitut für Arzneimittel und Medizinprodukte | 01170365, 01170371, 01262848, 02805446, 05968143, 05968166, 06799754, 07433133, 07465452 |
| EC | Agencia Nacional de Regulación, Control y Vigilancia Sanitaria | 640-MEE-0115 |
| EE | Ravimiamet | 1012194, 1026560 |
| ES | Centro de información online de medicamentos de la AEMPS | 61055, 71927 |
| FI | Lääkealan turvallisuus- ja kehittämiskeskus | 123242, 123253 |
| FR | Base de données publique des médicaments | 67949737 |
| GB | Medicines & Healthcare Products Regulatory Agency | 138470, 143466, 143467, 161468, 186251, 198673, 20823, 20826, 373498, 373517 |
| HK | Department of Health Drug Office | 41794, 49624 |
| HR | Agencija za lijekove i medicinske proizvode | HR-H-423625979, HR-H-959901547 |
| IE | Health Products Regulatory Authority | 88020, 88021, 88439, 88592 |
| IL | מִשְׂרַד הַבְּרִיאוּת | 3703 |
| IT | Agenzia del Farmaco | 031113018, 031113020 |
| JP | 医薬品医療機器総合機構 | 4291009F1039, 4291009F2027 |
| LT | Valstybinė vaistų kontrolės tarnyba | 1002118, 1003622 |
| MX | Comisión Federal para la Protección contra Riesgos Sanitarios | 071M97 |
| NG | Registered Drug Product Database | 04-2737, B4-0036 |
| NL | Z-Index G-Standaard, PRK | 42005 |
| RO | Agenția Națională a Medicamentului și a Dispozitivelor Medicale | W68106001, W68107001 |
| SG | Health Sciences Authority | 09772P, 11344P |
| TN | Direction de la Pharmacie et du Médicament | 4833011 |
| TR | İlaç ve Tıbbi Cihaz Kurumu | 8699586094286, 8699586094293 |
| US | FDA, National Drug Code | 62559-680 |
| ZA | Health Products Regulatory Authority | 30/21.12/0012, 33/21.12/0081 |
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