CASODEX

This brand name is authorized in Austria, Brazil, Canada, Cyprus, Germany, Ecuador, Estonia, Spain, Finland, France, Hong Kong, Croatia, Ireland, Israel, Italy, Japan, Lithuania, Mexico, Nigeria, Netherlands, Romania, Singapore, Tunisia, Turkey, United Kingdom, United States, South Africa

Active ingredients

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

1 Bicalutamide
UNII A0Z3NAU9DP - BICALUTAMIDE

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.

Read about Bicalutamide

Medication package inserts

Below package inserts are available for further reading:

Title Information Source Document Type  
CASODEX Film-coated tablets Medicines & Healthcare Products Regulatory Agency (GB) 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
L02BB03 Bicalutamide L Antineoplastic and immunomodulating agents → L02 Endocrine therapy → L02B Hormone antagonists and related agents → L02BB Anti-androgens
Discover more medicines within L02BB03

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): 502301101114318
Country: CA Health Products and Food Branch Identifier(s): 02184478
Country: DE Bundesinstitut für Arzneimittel und Medizinprodukte Identifier(s): 01170365, 01170371, 01262848, 02805446, 05968143, 05968166, 06799754, 07433133, 07465452
Country: EC Agencia Nacional de Regulación, Control y Vigilancia Sanitaria Identifier(s): 640-MEE-0115
Country: EE Ravimiamet Identifier(s): 1012194, 1026560
Country: ES Centro de información online de medicamentos de la AEMPS Identifier(s): 61055, 71927
Country: FI Lääkealan turvallisuus- ja kehittämiskeskus Identifier(s): 123242, 123253
Country: FR Base de données publique des médicaments Identifier(s): 67949737
Country: GB Medicines & Healthcare Products Regulatory Agency Identifier(s): 138470, 143466, 143467, 161468, 186251, 198673, 20823, 20826, 373498, 373517
Country: HK Department of Health Drug Office Identifier(s): 41794, 49624
Country: HR Agencija za lijekove i medicinske proizvode Identifier(s): HR-H-423625979, HR-H-959901547
Country: IE Health Products Regulatory Authority Identifier(s): 88020, 88021, 88439, 88592
Country: IL מִשְׂרַד הַבְּרִיאוּת Identifier(s): 3703
Country: IT Agenzia del Farmaco Identifier(s): 031113018, 031113020
Country: JP 医薬品医療機器総合機構 Identifier(s): 4291009F1039, 4291009F2027
Country: LT Valstybinė vaistų kontrolės tarnyba Identifier(s): 1002118, 1003622
Country: MX Comisión Federal para la Protección contra Riesgos Sanitarios Identifier(s): 071M97
Country: NG Registered Drug Product Database Identifier(s): 04-2737
Country: NL Z-Index G-Standaard, PRK Identifier(s): 42005
Country: RO Agenția Națională a Medicamentului și a Dispozitivelor Medicale Identifier(s): W68106001, W68107001
Country: SG Health Sciences Authority Identifier(s): 09772P, 11344P
Country: TN Direction de la Pharmacie et du Médicament Identifier(s): 4833011
Country: TR İlaç ve Tıbbi Cihaz Kurumu Identifier(s): 8699586094286, 8699586094293
Country: US FDA, National Drug Code Identifier(s): 62559-680
Country: ZA Health Products Regulatory Authority Identifier(s): 30/21.12/0012, 33/21.12/0081

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