PROSCAR

This brand name is authorized in Austria, Australia, Brazil, Canada, Germany, Ecuador, Spain, Finland, Hong Kong, Croatia, Ireland, Italy, Mexico, Netherlands, Poland, Romania, Singapore, Turkey, United Kingdom, United States, South Africa

Active ingredients

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

1 Finasteride
UNII 57GNO57U7G - FINASTERIDE

Finasteride is a competitive inhibitor of human 5α-reductase, an intracellular enzyme which metabolises testosterone into the more potent androgen, dihydrotestosterone (DHT). In benign prostatic hyperplasia (BPH), enlargement of the prostate gland is dependent upon the conversion of testosterone to DHT within the prostate. Finasteride is highly effective in reducing circulating and intraprostatic DHT. Finasteride has no affinity for the androgen receptor.

Read about Finasteride

Medication package inserts

Below package inserts are available for further reading:

Title Information Source Document Type  
PROSCAR Film-coated tablet 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
G04CB01 Finasteride G Genito urinary system and sex hormones → G04 Urologicals → G04C Drugs used in benign prostatic hypertrophy → G04CB Testosterone-5-alpha reductase inhibitors
Discover more medicines within G04CB01

Authorization and marketing

This drug has been assigned below unique identifiers within the countries it is being marketed:

Country Identification scheme Identifier(s)
Country: AU Pharmaceutical Benefits Scheme Identifier(s): 4233T
Country: BR Câmara de Regulação do Mercado de Medicamentos Identifier(s): 525501802115319
Country: CA Health Products and Food Branch Identifier(s): 02010909
Country: DE Bundesinstitut für Arzneimittel und Medizinprodukte Identifier(s): 00480135, 00480141, 00480158, 00708420, 02128514, 03412826, 07378581, 07777950, 07777973, 07777996, 08626354, 08635146, 08858892, 08858900, 09235963, 11004544, 11296067, 11519366, 15578526, 16927294
Country: EC Agencia Nacional de Regulación, Control y Vigilancia Sanitaria Identifier(s): 28634-11-08
Country: ES Centro de información online de medicamentos de la AEMPS Identifier(s): 59830
Country: FI Lääkealan turvallisuus- ja kehittämiskeskus Identifier(s): 445759
Country: GB Medicines & Healthcare Products Regulatory Agency Identifier(s): 143400, 186076, 198592, 373573, 387484
Country: HK Department of Health Drug Office Identifier(s): 36604
Country: HR Agencija za lijekove i medicinske proizvode Identifier(s): HR-H-039526411
Country: IE Health Products Regulatory Authority Identifier(s): 42560, 42583, 42655, 42661
Country: IT Agenzia del Farmaco Identifier(s): 028308017
Country: MX Comisión Federal para la Protección contra Riesgos Sanitarios Identifier(s): 205M92
Country: NL Z-Index G-Standaard, PRK Identifier(s): 34975
Country: PL Rejestru Produktów Leczniczych Identifier(s): 100055920
Country: RO Agenția Națională a Medicamentului și a Dispozitivelor Medicale Identifier(s): W68216001, W68216002, W68216003
Country: SG Health Sciences Authority Identifier(s): 07513P
Country: TR İlaç ve Tıbbi Cihaz Kurumu Identifier(s): 8699636090602
Country: US FDA, National Drug Code Identifier(s): 0006-0072
Country: ZA Health Products Regulatory Authority Identifier(s): 27/21.12/0069

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