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
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. |
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 |
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 |
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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