PROSCAR

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

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 more about Finasteride

Medication package inserts

Below package inserts are available for further reading:

Document	Type	Information Source
PROSCAR Film-coated tablet	MPI, EU: SmPC	Medicines & Healthcare Products Regulatory Agency (GB)

Medicine classification

This drug has been classified in the anatomical therapeutic chemical (ATC) classification system as follows:

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