AVODART

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

Active ingredients

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

1	Dutasteride UNII O0J6XJN02I - DUTASTERIDE
	Dutasteride reduces circulating levels of dihydrotestosterone (DHT) by inhibiting both type 1 and type 2, 5α-reductase isoenzymes which are responsible for the conversion of testosterone to DHT.
	Read more about Dutasteride

Medication package inserts

Below package inserts are available for further reading:

Document	Type	Information Source
Avodart 0.5mg soft capsules	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
G04CB02	Dutasteride	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 G04CB02

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	10095H, 5468T
BR	Câmara de Regulação do Mercado de Medicamentos	510610501118215, 510610502114213, 510610503110211
CA	Health Products and Food Branch	02247813
DE	Bundesinstitut für Arzneimittel und Medizinprodukte	00706059, 00805407, 00805413, 02182353, 02185587, 02329856, 03112314, 03125050, 03202916, 03780694, 03929647, 03929682, 04114686, 04114692, 04172962, 05961000, 10942217, 11342531, 16134122, 16354970, 16357508, 16357514, 16358436, 16363331, 17263034
EC	Agencia Nacional de Regulación, Control y Vigilancia Sanitaria	66-MEE-0214
EE	Ravimiamet	1155439, 1155440, 1155451, 1225729, 1262472, 1886328, 1886339, 1886340, 1886351, 1886362
FI	Lääkealan turvallisuus- ja kehittämiskeskus	012209, 012243
FR	Base de données publique des médicaments	60051234, 60429851, 63686819, 65346644
GB	Medicines & Healthcare Products Regulatory Agency	138349, 142015, 299793, 43619
HK	Department of Health Drug Office	61577
HR	Agencija za lijekove i medicinske proizvode	HR-H-357757654
IE	Health Products Regulatory Authority	53450, 53470, 53641, 53675
IL	מִשְׂרַד הַבְּרִיאוּת	4646
IT	Agenzia del Farmaco	035895010
LT	Valstybinė vaistų kontrolės tarnyba	1004309, 1016674, 1016675, 1023331, 1023852, 1093398
MT	Medicines Authority	MA192/02701, PI908/15802A
MX	Comisión Federal para la Protección contra Riesgos Sanitarios	363M2004
NL	Z-Index G-Standaard, PRK	68195
PL	Rejestru Produktów Leczniczych	100131733
RO	Agenția Națională a Medicamentului și a Dispozitivelor Medicale	W67626001, W67626002, W67626003, W67626004, W67626005
SG	Health Sciences Authority	12434P
TN	Direction de la Pharmacie et du Médicament	2113101
TR	İlaç ve Tıbbi Cihaz Kurumu	8699522196906
US	FDA, National Drug Code	0173-0712
ZA	Health Products Regulatory Authority	37/21.12/0282