AVODART

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

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 about Dutasteride

Medication package inserts

Below package inserts are available for further reading:

Title Information Source Document Type  
Avodart 0.5mg soft capsules 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
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)
Country: AU Pharmaceutical Benefits Scheme Identifier(s): 10095H, 5468T
Country: BR Câmara de Regulação do Mercado de Medicamentos Identifier(s): 510610501118215, 510610502114213, 510610503110211
Country: CA Health Products and Food Branch Identifier(s): 02247813
Country: DE Bundesinstitut für Arzneimittel und Medizinprodukte Identifier(s): 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
Country: EC Agencia Nacional de Regulación, Control y Vigilancia Sanitaria Identifier(s): 66-MEE-0214
Country: EE Ravimiamet Identifier(s): 1155439, 1155440, 1155451, 1225729, 1262472, 1886328, 1886339, 1886340, 1886351, 1886362
Country: FI Lääkealan turvallisuus- ja kehittämiskeskus Identifier(s): 012209, 012243
Country: FR Base de données publique des médicaments Identifier(s): 60051234, 60429851, 63686819, 65346644
Country: GB Medicines & Healthcare Products Regulatory Agency Identifier(s): 138349, 142015, 299793, 43619
Country: HK Department of Health Drug Office Identifier(s): 61577
Country: HR Agencija za lijekove i medicinske proizvode Identifier(s): HR-H-357757654
Country: IE Health Products Regulatory Authority Identifier(s): 53450, 53470, 53641, 53675
Country: IL מִשְׂרַד הַבְּרִיאוּת Identifier(s): 4646
Country: IT Agenzia del Farmaco Identifier(s): 035895010
Country: LT Valstybinė vaistų kontrolės tarnyba Identifier(s): 1004309, 1016674, 1016675, 1023331, 1023852, 1093398
Country: MT Medicines Authority Identifier(s): MA192/02701, PI908/15802A
Country: MX Comisión Federal para la Protección contra Riesgos Sanitarios Identifier(s): 363M2004
Country: NL Z-Index G-Standaard, PRK Identifier(s): 68195
Country: PL Rejestru Produktów Leczniczych Identifier(s): 100131733
Country: RO Agenția Națională a Medicamentului și a Dispozitivelor Medicale Identifier(s): W67626001, W67626002, W67626003, W67626004, W67626005
Country: SG Health Sciences Authority Identifier(s): 12434P
Country: TN Direction de la Pharmacie et du Médicament Identifier(s): 2113101
Country: TR İlaç ve Tıbbi Cihaz Kurumu Identifier(s): 8699522196906
Country: US FDA, National Drug Code Identifier(s): 0173-0712
Country: ZA Health Products Regulatory Authority Identifier(s): 37/21.12/0282

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