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
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. |
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 |
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 |
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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