COMBODART

This brand name is authorized in Brazil, Estonia, France, Ireland, Lithuania, Malta, Mexico, Netherlands, United Kingdom

Active ingredients

The drug COMBODART contains a combination of these active pharmaceutical ingredients (APIs):

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
2 Tamsulosin
UNII 11SV1951MR - TAMSULOSIN HYDROCHLORIDE

Tamsulosin binds selectively and competitively to post-synaptic α1-adrenoreceptors, prevailingly their subtypes designated α1A and α1D. Thus relaxation of smooth muscles of the prostate and urethra is achieved, which leads to a reduction of tonus and an improvement of the urinary flow.

Read about Tamsulosin

Medication package inserts

Below package inserts are available for further reading:

Title Information Source Document Type  
COMBODART Capsule, hard 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
G04CA52 Tamsulosin and dutasteride G Genito urinary system and sex hormones → G04 Urologicals → G04C Drugs used in benign prostatic hypertrophy → G04CA Alpha-adrenoreceptor antagonists
Discover more medicines within G04CA52

Authorization and marketing

This drug has been assigned below unique identifiers within the countries it is being marketed:

Country Identification scheme Identifier(s)
Country: BR Câmara de Regulação do Mercado de Medicamentos Identifier(s): 510612050047805, 510612050047905, 510614040051505
Country: EE Ravimiamet Identifier(s): 1390452, 1390463, 1390474
Country: FR Base de données publique des médicaments Identifier(s): 65913639
Country: GB Medicines & Healthcare Products Regulatory Agency Identifier(s): 171772, 373930, 381261
Country: IE Health Products Regulatory Authority Identifier(s): 13905, 13987, 54351
Country: LT Valstybinė vaistų kontrolės tarnyba Identifier(s): 1035097, 1055107, 1055108
Country: MT Medicines Authority Identifier(s): MA192/02601, PI1438/05701A, PI908/08101A, PI908/08101B
Country: MX Comisión Federal para la Protección contra Riesgos Sanitarios Identifier(s): 193M2012
Country: NL Z-Index G-Standaard, PRK Identifier(s): 93661

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