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Irish Medicines Database · HPRA register

Combodart 0.5 mg/ 0.4 mg hard capsules

Authorisation PA1077/118/001 · GlaxoSmithKline (Ireland) Limited

← All medicines
Combodart 0.5 mg/ 0.4 mg hard capsules
Licence PA1077/118/001 · Marketed
Licence holder
GlaxoSmithKline (Ireland) Limited (all products →)
Active substances
Dutasteride, Tamsulosin hydrochloride
Dosage form
Capsule, hard
Route of administration
Oral use
ATC codes
G04CA, G04CA52
First authorised
07/05/2010
Prescription status
Product subject to prescription which may not be renewed (A)
Supply
Supply through pharmacies only
Legal basis
Fixed combination application (Article 10b of Directive No 2001/83/EC)

Data: Health Products Regulatory Authority (HPRA) open dataset, licensed CC BY 4.0, published 04 Jul 2026. This listing is regulatory information, not medical advice — consult the package leaflet, SPC, or a healthcare professional. For the authoritative record see the HPRA register.