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Medicines
Spain
Dutasteride

AEMPS 2016

Dutasteride, Tamsulosin

Duodart 0,5 MG/0,4 MG Capsulas Duras

0,5 mg + 0,4 mg cápsula duraSpainWithdrawnAuthorised 23 Feb 2016

Open in the registerAsk Osler about it

On this page

In other countries
Packs
Documents
Sources and licences

This page is kept for reference and is not offered to search engines.

In other countries

The same active substances on other registers, the same brand first.

Duodart 0,5 mg/0,4 mg tvrde kapsuleCroatia · kapsula, tvrda · GlaxoSmithKline Trading Services Limited, 12 Riverwalk, Citywest Business Campus, Dublin 24, IrskaSame brand
DUODART 0,5mg/0,4mgRomania · 0,5mg/0,4mg · caps. · Glaxosmithkline (GSK) SRLSame brand
DUODART CapsuleSaudi Arabia · CatalentSame brand
DUODART CapsuleSaudi Arabia · CatalentSame brand
Duodart Capsules 0.5mg/0.4mgSingapore · 0.5 mg + 0.4 mg · capsule · Glaxosmithkline Pte LTDSame brand
Jalyn

More with the same substance on this register

Bidutam 0,5 MG/0,4 MG Capsulas Duras EfgDutasteride + Tamsulosin · 0,5 mg + 0,4 mg · cápsula duraSpain
Duodart 0,5 MG/0,4 MG Capsulas DurasDutasteride + Tamsulosin · 0,5 mg + 0,4 mg · cápsula duraSpain

Two medicines in one question?

Name two or more medicines and Osler runs an interaction check. A severe interaction is stated at the very top of the answer.

Canada · 0.5 MG + 0.4 MG · Capsule (Immediate- And Extended-Release · Glaxosmithkline INC

Same form

🇭🇷Atekago 0,5 mg/0,4 mg tvrde kapsuleCroatia · kapsula, tvrda · PharmaS d.o.o., Radnička cesta 47, Zagreb, HrvatskaSame form

🇭🇷Duitam 0,5 mg/0,4 mg tvrde kapsuleCroatia · kapsula, tvrda · Genericon Pharma Gesellschaft m.b.H., Hafnerstraße 211, Graz, AustrijaSame form

🇮🇹AnassoItaly · Capsula rigida · Farmitalia Industria Chimico Farmaceutica S.R.L.Same form

🇮🇹CombodartItaly · Capsula rigida · Glaxosmithkline S.P.A.Same form

🇮🇹Dutasteride e Tamsulosina OlphaItaly · Capsula rigida · Olpha AsSame form

🇳🇱Combodart 0,5 mg/0,4 mg, harde capsulesNetherlands · Capsule, hard · Euro Registratie Collectief B.V.Same form

🇳🇱Combodart 0,5 mg/0,4 mg, harde capsulesNetherlands · Capsule, hard · GlaxoSmithKline B.V.Same form

🇳🇱Combodart 0,5 mg/0,4 mg, harde capsulesNetherlands · Capsule, hard · Medcor Pharmaceuticals B.V.Same form

🇷🇴AVATERID DUO 0.5 mg/0.4 mgRomania · 0.5mg/0.4 mg · caps. · Sandoz S.R.L.Same form

🇷🇴DUTASTERIDA/TAMSULOSIN AUROBINDO 0,5 mg/0,4 mgRomania · 0,5mg/0.4 mg · caps. · Aurobindo Pharma Romania SRLSame form

🇷🇸AtekagoSerbia · 0.4mg+0.5mg · kapsula, tvrda · Pharmas D.O.O. BeogradSame form

🇷🇸Datust® DuoSerbia · 0.4mg+0.5mg · kapsula, tvrda · Hemofarm Ad VRŠAcSame form

🇷🇸Duotam®Serbia · 0.5mg+0.4mg · kapsula, tvrda · Alkaloid D.O.O. BeogradSame form

🇸🇬DUOFLOW CAPSULE 0.5mg/0.4mgSingapore · 0.5mg + 0.4mg · capsule · Intega Pte LTDSame form

🇸🇬Dutabit Plus 0.5/0.4 Capsules 0.5MG/0.4MGSingapore · 0.5mg + 0.4mg · capsule · Apotheca Marketing Pte LTDSame form

🇺🇸Dutasteride and Tamsulosin HydrochlorideUnited States · 0.5MG; 0.4MG · capsule · Zydus PharmsSame form

🇺🇸JalynUnited States · 0.5MG; 0.4MG · capsule · Waylis TherapSame form

🇸🇦Dusta plusSaudi Arabia · Laboratorios Leon Farma, S.A.Same substance

Packs

Pack	Code	Status
DUODART 0,5 MG/0,4 MG CAPSULAS DURAS, 30 capsulas	700699

Documents

The official texts, at the regulator.

Package leafletAEMPS
Register entryAEMPS

Sources and licences

Compiled by Prognia from the public register below; the register’s text is the official one.

Agencia Española de Medicamentos y Productos Sanitarios

Fuente de la información: Agencia Española de Medicamentos y Productos Sanitarios www.aemps.gob.es; CIMA medicamentos, acquired 11 October 2026 UTC; each source response/update date retained.

Licence: AEMPS explicit public open-data reuse for citizens and companies; source attribution and update date required · Added 12 Oct 2026

Report an error or request removalCorrections from the holder or the register are welcome.

Prognia shows this product information for reference and learning. It is not treatment advice and can lag behind the official text. Always check the current product information and local protocols before prescribing.

At a glance

Active substances: Dutasteride, Tamsulosin
Strength: 0,5 mg + 0,4 mg
Dosage form: cápsula dura
Route: vía oral
Register: Spain (AEMPS)
Status: Withdrawn
Status in the register: Revocado
Authorised: 23 Feb 2016
Registration: 20100347
Marketing authorisation holder: Glaxosmith Kline Ltd
Procedure: National, MRP or DCP
Supply: Medicamento Sujeto A Prescripción Médica

🇪🇸

AEMPSDuplotrip 0,5 MG/0,4 MG Capsulas Duras EfgDutasteride + Tamsulosin · 0,5 mg + 0,4 mg · cápsula dura🇪🇸Spain

AEMPSDuprost 0,5 MG/0,4 MG Capsulas Duras EfgDutasteride + Tamsulosin · 0,5 mg + 0,4 mg · cápsula dura🇪🇸Spain

AEMPSDutamsin 0,5 MG/0,4 MG Capsulas DurasDutasteride + Tamsulosin · 0,5 mg + 0,4 mg · cápsula dura🇪🇸Spain

AEMPSDutasterida/Tamsulosina Almus Pharma 0,5 MG/0,4 MG Capsulas DurasDutasteride + Tamsulosin · 0,5 mg + 0,4 mg · cápsula dura🇪🇸Spain

AEMPSDutasterida/Tamsulosina Alter Genericos 0,5 MG/0,4 MG Capsulas DurasDutasteride + Tamsulosin · 0,5 mg + 0,4 mg · cápsula dura🇪🇸Spain

AEMPSDutasterida/Tamsulosina Aristo 0,5 MG/0,4 MG Capsulas Duras EfgDutasteride + Tamsulosin · 0,5 mg + 0,4 mg · cápsula dura🇪🇸Spain

AEMPSDutasterida/Tamsulosina Aurovitas 0,5 MG/0,4 MG Capsulas Duras EfgDutasteride + Tamsulosin · 0,5 mg + 0,4 mg · cápsula dura🇪🇸Spain

AEMPSDutasterida/Tamsulosina Cinfa 0,5 MG/0,4 MG Capsulas Duras EfgDutasteride + Tamsulosin · 0,5 mg + 0,4 mg · cápsula dura🇪🇸Spain

AEMPSDutasterida/Tamsulosina Cinfalab 0,5 MG/0,4 MG Capsulas Duras EfgDutasteride + Tamsulosin · 0,5 mg + 0,4 mg · cápsula dura🇪🇸Spain

AEMPSDutasterida/Tamsulosina Combix Pharma 0,5 MG/0,4 MG Capsulas Duras EfgDutasteride + Tamsulosin · 0,5 mg + 0,4 mg · cápsula dura🇪🇸Spain