Germany· DE-A57-19e08dfadd9b08a5
Dutasterid-Tamsulosinhydrochlorid Glaxosmithkline
A medicinal product containing tamsulosin hydrochloride, dutasteride, registered in Germany by Glaxosmithkline Gmbh & Co. Kg.
Checked against EMA Article 57 (European Union) on
Informational only — not a medical device.
The record
At a glance
EMA Article 57 (European Union)- Active substance
- Tamsulosin Hydrochloride, Dutasteride
- Manufacturer
- Glaxosmithkline Gmbh & Co. Kg
- Country
- Germany (DE)
- ATC code
- —
- Reimbursed
- Not published by this register
- Source register
- EMA Article 57 (European Union)
- Last checked
- September 30, 2026
Packs & prices · 0
No packs listed by the register for this record.
Regulatory notes
No shortage, Orange Book or US label notes for this record.
Same medicine, other countries
Tamsulosin hydrochloride, dutasteride in 13 other countries
What each register calls a product with the same active substance — salts and hydrates count as the same.
- CzechiaADATAMAdamed Pharma S.A., Czosnów
- SpainBIDUTAM 0,5 MG/0,4 MG CAPSULAS DURAS EFGLaboratorios Q Pharma S.L.
- United KingdomCombodart 0.5mg/0.4mg capsulesWaymade Healthcare Plc
- PolandAdatam DuoAdamed Pharma S.A.
- SwitzerlandDuodart
- FinlandDuodartGlaxoSmithKline Oy
- FranceCOMBODART 0,5 mg/0,4 mg, géluleGLAXOSMITHKLINE
- NetherlandsCombodart 0,5 mg/0,4 mg, harde capsulesGlaxoSmithKline B.V.
Authorised across Europe · EMA
The same active substance is authorised in 28 EEA countries. Names it is sold under:
- Austria · Dutaglandin Comp., Dutamsul
- Belgium · Combodart, Dutasteride/Tamsulosine Eg
- Bulgaria · Агландин Комп, Дуодарт
- Cyprus · Dinaplex, Duodart
- Czechia · Adatam, Aglandut
- Denmark · Duta Tamsaxiro, Dutasterid/Tamsulosinhydrochlorid G.L. Pharma
- Estonia · Combodart, Dutasteride/Tamsulosin Olpha
- Spain · Bidutam, Duodart
- Finland · Duodart, Dutasterid/Tamulosin Stada
- France · Combodart, Dutasteride/Tamsulosine Accord
- United Kingdom (Northern Ireland) · Combodart, Dutasteride/Tamsulosin Hydrochloride Accord Healthcare
- Greece · Dinaplex, Doxared
- Croatia · Atekago, Duitam
- Hungary · Aglandin, Duodart
- Ireland · Combodart, Dutasteride/Tamsulosin Hydrochloride Accord Healthcare Ireland
- Iceland · Duodart, Duta Tamsaxiro
- Italy · Anasso, Combodart
- Lithuania · Aduzin, Combodart
- Luxembourg · Combodart, Dutasterid/Tamsulosin Ratiopharm
- Latvia · Combodart, Dutasteride/Tamsulosin Olpha
- Malta · Atucare, Combodart
- Netherlands · Combodart, Dutasteride/ Tamsulosinehydrochloride Aurobindo
- Norway · Duodart, Dutasterid/Tamsulosin Teva
- Poland · Duitam, Duodart
- Portugal · Combodart, Dutasterida + Tansulosina Accord
- Romania · Duodart, Dutasteridă / Tamsulosin
- Slovenia · Amdut Combo, Combodart
- Slovakia · Adatam, Aglandin
Source: European Medicines Agency, Article 57 product data.
Sourced from a public register and reproduced with attribution. Drug Database is not affiliated with, endorsed by, or a partner of EMA Article 57 (European Union). This is an informational data service and not a medical device — verify against the official source of record before any clinical decision.
For developers
The same record over the API, and the raw payload
GET /v1/drugs/d3cbda75-6295-4c53-901e-3bf3378ce633 GET /v1/drugs/d3cbda75-6295-4c53-901e-3bf3378ce633?format=fhir
Every response carries last_synced_at, so freshness is a field rather than a promise. Below is exactly what the ingestion wrote, before any presentation — the same JSON the API returns under payload.
{
"pzn": null,
"route": "Oral Use",
"source": "ema_art57_de",
"ma_number": null,
"substance": "Tamsulosin Hydrochloride, Dutasteride",
"atc_from_source": null,
"authorisation_country": "Germany"
}See everything about tamsulosin hydrochloride, dutasteride.
This page is the registration. A free account adds the label text as the regulator wrote it, what it costs per daily dose across the markets that publish a price, a feed of what changes in the registers, and an assistant that answers with its sources. Interaction severity is free; mechanism and management are on the Growth plan. No card, nothing to install.