Ireland· IE-PA-PA2315/222/001

Dutasteride/Tamsulosin Hydrochloride 0.5 mg/0.4 mg hard capsules

A tamsulosin and dutasteride product containing dutasteride + tamsulosin hydrochloride, registered in Ireland by Accord Healthcare Ireland Ltd.. The same ATC class is registered in 13 of our 19 countries.

ATC G04CA52

Checked against HPRA (Ireland) on September 28, 2026

Informational only — not a medical device.

Compare price across countriesPer daily dose · free account Ask the assistant about dutasteride + tamsulosin hydrochlorideAnswers with sources · free account Check interactionsSeverity free · mechanism on Growth

Where it is registered

Tamsulosin and dutasteride is registered in 13 of 19 countries.

Countries holding a registration under ATC G04CA52 (tamsulosin and dutasteride), each read from that country’s own register.

This record: Ireland, from HPRA (Ireland)
8 of them publish a price we can compare per daily dose

Search tamsulosin and dutasteride products by name

Tamsulosin and dutasteride · ATC G04CA52

13 / 19 countries

Belgiumprice
Canada
Czechiaprice
Denmark
Finlandprice
Icelandprice
Ireland
Netherlands
Norwayprice
Polandprice
Switzerlandprice
United Kingdom
United Statesprice

Blue: a registration under this ATC code. The ringed marker is this record’s country. Markets marked price publish a price we can compare per daily dose.

The record

At a glance

HPRA (Ireland)

Active substance: Dutasteride + Tamsulosin hydrochloride
Manufacturer: Accord Healthcare Ireland Ltd.
Country: Ireland (IE)
ATC code: G04CA52
ATC class: Tamsulosin and dutasteride
Reimbursed: Not published by this register
Source register: HPRA (Ireland)
Last checked: September 28, 2026

Packs & prices · 1

ie_pa_number
PA2315/222/001

Regulatory notes

No shortage, Orange Book or US label notes for this record.

Interactions

1 interaction on record for tamsulosin and dutasteride.

Mechanism, severity and management for each pair, from a commercially licensed source — included with Growth.

Severity for every pair — free, no plan needed
The source, licence and sync date on every record
Mechanism and what to do for each pair — Growth plan

Check tamsulosin and dutasteride against other medicines How interaction checks work

Tamsulosin and dutasteride · interactions on record

1 record

1 more interaction with mechanism and management, from a commercially licensed source.

Mechanism and what to do, in the interaction check

Interaction register. Grades as the source publishes them.

Same medicine, other countries

Tamsulosin and dutasteride in 13 other countries

What each register calls a product with the same active substance — salts and hydrates count as the same.

All tamsulosin and dutasteride products

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
Germany · Duodart, Duta-Tamsaxiro
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
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 HPRA (Ireland). 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/d41978ba-4f00-4a80-b3ca-99ac9540ec27
GET /v1/drugs/d41978ba-4f00-4a80-b3ca-99ac9540ec27?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.

{
  "form": "Capsule, hard",
  "routes": [
    "Oral use"
  ],
  "source": "hpra",
  "atc_all": [
    "G04CA",
    "G04CA52"
  ],
  "strength": null,
  "pa_number": "PA2315/222/001",
  "substances": [
    "Dutasteride",
    "Tamsulosin hydrochloride"
  ],
  "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)",
  "market_info": "Marketed",
  "authorised_at": "22/11/2019",
  "dispensing_status": "Product subject to prescription which may not be renewed (A)",
  "registration_status": "AU",
  "supply_legal_status": "Supply through pharmacies only",
  "interchangeable_code": "IC0036-065-001"
}

API reference MCP server Plans

See everything about tamsulosin and 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.

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