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Ireland· IE-PA-PA0281/216/001

Dutasteride/Tamsulosin hydrochloride Pinewood 0.5 mg/0.4 mg hard capsules

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

ATC G04CA52

Checked against HPRA (Ireland) on

Informational only — not a medical device.

SOURCE REGISTER · IEHPRA (Ireland)normalisedDutasteride/Tamsulosin hydrochloride …ATCG04CA52REGISTER NO.IE-PA-PA0281/216/001PACKS LISTED1CHECKEDSeptember 28, 2026

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

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
Pinewood Laboratories 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
    PA0281/216/001

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

Tamsulosin and dutasteride · interactions on record

1 record

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

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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/fd434499-7d2b-4f2b-a81e-9b2f91bbc19c
GET /v1/drugs/fd434499-7d2b-4f2b-a81e-9b2f91bbc19c?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": [
    "G04CA52"
  ],
  "strength": null,
  "pa_number": "PA0281/216/001",
  "substances": [
    "Dutasteride",
    "Tamsulosin hydrochloride"
  ],
  "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)",
  "market_info": "Marketed",
  "authorised_at": "09/10/2020",
  "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"
}

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.