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Spain· ES:84551

DUTASTERIDA/TAMSULOSINA AUROBINDO 0,5 MG/0,4 MG CAPSULAS DURAS EFG

A medicinal product containing dutasterida + tamsulosina, registered in Spain by Laboratorios Aurobindo S.L.U..

Checked against AEMPS CIMA (Spain) on

Informational only — not a medical device.

SOURCE REGISTER · ESAEMPS CIMA (Spain)normalisedDUTASTERIDA/TAMSULOSINA AUROBINDO 0,5…ATC—REGISTER NO.ES:84551PACKS LISTED0CHECKEDJune 3, 2026

The record

At a glance

AEMPS CIMA (Spain)
Active substance
dutasterida + tamsulosina
Manufacturer
Laboratorios Aurobindo S.L.U.
Country
Spain (ES)
ATC code
—
Reimbursed
Not published by this register
Source register
AEMPS CIMA (Spain)
Last checked
June 3, 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

Dutasterida + tamsulosina in 13 other countries

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

All dutasterida + tamsulosina 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
  • 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 AEMPS CIMA (Spain). 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/876a0620-adae-4945-880c-c7d880194b7b
GET /v1/drugs/876a0620-adae-4945-880c-c7d880194b7b?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.

{
  "cpresc": "Medicamento Sujeto A Prescripción Médica",
  "estado": "{\"aut\":1571090400000,\"rev\":1627976699000}",
  "nregistro": "84551",
  "substance": "dutasterida + tamsulosina"
}

See everything about dutasterida + tamsulosina.

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.