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Belgium· BE-AMP-SAM369774-00

Combodart 0.5 mg - 0.4 mg

A tamsulosin and dutasteride product containing tamsulosin hydrochloride, registered in Belgium by GlaxoSmithKline Pharmaceuticals. The same ATC class is registered in 13 of our 19 countries.

ATC G04CA52

Checked against FAMHP / AFMPS (Belgium) on

Informational only — not a medical device.

SOURCE REGISTER · BEFAMHP / AFMPS (Belgium)normalisedCombodart 0.5 mg - 0.4 mgATCG04CA52REGISTER NO.BE-AMP-SAM369774-00PACKS LISTED2CHECKEDSeptember 26, 2026
Compare price across countriesPer daily dose · free accountAsk the assistant about tamsulosin hydrochlorideAnswers with sources · free accountCheck 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: Belgium, from FAMHP / AFMPS (Belgium)
  • 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

FAMHP / AFMPS (Belgium)
Active substance
Tamsulosin Hydrochloride
Manufacturer
GlaxoSmithKline Pharmaceuticals
Country
Belgium (BE)
ATC code
G04CA52
ATC class
Tamsulosin and dutasteride
Reimbursed
Not published by this register
Source register
FAMHP / AFMPS (Belgium)
Last checked
September 26, 2026

Packs & prices · 2

  • be_apb
    2697993
  • be_apb
    2719474

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 medicinesHow interaction checks work

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 17 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 29 EEA countries. Names it is sold under:

  • Austria · Aglandin Retard, Tamsu
  • Bulgaria · Tamaliz, Омник Токас
  • Cyprus · Tamsulijn, Tamsulosin Aurobindo
  • Czechia · Fokusin, Lannatam
  • Germany · Omnic Ocas, Prostadil
  • Denmark · Bladasin, Miktosan
  • Estonia · Flosin, Omsal
  • Spain · Inreq, Omnic
  • Finland · Expros, Omnic Ocas
  • France · Mecir L.P., Omexel L.P.
  • United Kingdom (Northern Ireland) · Contiflo Xl, Cositam Xl
  • Greece · Omnic Τocas, Prosolvin
  • Croatia · Bazetham, Flosin
  • Hungary · Galebon, Omnic
  • Ireland · Omnexel, Tamnexyl Xl
  • Iceland · Tamsulosin Hydrochloride Synthon, Tamsulosin Medical
  • Italy · Antunes, Botam
  • Lithuania · Flosin, Fokusin
  • Luxembourg · Omic Ocas, Ranomax
  • Latvia · Fokusin, Tamsulosin Lannacher
  • Malta · Tamnic, Tamnic 400 Micrograms Modified-Release Capsules, Hard
  • Netherlands · Duktam, Omnic 0,4
  • Norway · Miktosan, Omnic
  • Poland · Adatam, Adatam Xr
  • Portugal · Omnic, Sebrane Xr
  • Romania · Contiflo Mr, Fokusin
  • Sweden · Tamicten
  • Slovenia · Miktan, Omnic Ocas
  • Slovakia · Fokusin, Geroprostan

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 FAMHP / AFMPS (Belgium). 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/becf5d19-064f-4add-9461-98fc89b55732
GET /v1/drugs/becf5d19-064f-4add-9461-98fc89b55732?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",
  "source": "afmps",
  "status": "AUTHORIZED",
  "name_en": "Combodart 0.5 mg - 0.4 mg",
  "name_fr": "Combodart 0.5 mg - 0.4 mg",
  "name_nl": "Combodart 0.5 mg - 0.4 mg",
  "amp_code": "SAM369774-00",
  "strengths": [
    "0.4000",
    "0.3670",
    "0.5000",
    "0.0300",
    "66.3200"
  ],
  "pack_count": 3,
  "substances": [
    "Tamsulosin Hydrochloride",
    "Tamsulosin",
    "Dutasteride",
    "Butylhydroxytoluene",
    "E 110",
    "Glycerol",
    "Potassium Chloride"
  ],
  "medicine_type": "ALLOPATHIC",
  "atc_description": "Tamsulosin and Dutasteride",
  "authorisation_numbers": [
    "BE369774"
  ]
}
API referenceMCP serverPlans

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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