Belgium· BE-AMP-SAM545040-00
Dutasteride/Tamsulosine HCl AB 0,5 mg - 0,4 mg
A medicinal product containing dutasteride, registered in Belgium by Aurobindo Pharma.
Checked against FAMHP / AFMPS (Belgium) on
Informational only — not a medical device.
The record
At a glance
FAMHP / AFMPS (Belgium)- Active substance
- Dutasteride
- Manufacturer
- Aurobindo Pharma
- Country
- Belgium (BE)
- ATC code
- —
- Reimbursed
- Not published by this register
- Source register
- FAMHP / AFMPS (Belgium)
- Last checked
- September 26, 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
Dutasteride in 17 other countries
What each register calls a product with the same active substance — salts and hydrates count as the same.
- ItalyAVODARTGLAXOSMITHKLINE S.P.A.
- United KingdomAvodart 500microgram capsulesDowelhurst Ltd
- CanadaACT DUTASTERIDETEVA CANADA LIMITED
- NetherlandsAvodart 0,5 mg zachte capsulesGlaxoSmithKline B.V.
- SwitzerlandAvodart
- United StatesDutasterideAmneal Pharmaceuticals LLC
- CzechiaADADUTAdamed Pharma S.A., Czosnów
- SpainAVIDART 0,5 mg CAPSULAS BLANDASGlaxosmithkline S.P.A.
Authorised across Europe · EMA
The same active substance is authorised in 29 EEA countries. Names it is sold under:
- Austria · Avodart, Dutaglandin
- Bulgaria · Дутастерид Акорд, Дутрис
- Cyprus · Avodart, Rafuster
- Czechia · Adadut, Avodart
- Germany · Avodart, Dutascar
- Denmark · Deridust, Dutasterid "alkaloid"
- Estonia · Avodart, Dutasteride Elvim
- Spain · Avidart, Dutacap
- Finland · Avodart, Dutasteride Krka
- France · Avodart, Dutasteride Accord
- United Kingdom (Northern Ireland) · Avodart, Dutasteride
- Greece · Avodart, Dastidem
- Croatia · Avodart, Dupro
- Hungary · Avodart
- Ireland · Avodart, Dutasteride Krka
- Iceland · Dutasteride Alvogen, Dutasteride Medical Valley
- Italy · Avodart, Decuster
- Lithuania · Dortilla, Dutasteride Elvim
- Luxembourg · Avodart
- Latvia · Avodart, Dutasteride Elvim
- Malta · Avodart, Dutalan
- Netherlands · Avodart, Dutasteride Aurobindo
- Norway · Dutasteride Medical Valley
- Poland · Adadut, Avodart
- Portugal · Aripsa, Avodart
- Romania · Asium, Avodart
- Sweden · Avodart, Duagen
- Slovenia · Amdut, Avodart
- Slovakia · Adadut, Dutalan
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/b5b38cb8-dc85-4206-aee9-4788e2676fc8 GET /v1/drugs/b5b38cb8-dc85-4206-aee9-4788e2676fc8?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": "Dutasteride/Tamsulosine HCl AB 0,5 mg - 0,4 mg",
"name_fr": "Dutasteride/Tamsulosine HCl AB 0,5 mg - 0,4 mg",
"name_nl": "Dutasteride/Tamsulosine HCl AB 0,5 mg - 0,4 mg",
"amp_code": "SAM545040-00",
"strengths": [
"0.5000",
"0.4000"
],
"pack_count": 0,
"substances": [
"Dutasteride",
"Tamsulosin Hydrochloride"
],
"medicine_type": "ALLOPATHIC",
"atc_description": null,
"authorisation_numbers": null
}See everything about 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.