Belgium· BE-AMP-SAM542782-00
Tamsulosine HCl Krka 0,4 mg
A medicinal product containing tamsulosin hydrochloride, registered in Belgium by KRKA d.d. Novo mesto.
Checked against FAMHP / AFMPS (Belgium) on
Informational only — not a medical device.
The record
At a glance
FAMHP / AFMPS (Belgium)- Active substance
- Tamsulosin Hydrochloride
- Manufacturer
- KRKA d.d. Novo mesto
- 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
Tamsulosin hydrochloride in 17 other countries
What each register calls a product with the same active substance — salts and hydrates count as the same.
- CzechiaOMNIC TOCASAstellas Pharma s.r.o., Praha
- SpainINREQ 0,4 mg COMPRIMIDOS DE LIBERACION PROLONGADA EFGLaboratorios Q Pharma S.L.
- United KingdomCositam XL 400microgram tabletsConsilient Health Ltd
- NetherlandsOmnic Ocas 0,4, tabletten met verlengde afgifte 0,4 mgAstellas Pharma Europe B.V.
- PolandAdatam XRAdamed Pharma S.A.
- CanadaAPO-TAMSULOSIN CRAPOTEX INC
- FinlandMasulinSandoz A/S
- IrelandOmnexel 400 micrograms prolonged release tablets, film-coatedIMED Healthcare Ltd.,
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/e0bb56f8-d777-464f-8b7c-b3da2f6eab75 GET /v1/drugs/e0bb56f8-d777-464f-8b7c-b3da2f6eab75?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": "Prolonged-release tablet",
"source": "afmps",
"status": "AUTHORIZED",
"name_en": "Tamsulosine HCl Krka 0,4 mg",
"name_fr": "Tamsulosine HCl Krka 0,4 mg",
"name_nl": "Tamsulosine HCl Krka 0,4 mg",
"amp_code": "SAM542782-00",
"strengths": [
"0.4000"
],
"pack_count": 0,
"substances": [
"Tamsulosin Hydrochloride"
],
"medicine_type": "ALLOPATHIC",
"atc_description": null,
"authorisation_numbers": null
}See everything about tamsulosin hydrochloride.
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.