Sweden· SE-20160206000021
elmiron 100 mg Kapsel, hård
A medicinal product containing pentosan polysulfate sodium, registered in Sweden by bene Arzneimittel GmbH.
Checked against Swedish Medical Products Agency (Sweden) on
Informational only — not a medical device.
The record
At a glance
Swedish Medical Products Agency (Sweden)- Active substance
- Pentosan Polysulfate Sodium
- Manufacturer
- bene Arzneimittel GmbH
- Country
- Sweden (SE)
- ATC code
- —
- Reimbursed
- Not published by this register
- Source register
- Swedish Medical Products Agency (Sweden)
- Last checked
- October 1, 2026
Packs & prices · 1
- se_varunummer20160206000021
Regulatory notes
No shortage, Orange Book or US label notes for this record.
Same medicine, other countries
Pentosan polysulfate sodium in 12 other countries
What each register calls a product with the same active substance — salts and hydrates count as the same.
- United KingdomElmiron 100mg capsulesImported (United States)
- CzechiaELMIRONbene-Arzneimittel GmbH, Mnichov
- SpainELMIRON 100 MG CAPSULAS DURASBene-Arzneimittel Gmbh
- FinlandelmironBene-Arzneimittel GmbH
- Irelandelmiron 100 mg capsules, hardbene-Arzneimittel GmbH
- IcelandElmironBene-Artzneimittel GmbH
- NorwayElmironbene-Arzneimittel GmbH
- BelgiumElmiron 100 mgBene-Arzneimittel
Authorised across Europe · EMA
The same active substance is authorised in 9 EEA countries. Names it is sold under:
- Czechia · Thrombocid
- Germany · Thrombocid
- Spain · Thrombocid, Thrombocid Forte
- Hungary · Dimovena, Sp 54
- Iceland · Elmiron
- Italy · Fibrase
- Liechtenstein · Elmiron
- Norway · Elmiron
- Portugal · Comfora, Thrombocid
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 Swedish Medical Products Agency (Sweden). 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/1b76d0ec-6497-4155-a255-28c108ad5899 GET /v1/drugs/1b76d0ec-6497-4155-a255-28c108ad5899?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.
{
"source": "lakemedelsverket",
"doc_types": [
"EMA",
"EPAR"
],
"se_npl_id": "20160206000021",
"product_page": "https://www.lakemedelsverket.se/sv/sok-lakemedelsfakta/lakemedel?id=20160206000021",
"product_doc_link": "https://www.ema.europa.eu/en/medicines/human/EPAR/elmiron"
}See everything about pentosan polysulfate sodium.
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.