Spain· ES:1171189001
ELMIRON 100 MG CAPSULAS DURAS
A medicinal product containing pentosano polisulfato de sodio, registered in Spain by Bene-Arzneimittel Gmbh.
Checked against AEMPS CIMA (Spain) on
Informational only — not a medical device.
The record
At a glance
AEMPS CIMA (Spain)- Active substance
- pentosano polisulfato de sodio
- Manufacturer
- Bene-Arzneimittel Gmbh
- 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
Pentosano polisulfato de sodio 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
- FinlandelmironBene-Arzneimittel GmbH
- Irelandelmiron 100 mg capsules, hardbene-Arzneimittel GmbH
- IcelandElmironBene-Artzneimittel GmbH
- NorwayElmironbene-Arzneimittel GmbH
- PolandElmironbene Arzneimittel GmbH
- BelgiumElmiron 100 mgBene-Arzneimittel
Authorised across Europe · EMA
The same active substance is authorised in 8 EEA countries. Names it is sold under:
- Czechia · Thrombocid
- Germany · Thrombocid
- 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 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/02f10766-7e5d-4875-91ff-38a62cf67e22 GET /v1/drugs/02f10766-7e5d-4875-91ff-38a62cf67e22?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\":1563519044000}",
"nregistro": "1171189001",
"substance": "pentosano polisulfato de sodio"
}See everything about pentosano polisulfato de sodio.
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.