Germany· DE-A57-a37bf97a9a59b161
Thrombocid
A medicinal product containing pentosan polysulfate sodium, registered in Germany by Bene-Arzneimittel Gmbh.
Checked against EMA Article 57 (European Union) on
Informational only — not a medical device.
The record
At a glance
EMA Article 57 (European Union)- Active substance
- Pentosan Polysulfate Sodium
- Manufacturer
- Bene-Arzneimittel Gmbh
- Country
- Germany (DE)
- ATC code
- —
- Reimbursed
- Not published by this register
- Source register
- EMA Article 57 (European Union)
- Last checked
- September 30, 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
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.
- SpainELMIRON 100 MG CAPSULAS DURASBene-Arzneimittel Gmbh
- United KingdomElmiron 100mg capsulesConsilient Health Ltd
- CzechiaELMIRONbene-Arzneimittel GmbH, Mnichov
- FinlandCartrophen Equine Forte
- CanadaCARTROPHEN VET INJ.SC 100MG/MLBIOPHARM AUSTRALIA PTY LTD.
- Swedenelmiron 100 mg Kapsel, hårdbene Arzneimittel GmbH
- BelgiumElmiron 100 mgBene-Arzneimittel
- United StatesELMIRONJanssen Pharmaceuticals, Inc.
Authorised across Europe · EMA
The same active substance is authorised in 8 EEA countries. Names it is sold under:
- Czechia · 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 EMA Article 57 (European Union). 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/10710f77-5378-4f10-9797-d9bd9d97eb11 GET /v1/drugs/10710f77-5378-4f10-9797-d9bd9d97eb11?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.
{
"pzn": null,
"route": "Cutaneous Use",
"source": "ema_art57_de",
"ma_number": null,
"substance": "Pentosan Polysulfate Sodium",
"atc_from_source": null,
"authorisation_country": "Germany"
}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.