Poland· PL-100340023
Simdax
A levosimendan product containing levosimendanum, registered in Poland by Orion Corporation. The same ATC class is registered in 14 of our 19 countries.
Checked against URPL (Poland) on
Informational only — not a medical device.
Where it is registered
Levosimendan is registered in 14 of 19 countries.
Countries holding a registration under ATC C01CX08 (levosimendan), each read from that country’s own register.
- This record: Poland, from URPL (Poland)
- 8 of them publish a price we can compare per daily dose
Levosimendan · ATC C01CX08
14 / 19 countries
- Belgiumprice
- Czechiaprice
- Denmark
- Finlandprice
- Franceprice
- Germany
- Icelandprice
- Ireland
- Netherlands
- Norwayprice
- Polandprice
- Sweden
- Switzerlandprice
- United Kingdom
The record
At a glance
URPL (Poland)- Active substance
- Levosimendanum
- Manufacturer
- Orion Corporation
- Country
- Poland (PL)
- ATC code
- C01CX08
- ATC class
- Levosimendan
- Defined daily dose
- 11 mg, P
- Reimbursed
- Not published by this register
- Source register
- URPL (Poland)
- Last checked
- September 27, 2026
Packs & prices · 2
- gtin05909991225438
- gtin05909991279486
Regulatory notes
No shortage, Orange Book or US label notes for this record.
Same medicine, other countries
Levosimendan in 13 other countries
What each register calls a product with the same active substance — salts and hydrates count as the same.
- CzechiaLEVOSIMENDAN FMKFARMAK INTERNATIONAL Sp.z.o.o., Varšava
- FinlandLevosimendan AltanAltan Pharma Ltd
- SwedenLevosimendan Altan 2,5 mg/ml Koncentrat till infusionsvätska, lösningAltan Pharma Limited
- SwitzerlandLevosimendan Ideogen 12,5 mg/5 ml, Konzentrat zur Herstellung einer InfusionslösungIDEOGEN AG
- BelgiumLevosimendan Altan 2.5 mg/mlAltan Pharma
- NorwayLevosimendan KalceksAS Kalceks
- IcelandLevosimendan STADASTADA Arzneimittel AG
- IrelandLevosimendan 2.5 mg/ml concentrate for solution for infusionAS Kalceks
Authorised across Europe · EMA
The same active substance is authorised in 26 EEA countries. Names it is sold under:
- Austria · Cordenova, Levosimendan Accord
- Belgium · Levosimendan Kabi, Levosimendan Kalceks
- Bulgaria · Левосимендан Калцекс, Симдакс
- Cyprus · Levosimendan Win Medica, Simdax
- Czechia · Levosimendan Fmk, Levosimendan Kalceks
- Germany · Levosimendan Accord, Levosimendan Altan
- Denmark · Levosimendan, Levosimendan Amdipharm
- Estonia · Levosimendan Auxilia, Levosimendan Kalceks
- Spain · Levosimendán Accord, Levosimendán Altan
- Finland · Levosimendan Amdipharm, Levosimendan Bioglan
- France · Levosimendan Accord, Levosimendan Altan
- Greece · Levosimendan Win Medica, Simdax
- Croatia · Levosimendan Alpha-Medical, Levosimendan Kalceks
- Hungary · Levosimendan Kalceks, Levosimendan Stada
- Ireland · Levosimendan Kalceks
- Iceland · Levosimendan Stada, Simdax
- Italy · Levosimendan Accord, Levosimendan Altan
- Lithuania · Levosimendan Kalceks
- Latvia · Levosimendan Kalceks
- Netherlands · Levosimendan Carinopharm, Levosimendan Kalceks
- Norway · Levosimendan Amdipharm, Levosimendan Bioglan
- Portugal · Levossimendano Accord, Levossimendano Altan
- Romania · Levatrop, Levosimendan
- Sweden · Levosimendan Amdipharm, Levosimendan Bioglan
- Slovenia · Levosimendan Carinopharm, Levosimendan Kalceks
- Slovakia · Levosimendan Fmk, Levosimendan Kalceks
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 URPL (Poland). 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/e157ade9-f293-45f3-9990-b69892a7b51a GET /v1/drugs/e157ade9-f293-45f3-9990-b69892a7b51a?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": "Koncentrat do sporządzania roztworu do infuzji",
"source": "urpl",
"strength": "2,5 mg/ml",
"packaging": "05909991225438 ¦ Lz ¦ 108837\n1 fiol. 5 ml\n05909991279486 ¦ Lz ¦ 116183\n1 fiol. 5 ml",
"substance": "Levosimendanum 2.5 mg/ml",
"common_name": "Levosimendanum",
"pl_product_id": "100340023",
"pozwolenie_nr": "22499",
"auth_procedure": "DCP",
"authorisation_validity": "Bezterminowe"
}See everything about levosimendan.
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.