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Poland· PL-100438650

Levosimendan Kabi

A levosimendan product containing levosimendanum, registered in Poland by Fresenius Kabi Polska Sp. z o.o.. The same ATC class is registered in 14 of our 19 countries.

ATC C01CX08

Checked against URPL (Poland) on

Informational only — not a medical device.

SOURCE REGISTER · PLURPL (Poland)normalisedLevosimendan KabiATCC01CX08REGISTER NO.PL-100438650PACKS LISTED3CHECKEDSeptember 27, 2026

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
Blue: a registration under this ATC code. The ringed marker is this record’s country. Markets marked price publish a price we can compare per daily dose.

The record

At a glance

URPL (Poland)
Active substance
Levosimendanum
Manufacturer
Fresenius Kabi Polska Sp. z o.o.
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 · 3

  • gtin
    05909991485894
  • gtin
    05909991485900
  • gtin
    05909991485917

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.

All levosimendan products

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/c599726d-18ab-4e10-b2fd-ae583d55b725
GET /v1/drugs/c599726d-18ab-4e10-b2fd-ae583d55b725?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": "05909991485894 ¦ Lz ¦ 145368\n1 fiol. 5 ml\n05909991485900 ¦ Lz ¦ 145369\n10 fiol. 5 ml\n05909991485917 ¦ Lz ¦ 145370\n4 fiol. 5 ml",
  "substance": "Levosimendanum 2,5 mg/ml",
  "common_name": "Levosimendanum",
  "pl_product_id": "100438650",
  "pozwolenie_nr": "27118",
  "auth_procedure": "DCP",
  "authorisation_validity": "2025-10-03"
}

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.