Drug Database
Back to search

Ireland· IE-PA-PA2165/015/001

Levosimendan 2.5 mg/ml concentrate for solution for infusion

A levosimendan product containing levosimendan, registered in Ireland by AS Kalceks. The same ATC class is registered in 14 of our 19 countries.

ATC C01CX08

Checked against HPRA (Ireland) on

Informational only — not a medical device.

SOURCE REGISTER · IEHPRA (Ireland)normalisedLevosimendan 2.5 mg/ml concentrate fo…ATCC01CX08REGISTER NO.IE-PA-PA2165/015/001PACKS LISTED1CHECKEDSeptember 28, 2026
Compare price across countriesPer daily dose · free accountAsk the assistant about levosimendanAnswers with sources · free accountCheck interactionsSeverity free · mechanism on Growth

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: Ireland, from HPRA (Ireland)
  • 8 of them publish a price we can compare per daily dose
Search levosimendan products by name

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

HPRA (Ireland)
Active substance
Levosimendan
Manufacturer
AS Kalceks
Country
Ireland (IE)
ATC code
C01CX08
ATC class
Levosimendan
Defined daily dose
11 mg, P
Reimbursed
Not published by this register
Source register
HPRA (Ireland)
Last checked
September 28, 2026

Packs & prices · 1

  • ie_pa_number
    PA2165/015/001

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
  • 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
  • Poland · Levosimendan Accord, Levosimendan Farmak
  • 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 HPRA (Ireland). 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/4be2febb-b6c2-443a-a7a5-34d897bba349
GET /v1/drugs/4be2febb-b6c2-443a-a7a5-34d897bba349?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": "Concentrate for solution for infusion",
  "routes": [
    "Intravenous use"
  ],
  "source": "hpra",
  "atc_all": [
    "C01CX08"
  ],
  "strength": null,
  "pa_number": "PA2165/015/001",
  "substances": [
    "Levosimendan"
  ],
  "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)",
  "market_info": "Marketed",
  "authorised_at": "01/04/2022",
  "dispensing_status": "Product subject to prescription which may not be renewed (A)",
  "registration_status": "AU",
  "supply_legal_status": "Supply through pharmacies only",
  "interchangeable_code": null
}
API referenceMCP serverPlans

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.

Try it freeOpen in the console