Ireland· IE-PA-PA2021/002/002
Accusol 35 Potassium 4 mmol/lSolution for haemofiltration, haemodialysis and haemodiafiltration
A hemofiltrates product containing sodium chloride + calcium chloride + magnesium chloride + sodium bicarbonate, registered in Ireland by Nikkiso Belgium bvba. The same ATC class is registered in 11 of our 19 countries.
Checked against HPRA (Ireland) on
Informational only — not a medical device.
Where it is registered
Sodium chloride + calcium chloride + magnesium chloride + sodium bicarbonate is registered in 11 of 19 countries.
Countries holding a registration under ATC B05ZB (hemofiltrates), each read from that country’s own register.
- This record: Ireland, from HPRA (Ireland)
- 7 of them publish a price we can compare per daily dose
Sodium chloride + calcium chloride + magnesium chloride + sodium bicarbonate · ATC B05ZB
11 / 19 countries
- Belgiumprice
- Canada
- Czechiaprice
- Denmark
- Finlandprice
- Icelandprice
- Ireland
- Netherlands
- Norwayprice
- Polandprice
- Switzerlandprice
The record
At a glance
HPRA (Ireland)- Active substance
- Sodium chloride + Calcium chloride + Magnesium chloride + Sodium bicarbonate
- Manufacturer
- Nikkiso Belgium bvba
- Country
- Ireland (IE)
- ATC code
- B05ZB
- ATC class
- Hemofiltrates
- Reimbursed
- Not published by this register
- Source register
- HPRA (Ireland)
- Last checked
- September 28, 2026
Packs & prices · 1
- ie_pa_numberPA2021/002/002
Regulatory notes
No shortage, Orange Book or US label notes for this record.
Same medicine, other countries
Sodium chloride + calcium chloride + magnesium chloride + sodium bicarbonate in 6 other countries
What each register calls a product with the same active substance — salts and hydrates count as the same.
- FinlandBicanova 1.5 % GlukoosiFresenius Medical Care Deutschland GmbH
- FranceACCUSOL 35, solution pour hémofiltration, hémodialyse et hémodiafiltrationNIKKISO BELGIUM (BELGIQUE)
- CanadaPHYSIONEAL 40 GLUCOSE 3.86%VANTIVE ULC
- SpainACCUSOL 35 SOLUCION PARA HEMOFILTRACION, HEMODIALISIS Y HEMODIAFILTRACIONNikkiso Belgium
- CzechiaDUOSOL BEZ KALIAB.Braun Avitum AG, Melsungen
- GermanyAccusol 35Nikkiso Belgium
Authorised across Europe · EMA
The same active substance is authorised in 7 EEA countries. Names it is sold under:
- Belgium · Accusol 35
- Germany · Accusol 35
- Spain · Accusol 35
- France · Accusol 35
- United Kingdom (Northern Ireland) · Accusol 35
- Greece · Accusol 35, Vermalton
- Slovakia · Accusol 35
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/c2b6f8d9-6999-4e36-a175-9c4254533096 GET /v1/drugs/c2b6f8d9-6999-4e36-a175-9c4254533096?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": "Solution for haemodialysis/haemofiltration",
"routes": [
"Haemodialysis",
"Intraarterial use"
],
"source": "hpra",
"atc_all": [
"B05ZB"
],
"strength": null,
"pa_number": "PA2021/002/002",
"substances": [
"Sodium chloride",
"Calcium chloride",
"Magnesium chloride",
"Sodium bicarbonate",
"Potassium chloride",
"Glucose anhydrous"
],
"legal_basis": "Well-established use application (Article 10a of Directive No 2001/83/EC)",
"market_info": "Marketed",
"authorised_at": "28/04/2006",
"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
}See everything about sodium chloride + calcium chloride + magnesium chloride + sodium bicarbonate.
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.