Ireland· IE-PA-EU/1/22/1643/001-002
Kapruvia 50 micrograms/mL solution for injection
A other therapeutic products product containing difelikefalin acetate, registered in Ireland by Vifor France. The same ATC class is registered in 4 of our 19 countries.
Checked against HPRA (Ireland) on
Informational only — not a medical device.
Where it is registered
Difelikefalin acetate is registered in 4 of 19 countries.
Countries holding a registration under ATC V03AX (other therapeutic products), each read from that country’s own register.
- This record: Ireland, from HPRA (Ireland)
- 3 of them publish a price we can compare per daily dose
Difelikefalin acetate · ATC V03AX
4 / 19 countries
- Belgiumprice
- Ireland
- Norwayprice
- Polandprice
The record
At a glance
HPRA (Ireland)- Active substance
- Difelikefalin Acetate
- Manufacturer
- Vifor France
- Country
- Ireland (IE)
- ATC code
- V03AX
- ATC class
- Other therapeutic products
- Reimbursed
- Not published by this register
- Source register
- HPRA (Ireland)
- Last checked
- September 28, 2026
Packs & prices · 1
- ie_pa_numberEU/1/22/1643/001-002
Regulatory notes
No shortage, Orange Book or US label notes for this record.
Same medicine, other countries
Difelikefalin acetate in 14 other countries
What each register calls a product with the same active substance — salts and hydrates count as the same.
- FinlandKapruviaAbacus Medicine A/S
- United StatesKorsuvaVifor (International), Inc.
- CzechiaKAPRUVIAVifor Fresenius Medical Care Renal Pharma France, Paříž
- SwitzerlandKapruvia
- FranceKAPRUVIA 50 microgrammes/mL, solution injectableVIFOR FRESENIUS MEDICAL CARE RENAL PHARMA FRANCE
- United KingdomKapruvia 50micrograms/1ml solution for injection vialsVifor Fresenius Medical Care Renal Pharma UK Ltd
- IcelandKapruviaVifor Fresenius Medical Care Renal Pharma France*
- NetherlandsKapruvia 50 microgram/ml oplossing voor injectieVifor Fresenius Medical Care Renal Pharma France
Authorised across Europe · EMA
The same active substance is authorised in 3 EEA countries. Names it is sold under:
- Iceland · Kapruvia
- Liechtenstein · Kapruvia
- Norway · Kapruvia
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/703f78c8-8164-41e9-b26e-97066b3efedd GET /v1/drugs/703f78c8-8164-41e9-b26e-97066b3efedd?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 injection",
"routes": [
"Intravenous use"
],
"source": "hpra",
"atc_all": [
"V03AX"
],
"strength": null,
"pa_number": "EU/1/22/1643/001-002",
"substances": [
"Difelikefalin Acetate"
],
"legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)",
"market_info": "Unknown",
"authorised_at": "25/04/2022",
"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
}See everything about difelikefalin acetate.
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.