Belgium· BE-AMP-SAM598995-00
Kapruvia 50 µg/ml
A difelikefalin product containing difelikefalin acetate, registered in Belgium by Vifor Fresenius Medical Care Renal Pharma France. The same ATC class is registered in 14 of our 19 countries.
Checked against FAMHP / AFMPS (Belgium) on
Informational only — not a medical device.
Where it is registered
Difelikefalin is registered in 14 of 19 countries.
Countries holding a registration under ATC V03AX04 (difelikefalin), each read from that country’s own register.
- This record: Belgium, from FAMHP / AFMPS (Belgium)
- 9 of them publish a price we can compare per daily dose
Difelikefalin · ATC V03AX04
14 / 19 countries
- Belgiumprice
- Canada
- Czechiaprice
- Denmark
- Finlandprice
- Franceprice
- Icelandprice
- Japan
- Netherlands
- Norwayprice
- Polandprice
- Switzerlandprice
- United Kingdom
- United Statesprice
The record
At a glance
FAMHP / AFMPS (Belgium)- Active substance
- Difelikefalin Acetate
- Manufacturer
- Vifor Fresenius Medical Care Renal Pharma France
- Country
- Belgium (BE)
- ATC code
- V03AX04
- ATC class
- Difelikefalin
- Defined daily dose
- 15 mcg, P
- Reimbursed
- Not published by this register
- Source register
- FAMHP / AFMPS (Belgium)
- Last checked
- September 26, 2026
Packs & prices · 1
- be_apb4801858
Regulatory notes
No shortage, Orange Book or US label notes for this record.
Same medicine, other countries
Difelikefalin in 14 other countries
What each register calls a product with the same active substance — salts and hydrates count as the same.
- SwitzerlandKapruvia
- CzechiaKAPRUVIAVifor Fresenius Medical Care Renal Pharma France, Paříž
- SpainKAPRUVIA 50 MICROGRAMOS/ML SOLUCION INYECTABLEVifor Fresenius Medical Care Renal Pharma France
- NetherlandsKapruvia 50 microgram/ml oplossing voor injectieVifor Fresenius Medical Care Renal Pharma France
- NorwayKapruviaVifor Fresenius Medical Care Renal Pharma France
- SwedenKapruvia 50 mikrogram/ml Injektionsvätska, lösningVifor Fresenius Medical Care Renal Pharma France
- FinlandKapruviaVifor Fresenius Medical Care Renal Pharma France
- United KingdomKapruvia 50micrograms/1ml solution for injection vialsVifor Fresenius Medical Care Renal Pharma UK Ltd
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 FAMHP / AFMPS (Belgium). 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/c946ade1-7860-48c6-80cb-1b1eb5e8315f GET /v1/drugs/c946ade1-7860-48c6-80cb-1b1eb5e8315f?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",
"source": "afmps",
"status": "AUTHORIZED",
"name_en": "Kapruvia 50 µg/ml",
"name_fr": "Kapruvia 50 µg/ml",
"name_nl": "Kapruvia 50 µg/ml",
"amp_code": "SAM598995-00",
"strengths": [
"50.0000"
],
"pack_count": 2,
"substances": [
"Difelikefalin Acetate",
"Difelikefalin",
"Sodium Acetate Trihydrate",
"Sodium Chloride"
],
"medicine_type": "ALLOPATHIC",
"atc_description": "Difelikefalin",
"authorisation_numbers": [
"EU/1/22/1643/001",
"EU/1/22/1643/002"
]
}See everything about difelikefalin.
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.