Netherlands· NL-20fc1d0e3ba4
KAYFANDA 1200 microgram harde capsules
A odevixibat product containing odevixibat 1,5-water, registered in Netherlands by Ipsen Pharma. The same ATC class is registered in 15 of our 19 countries.
Checked against CBG-MEB (Netherlands) on
Informational only — not a medical device.
Where it is registered
Odevixibat is registered in 15 of 19 countries.
Countries holding a registration under ATC A05AX05 (odevixibat), each read from that country’s own register.
- This record: Netherlands, from CBG-MEB (Netherlands)
- 9 of them publish a price we can compare per daily dose
Odevixibat · ATC A05AX05
15 / 19 countries
- Belgiumprice
- Canada
- Czechiaprice
- Denmark
- Finlandprice
- Franceprice
- Icelandprice
- Ireland
- Japan
- Netherlands
- Polandprice
- Spainprice
- Switzerlandprice
- United Kingdom
- United Statesprice
The record
At a glance
CBG-MEB (Netherlands)- Active substance
- ODEVIXIBAT 1,5-WATER
- Manufacturer
- Ipsen Pharma
- Country
- Netherlands (NL)
- ATC code
- A05AX05
- ATC class
- Odevixibat
- Defined daily dose
- 2.4 mg, O
- Reimbursed
- Not published by this register
- Source register
- CBG-MEB (Netherlands)
- Last checked
- September 29, 2026
Packs & prices · 1
- cbg_meb_idEU/1/24/1854
Regulatory notes
No shortage, Orange Book or US label notes for this record.
Same medicine, other countries
Odevixibat in 9 other countries
What each register calls a product with the same active substance — salts and hydrates count as the same.
- PolandBylvayIpsen Pharma
- SwedenBylvay 1200 mikrogram Kapsel, hårdIpsen Pharma
- SpainBYLVAY 1200 MICROGRAMOS CAPSULAS DURASIpsen Pharma
- IrelandKAYFANDA 1200 microgram hard capsulesIpsen Pharma
- CanadaBYLVAYMEDISON PHARMA CANADA INC.
- United StatesBylvayIpsen Biopharmaceuticals, Inc.
- SwitzerlandBylvay 1200 μg, HartkapselnIPSEN Pharma Schweiz GmbH
- United KingdomBylvay 1200microgram capsulesIpsen Ltd
Authorised across Europe · EMA
The same active substance is authorised in 3 EEA countries. Names it is sold under:
- Iceland · Bylvay, Kayfanda
- Liechtenstein · Bylvay, Kayfanda
- Norway · Bylvay, Kayfanda
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 CBG-MEB (Netherlands). 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/f46f37aa-3764-4928-b5ca-acee3411f0ad GET /v1/drugs/f46f37aa-3764-4928-b5ca-acee3411f0ad?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": "Capsule, hard",
"route": "Oraal gebruik",
"soort": null,
"source": "cbg_meb",
"smpc_url": "https://www.ema.europa.eu/en/documents/product-information/kayfanda-epar-product-information_nl.pdf",
"strength": null,
"atc_label": "Odevixibat",
"detail_url": "https://www.geneesmiddeleninformatiebank.nl/nl/cp132747",
"excipients": [
"AMMONIA (E 527)",
"CELLULOSE, MICROKRISTALLIJN (E 460(i))",
"HYPROMELLOSE (E 464)",
"HYPROMELLOSE (E 464)",
"IJZEROXIDE GEEL (E 172)",
"IJZEROXIDE ROOD (E 172)",
"IJZEROXIDE ZWART (E 172)",
"PROPYLEENGLYCOL (E 1520)",
"SCHELLAK GLAZE, GEDEELTELIJK VERESTERD",
"TITAANDIOXIDE (E 171)",
"ZWARTE INKT"
],
"substances": [
"ODEVIXIBAT 1,5-WATER"
],
"leaflet_url": null,
"authorised_at": "2024/09/19",
"procedure_number": "EMEA/H/C/006462",
"dispensing_status": "Uitsluitend recept",
"registration_number": "EU/1/24/1854",
"additional_monitoring": "Y"
}See everything about odevixibat.
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.