Netherlands· NL-3ab4b1873dba
Bylvay 400 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/1/21/1566
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 400 mikrogram Kapsel, hårdIpsen Pharma
- SpainBYLVAY 400 MICROGRAMOS CAPSULAS DURASIpsen Pharma
- IrelandKAYFANDA 400 microgram hard capsulesIpsen Pharma
- CanadaBYLVAYMEDISON PHARMA CANADA INC.
- United StatesBylvayIpsen Biopharmaceuticals, Inc.
- SwitzerlandBylvay 400 μg, HartkapselnIPSEN Pharma Schweiz GmbH
- United KingdomBylvay 400microgram 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/e718891b-32cc-4760-8ac1-17e9b0eb51d0 GET /v1/drugs/e718891b-32cc-4760-8ac1-17e9b0eb51d0?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/bylvay-epar-product-information_nl.pdf",
"strength": null,
"atc_label": "Odevixibat",
"detail_url": "https://www.geneesmiddeleninformatiebank.nl/nl/cp127605",
"excipients": [
"AMMONIA (E 527)",
"CELLULOSE, MICROKRISTALLIJN (E 460(i))",
"HYPROMELLOSE (E 464)",
"HYPROMELLOSE 2910 (3 - 15 mPa.s) (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": "2021/07/16",
"procedure_number": "EMEA/H/C/004691",
"dispensing_status": "Uitsluitend recept",
"registration_number": "EU/1/21/1566",
"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.