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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.

ATC A05AX05

Checked against CBG-MEB (Netherlands) on

Informational only — not a medical device.

SOURCE REGISTER · NLCBG-MEB (Netherlands)normalisedBylvay 400 microgram harde capsulesATCA05AX05REGISTER NO.NL-3ab4b1873dbaPACKS LISTED1CHECKEDSeptember 29, 2026

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
Blue: a registration under this ATC code. The ringed marker is this record’s country. Markets marked price publish a price we can compare per daily dose.

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_id
    EU/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.

All odevixibat products

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.