Poland· PL-100457061
Bylvay
A odevixibat product containing odevixibatum, registered in Poland by Ipsen Pharma. The same ATC class is registered in 15 of our 19 countries.
Checked against URPL (Poland) 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: Poland, from URPL (Poland)
- 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
URPL (Poland)- Active substance
- Odevixibatum
- Manufacturer
- Ipsen Pharma
- Country
- Poland (PL)
- ATC code
- A05AX05
- ATC class
- Odevixibat
- Defined daily dose
- 2.4 mg, O
- Reimbursed
- Not published by this register
- Source register
- URPL (Poland)
- Last checked
- September 27, 2026
Packs & prices · 1
- gtin09120121720012
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.
- NetherlandsBylvay 200 microgram harde capsulesIpsen Pharma
- SpainBYLVAY 200 MICROGRAMOS CAPSULAS DURASIpsen Pharma
- SwedenBylvay 200 mikrogram Kapsel, hårdIpsen Pharma
- CanadaBYLVAYMEDISON PHARMA CANADA INC.
- IrelandKAYFANDA 200 microgram hard capsulesIpsen Pharma
- SwitzerlandBylvay 200 μg, HartkapselnIPSEN Pharma Schweiz GmbH
- United KingdomBylvay 200microgram capsulesIpsen Ltd
- United StatesBylvayIpsen Biopharmaceuticals, Inc.
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 URPL (Poland). 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/28b8135e-3d76-4ad3-bb1b-973eea808057 GET /v1/drugs/28b8135e-3d76-4ad3-bb1b-973eea808057?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": "Kapsułki twarde",
"source": "urpl",
"strength": "200 mcg",
"packaging": "09120121720012 ¦ Rpz ¦ EU/1/21/1566/001 ¦ 141713\n30 kaps.\n¦ UR/Z/4b/001/23 - 09120121720012 ¦ UR/Z/4b/136/22 - 09120121720012 ¦ UR/Z/4b/088/24 - 09120121720012 ¦ UR/Z/4b/004/24 - 09120121720012",
"substance": "Odevixibatum 200 mcg",
"common_name": "Odevixibatum",
"pl_product_id": "100457061",
"pozwolenie_nr": null,
"auth_procedure": "CEN",
"authorisation_validity": null
}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.