Iceland· IS-EU/1/21/1566/002
Bylvay
A odevixibat product containing odevixibatum inn, registered in Iceland by Ipsen Pharma. The same ATC class is registered in 15 of our 19 countries.
Checked against Icelandic Medicines Agency (Iceland) 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: Iceland, from Icelandic Medicines Agency (Iceland)
- 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
Icelandic Medicines Agency (Iceland)- Active substance
- Odevixibatum INN
- Manufacturer
- Ipsen Pharma
- Country
- Iceland (IS)
- ATC code
- A05AX05
- ATC class
- Odevixibat
- Defined daily dose
- 2.4 mg, O
- Reimbursed
- Not published by this register
- Source register
- Icelandic Medicines Agency (Iceland)
- Last checked
- September 29, 2026
Packs & prices · 0
No packs listed by the register for this record.
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.
- United StatesBylvayIpsen Biopharmaceuticals, Inc.
- NetherlandsBylvay 1200 micorgram harde capsulesIpsen Pharma
- PolandBylvayIpsen Pharma
- SwedenBylvay 1200 mikrogram Kapsel, hårdIpsen Pharma
- SpainBYLVAY 1200 MICROGRAMOS CAPSULAS DURASIpsen Pharma
- CanadaBYLVAYMEDISON PHARMA CANADA INC.
- SwitzerlandBylvay 1200 μg, HartkapselnIPSEN Pharma Schweiz GmbH
- United KingdomBylvay 1200microgram capsulesIpsen Ltd
Authorised across Europe · EMA
The same active substance is authorised in 2 EEA countries. Names it is sold under:
- 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 Icelandic Medicines Agency (Iceland). 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/c8367f8c-e93d-4351-a41c-79a6e13a14da GET /v1/drugs/c8367f8c-e93d-4351-a41c-79a6e13a14da?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": "Hart hylki",
"source": "lyfjastofnun",
"atc_raw": "A05AX05",
"marketed": false,
"strength": "400 míkróg",
"ma_number": "EU/1/21/1566/002",
"substance": "Odevixibatum INN",
"other_info": "Ávísun lyfsins er bundin við sérfræðinga í meltingarsjúkdómum barna og fullorðinna.",
"legal_status": "(R Z) Sérfræðingsmerkt (og lyfseðilsskylt)",
"ma_issued_serial": "44393"
}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.