Bylvay
- Prescription status not stated
- Digestion, stomach, diabetes and nutrition
- Active substance
- Odevixibat
- Made by
- Ipsen Pharma
- Source
- Official label
Quoted from the official source. Not yet reviewed by Mediclarum — the leaflet in your pack is authoritative.
What it is for
- Bylvay is indicated for the treatment of progressive familial intrahepatic cholestasis (PFIC) in patients aged 6 months or older (see sections 4.4 and 5.1).
From the official label · 2026-09-30 · European Medicines Agency
How it works
From the US prescribing label for the same active substance (Bylvay). It describes the substance, not this exact product.
Odevixibat is a reversible inhibitor of the ileal bile acid transporter (IBAT).
It decreases the reabsorption of bile acids (primarily the salt forms) from the terminal ileum.
In vitro, odevixibat was metabolized via mono-hydroxylation.
In pediatric patients with ALGS who received BYLVAY 120 mcg/kg once daily with food in the morning, the measurable odevixibat concentrations ranged from 0.05 to 3.4 ng/mL.
Quoted from the prescribing label, sections “Mechanism of Action” and “Pharmacokinetics”. DailyMed · 2025-12-29
Same active substance, strength and form in other countries
Matched on active substance, strength and kind of form only. This is not a statement that the products are equivalent or interchangeable: other ingredients, release and approved uses can differ — ask a pharmacist before swapping.
Medicine passport: one printable page to show a pharmacist abroad
United StatesNo exact match for this strength and form
SpainNo exact match for this strength and form
CanadaNo exact match for this strength and form
Details
| Made by | Ipsen Pharma |
|---|---|
| Active substance | Odevixibat |
| Used in | Digestion, stomach, diabetes and nutrition |
| Classification | A05AX · Digestion, stomach, diabetes and nutrition |
| Orphan medicine | Yes — designated for a rare disease, according to the register |
| Authorised on | 2021-07-16 |
| Last updated by the regulator | 2026-05-08 |
| EMA product number | EMEA/H/C/004691 |
Source: European Medicines Agency — medicine data · 2026-09-30 · not reviewed by a clinician
Source: European Medicines Agency (EMA). Product information as published by EMA. Reuse terms: EMA legal notice (reproduction authorised).
Same active substance
These contain the same substance. That does not mean one can replace another — ask a pharmacist.