Lyvdelzi (previously Seladelpar Gilead)
·
- Prescription status not stated
- Digestion, stomach, diabetes and nutrition
- Active substance
- Seladelpar lysine dihydrate
- Made by
- Gilead Sciences Ireland Unlimited Company
- Source
- Official label
Quoted from the official source. Not yet reviewed by Mediclarum — the leaflet in your pack is authoritative.
What it is for
- Lyvdelzi is indicated for the treatment of primary biliary cholangitis (PBC) in combination with ursodeoxycholic acid (UDCA) in adults who have an inadequate response to UDCA alone, or as monotherapy in those unable to tolerate UDCA.
From the official label · 2026-09-30 · European Medicines Agency
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
NetherlandsNo exact match for this strength and form
SwitzerlandNo exact match for this strength and form
Details
| Made by | Gilead Sciences Ireland Unlimited Company |
|---|---|
| Active substance | Seladelpar lysine dihydrate |
| Used in | Digestion, stomach, diabetes and nutrition |
| Classification | A05AX07 · Digestion, stomach, diabetes and nutrition |
| Orphan medicine | Yes — designated for a rare disease, according to the register |
| Additional monitoring ▼ | Yes — under additional monitoring (black triangle). Report suspected side effects. |
| Last updated by the regulator | 2026-02-20 |
| EMA product number | EMEA/H/C/004692 |
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).