Ocaliva
·
- Prescription status not stated
- Digestion, stomach, diabetes and nutrition
- Active substance
- Obeticholic acid
- Made by
- Advanz Pharma Limited
- Source
- Official label
Quoted from the official source. Not yet reviewed by Mediclarum — the leaflet in your pack is authoritative.
What it is for
- Ocaliva is indicated for the treatment of primary biliary cholangitis (also known as primary biliary cirrhosis) in combination with ursodeoxycholic acid (UDCA) in adults with an inadequate response to UDCA or as monotherapy in adults 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
SpainNo exact match for this strength and form
CanadaNo exact match for this strength and form
Details
| Made by | Advanz Pharma Limited |
|---|---|
| Active substance | Obeticholic acid |
| Used in | Digestion, stomach, diabetes and nutrition |
| Classification | A05AA04 · Digestion, stomach, diabetes and nutrition |
| Additional monitoring ▼ | Yes — under additional monitoring (black triangle). Report suspected side effects. |
| Authorised on | 2016-12-12 |
| Last updated by the regulator | 2025-01-20 |
| EMA product number | EMEA/H/C/004093 |
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).