Ocaliva
obeticholic acid
Table of contents
Overview
Ocaliva is used to treat adults with a liver disease known as primary biliary cholangitis.
Primary biliary cholangitis is an autoimmune condition in which there is gradual destruction of the small bile ducts in the liver. These ducts transport fluid called bile from the liver to the intestines, where it is used to help digest fats. As a result of the damage to the ducts, bile builds up in the liver causing damage to the liver tissue. This may lead to scarring and liver failure, and may increase the risk of liver cancer.
Ocaliva contains the active substance obeticholic acid. It is used together with another medicine, ursodeoxycholic acid (UDCA), in patients who do not respond sufficiently to UDCA alone, and on its own in patients who cannot take UDCA.
Primary biliary cholangitis is rare, and Ocaliva was designated an ‘orphan medicine’ (a medicine used in rare diseases) on 27 July 2010.
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Ocaliva : EPAR - Summary for the public (PDF/78.84 KB)
First published: 19/12/2016
Last updated: 14/05/2018 -
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Ocaliva : EPAR - Risk management plan summary (PDF/223.38 KB)
First published: 17/11/2021
Last updated: 02/05/2023
Authorisation details
| Product details | |
|---|---|
| Name |
Ocaliva
|
| Agency product number |
EMEA/H/C/004093
|
| Active substance |
Obeticholic acid
|
| International non-proprietary name (INN) or common name |
obeticholic acid
|
| Therapeutic area (MeSH) |
Liver Cirrhosis, Biliary
|
| Anatomical therapeutic chemical (ATC) code |
A05AA04
|
Additional monitoring |
This medicine is under additional monitoring, meaning that it is monitored even more intensively than other medicines. For more information, see Medicines under additional monitoring. |
Conditional approval |
This medicine received a conditional marketing authorisation. This was granted in the interest of public health because the medicine addresses an unmet medical need and the benefit of immediate availability outweighs the risk from less comprehensive data than normally required. For more information, see Conditional marketing authorisation. |
Orphan |
This medicine was designated an orphan medicine. This means that it was developed for use against a rare, life-threatening or chronically debilitating condition or, for economic reasons, it would be unlikely to have been developed without incentives. For more information, see Orphan designation. |
| Publication details | |
|---|---|
| Marketing-authorisation holder |
ADVANZ PHARMA Limited
|
| Revision |
16
|
| Date of issue of marketing authorisation valid throughout the European Union |
12/12/2016
|
| Contact address |
Suite 17, Northwood House |
Product information
16/03/2023 Ocaliva - EMEA/H/C/004093 - II/0039
This medicine’s product information is available in all official EU languages.
Select ‘available languages’ to access the language you need.
Product information documents contain:
- summary of product characteristics (annex I);
- manufacturing authorisation holder responsible for batch release (annex IIA);
- conditions of the marketing authorisation (annex IIB);
- labelling (annex IIIA);
- package leaflet (annex IIIB).
You can find product information documents for centrally authorised human medicines on this website. For centrally authorised veterinary medicines authorised or updated from February 2022, see the Veterinary Medicines Information website.
Pharmacotherapeutic group
Bile and liver therapy
Therapeutic indication
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.