Basic Information
Ocaliva
Regulatory Information
EMEA/H/C/004093
December 12, 2016
October 13, 2016
21
April 17, 2024
Company Information
Ireland
Unit 17 Northwood House Northwood Crescent Dublin 9 D09 V504
Advanz Pharma International LIMITED
Drug Classification
Active Substances Detail
EMA Resources
Detailed Information
Therapeutic Indication
### 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.
Overview Summary
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.