Ocaliva
Revoked
obeticholic acid
Medicine
Human
Revoked
The marketing authorization of Ocaliva was revoked by the Commission Implementing Decision of 30 August 2024.
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Product information documents contain:
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.