Ocaliva® | FAMHP

Active substance	obeticholic acid
Holder	Intercept Pharma Nederland BV
Status	Running
Indication	Treatment of patients with Primary Biliary cholangitis who completed the Long-Term Safety Extension of the POISE phase 3 trial (747-301 / EudraCT 2011-004728-36)
Public documents	Approbation Approbation amendment 1 Approbation amendment 2
	Information for the patient Information for the patient amendment 1 Information for the patient amendment 2 Information for the patient - outcome re-evaluation
	Informed consent Informed consent amendment 1 Informed consent amendment 2 Informed consent - outcome re-evaluation
Last update	07/01/2026