Ocaliva®

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

Informed consent

Informed consent amendment 1

Informed consent amendment 2

Last update

08/03/2024

Last updated on 08/03/2024