EMEA-001304-PIP02-13-M05

Adopted

First published: 19/05/2021
EMA/18871/2021

Invented name	Ocaliva
Active substance	Obeticholic acid
Therapeutic area	Gastroentology-Hepatology
Decision number	P/0041/2021
PIP number	EMEA-001304-PIP02-13-M05
Pharmaceutical form(s)	Coated tablet Tablet Age-appropriate oral solid dosage form
Condition(s) / indication(s)	Treatment of biliary atresia Treatment of primary biliary cirrhosis
Route(s) of administration	Oral use
Contact for public enquiries	Intercept Pharma Ltd. Tel. +1 6195417227 E-mail: reginfo@interceptpharma.com
Decision type	PM: decision on the application for modification of an agreed PIP