EMEA-001857-PIP02-20

Table of contents

Key facts

Active substance
Elafibranor
Therapeutic area
Gastroentology-Hepatology
Decision number
P/0295/2020
PIP number
EMEA-001857-PIP02-20
Pharmaceutical form(s)
Film-coated tablet
Condition(s) / indication(s)
Treatment of primary biliary cholangitis
Route(s) of administration
Oral use
Contact for public enquiries
Ipsen Pharma

E-mail: elafibranor.enquiries@ipsen.com
Tel. +1 857-600-8195

Decision type
W: decision granting a waiver in all age groups for all conditions or indications

Decision

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