EMEA-001304-PIP03-17

Key facts

Invented name
Ocaliva
Active substance
Obeticholic acid
Therapeutic area
Gastroentology-Hepatology
Decision number
P/0104/2018
PIP number
EMEA-001304-PIP03-17
Pharmaceutical form(s)
  • Age-appropriate oral solid dosage form
  • Tablet
Condition(s) / indication(s)
Treatment of non-alcoholic steatohepatitis (NASH)
Route(s) of administration
Oral use
Contact for public enquiries
Intercept Pharma Ltd.
Tel.: +1 6195417227
E-mail: reginfo@interceptpharma.com
Decision type
P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)

Decision

How useful was this page?

Add your rating