EMEA-001304-PIP02-13-M04

Key facts

Invented name
Ocaliva
Active substance
Obeticholic acid
Therapeutic area
Gastroentology-Hepatology
Decision number
P/0204/2019
PIP number
EMEA-001304-PIP02-13-M04
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

Decision

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