EMEA-001857-PIP02-20 - paediatric investigation plan

Elafibranor

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
• Decision type:
  W: decision granting a waiver in all age groups for all conditions or indications
• Decision date:
  12/08/2020

Decision

P/0295/2020 : EMA decision of 12 August 2020 on the granting of a product specific waiver for elafibranor (EMEA-001857-PIP02-20)

AdoptedReference Number: EMA/413447/2020