EMEA-002527-PIP01-18 - paediatric investigation plan

seladelpar

Key facts

• Active substance:
  seladelpar
• Therapeutic area:
  Gastroentology-Hepatology
• Decision number:
  P/0192/2019
• PIP number:
  EMEA-002527-PIP01-18
• Pharmaceutical form(s):
  Capsule, hard
• 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:
  15/05/2019
• Compliance check done:
  No

Decision

P/0192/2019: EMA decision of 15 May 2019 on the granting of a product specific waiver for seladelpar (EMEA-002527-PIP01-18)

Adopted Reference Number: EMA/216782/2019