EMEA-003296-PIP01-22 - paediatric investigation plan

crofelemer

Key facts

• Active substance:
  crofelemer
• Therapeutic area:
  Gastroentology-Hepatology
• Decision number:
  P/0222/2023
• PIP number:
  EMEA-003296-PIP01-22
• Pharmaceutical form(s):
  Powder for oral solution
• Condition(s) / indication(s):
  Treatment of short bowel syndrome
• Route(s) of administration:
  • Oral use
  • Gastroenteral use
  • Naso-gastric use
• Decision type:
  P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
• Decision date:
  14/06/2023
• Compliance check done:
  No

Decision

P/0222/2023 : EMA decision of 14 June 2023 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the granting of a waiver for crofelemer (EMEA-003296-PIP01-22)

Reference Number: EMA/236242/2023