EMEA-003096-PIP02-22 - paediatric investigation plan

enzastaurin hydrochloride

Key facts

• Active substance:
  enzastaurin hydrochloride
• Therapeutic area:
  Other
• Decision number:
  P/0544/2022
• PIP number:
  EMEA-003096-PIP02-22
• Pharmaceutical form(s):
  Tablet
• Condition(s) / indication(s):
  Treatment of Ehlers-Danlos Syndrome
• Route(s) of administration:
  Oral use
• Decision type:
  P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
• Decision date:
  30/12/2023
• Compliance check done:
  No

Decision

P/0544/2022 : EMA decision of 30 December 2022 on the agreement of a paediatric investigation plan and on the granting of a waiver for enzastaurin (hydrochloride) (EMEA-003096-PIP02-22)

Draft Reference Number: EMA/876030/2022