EMEA-003271-PIP01-22 - paediatric investigation plan

XEN1101

Key facts

• Active substance:
  XEN1101
• Therapeutic area:
  Neurology
• Decision number:
  P/0291/2023
• PIP number:
  EMEA-003271-PIP01-22
• Pharmaceutical form(s):
  • Age appropriate intravenous dosage form
  • Age appropriate oral liquid dosage formulation
  • Capsule, hard
• Condition(s) / indication(s):
  Treatment of focal onset seizures
• Route(s) of administration:
  • Intravenous use
  • Oral use
• Decision type:
  P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
• Decision date:
  04/08/2023
• Compliance check done:
  No

Decision

P/0291/2023 : EMA decision of 4 August 2023 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the refusal of a waiver for XEN1101 (EMEA-003271-PIP01-22)

Reference Number: EMA/339288/2023