EMEA-003043-PIP01-21-M01 - paediatric investigation plan

alprazolam

Key facts

• Active substance:
  alprazolam
• Therapeutic area:
  Nervous system disorders
• Decision number:
  P/0499/2023
• PIP number:
  EMEA-003043-PIP01-21-M01
• Pharmaceutical form(s):
  Inhalation powder
• Condition(s) / indication(s):
  Treatment of epileptic seizures
• Route(s) of administration:
  Inhalation use
• Decision type:
  PM: decision on the application for modification of an agreed PIP
• Decision date:
  01/12/2023
• Compliance check done:
  No

Decision

P/0499/2023 : EMA decision of 1 December 2023 on the acceptance of a modification of an agreed paediatric investigation plan for alprazolam, (EMEA- 003043-PIP01-21-M01)

Adopted Reference Number: EMA/515863/2023