EMA/PE/0000230484 - paediatric investigation plan

alprazolam

Key facts

• Active substance:
  alprazolam
• Therapeutic area:
  Nervous system disorders
• Decision number:
  EMA/PE/0000230484
• PIP number:
  EMA/PE/0000230484
• 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:
  28/01/2025
• Compliance check done:
  Όχι

Decision

EMA/PE/0000230484 : EMA decision of 28 January 2025 on the acceptance of a modification of an agreed paediatric investigation plan for alprazolam

Adopted Reference Number: EMADOC-1700519818-1840322