EMEA-002184-PIP01-17-M01 - paediatric investigation plan

solriamfetol

Key facts

• Active substance:
  solriamfetol
• Therapeutic area:
  Neurology
• Decision number:
  P/0394/2021
• PIP number:
  EMEA-002184-PIP01-17-M01
• Pharmaceutical form(s):
  Tablet
• Condition(s) / indication(s):
  • Treatment of narcolepsy
  • Treatment of obstructive sleep apnoea
• Route(s) of administration:
  Oral use
• Decision type:
  PM: decision on the application for modification of an agreed PIP
• Decision date:
  08/09/2021
• Compliance check done:
  No

Decision

P/0394/2021 : EMA decision of 8 September 2021 on the acceptance of a modification of an agreed paediatric investigation plan for solriamfetol (EMEA- 002184-PIP01-17-M01)

Adopted Reference Number: EMA/470765/2021