EMEA-003119-PIP01-21-M01 - paediatric investigation plan

zuranolone

Key facts

• Active substance:
  zuranolone
• Therapeutic area:
  Psychiatry
• Decision number:
  P/0019/2023
• PIP number:
  EMEA-003119-PIP01-21-M01
• Pharmaceutical form(s):
  Capsule, hard
• Condition(s) / indication(s):
  Treatment of postpartum depression
• Route(s) of administration:
  Oral use
• Decision type:
  PM: decision on the application for modification of an agreed PIP
• Decision date:
  31/01/2023
• Compliance check done:
  No

Decision

P/0019/2023 : EMA decision of 31 January 2023 on the acceptance of a modification of an agreed paediatric investigation plan for zuranolone (EMEA- 003119-PIP01-21-M01)

Reference Number: EMA/19428/2023