EMEA-002051-PIP02-16 - paediatric investigation plan

allopregnanolone

Key facts

• Active substance:
  allopregnanolone
• Therapeutic area:
  Psychiatry
• Decision number:
  P/0357/2017
• PIP number:
  EMEA-002051-PIP02-16
• Pharmaceutical form(s):
  Intravenous use
• Condition(s) / indication(s):
  Treatment of postpartum depression
• Route(s) of administration:
  Solution for infusion
• Decision type:
  P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
• Decision date:
  01/12/2017
• Compliance check done:
  Ne

Decision

P/0357/2017: EMA decision of 1 December 2017 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the granting of a waiver for allopregnanolone (EMEA-002051-PIP02-16)

Adopted Reference Number: EMA/704280/2017