EMEA-003276-PIP01-22 - paediatric investigation plan

±3,4-methylenedioxymethamphetamine hydrochloride (MDMA)

Key facts

• Active Substance:
  ±3,4-methylenedioxymethamphetamine hydrochloride (MDMA)
• Therapeutic area:
  Psychiatry
• Decision number:
  P/0280/2023
• PIP number:
  EMEA-003276-PIP01-22
• Pharmaceutical form(s):
  Capsule (hard)
• Condition(s) / indication(s):
  Treatment of post-traumatic stress disorder
• Route(s) of administration:
  Oral use
• Contact for public enquiries:

  MAPS Europe B.V.; E-mail: [e-mail] ; Tel.: [phone]

• Decision type:
  P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
• Decision date:
  14/07/2023

Decision

P/0280/2023 : EMA decision of 14 July 2023 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the granting of a waiver for ±3,4-methylenedioxymethamphetamine hydrochloride (MDMA) (EMEA- 003276-PIP01-22)

Reference Number: EMA/283234/2023