EMEA-002990-PIP02-23 - paediatric investigation plan

3-[2-(Dimethylamino)ethyl]-1H-indol-4-yl dihydrogen phosphate

Key facts

• Active substance:
  3-[2-(Dimethylamino)ethyl]-1H-indol-4-yl dihydrogen phosphate
• Therapeutic area:
  Psychiatry
• Decision number:
  P/0366/2023
• PIP number:
  EMEA-002990-PIP02-23
• Pharmaceutical form(s):
  Capsule, soft
• Condition(s) / indication(s):
  Treatment of major depressive disorder
• Route(s) of administration:
  Oral use
• Decision type:
  W: decision granting a waiver in all age groups for all conditions or indications
• Decision date:
  09/08/2023
• Compliance check done:
  No

Decision

P/0366/2023 : EMA decision of 8 September 2023 on the granting of a product specific waiver for 3-[2-(Dimethylamino)ethyl]-1H-indol-4-yl dihydrogen phosphate (EMEA-002990-PIP02-23)

Reference Number: EMA/384112/2023