EMEA-003319-PIP02-22 - paediatric investigation plan

substituted 3,7-dihydro-1H-purine-2,6-dione (BI 1358894)

Key facts

• Active substance:
  substituted 3,7-dihydro-1H-purine-2,6-dione (BI 1358894)
• Therapeutic area:
  Psychiatry
• Decision number:
  P/0363/2023
• PIP number:
  EMEA-003319-PIP02-22
• Pharmaceutical form(s):
  Film-coated tablet
• Condition(s) / indication(s):
  Treatment of major depressive disorder
• Route(s) of administration:
  Oral use
• Decision type:
  P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
• Decision date:
  08/09/2023
• Compliance check done:
  No

Decision

P/0363/2023: EMA decision of 8 September 2023 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the granting of a waiver for substituted 3,7-dihydro-1H-purine-2,6-dione (BI 1358894) (EMEA-003319-PIP02-22)

Reference Number: EMA/347592/2023