EMA/PE/0000181243 - paediatric investigation plan

glutamatergic neurotransmission enhancer BI 1569912

Key facts

• Active substance:
  glutamatergic neurotransmission enhancer BI 1569912
• Therapeutic area:
  Psychiatric disorders
• Decision number:
  EMA/PE/0000181243
• PIP number:
  EMA/PE/0000181243
• Pharmaceutical form(s):
  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:
  03/01/2025
• Compliance check done:
  No

Decision

EMA/PE/0000181243 : EMA decision of 3 January 2025 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the granting of a waiver for glutamatergic neurotransmission enhancer BI 1569912

Adopted Reference Number: EMADOC-1700519818-1752876