EMEA-002653-PIP01-19 - paediatric investigation plan

BI 425809

Key facts

• Active Substance:
  BI 425809
• Therapeutic area:
  Psychiatry
• Decision number:
  P/0473/2020
• PIP number:
  EMEA-002653-PIP01-19
• Pharmaceutical form(s):
  Film-coated tablet
• Condition(s) / indication(s):
  Treatment of schizophrenia
• Route(s) of administration:
  Oral use
• Contact for public enquiries:

  Boehringer Ingelheim International GmbH

  Tel. [phone]; Email: [e-mail]

• Decision type:
  P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
• Decision date:
  01/12/2020

Decision

P/0473/2020 : EMA decision of 1 December 2020 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the granting of a waiver for BI 425809 (EMEA-002653-PIP01-19)

AdoptedReference Number: EMA/627315/2020