EMEA-003440-PIP01-23 - paediatric investigation plan

cyclic GMP-AMP synthase inhibitor (BI 3000202)

Key facts

• Active substance:
  cyclic GMP-AMP synthase inhibitor (BI 3000202)
• Therapeutic area:
  Congenital, familial and genetic disorders
• Decision number:
  P/0371/2024
• PIP number:
  EMEA-003440-PIP01-23
• Pharmaceutical form(s):
  Film-coated tablet
• Condition(s) / indication(s):
  Treatment of type 1 Interferonopathies
• 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:
  25/10/2024
• Compliance check done:
  No

Decision

P/0371/2024 : EMA decision of 25 October 2024 on the agreement of a paediatric investigation plan for cyclic GMP-AMP synthase inhibitor (BI 3000202), (EMEA-003440-PIP01-23)

Adopted Reference Number: EMA/483235/2024