EMA/PE/0000233998 - paediatric investigation plan

sebetralstat

Key facts

• Active substance:
  sebetralstat
• Therapeutic area:
  Congenital, familial and genetic disorders
• Decision number:
  EMA/PE/0000233998
• PIP number:
  EMA/PE/0000233998
• Pharmaceutical form(s):
  • Film-coated tablet
  • Age appropriate oral solid dosage form
• Condition(s) / indication(s):
  Treatment of hereditary angioedema
• Route(s) of administration:
  Oral use
• Decision type:
  PM: decision on the application for modification of an agreed PIP
• Decision date:
  15/05/2025
• Compliance check done:
  No

Decision

EMA/PE/0000233998: EMA decision of 15 May 2025 on the acceptance of a modification of an agreed paediatric investigation plan for sebetralstat

Adopted Reference Number: EMADOC-1700519818-2117591