EMEA-002449-PIP02-18-M02 - paediatric investigation plan

Berotralstat

Key facts

• Invented name:
  Orladeyo
• Active substance:
  Berotralstat
• Therapeutic area:
  Congenital, familial and genetic disorders
• Decision number:
  P/0151/2024
• PIP number:
  EMEA-002449-PIP02-18-M02
• Pharmaceutical form(s):
  • Capsule, hard
  • 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:
  06/05/2024
• Compliance check done:
  No

Decision

P/0151/2024: EMA decision of 6 May 2024 on the acceptance of a modification of an agreed paediatric investigation plan for berotralstat (Orladeyo), (EMEA-002449-PIP02-18-M02)

Adopted Reference Number: EMA/148123/2024