EMA/PE/0000236723 - paediatric investigation plan

brigatinib

Key facts

• Invented name:
  Alunbrig
• Active substance:
  brigatinib
• Therapeutic area:
  Blood and lymphatic system disorders
• Decision number:
  P/0405/2021
• PIP number:
  EMA/PE/0000236723
• Pharmaceutical form(s):
  • Film-coated tablet
  • Age appropriate oral liquid dosage formulation
• Condition(s) / indication(s):
  Treatment of anaplastic large cell lymphoma
• Route(s) of administration:
  Oral use
• Decision type:
  PM: decision on the application for modification of an agreed PIP
• Decision date:
  15/04/2025
• Compliance check done:
  Ne

Decision

EMA/PE/0000236723: EMA decision of 15 April 2025 on the acceptance of a modification of an agreed paediatric investigation plan for brigatinib (Alunbrig)

Adopted Reference Number: EMADOC-1700519818-2039290