EMEA-002296-PIP01-17-M03 - paediatric investigation plan

brigatinib

Key facts

• Invented name:
  Alunbrig
• Active substance:
  brigatinib
• Therapeutic area:
  Oncology
• Decision number:
  P/0405/2021
• PIP number:
  EMEA-002296-PIP01-17-M03
• Pharmaceutical form(s):
  • Film-coated tablet
  • Age appropriate oral liquid dosage formulation
• Condition(s) / indication(s):
  • Treatment of anaplastic large cell lymphoma
  • Treatment of inflammatory myofibroblastic tumours
  • Treatment of non-small cell lung cancer
• Route(s) of administration:
  Oral use
• Decision type:
  PM: decision on the application for modification of an agreed PIP
• Decision date:
  01/10/2021
• Compliance check done:
  Nu

Decision

P/0405/2021: EMA decision of 1 October 2021 on the acceptance of a modification of an agreed paediatric investigation plan for brigatinib (Alunbrig), (EMEA-002296-PIP01-17-M03)

Reference Number: EMA/532839/2021