EMEA-002354-PIP02-18-M01 - paediatric investigation plan

zanubrutinib

Key facts

• Invented name:
  Brukinsa
• Active substance:
  zanubrutinib
• Therapeutic area:
  Oncology
• Decision number:
  P/0205/2022
• PIP number:
  EMEA-002354-PIP02-18-M01
• Pharmaceutical form(s):
  Capsule, hard
• Condition(s) / indication(s):
  • Treatment of lymphoplasmacytic lymphoma
  • Treatment of mature B-cell neoplasms (excluding lymphoplasmacytic lymphoma)
• Route(s) of administration:
  Oral use
• Decision type:
  PM: decision on the application for modification of an agreed PIP
• Decision date:
  10/06/2022
• Compliance check done:
  Ne

Decision

P/0205/2022 : EMA decision of 10 June 2022 on the acceptance of a modification of an agreed paediatric investigation plan for zanubrutinib (Brukinsa), (EMEA-002354-PIP02-18-M01)

Reference Number: EMA/275723/2022