EMEA-002354-PIP03-24 - paediatric investigation plan

zanubrutinib

Key facts

• Invented name:
  Brukinsa
• Active substance:
  zanubrutinib
• Therapeutic area:
  Blood and lymphatic system disorders
• Decision number:
  P/0226/2024
• PIP number:
  EMEA-002354-PIP03-24
• Pharmaceutical form(s):
  Film-coated tablet
• 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:
  W: decision granting a waiver in all age groups for all conditions or indications
• Decision date:
  10/07/2024
• Compliance check done:
  No

Decision

P/0226/2024: EMA decision of 10 July 2024 on the granting of a product specific waiver for zanubrutinib (Brukinsa), (EMEA-002354-PIP03-24)

Adopted Reference Number: EMA/313177/2024