EMEA-001796-PIP03-16-M03 - paediatric investigation plan

acalabrutinib

Key facts

• Invented name:
  Calquence
• Active substance:
  acalabrutinib
• Therapeutic area:
  Oncology
• Decision number:
  P/0111/2023
• PIP number:
  EMEA-001796-PIP03-16-M03
• Pharmaceutical form(s):
  • Capsule, hard
  • Film-coated tablet
• Condition(s) / indication(s):
  Treatment of mature B-cell neoplasms
• Route(s) of administration:
  Oral use
• Decision type:
  PM: decision on the application for modification of an agreed PIP
• Decision date:
  14/04/2023
• Compliance check done:
  Nu

Decision

P/0111/2023 : EMA decision of 14 April 2023 on the acceptance of a modification of an agreed paediatric investigation plan for acalabrutinib (Calquence), (EMEA-001796-PIP03-16-M03)

Reference Number: EMA/143821/2023