EMEA-002269-PIP01-17-M03 - paediatric investigation plan

olaparib

Key facts

• Invented name:
  Lynparza
• Active substance:
  olaparib
• Therapeutic area:
  Oncology
• Decision number:
  P/0148/2024
• PIP number:
  EMEA-002269-PIP01-17-M03
• Pharmaceutical form(s):
  • Film-coated tablet
  • Age appropriate oral solid dosage form
• Condition(s) / indication(s):
  Treatment of all conditions included in the category of malignant neoplasms (except central nervous system tumours, haematopoietic and lymphoid tissue neoplasms)
• Route(s) of administration:
  Oral use
• Decision type:
  PM: decision on the application for modification of an agreed PIP
• Decision date:
  06/05/2024
• Compliance check done:
  Ne

Decision

P/0148/2024: EMA decision of 6 May 2024 on the acceptance of a modification of an agreed paediatric investigation plan for olaparib (Lynparza), (EMEA-002269-PIP01-17-M03)

Adopted Reference Number: EMA/155893/2024