EMEA-001757-PIP02-15-M03 - paediatric investigation plan

Copanlisib

Key facts

• Active substance:
  Copanlisib
• Therapeutic area:
  Oncology
• Decision number:
  P/0385/2022
• PIP number:
  EMEA-001757-PIP02-15-M03
• Pharmaceutical form(s):
  Powder for solution for injection
• Condition(s) / indication(s):
  • Treatment of all conditions included in the category of malignant neoplasms (except haematopoietic and lymphoid tissue)
  • Treatment of mature B-cell neoplasms
• Route(s) of administration:
  Intravenous use
• Decision type:
  PM: decision on the application for modification of an agreed PIP
• Decision date:
  09/09/2022
• Compliance check done:
  Nem

Decision

P/0385/2022: EMA decision of 9 September 2022 on the acceptance of a modification of an agreed paediatric investigation plan for copanlisib (EMEA- 001757-PIP02-15-M03)

Reference Number: EMA/677533/2022