EMEA-001019-PIP01-10-M05 - paediatric investigation plan

lipegfilgrastim

Key facts

• Invented name:
  Lonquex
• Active substance:
  lipegfilgrastim
• Therapeutic area:
  Oncology
• Decision number:
  P/0034/2020
• PIP number:
  EMEA-001019-PIP01-10-M05
• Pharmaceutical form(s):
  Solution for injection
• Condition(s) / indication(s):
  • Prevention of chemotherapy-induced febrile neutropenia
  • Treatment of chemotherapy-induced neutropenia
• Route(s) of administration:
  Subcutaneous use
• Decision type:
  PM: decision on the application for modification of an agreed PIP
• Decision date:
  29/01/2020
• Compliance check done:
  Da
• Compliance procedure number:
  EMEA-C-001019-PIP01-10-M05
• Compliance opinion date:
  30/04/2020
• Compliance outcome:
  Positive

Decision

P/0034/2020: EMA decision of 29 January 2020 on the acceptance of a modification of an agreed paediatric investigation plan for lipegfilgrastim (Lonquex), (EMEA-001019-PIP01-10-M05)

Adopted Reference Number: EMA/26689/2020