EMEA-002671-PIP02-20 - paediatric investigation plan

pegfilgrastim

Key facts

• Invented name:
  Pelgraz
• Active substance:
  pegfilgrastim
• Therapeutic area:
  Haematology-Hemostaseology
• Decision number:
  P/0206/2021
• PIP number:
  EMEA-002671-PIP02-20
• Pharmaceutical form(s):
  Solution for injection in pre-filled syringe
• Condition(s) / indication(s):
  • Prevention of chemotherapy-induced febrile neutropenia
  • Treatment of chemotherapy-induced neutropenia
• Route(s) of administration:
  Subcutaneous use
• Decision type:
  P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
• Decision date:
  10/05/2021
• Compliance check done:
  Da
• Compliance procedure number:
  EMEA-C-002671-PIP02-20
• Compliance opinion date:
  19/01/2024
• Compliance outcome:
  Positive

Decision

P/0206/2021 : EMA decision of 10 May 2021 on the agreement of a paediatric investigation plan for pegfilgrastim (Pelgraz), (EMEA-002671-PIP02-20)

Adopted Reference Number: EMA/245270/2021