EMEA-000329-PIP02-09-M05 - paediatric investigation plan

darbepoetin alfa

Key facts

• Invented name:
  • Aranesp
  • Aranesp
• Active substance:
  darbepoetin alfa
• Therapeutic area:
  Oncology
• Decision number:
  P/0147/2016
• PIP number:
  EMEA-000329-PIP02-09-M05
• Pharmaceutical form(s):
  Solution for injection
• Condition(s) / indication(s):
  Treatment of anaemia due to chronic disorders
• Route(s) of administration:
  • Subcutaneous use
  • Intravenous use
• Decision type:
  PM: decision on the application for modification of an agreed PIP
• Decision date:
  14/06/2016
• Compliance check done:
  Yes
• Compliance procedure number:
  EMEA-000329-PIP02-09-M05
• Compliance opinion date:
  24/03/2017

Decision

P/0147/2016: EMA decision of 14 June 2016 on the acceptance of a modification of an agreed paediatric investigation plan for darbepoetin alfa (Aranesp), (EMEA-000329-PIP02-09-M05)

Adopted Reference Number: EMA/347579/2016