EMEA-000373-PIP02-09-M05 - paediatric investigation plan

Ferumoxytol

Key facts

• Invented name:
  • Rienso
  • Rienso
• Active substance:
  Ferumoxytol
• Therapeutic area:
  • Haematology-Hemostaseology
  • Uro-nephrology
• Decision number:
  P/0109/2022
• PIP number:
  EMEA-000373-PIP02-09-M05
• Pharmaceutical form(s):
  Solution for infusion
• Condition(s) / indication(s):
  Treatment of iron deficiency anaemia (IDA)
• Route(s) of administration:
  Intravenous use
• Decision type:
  PM: decision on the application for modification of an agreed PIP
• Decision date:
  13/04/2022
• Compliance check done:
  No

Decision

P/0109/2022 : EMA decision of 13 April 2022 on the acceptance of a modification of an agreed paediatric investigation plan for ferumoxytol, (EMEA-000373-PIP02-09-M05)

Adopted Reference Number: EMA/145472/2022