EMEA-001195-PIP01-11-M07 - paediatric investigation plan

ferric maltol

Key facts

• Invented name:
  Feraccru
• Active substance:
  ferric maltol
• Therapeutic area:
  Blood and lymphatic system disorders
• Decision number:
  P/0503/2023
• PIP number:
  EMEA-001195-PIP01-11-M07
• Pharmaceutical form(s):
  • Capsule, hard
  • Oral suspension
• Condition(s) / indication(s):
  Treatment of iron deficiency
• Route(s) of administration:
  Oral use
• Decision type:
  PM: decision on the application for modification of an agreed PIP
• Decision date:
  29/12/2023
• Compliance check done:
  Ei

Decision

P/0503/2023: EMA decision of of 29 December 2023 on the acceptance of a modification of an agreed paediatric investigation plan for iron as ferric maltol (Feraccru), (EMEA-001195-PIP01-11-M07)

Adopted Reference Number: EMA/528355/2023