EMEA-001213-PIP02-12-M02 - paediatric investigation plan

ferric citrate coordination complex

Key facts

• Invented name:
  • Fexeric
  • Fexeric
• Active substance:
  ferric citrate coordination complex
• Therapeutic area:
  Uro-nephrology
• Decision number:
  P/0160/2016
• PIP number:
  EMEA-001213-PIP02-12-M02
• Pharmaceutical form(s):
  • Film-coated tablet
  • Powder for oral suspension
• Condition(s) / indication(s):
  Treatment of hyperphosphataemia
• Route(s) of administration:
  Oral use
• Decision type:
  PM: decision on the application for modification of an agreed PIP
• Decision date:
  15/06/2016
• Compliance check done:
  Ne

Decision

P/0160/2016: EMA decision of 15 June 2016 on the acceptance of a modification of an agreed paediatric investigation plan for ferric citrate (coordination complex) (EMEA-001213-PIP02-12-M02)

Adopted Reference Number: EMA/380513/2016