EMEA-001061-PIP01-10-M03 - paediatric investigation plan

sucroferric oxyhydroxide

Key facts

• Invented name:
  • Velphoro
  • Velphoro
• Active substance:
  sucroferric oxyhydroxide
• Therapeutic area:
  Uro-nephrology
• Decision number:
  P/0196/2018
• PIP number:
  EMEA-001061-PIP01-10-M03
• Pharmaceutical form(s):
  • Powder for oral suspension
  • Chewable tablet
• 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:
  17/07/2018
• Compliance check done:
  Yes
• Compliance procedure number:
  EMEA-C-001061-PIP01-10-M03
• Compliance opinion date:
  20/09/2019
• Compliance outcome:
  Positive

Decision

P/0196/2018: EMA decision of 17 July 2018 of 17 July 2018 on the acceptance of a modification of an agreed paediatric investigation plan for sucroferric oxyhydroxide (mixture of iron (III)-oxyhydroxide, sucrose, starch) (PA21) (EMEA-001061-PIP01-10-M03)

Adopted Reference Number: EMA/379809/2018