EMEA-000637-PIP02-10-M07 - paediatric investigation plan

Lanthanum carbonate hydrate

Key facts

• Invented name:
  Fosrenol and associated names
• Active substance:
  Lanthanum carbonate hydrate
• Therapeutic area:
  Uro-nephrology
• Decision number:
  P/0507/2022
• PIP number:
  EMEA-000637-PIP02-10-M07
• Pharmaceutical form(s):
  • Chewable tablet
  • Oral powder
• Condition(s) / indication(s):
  Treatment of hyperphosphataemia
• Route(s) of administration:
  Oral use
• Decision type:
  RPM: decision refers to a refusal on the application for modification of an agreed PIP
• Decision date:
  02/12/2022
• Compliance check done:
  Yes
• Compliance procedure number:
  EMEA-C-000637-PIP02-10-M07
• Compliance opinion date:
  23/06/2023
• Compliance outcome:
  Positive

Decision

P/0507/2022: EMA decision of 2 December 2022 on the refusal of a modification of an agreed paediatric investigation plan for lanthanum carbonate hydrate (Fosrenol), (EMEA-000637-PIP02-10-M07)

Adopted Reference Number: EMA/898472/2022