EMEA-001539-PIP01-13-M06 - paediatric investigation plan

sodium zirconium cyclosilicate

Key facts

• Invented name:
  • Lokelma
  • Lokelma
• Active substance:
  sodium zirconium cyclosilicate
• Therapeutic area:
  Metabolism and nutrition disorders
• Decision number:
  P/0077/2024
• PIP number:
  EMEA-001539-PIP01-13-M06
• Pharmaceutical form(s):
  Powder for oral suspension
• Condition(s) / indication(s):
  Treatment of hyperkalaemia
• Route(s) of administration:
  Oral use
• Decision type:
  PM: decision on the application for modification of an agreed PIP
• Decision date:
  08/03/2024
• Compliance check done:
  No

Decision

P/0077/2024 : EMA decision of 8 March 2024 on the acceptance of a modification of an agreed paediatric investigation plan for sodium zirconium cyclosilicate (Lokelma), (EMEA-001539-PIP01-13-M06)

Adopted Reference Number: EMA/89807/2024