EMA/PE/0000225241 - paediatric investigation plan

calcium chloride dihydrate

magnesium chloride hexahydrate

sodium chloride

sodium lactate

xylitol

d-glucose

levocarnitine

Key facts

• Active substance:
  • calcium chloride dihydrate
  • magnesium chloride hexahydrate
  • sodium chloride
  • sodium lactate
  • xylitol
  • d-glucose
  • levocarnitine
• Therapeutic area:
  Renal and urinary disorders
• Decision number:
  EMA/PE/0000225073
• PIP number:
  EMA/PE/0000225241
• Pharmaceutical form(s):
  Solution for peritoneal dialysis
• Condition(s) / indication(s):
  • Acute pain
  • Treatment of renal failure
• Route(s) of administration:
  Intraperitoneal use
• Decision type:
  P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
• Decision date:
  03/01/2025
• Compliance check done:
  No

Decision

EMA/PE/0000225241 : EMA decision of 3 January 2025 on the agreement of a paediatric investigation plan and on the granting of a deferral for calcium chloride dihydrate, d-glucose, levocarnitine, magnesium chloride hexahydrate, sodium chloride, sodium...

Adopted Reference Number: EMA/PE/0000225241