EMEA-003049-PIP01-21-M01 - paediatric investigation plan

L-carnitine

glucose

calcium chloride dihydrate

sodium lactate

sodium chloride

magnesium chloride hexahydrate

Key facts

• Active substance:
  • L-carnitine
  • glucose
  • calcium chloride dihydrate
  • sodium lactate
  • sodium chloride
  • magnesium chloride hexahydrate
• Therapeutic area:
  Renal and urinary disorders
• Decision number:
  P/0083/2024
• PIP number:
  EMEA-003049-PIP01-21-M01
• Pharmaceutical form(s):
  Solution for peritoneal dialysis
• Condition(s) / indication(s):
  Treatment of renal failure with carnitine deficiency
• Route(s) of administration:
  Intraperitoneal use
• Decision type:
  PM: decision on the application for modification of an agreed PIP
• Decision date:
  15/03/2024
• Compliance check done:
  No

Decision

P/0083/2024: EMA decision of the 15 of March on the acceptance of a modification of an agreed paediatric investigation plan for L-carnitine / glucose / calcium chloride dihydrate / magnesium chloride hexahydrate... (EMEA-003049-PIP01-21-M01)

Adopted Reference Number: EMA/103624/2024