EMEA-003049-PIP01-21 - paediatric investigation plan

L-carnitine

glucose

calcium chloride dihydrate

magnesium chloride hexahydrate

sodium lactate

sodium chloride

Key facts

• Active Substance:
  • L-carnitine
  • glucose
  • calcium chloride dihydrate
  • magnesium chloride hexahydrate
  • sodium lactate
  • sodium chloride
• Therapeutic area:
  Uro-nephrology
• Decision number:
  P/0060/2022
• PIP number:
  EMEA-003049-PIP01-21
• Pharmaceutical form(s):
  Solution for peritoneal dialysis
• Condition(s) / indication(s):
  Treatment of renal failure with carnitine deficiency
• Route(s) of administration:
  Intraperitoneal use
• Contact for public enquiries:

  Iperboreal Pharma Srl

  E-mail: [e-mail]; Tel: [phone]

• Decision type:
  P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
• Decision date:
  07/03/2022

Decision

P/0060/2022 - EMA decision of 7 March 2022 on the agreement of a paediatric investigation plan and on the granting of a deferral for L-carnitine/glucose/calcium chloride dihydrate/magnesium chloride hexahydrate/sodium lactate/sodium..(EMA-003049-PIP01-21)

AdoptedReference Number: EMA/107971/2022