EMA/PE/0000229606 - paediatric investigation plan

Deferoxamine (mesylate)

histidine

tryptophan

aspartic acid

n-acetyl-histidine (monohydrate)

glycine

arginine

potassium chloride

calcium chloride (dihydrate)

sodium chloride

alanine

3,4-dimethoxy-N-methylbenzohydroxamic

magnesium chloride hexahydrate

L-tryptophan

oxogluric acid

n-hydroxy-3

Key facts

• Active substance:
  • Deferoxamine (mesylate)
  • histidine
  • tryptophan
  • aspartic acid
  • n-acetyl-histidine (monohydrate)
  • glycine
  • arginine
  • potassium chloride
  • calcium chloride (dihydrate)
  • sodium chloride
  • alanine
  • 3,4-dimethoxy-N-methylbenzohydroxamic
  • magnesium chloride hexahydrate
  • L-tryptophan
  • oxogluric acid
  • n-hydroxy-3
• Therapeutic area:
  Surgical and medical procedures
• Decision number:
  EMA/PE/0000229606
• PIP number:
  EMA/PE/0000229606
• Pharmaceutical form(s):
  Concentrate and solvent for solution for infusion
• Condition(s) / indication(s):
  Cardioplegia
• Route(s) of administration:
  Intracardiac use
• Decision type:
  PM: decision on the application for modification of an agreed PIP
• Decision date:
  14/04/2025
• Compliance check done:
  Ei

Decision

P/0210/2023 : EMA decision of 14 June 2023 on the acceptance of a modification of an agreed PIP for deferoxamine / histidine / tryptophan / aspartic acid / n-acetyl-histidine / glycine / alphaketoglutaric acid / ... (EMEA- 002735-PIP01-19-M01)

Reference Number: EMA/236601/2023

EMA/PE/0000229606 : EMA decision of 14 April 2025 on the acceptance of a modification of an agreed paediatric investigation plan for alanine, arginine, aspartic acid, calcium chloride dihydrate, deferoxamine mesilate, glycine, histidine, L-tryptophan,...

Adopted Reference Number: EMADOC-1700519818-2035722