EMA/PE/0000229486 - paediatric investigation plan

histidine

tryptophan

aspartic acid

n-acetyl-histidine (monohydrate)

glycine

alpha-ketoglutaric acid

arginine

potassium chloride

calcium chloride (dihydrate)

sodium chloride

alanine

3,4-dimethoxy-N-methylbenzohydroxamic acid (Custodiol-N)

magnesium chloride hexahydrate

Key facts

• Active substance:
  • histidine
  • tryptophan
  • aspartic acid
  • n-acetyl-histidine (monohydrate)
  • glycine
  • alpha-ketoglutaric acid
  • arginine
  • potassium chloride
  • calcium chloride (dihydrate)
  • sodium chloride
  • alanine
  • 3,4-dimethoxy-N-methylbenzohydroxamic acid (Custodiol-N)
  • magnesium chloride hexahydrate
• Therapeutic area:
  Injury, poisoning and procedural complications
• Decision number:
  P/0213/2023
• PIP number:
  EMA/PE/0000229486
• Pharmaceutical form(s):
  Solution for organ preservation
• Condition(s) / indication(s):
  Heart transplantation
• Decision type:
  PM: decision on the application for modification of an agreed PIP
• Decision date:
  14/04/2025
• Compliance check done:
  Nein

Decision

EMA/PE/0000229486: 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-1700519818-2035699