EMEA-002735-PIP03-20-M01 - paediatric investigation plan

Deferoxamine (mesylate)

histidine

tryptophan

aspartic acid

n-acetyl-histidine (monohydrate)

glycine

alpha-ketoglutaric acid

arginine

potassium chloride

magnesium chloride (hexahydrate)

calcium chloride (dihydrate)

sodium chloride

alanine

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

Key facts

• Active Substance:
  • Deferoxamine (mesylate)
  • histidine
  • tryptophan
  • aspartic acid
  • n-acetyl-histidine (monohydrate)
  • glycine
  • alpha-ketoglutaric acid
  • arginine
  • potassium chloride
  • magnesium chloride (hexahydrate)
  • calcium chloride (dihydrate)
  • sodium chloride
  • alanine
  • 3,4-dimethoxy-N-methylbenzohydroxamic acid (Custodiol-N)
• Therapeutic area:
  Cardiovascular diseases
• Decision number:
  P/0484/2021
• PIP number:
  EMEA-002735-PIP03-20-M01
• Pharmaceutical form(s):
  Solution for organ preservation
• Condition(s) / indication(s):
  Heart transplantation
• Contact for public enquiries:

  Dr. Franz Köhler Chemie GmbH

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

• Decision type:
  PM: decision on the application for modification of an agreed PIP
• Decision date:
  03/12/2021

Decision

P/0484/2021 : EMA decision of 3 December 2021 on the acceptance of a modification of an agreed paediatric investigation plan for deferoxamine (mesylate) / histidine / tryptophan / aspartic acid... (EMEA-002735-PIP03-20-M01)

AdoptedReference Number: EMA/627334/2021