EMEA-002735-PIP01-19 - 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

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
• Therapeutic area:
  Cardiovascular diseases
• Decision number:
  P/0228/2021
• PIP number:
  EMEA-002735-PIP01-19
• Pharmaceutical form(s):
  Concentrate and solvent for solution for infusion
• Condition(s) / indication(s):
  Cardioplegia
• Route(s) of administration:
  Intracoronary use
• Contact for public enquiries:

  Dr. Franz Köhler Chemie GmbH

  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:
  09/06/2021

Decision

P/0228/2021 : EMA decision of 9 June 2021 on the agreement of a paediatric investigation plan and on the granting of a deferral for deferoxamine (mesylate) / histidine / tryptophan / aspartic acid / n-acetyl-histidine ....... (EMEA-002735-PIP01-19)

AdoptedReference Number: EMA/245847/2021