EMEA-003232-PIP01-22 - paediatric investigation plan

recombinant human ectonucleotide pyrophosphatase/phosphodiesterase 1 fused to the Fc fragment of IgG1

Key facts

• Active Substance:
  recombinant human ectonucleotide pyrophosphatase/phosphodiesterase 1 fused to the Fc fragment of IgG1
• Therapeutic area:
  • Cardiovascular diseases
  • Endocrinology-Gynaecology-Fertility-Metabolism
  • Other
• Decision number:
  P/0125/2023
• PIP number:
  EMEA-003232-PIP01-22
• Pharmaceutical form(s):
  Powder for solution for injection
• Condition(s) / indication(s):
  Treatment of ectonucleotide pyrophosphatase / phosphodiesterase 1 deficiency
• Route(s) of administration:
  Subcutaneous use
• Contact for public enquiries:

  Inozyme Pharma Ireland; 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:
  18/04/2023

Decision

P/0125/2023 : EMA decision of 18 April 2023 on the agreement of a paediatric investigation plan for recombinant human ectonucleotide pyrophosphatase/phosphodiesterase 1 fused to the Fc fragment of IgG1 (INZ-701) (EMEA-003232-PIP01-22)

Reference Number: EMA/135005/2023