EMEA-003232-PIP01-22-M01 - 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/0369/2023
• PIP number:
  EMEA-003232-PIP01-22-M01
• 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
• Decision type:
  PM: decision on the application for modification of an agreed PIP
• Decision date:
  08/09/2023
• Compliance check done:
  No

Decision

P/0369/2023: EMA decision of 8 September 2023 on the acceptance of a modification of an agreed paediatric investigation plan for recombinant human ectonucleotide pyrophosphatase/phosphodiesterase 1 fused to the Fc fragment of IgG1 (INZ-701) (EMEA-003232-P

Adopted Reference Number: EMA/385776/2023