EMA/PE/0000225681 - 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:
  Musculoskeletal and connective tissue disorders
• Decision number:
  EMA/PE/0000225681
• PIP number:
  EMA/PE/0000225681
• Pharmaceutical form(s):
  Powder for solution for injection
• Condition(s) / indication(s):
  Treatment of ectonucleotide pyrophosphatase/phosphodiesterase 1 (ENPP1) deficiency
• Route(s) of administration:
  Subcutaneous use
• Decision type:
  PM: decision on the application for modification of an agreed PIP
• Decision date:
  03/01/2025
• Compliance check done:
  No

Decision

EMA/PE/0000225681 : EMA decision of 3 January 2025 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

Adopted Reference Number: EMADOC-1700519818-1810978