EMA/PE/0000248697 - paediatric investigation plan

efzimfotase alfa

Key facts

• Active substance:
  efzimfotase alfa
• Therapeutic area:
  • Congenital, familial and genetic disorders
  • Endocrinology-Gynaecology-Fertility-Metabolism
• Decision number:
  EMA/PE/0000248697
• PIP number:
  EMA/PE/0000248697
• Pharmaceutical form(s):
  Solution for injection
• Condition(s) / indication(s):
  Treatment of hypophosphatasia
• Route(s) of administration:
  Subcutaneous use
• Decision type:
  PM: decision on the application for modification of an agreed PIP
• Decision date:
  10/07/2025
• Compliance check done:
  Ne

Decision

EMA/PE/0000248697 : EMA decision of 10 July 2025 on the acceptance of a modification of an agreed paediatric investigation plan for efzimfotase alfa

Adopted Reference Number: EMADOC-1700519818-2254191