EMA/PE/0000235382 - paediatric investigation plan

vosoritide

Key facts

• Invented name:
  Voxzogo
• Active substance:
  vosoritide
• Therapeutic area:
  Congenital, familial and genetic disorders
• Decision number:
  EMA/PE/0000235382
• PIP number:
  EMA/PE/0000235382
• Pharmaceutical form(s):
  Powder for solution for injection
• Condition(s) / indication(s):
  Treatment of hypochondroplasia
• Route(s) of administration:
  Subcutaneous use
• Decision type:
  PM: decision on the application for modification of an agreed PIP
• Decision date:
  11/07/2025
• Compliance check done:
  Ne

Decision

EMA/PE/0000235382: EMA decision of 11 July 2025 on the acceptance of a modification of an agreed paediatric investigation plan for vosoritide (Voxzogo)

Adopted Reference Number: EMADOC-1700519818-2235490