EMEA-001659-PIP01-15-M06 - paediatric investigation plan

burosumab

Key facts

• Invented name:
  Crysvita
• Active substance:
  burosumab
• Therapeutic area:
  Other
• Decision number:
  P/0411/2022
• PIP number:
  EMEA-001659-PIP01-15-M06
• Pharmaceutical form(s):
  Solution for injection
• Condition(s) / indication(s):
  Treatment of X-linked hypophosphataemia
• Route(s) of administration:
  Subcutaneous use
• Decision type:
  PM: decision on the application for modification of an agreed PIP
• Decision date:
  30/09/2022
• Compliance check done:
  Sim
• Compliance procedure number:
  EMA/PE/0000228048
• Compliance opinion date:
  13/12/2024
• Compliance outcome:
  Positive

Decision

P/0411/2022: EMA decision of 30 September 2022 on the acceptance of a modification of an agreed paediatric investigation plan for burosumab (Crysvita), (EMEA-001659-PIP01-15-M06)

Reference Number: EMA/775829/2022