EMA/PE/0000223351 - paediatric investigation plan

Cipaglucosidase alfa

Key facts

• Invented name:
  Pombiliti
• Active substance:
  Cipaglucosidase alfa
• Therapeutic area:
  Congenital, familial and genetic disorders
• Decision number:
  EMA/PE/0000223351
• PIP number:
  EMA/PE/0000223351
• Pharmaceutical form(s):
  Powder for concentrate for solution for infusion
• Condition(s) / indication(s):
  Treatment of glycogen storage disease Type II (Pompe's disease)
• Route(s) of administration:
  Intravenous use
• Decision type:
  PM: decision on the application for modification of an agreed PIP
• Decision date:
  03/01/2025
• Compliance check done:
  Ne

Decision

EMA/PE/0000223351 : EMA decision of 3 January 2025 on the acceptance of a modification of an agreed paediatric investigation plan for cipaglucosidase alfa (Pombiliti)

Adopted Reference Number: EMADOC-1700519818-1799764