EMA/PE/0000238632 - paediatric investigation plan

avalglucosidase alfa

Key facts

• Invented name:
  Nexviadyme
• Active substance:
  avalglucosidase alfa
• Therapeutic area:
  Congenital, familial and genetic disorders
• Decision number:
  EMA/PE/0000238632
• PIP number:
  EMA/PE/0000238632
• Pharmaceutical form(s):
  Powder for concentrate for solution for infusion
• Condition(s) / indication(s):
  Treatment of Pompe disease
• Route(s) of administration:
  Intravenous use
• Decision type:
  PM: decision on the application for modification of an agreed PIP
• Decision date:
  14/04/2025
• Compliance check done:
  Nej

Decision

EMA/PE/0000238632 : EMA decision of 14 April 2025 on the acceptance of a modification of an agreed paediatric investigation plan for avalglucosidase alfa (Nexviadyme)

Adopted Reference Number: EMADOC-1700519818-2035725