EMA/PE/0000232755 - paediatric investigation plan

Dasiglucagon

Key facts

• Active substance:
  Dasiglucagon
• Therapeutic area:
  Congenital, familial and genetic disorders
• Decision number:
  EMA/PE/0000232755
• PIP number:
  EMA/PE/0000232755
• Pharmaceutical form(s):
  Solution for injection
• Condition(s) / indication(s):
  Treatment of congenital hyperinsulinism
• Route(s) of administration:
  Subcutaneous use
• Decision type:
  RP: decision refers to a refusal on a proposed Paediatric Investigation Plan
• Decision date:
  20/03/2025
• Compliance check done:
  Non

Decision

EMA/PE/0000232755 : EMA decision of 20 March 2025 on the refusal of a paediatric investigation plan for dasiglucagon

Adopted Reference Number: EMADOC-1700519818-1976496