EMEA-003170-PIP01-21-M02 - paediatric investigation plan

glucagon analogue linked to a human immunoglobulin Fc fragment (HM15136)

Key facts

• Active substance:
  glucagon analogue linked to a human immunoglobulin Fc fragment (HM15136)
• Therapeutic area:
  Metabolism and nutrition disorders
• Decision number:
  P/0086/2024
• PIP number:
  EMEA-003170-PIP01-21-M02
• Pharmaceutical form(s):
  Solution for injection
• Condition(s) / indication(s):
  Treatment of congenital hyperinsulinism
• Route(s) of administration:
  Subcutaneous use
• Decision type:
  PM: decision on the application for modification of an agreed PIP
• Decision date:
  21/03/2024
• Compliance check done:
  No

Decision

P/0086/2024: EMA decision of 21 March 2024 on the acceptance of a modification of an agreed paediatric investigation plan for glucagon analogue linked to a human immunoglobulin Fc fragment (HM15136) (EMEA-003170-PIP01-21-M02)

Adopted Reference Number: EMA/108301/2024