EMEA-003170-PIP01-21-M01 - paediatric investigation plan

Glucagon analogue linked to a human immunoglobulin Fc fragment

Key facts

• Active Substance:
  Glucagon analogue linked to a human immunoglobulin Fc fragment
• Therapeutic area:
  Endocrinology-Gynaecology-Fertility-Metabolism
• Decision number:
  P/0100/2023
• PIP number:
  EMEA-003170-PIP01-21-M01
• Pharmaceutical form(s):
  Solution for injection
• Condition(s) / indication(s):
  Treatment of congenital hyperinsulinism
• Route(s) of administration:
  Subcutaneous use
• Contact for public enquiries:

  Hanmi Pharm. Co., Ltd.

  Email: [e-mail]

  Tel. [phone]

• Decision type:
  PM: decision on the application for modification of an agreed PIP
• Decision date:
  10/03/2023

Decision

P/0100/2023 : EMA decision of 10 March 2023 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-M01)

Reference Number: EMA/108322/2023