EMEA-003125-PIP02-21 - paediatric investigation plan

Avexitide (acetate)

Key facts

• Active Substance:
  Avexitide (acetate)
• Therapeutic area:
  Endocrinology-Gynaecology-Fertility-Metabolism
• Decision number:
  P/0023/2023
• PIP number:
  EMEA-003125-PIP02-21
• Pharmaceutical form(s):
  Solution for injection
• Condition(s) / indication(s):
  Treatment of congenital hyperinsulinism
• Route(s) of administration:
  Subcutaneous use
• Contact for public enquiries:

  EigerBio Europe Limited

  E-mail: [e-mail]; Tel: [phone]

• Decision type:
  P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
• Decision date:
  31/01/2023

Decision

P/0023/2023: EMA decision of 31 January 2023 on n the agreement of a paediatric investigation plan for avexitide (acetate) (EMEA-003125-PIP02-21)