EMEA-003125-PIP01-21 - paediatric investigation plan

avexitide acetate

Key facts

• Active substance:
  avexitide acetate
• Therapeutic area:
  Endocrinology-Gynaecology-Fertility-Metabolism
• Decision number:
  P/0057/2022
• PIP number:
  EMEA-003125-PIP01-21
• Pharmaceutical form(s):
  Solution for injection
• Condition(s) / indication(s):
  Treatment of postbariatric hypoglycaemia
• Route(s) of administration:
  Subcutaneous use
• Decision type:
  W: decision granting a waiver in all age groups for all conditions or indications
• Decision date:
  11/03/2022
• Compliance check done:
  No

Decision

P/0057/2022 : EMA decision of 11 March 2022 on the granting of a product-specific waiver for avexitide (acetate) (EMEA-003125-PIP01-21)

Adopted Reference Number: EMA/94186/2022