EMEA-002926-PIP01-20 - paediatric investigation plan

Glepaglutide

Key facts

• Active substance:
  Glepaglutide
• Therapeutic area:
  Gastroentology-Hepatology
• Decision number:
  P/0455/2021
• PIP number:
  EMEA-002926-PIP01-20
• Pharmaceutical form(s):
  Solution for injection
• Condition(s) / indication(s):
  Treatment of short bowel syndrome
• Route(s) of administration:
  Subcutaneous use
• Decision type:
  P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
• Decision date:
  29/10/2021
• Compliance check done:
  No

Decision

P/0455/2021: EMA decision of 29 October 2021 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the granting of a waiver for glepaglutide, (EMEA-002926-PIP01-20)

Reference Number: EMA/532157/2021