EMEA-003016-PIP01-21 - paediatric investigation plan

apraglutide

Key facts

• Active Substance:
  apraglutide
• Therapeutic area:
  Gastroentology-Hepatology
• Decision number:
  P/0197/2022
• PIP number:
  EMEA-003016-PIP01-21
• Pharmaceutical form(s):
  Powder for solution for injection
• Condition(s) / indication(s):
  Treatment of short bowel syndrome
• Route(s) of administration:
  Subcutaneous use
• Contact for public enquiries:

  VectivBio AG

  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:
  09/06/2022

Decision

P/197/2022: EMA decision of 9 June 2022 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the granting of a waiver for apraglutide (EMEA-003016-PIP01-21)

AdoptedReference Number: EMA/352542/2022