EMEA-000482-PIP01-08-M06 - paediatric investigation plan

teduglutide

Key facts

• Invented name:
  • Revestive
  • Revestive
• Active substance:
  teduglutide
• Therapeutic area:
  Gastroentology-Hepatology
• Decision number:
  P/0479/2020
• PIP number:
  EMEA-000482-PIP01-08-M06
• Pharmaceutical form(s):
  Powder and solvent for solution for injection
• Condition(s) / indication(s):
  Treatment of short bowel syndrome
• Route(s) of administration:
  Subcutaneous use
• Decision type:
  PM: decision on the application for modification of an agreed PIP
• Decision date:
  01/12/2020
• Compliance check done:
  Kyllä
• Compliance procedure number:
  EMEA-C-000482-PIP01-08-M06
• Compliance opinion date:
  26/03/2021
• Compliance outcome:
  Positive

Decision

P/0479/2020 : EMA decision of 1 December 2020 on the acceptance of a modification of an agreed paediatric investigation plan for teduglutide (Revestive) (EMEA-000482-PIP01-08-M06)

Adopted Reference Number: EMA/627335/2020