EMEA-001441-PIP05-20 - paediatric investigation plan

semaglutide

Key facts

• Invented name:
  Ozempic
• Active substance:
  semaglutide
• Therapeutic area:
  Gastroentology-Hepatology
• Decision number:
  P/0464/2021
• PIP number:
  EMEA-001441-PIP05-20
• Pharmaceutical form(s):
  Solution for injection in pre-filled pen
• Condition(s) / indication(s):
  Treatment of non-alcoholic steatohepatitis (NASH)
• 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/0464/2021: 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 semaglutide (Ozempic), (EMEA-001441-PIP05-20)

Adopted Reference Number: EMA/532235/2021 corr