EMEA-001441-PIP01-13-M03 - paediatric investigation plan

semaglutide

Key facts

• Invented name:
  Ozempic
• Active substance:
  semaglutide
• Therapeutic area:
  Endocrinology-Gynaecology-Fertility-Metabolism
• Decision number:
  P/0137/2020
• PIP number:
  EMEA-001441-PIP01-13-M03
• Pharmaceutical form(s):
  Solution for injection
• Condition(s) / indication(s):
  Treatment of type II diabetes mellitus
• Route(s) of administration:
  Subcutaneous use
• Decision type:
  PM: decision on the application for modification of an agreed PIP
• Decision date:
  18/04/2020
• Compliance check done:
  Ei

Decision

P/0137/2020: EMA decision of 18 April 2020 on the acceptance of a modification of an agreed paediatric investigation plan for semaglutide (Ozempic) (EMEA-001441-PIP01-13-M03)

Adopted Reference Number: EMA/174056/2020