EMEA-001441-PIP03-17-M02 - paediatric investigation plan

semaglutide

Key facts

• Invented name:
  Ozempic
• Active Substance:
  semaglutide
• Therapeutic area:
  Endocrinology-Gynaecology-Fertility-Metabolism
• Decision number:
  P/0461/2021
• PIP number:
  EMEA-001441-PIP03-17-M02
• Pharmaceutical form(s):
  Solution for injection in pre-filled pen
• Condition(s) / indication(s):
  Treatment of obesity
• Route(s) of administration:
  Subcutaneous use
• Decision type:
  PM: decision on the application for modification of an agreed PIP
• Decision date:
  29/10/2021

Decision

P/0461/2021: EMA decision of 29 October 2021 on the acceptance of a modification of an agreed paediatric investigation plan for semaglutide (Ozempic) (EMEA-001441-PIP03-17-M02)

AdoptedReference Number: EMA/521852/2021