EMEA-001441-PIP08-23 - paediatric investigation plan

semaglutide

Key facts

• Invented name:
  Wegovy
• Active Substance:
  semaglutide
• Therapeutic area:
  Endocrinology-Gynaecology-Fertility-Metabolism
• Decision number:
  P/0296/2023
• PIP number:
  EMEA-001441-PIP08-23
• Pharmaceutical form(s):
  All pharmaceutical forms
• Condition(s) / indication(s):
  Prevention of cardiovascular events in patients with atherosclerosis
• Route(s) of administration:
  All routes of administration
• Decision type:
  W: decision granting a waiver in all age groups for all conditions or indications
• Decision date:
  11/08/2023

Decision

P/0296/2023 : EMA decision of 11 August 2023 on the granting of a product specific waiver for semaglutide (Wegovy), (EMEA-001441-PIP08-23)

Reference Number: EMA/336536/2023