EMEA-001441-PIP07-21 - paediatric investigation plan

semaglutide

Key facts

• Active Substance:
  semaglutide
• Therapeutic area:
  Endocrinology-Gynaecology-Fertility-Metabolism
• Decision number:
  P/0481/2022
• PIP number:
  EMEA-001441-PIP07-21
• Pharmaceutical form(s):
  Tablet
• Condition(s) / indication(s):
  Treatment of obesity
• Route(s) of administration:
  Oral use
• Contact for public enquiries:

  Novo Nordisk A/S

  E-mail: [e-mail] ; Tel.: [phone]

• Decision type:
  P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
• Decision date:
  02/12/2022

Decision

P/0481/2022 : EMA decision of 2 December 2022 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the granting of a waiver for semaglutide (EMEA-001441-PIP07-21)

Reference Number: EMA/899044/2022