EMEA-000128-PIP02-09-M04 - paediatric investigation plan

liraglutide

Key facts

• Invented name:
  • Saxenda
  • Saxenda
• Active Substance:
  liraglutide
• Therapeutic area:
  Endocrinology-Gynaecology-Fertility-Metabolism
• Decision number:
  P/0309/2021
• PIP number:
  EMEA-000128-PIP02-09-M04
• Pharmaceutical form(s):
  Solution for injection
• Condition(s) / indication(s):
  Treatment of obesity
• Route(s) of administration:
  Subcutaneous use
• Contact for public enquiries:

  Novo Nordisk A/S

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

• Decision type:
  PM: decision on the application for modification of an agreed PIP
• Decision date:
  13/08/2021

Decision

P/0309/2021 : EMA decision of 13 August 2021 on the acceptance of a modification of an agreed paediatric investigation plan for liraglutide (Saxenda) (EMEA-000128-PIP02-09-M04)

AdoptedReference Number: EMA/395803/2021