EMEA-000916-PIP01-10-M07 - paediatric investigation plan

lixisenatide

Key facts

• Invented name:
  Lyxumia
• Active Substance:
  lixisenatide
• Therapeutic area:
  Endocrinology-Gynaecology-Fertility-Metabolism
• Decision number:
  P/0443/2020
• PIP number:
  EMEA-000916-PIP01-10-M07
• Pharmaceutical form(s):
  Solution for injection (in pre-filled pen)
• Condition(s) / indication(s):
  Treatment of type II diabetes mellitus
• Route(s) of administration:
  Subcutaneous use
• Contact for public enquiries:

  Sanofi-Aventis R&D

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

• Decision type:
  PM: decision on the application for modification of an agreed PIP
• Decision date:
  01/12/2020

Decision

P/0443/2020 : EMA decision of 1 December 2020 on the acceptance of a modification of an agreed paediatric investigation plan for lixisenatide (Lyxumia) (EMEA-000916-PIP01-10-M07)

AdoptedReference Number: EMA/598855/2020