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

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)

Adopted Reference Number: EMA/598855/2020