EMEA-000689-PIP01-09-M11 - paediatric investigation plan

exenatide

Key facts

• Invented name:
  • Bydureon
  • Byetta
• Active substance:
  exenatide
• Therapeutic area:
  Endocrinology-Gynaecology-Fertility-Metabolism
• Decision number:
  P/0064/2021
• PIP number:
  EMEA-000689-PIP01-09-M11
• Pharmaceutical form(s):
  • Solution for injection
  • Powder and solvent for prolonged-release suspension for injection
  • Solution for injection in pre-filled injector
• 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:
  18/02/2021
• Compliance check done:
  Jah
• Compliance procedure number:
  EMEA-C-000689-PIP01-09-M11
• Compliance opinion date:
  21/05/2021
• Compliance outcome:
  Positive

Decision

P/0064/2021 : EMA decision of 18 February 2021 on the acceptance of a modification of an agreed paediatric investigation plan for exenatide (Byetta, Bydureon) (EMEA-000689-PIP01-09-M11)

Adopted Reference Number: EMA/72987/2021