MHRA-100157-PIP01-21-M01 (update)

Key Facts

Active Substance
Active Substance:
  • EXENATIDE
Invented Name
  • Byetta
  • Bydureon
  • Bydureon BCise
  • Byetta
  • Byetta
  • Bydureon
  • Bydureon
  • Byetta
  • Bydureon
PIP Number MHRA-100157-PIP01-21-M01 (update)
Pharmaceutical form(s)
  • Solution for injection
  • Powder and solvent for prolonged-release suspension for injection
  • Solution for injection in pre-filled pen
Therapeutic area
Therapeutic area:
  • Endocrinology-Gynaecology-Fertility-metabolism
Conditions / Indications
Conditions / Indications:
  • Type 2 diabetes mellitus
Route(s) of administration
Route(s) of administration:
  • Subcutaneous use
PIP applicant
Decision Type
Decision Type
PM: decision on the application for modification of an agreed paediatric investigation plan.
Compliance Check
Compliance Check
Yes
Compliance Check Decision Date
Compliance opinion date
22/12/2021
Compliance Check Procedure Number
Compliance procedure number
MHRA-100157-PIP01-21-M01-C

Decision Document

Decision Document Decision Document on a Paediatric Investigation Plan (PIP):EXENATIDE.pdf
Published Date 18/03/2022