EMEA-000689-PIP01-09-M11

Table of contents

Key facts

Invented name
  • Bydureon
  • Byetta
Active substance
exenatide
Therapeutic area
Endocrinology, -gynacology-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
Contact for public enquiries
AstraZeneca AB
E-mail: paediatrics@astrazeneca.com
Tel: +46 855327591
Decision type
PM: decision on the application for modification of an agreed PIP

Decision

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