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

exenatide
PIPHuman

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
Contact for public enquiries

AstraZeneca AB

E-mail: paediatrics@astrazeneca.com

Tel. +46 8553 27591

Decision type
PM: decision on the application for modification of an agreed PIP
Decision date
Compliance procedure number
EMEA-C-000689-PIP01-09-M11
Compliance opinion date
Compliance outcome
Positive

Decision

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