Extended indication Extension of indication to include the treatment of type 2 diabetes in adolescents and children aged 10 years and above
Therapeutic value No estimate possible yet
Registration phase Registration application pending

Product

Active substance Exenatide
Domain Metabolism and Endocrinology
Reason of inclusion Indication extension IND
Main indication Diabetes
Extended indication Extension of indication to include the treatment of type 2 diabetes in adolescents and children aged 10 years and above
Proprietary name Bydureon
Manufacturer AstraZeneca
Mechanism of action Unknown
Route of administration Subcutaneous
Therapeutical formulation Injection
Budgetting framework Extramural (GVS)

Registration

Registration route Decentralised
Type of trajectory Unknown
Particularity Unknown
ATMP No
Submission date August 2021
Expected Registration June 2022
Orphan drug No
Registration phase Registration application pending

Therapeutic value

Therapeutic value No estimate possible yet

This assessment does not indicate any potential inclusion in the package.

Expected patient volume per year

Patient volume

Market share is generally not included unless otherwise stated.

Expected cost per patient per year

Potential total cost per year

Off label use

Off label use Unknown

Indication extension

Indication extensions Unknown

Other information