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Empagliflozine

Jardiance

Extended indication

Extension of indication for Jardiance to include treatment of children aged 10 years and above with

Therapeutic value

No estimate possible yet
Registration phase

Registration application pending

Product

Active substance

Empagliflozine
Domain

Metabolism and Endocrinology
Reason of inclusion

Indication extension
Main indication

Diabetes
Extended indication

Extension of indication for Jardiance to include treatment of children aged 10 years and above with type 2 diabetes.
Proprietary name

Jardiance
Manufacturer

Boehringer Ingelheim
Portfolio holder

Boehringer Ingelheim
Mechanism of action

SGLT inhibitor
Route of administration

Oral
Therapeutical formulation

Tablet
Budgetting framework

Extramural (GVS)

Registration

Registration route

Centralised (EMA)
Type of trajectory

Normal trajectory
ATMP

No
Submission date

January 2023
Expected Registration

November 2023
Orphan drug

No
Registration phase

Registration application pending

Therapeutic value

Therapeutic value

No estimate possible yet
Duration of treatment

continuous
Frequency of administration

1 times a day
Dosage per administration

10 - 25mg
References 
NCT03429543 (DINAMO)

Expected patient volume per year

There is currently nothing known about the expected patient volume.

Expected cost per patient per year

Cost

383.00 - 898.00
References 
Farmacotherapeutisch Kompas
Additional remarks 
Op basis van het FK, zal de behandeling tussen de €383  en €898 per patiënt per jaar kosten

Potential total cost per year

There is currently nothing known about the possible total cost.

Off label use

There is currently nothing known about off label use.

Indication extension

There is currently nothing known about indication extensions.

Other information

There is currently no futher information available.