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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.