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Empagliflozine / metformine

Synjardy

Extended indication Synjardy is indicated in adults and children aged 10 years and above for the treatment of type 2 dia
Therapeutic value No estimate possible yet
Registration phase Positive CHMP opinion

Product

Active substance Empagliflozine / metformine
Domain Metabolism and Endocrinology
Reason of inclusion Indication extension
Main indication Diabetes
Extended indication Synjardy is indicated in adults and children aged 10 years and above for the treatment of type 2 diabetes mellitus as an adjunct to diet and exercise
Proprietary name Synjardy
Manufacturer 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 March 2024
Expected Registration January 2025
Orphan drug No
Registration phase Positive CHMP opinion
Additional remarks Positieve CHMP-opinie in september 2024.

Therapeutic value

Therapeutic value No estimate possible yet
References NCT03429543 (DINAMO)

Expected patient volume per year

There is currently nothing known about the expected patient volume.

Expected cost per patient per year

There is currently nothing known about the expected cost.

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.