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Canagliflozine

Invokana

Extended indication Extension of indication to include treatment of paediatric patients with type 2 diabetes mellitus ag
Therapeutic value No estimate possible yet
Registration phase Registration application pending

Product

Active substance Canagliflozine
Domain Metabolism and Endocrinology
Reason of inclusion Indication extension
Main indication Diabetes
Extended indication Extension of indication to include treatment of paediatric patients with type 2 diabetes mellitus aged 10 years old and older
Proprietary name Invokana
Manufacturer Mundipharma
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 August 2024
Expected Registration March 2025
Orphan drug No
Registration phase Registration application pending
Additional remarks Verwachte registratie op basis van IHSI-inschatting.

Therapeutic value

Current treatment options Dieet en glucosecontrole
Therapeutic value No estimate possible yet
Frequency of administration 1 times a day
Dosage per administration 100 tot 300 mg
Additional remarks 100 mg once daily -or- Up-titrate to 300 mg once daily

Expected patient volume per year

There is currently nothing known about the expected patient volume.

Expected cost per patient per year

Cost 535.40
References GIPdatabank (1)
Additional remarks In 2023 werd er €535,40 per gebruiker voor canagliflozine vergoed (1).

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.