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Ciclosporine

CyclASol

Extended indication Treatment of Signs and Symptoms of Dry Eye Disease
Therapeutic value No estimate possible yet
Registration phase Registration application pending

Product

Active substance Ciclosporine
Domain Neurological disorders
Reason of inclusion New medicine (specialité)
Main indication Eye disorders
Extended indication Treatment of Signs and Symptoms of Dry Eye Disease
Proprietary name CyclASol
Manufacturer Novaliq
Portfolio holder Novaliq
Route of administration Ocular
Therapeutical formulation Eye drops
Budgetting framework Extramural (GVS)
Additional remarks CyclASol is a preservative-free, water-free, anti-inflammatory and immunomodulating ophthalmic solution, containing 0.1% cyclosporine.

Registration

Registration route Centralised (EMA)
Type of trajectory Normal trajectory
ATMP No
Submission date August 2023
Expected Registration September 2024
Registration phase Registration application pending

Therapeutic value

Therapeutic value No estimate possible yet
Frequency of administration 2 times a day
References NCT04523129

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.