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Ciclosporin

Verkazia

Extended indication Treatment of severe vernal keratoconjunctivitis in children from 4 years of age and adolescents.
Therapeutic value No judgement
Registration phase Registered

Product

Active substance Ciclosporin
Domain Neurological disorders
Reason of inclusion New medicine (specialité)
Main indication Eye disorders
Extended indication Treatment of severe vernal keratoconjunctivitis in children from 4 years of age and adolescents.
Proprietary name Verkazia
Manufacturer Santen
Route of administration Ocular
Therapeutical formulation Eye drops
Budgetting framework Extramural (GVS)

Registration

Registration route Centralised (EMA)
Type of trajectory Accelerated assessment
Submission date December 2016
Expected Registration July 2018
Orphan drug Yes
Registration phase Registered
Additional remarks Positieve CHMP opinie 21 juli 2017. Registratie in juli 2018.

Therapeutic value

Therapeutic value No judgement

Expected patient volume per year

Patient volume

< 870

Market share is generally not included unless otherwise stated.
References EMA
Additional remarks Vernal keratoconjunctivitis affected between 1 to 3 in 10,000 people in the European Union (EU).' (EMA). Dit zijn 5.100 patiënten per 17 miljoen Nederlanders. Gezien de behandeling alleen van 4-18 jaar gegeven zal worden, en dit 17% van de Nederlandse bevolking betreft, komen er waarschijnlijk maximaal 870 patiënten in aanmerking voor deze behandeling.

Expected cost per patient per year

References Medicijnkosten.nl
Additional remarks Flacon ciclosporin 10 ml, 1mg/ml: €37,04.

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.