Hydroxycarbamide Medicine 13 December 2018 Extended indication Geïndiceerd voor de preventie van recidiverende, pijnlijke vaso-occlusieve crises waaronder het 'acute chest syndrome' bij volwassenen, adolescenten en kinderen ouder dan 2 jaar met symptomatische sikkelcelziekte. Therapeutic value Possible equal value Total cost Registration phase Registered Product Active substance Hydroxycarbamide Domain Cardiovascular diseases Reason of inclusion Generic G Main indication Other non-oncological hematological medications Extended indication Geïndiceerd voor de preventie van recidiverende, pijnlijke vaso-occlusieve crises waaronder het 'acute chest syndrome' bij volwassenen, adolescenten en kinderen ouder dan 2 jaar met symptomatische sikkelcelziekte. Current proprietary name Siklos (Addmedica) Already available biosimilars / generics Proprietary name Xromi Manufacturer Nova Laboratories Portfolio holder Mechanism of action Enzyme inhibitor Route of administration Unknown Therapeutical formulation Unknown Budgetting framework Unknown Centre of expertise Additional remarks Registration Registration route Centralised (EMA) Type of trajectory Unknown Particularity Unknown ATMP Unknown Submission date March 2018 Expected Registration July 2019 Orphan drug Yes Registration phase Registered Reimbursement Medicine sluice Additional remarks Geen SPC voor Siklos gevonden. Positieve CHMP-opinie april 2019. Geregistreerd in juli 2019. Therapeutic value Current treatment options Therapeutic value Possible equal value This assessment does not indicate any potential inclusion in the package. Substantiation Duration of treatment Frequency of administration Dosage per administration References Additional remarks Expected patient volume per year Patient volume Market share is generally not included unless otherwise stated. Maximum patient volume for sluice References Additional remarks Expected cost per patient per year Cost References Additional remarks Potential total cost per year Total cost Total cost for sluice Additional remarks Off label use Off label use Unknown Indications off label use References Additional remarks Indication extension Indication extensions Unknown Indication extensions References Additional remarks Other information Additional remarks