Diclofenamide Medicine 12 June 2019 Extended indication Glaucoom Therapeutic value No judgement Total cost Registration phase Withdrawn Product Active substance Diclofenamide Domain Neurological disorders Reason of inclusion Generic G Main indication Eye disorders Extended indication Glaucoom Current proprietary name Geen Already available biosimilars / generics Proprietary name Ekesivy Manufacturer Portfolio holder Mechanism of action Enzyme inhibitor Route of administration Unknown Therapeutical formulation Unknown Budgetting framework Unknown Centre of expertise Additional remarks Momenteel is diclofenamide niet beschikbaar in Nederland. Registration Registration route Centralised (EMA) Type of trajectory Normal trajectory Particularity Unknown ATMP Unknown Submission date February 2019 Expected Registration Orphan drug Unknown Registration phase Withdrawn Reimbursement Medicine sluice Additional remarks Diclofenamide heeft een weesgeneesmiddelstatus voor de indicatie periodieke paralyse. In de VS is diclofenamide geregistreerd voor periodieke paralyse en is de prijs voor 100 pillen gestegen van $50 naar $15.000 (This old drug was free. Now it’s $109,500 a year, Washington Post, December 18, 2017). Registratieaanvraag ingetrokken in oktober 2019. Fabrikant acht dat de date niet afdoende is voor positieve CHMP-opinie. Therapeutic value Current treatment options Therapeutic value No judgement This assessment does not indicate any potential inclusion in the package. Substantiation Duration of treatment Frequency of administration Dosage per administration References https://www.washingtonpost.com/news/wonk/wp/2017/12/18/this-old-drug-was-free-now-its-109500-a-year/?utm_term=.7c71e06e5894 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