Mexiletine HCl Medicine 09 January 2018 Extended indication Myotonic disorders. Therapeutic value No judgement Total cost Registration phase Registration application pending Product Active substance Mexiletine HCl Domain Neurological disorders Reason of inclusion Main indication Muscular diseases Extended indication Myotonic disorders. Current proprietary name Already available biosimilars / generics Proprietary name Manufacturer Lupin Portfolio holder Mechanism of action Unknown Route of administration Oral Therapeutical formulation Capsule Budgetting framework Extramural (GVS) Centre of expertise Additional remarks Toedieningsvorm: naast Capsules komt Mexiletine HCl ook als Oplossing beschikbaar (bron EMA). Registration Registration route Centralised (EMA) Type of trajectory Normal trajectory Particularity New medicine ATMP Unknown Submission date September 2017 Expected Registration October 2018 Orphan drug Yes Registration phase Registration application pending Reimbursement Medicine sluice Additional remarks Mexiletine HCl is al op de markt in Frankrijk. 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 3 times a day Dosage per administration 150 mg References NCT01406873 Additional remarks Expected patient volume per year Patient volume Market share is generally not included unless otherwise stated. Maximum patient volume for sluice References EMA Additional remarks EMA: 2 in 10.000 inwoners in de EU. Dit betreft maximaal zo'n 3400 patiënten in Nederland. 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