Levonorgestrel Medicine 07 December 2021 Extended indication Anticonceptie. Hevig menstrueel bloedverlies. Therapeutic value Possible equal value Total cost Registration phase Registered Product Active substance Levonorgestrel Domain Metabolism and Endocrinology Reason of inclusion Generic G Main indication Unknown Extended indication Anticonceptie. Hevig menstrueel bloedverlies. Current proprietary name Mirena Already available biosimilars / generics Proprietary name Levosert Manufacturer Gedeon Portfolio holder Gedeon Mechanism of action Hormonal therapy Route of administration Intrauterine Therapeutical formulation Implant Budgetting framework Extramural (GVS) Centre of expertise Additional remarks Registration Registration route Decentralised Type of trajectory Informed consent application Particularity Unknown ATMP No Submission date 2021 Expected Registration September 2021 Orphan drug No Registration phase Registered Reimbursement Medicine sluice Additional remarks In afwachting van goedkeuring en distributie RMA materiaal om het product op de markt te kunnen brengen. Therapeutic value Current treatment options Mirena, Kyleena Therapeutic value Possible equal value This assessment does not indicate any potential inclusion in the package. Substantiation Levosert is een hybride generiek en heeft een ander inbrengsysteem dan spécialité Mirena. Duration of treatment Maximal 6 year / years Frequency of administration Dosage per administration 1 IUD voor max. 6 jaar References SmPC 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