Clindamycin Medicine 07 December 2021 Extended indication Bacterial Vaginosis Therapeutic value Possible equal value Total cost € 126,000.00 Registration phase Clinical trials Product Active substance Clindamycin Domain Infectious diseases Reason of inclusion New medicine (specialité) Main indication Bacterial infections Extended indication Bacterial Vaginosis Current proprietary name Already available biosimilars / generics Proprietary name Manufacturer Daré Bioscience Portfolio holder Mechanism of action Other Route of administration Vaginal Therapeutical formulation Gel Budgetting framework Extramural (GVS) Centre of expertise Additional remarks fabrikant: Daré Bioscience, Inc. Registration Registration route Unknown Type of trajectory Unknown Particularity Unknown ATMP No Submission date 2024 Expected Registration 2025 Orphan drug No Registration phase Clinical trials Reimbursement Medicine sluice Additional remarks Therapeutic value Current treatment options Clindamycine crème (ook oraal) Therapeutic value Possible equal value This assessment does not indicate any potential inclusion in the package. Substantiation Er is al een crème op de markt om lokaal te behandelen, huidig product is een gel. Beiden zijn geschikt voor intra vaginale toediening (applicator bijgeleverd). Er wordt een vergelijkbare effectiviteit verwacht. Duration of treatment Frequency of administration 1 times a day Dosage per administration 5 g clindamycin phosphate vaginal gel, 2% (100 mg clindamycin) References NCT04370548 Additional remarks Expected patient volume per year Patient volume < 3,600 Market share is generally not included unless otherwise stated. Maximum patient volume for sluice References GIP databank Additional remarks In 2020 waren er 3.562 gebruikers van ATC-subgroep G01AA10 : Clindamycine. Expected cost per patient per year Cost € < 35.00 This amount gives an indication of the total cost. It is the result of the average expected patient volume times the average cost per patient. both per year. References GIP databank Additional remarks In 2020 was de prijs per patiënt per jaar van ATC-subgroep G01AA10 : Clindamycine €34,91. Potential total cost per year Total cost € 126,000.00 Total cost for sluice Additional remarks Off label use Off label use Unknown Indications off label use References Additional remarks Indication extension Indication extensions No Indication extensions References Adis Insight Additional remarks Other information Additional remarks