Amoxicilline / omeprazol / rifabutin Medicine 09 January 2018 Extended indication Eradicatie van Helicobacter pylori bij een ulcus pepticum. Therapeutic value No judgement Total cost € 1,704,010.00 Registration phase Clinical trials Product Active substance Amoxicilline / omeprazol / rifabutin Domain Infectious diseases Reason of inclusion Main indication Bacterial infections Extended indication Eradicatie van Helicobacter pylori bij een ulcus pepticum. Current proprietary name Already available biosimilars / generics Proprietary name Manufacturer RedHill Portfolio holder Mechanism of action Unknown Route of administration Oral Therapeutical formulation Capsule Budgetting framework Extramural (GVS) Centre of expertise Additional remarks Combinatie van twee antibiotica en een maagzuurremmer. Registration Registration route Centralised (EMA) Type of trajectory Unknown Particularity New therapeutical formulation ATMP Unknown Submission date Expected Registration 2018 Orphan drug No Registration phase Clinical trials Reimbursement Medicine sluice Additional remarks Therapeutic value Current treatment options Betreft alternatief voor Panclamox. 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 Additional remarks Expected patient volume per year Patient volume 10,000 - 20,981 Market share is generally not included unless otherwise stated. Maximum patient volume for sluice References GIP databank Additional remarks 20981 gebruikers Panclamox (alternatief) in 2016. Expected cost per patient per year Cost € 70.00 - 150.00 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 Additional remarks Beperkte kosten, naar verwachting vergelijkbaar met Panclamox (uitgaande van 7 - 14 dagen, 2x per dag). Potential total cost per year Total cost € 1,704,010.00 Total cost for sluice Additional remarks Off label use Off label use Unknown Indications off label use References Additional remarks Indication extension Indication extensions Unknown Indication extensions References Additional remarks Other information Additional remarks