Tigecycline Medicine 13 December 2018 Extended indication Tigecycline Accord is indicated in adults and in children from the age of eight years for the treatment of the following infections: Complicated skin and soft tissue infections (cSSTI), excluding diabetic foot infections; Complicated intra-abdominal infections (cIAI). Therapeutic value Possible equal value Total cost Registration phase Registered Product Active substance Tigecycline Domain Infectious diseases Reason of inclusion Generic G Main indication Bacterial infections Extended indication Tigecycline Accord is indicated in adults and in children from the age of eight years for the treatment of the following infections: Complicated skin and soft tissue infections (cSSTI), excluding diabetic foot infections; Complicated intra-abdominal infections (cIAI). Current proprietary name Tygacil (Pfizer) Already available biosimilars / generics Proprietary name Tigecycline Accord Manufacturer Accord Healthcare Portfolio holder Mechanism of action Antibiotic Route of administration Unknown Therapeutical formulation Unknown Budgetting framework Unknown Centre of expertise Additional remarks Registration Registration route Centralised (EMA) Type of trajectory Unknown Particularity Unknown ATMP Unknown Submission date August 2018 Expected Registration April 2020 Orphan drug No Registration phase Registered Reimbursement Medicine sluice Additional remarks SPC Tygacil is verlopen. Positieve CHMP-opinie in februari 2020. Geregistreerd in april 2020. Therapeutic value Current treatment options Therapeutic value Possible equal value 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 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 Yes Indications off label use References Floto et al., Thorax 2016 Jan;71 Suppl 1:i1-22 ; Haworth et al., Thorax Nov;72(Suppl 2):ii1-ii64. Additional remarks Indication extension Indication extensions Unknown Indication extensions References Additional remarks Other information Additional remarks