Tigecycline Medicine 13 December 2018 Extended indication Geïndiceerd bij volwassenen en bij kinderen vanaf acht jaar voor de behandeling van de volgende infecties: 1) Gecompliceerde infecties van huid en weke delen (cSSTI), uitgezonderd diabetische voetinfecties; 2) Gecompliceerde intra-abdominale infecties (cIAI). Therapeutic value Possible equal value Total cost Registration phase Registration application pending Product Active substance Tigecycline Domain Infectious diseases Reason of inclusion Generic G Main indication Bacterial infections Extended indication Geïndiceerd bij volwassenen en bij kinderen vanaf acht jaar voor de behandeling van de volgende infecties: 1) Gecompliceerde infecties van huid en weke delen (cSSTI), uitgezonderd diabetische voetinfecties; 2) Gecompliceerde intra-abdominale infecties (cIAI). Current proprietary name Tygacil (Pfizer) Already available biosimilars / generics Proprietary name Manufacturer 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 August 2019 Orphan drug No Registration phase Registration application pending Reimbursement Medicine sluice Additional remarks SPC Tygacil is verlopen. 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